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Practice Research Database (practice + research_database)
Kinds of Practice Research Database Selected AbstractsInfluence of ursodeoxycholic acid on the mortality and malignancy associated with primary biliary cirrhosis: A population-based cohort study,HEPATOLOGY, Issue 4 2007Hannah Jackson There is debate over the mortality and malignancy risk in people with primary biliary cirrhosis (PBC) and whether this risk is reduced by use of ursodeoxycholic acid. To investigate this issue, we identified 930 people with PBC and 9,202 control subjects from the General Practice Research Database in the United Kingdom. We categorized regular ursodeoxycholic acid as treatment with 6 or more prescriptions and nonregular treatment as less than 6. We found a 2.7-fold increase in mortality for the PBC cohort compared with the general population [adjusted hazard ratio (HR), 2.69; 95% CI, 2.35,3.09]. In those having regular ursodeoxycholic acid (43%), the mortality increase was 2.2-fold (HR, 2.19; 95% CI, 1.66,2.87) and in those not treated 2.7-fold (HR, 2.69; 95% CI, 2.18,3.33). This apparent reduction in mortality was not explained by less severe disease in the ursodeoxycholic acid,treated group. The increased risk of primary liver cancer in ursodeoxycholic acid,treated patients was 3-fold (HR, 3.17; 95% CI, 0.64,15.62), in contrast to an 8-fold increase in those not treated (HR, 7.77; 95% CI, 1.30,46.65). Conclusion: We found that people with PBC had a 3-fold mortality increase when compared with the general population, which was somewhat reduced by regular treatment with ursodeoxycholic acid. However, the observed effect of ursodeoxycholic acid was not statistically significant. (HEPATOLOGY 2007.) [source] The effect of concurrent pain on the management of patients with depression: an analysis of NHS healthcare resource utilisation using the GPRD databaseINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 5 2009L. Watson Summary Introduction:, Patients with depression frequently report painful physical symptoms. However, there are scant data from the UK concerning differences in primary and secondary care resource use between depressed patients with and without pain treated in general practice. Methods:, Patients with depression codes were identified from the General Practice Research Database (GPRD) excluding those with psychoses. The observation period was 1st January 2000,31st December 2006. Patients were further categorised into three groups: (i) no painful physical symptom codes ever in the observation period (NO PAIN); (ii) patients with no other diagnostic or test codes 30 days either side of a pain code (PAIN MINUS DIAGNOSIS) and (iii) patients with pain codes and other diagnostic codes (PAIN PLUS DIAGNOSIS). Rates of general practitioner (GP) visits, antidepressant and concomitant prescribing and switching, secondary care referrals and diagnostic tests were reported per group with 95% confidence limits (CI). Results:, A total of 145,784 patients with depression aged 18,50 years were selected. Of these, 48,615 (33.3%) were classed as NO PAIN, the remaining 66.6% having pain. PAIN MINUS DIAGNOSIS patients constituted 5654 (5.8%) of those with pain. PAIN MINUS DIAGNOSIS and PAIN PLUS DIAGNOSIS had a significantly higher rate of GP visits than NO PAIN patients, 10.37 (95% CI 10.23, 10.52); 11.15 (11.11,11.20) and 7.04 (7.00, 7.08) respectively. Inter and intraclass drug switching was high with 13% of PAIN MINUS DIAGNOSIS and 14% of PAIN PLUS DIAGNOSIS patients having three or more switches compared with 7% of NO PAIN patients. Referral rates to secondary care were significantly higher in both pain groups compared with patients with no pain. Diagnostic testing was significantly greater in PAIN MINUS DIAGNOSIS and PAIN PLUS DIAGNOSIS groups than NO PAIN patients for all test types, with X-rays being the most common test; 3.85 (3.69,4.00); 2.77 (2.74,2.80); 0.91 (0.89, 0.94) respectively. Conclusion:, Patients in general practice diagnosed with depression and concurrent painful physical symptoms have higher resource use in primary and secondary care. [source] Unspecified abdominal pain in primary care: the role of gastrointestinal morbidityINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 10 2007M.-A. Wallander Summary Background:, Many patients with abdominal pain have no obvious cause for their symptoms and receive a diagnosis of unspecified abdominal pain. Aim:, The objective of this study was to ascertain risk factors and consequences of a diagnosis of unspecified abdominal pain in primary care. Methods:, A population-based, case,control study was conducted using the UK General Practice Research Database. We identified 29,299 patients with a new diagnosis of abdominal pain, and 30,000 age- and sex-matched controls. Only diagnostic codes that did not specify the type or location of abdominal pain were included. Results and discussion:, The incidence of newly diagnosed unspecified abdominal pain was 22.3 per 1000 person-years. The incidence was higher in females than in males, and 29% of patients were below 20 years of age. Prior gastrointestinal morbidity was associated with abdominal pain, but high body mass index, smoking and alcohol intake were not. Patients newly diagnosed with abdominal pain were 16 to 27 times more likely than controls to receive a subsequent new diagnosis of gallbladder disease, diverticular disease, pancreatitis or appendicitis in the year after the diagnosis of abdominal pain. The likelihood of receiving other gastrointestinal diagnoses such as peptic ulcer disease, hiatus hernia, gastro-oesophageal reflux disease (GERD), irritable bowel syndrome (IBS) or dyspepsia was increased three- to 14-fold among patients consulting for abdominal pain. Conclusion:, When managing abdominal pain in primary care, morbidities such as GERD and IBS should be considered as diagnoses once potentially life-threatening problems have been excluded. [source] Update on the Epidemiology of Paget's Disease of BoneJOURNAL OF BONE AND MINERAL RESEARCH, Issue S2 2006Cyrus Cooper Abstract Paget's disease of bone (PDB) is characterized by rapid bone remodeling and the formation of bone that is structurally abnormal. Recent studies have confirmed that both genetic and environmental factors are important in its etiology. Epidemiological studies in Europe and North America have revealed that PDB shows an increasing frequency of occurrence with age and is more prevalent among men than women. There is marked geographic variation in the prevalence of PDB throughout western nations, with the highest rates reported during the 1970s in Britain. Recent studies of the secular trends in PDB suggest declining rates in both prevalence and severity at diagnosis. Thus, the overall age/sex standardized prevalence rate in Britain during the period 1993,1995 was found to be 2.5% among men and 1.6% among women ,55 years of age. Prevalence rates had fallen by ,50% in several of the centers studied, suggesting an environmental contribution to the etiology of this disorder. Similar findings have been reported from other European countries and New Zealand. Recent study of the incidence and clinical manifestations of PDB have emerged from large cohort studies in primary care record linkage resources, such as the General Practice Research Database. Over the period 1988,1999, the incidence rate of clinically diagnosed PDB was found to be 5 per 10,000 person-years among men and 3 per 10,000 person-years among women 75 years of age. The disorder was associated with an increased risk of back pain (RR, 2.1; 95% CI, 1.9,2.3); osteoarthritis (RR, 1.7; 95% CI, 1.5,1.9); and fracture (RR, 1.2; 95% CI, 1.0,1.5). Using life table methodology, the estimated proportion of patients dying within 5 years of follow-up was 32.7% among the cohort with PDB compared with 28.0% among control patients (p < 0.05). [source] Use of Inhaled Corticosteroids and Risk of FracturesJOURNAL OF BONE AND MINERAL RESEARCH, Issue 3 2001T. P. Van Staa Abstract Treatment with systemic corticosteroids is known to increase the risk of fractures but little is known of the fracture risks associated with inhaled corticosteroids. A retrospective cohort study was conducted using a large UK primary care database (the General Practice Research Database [GPRD]). Inhaled corticosteroid users aged 18 years or older were compared with matched control patients and to a group of noncorticosteroid bronchodilator users. Patients with concomitant use of systemic corticosteroids were excluded. The study comprised 170,818 inhaled corticosteroid users, 108,786 bronchodilator users, and 170,818 control patients. The average age was 45.1 years in the inhaled corticosteroid, 49.3 years in the bronchodilator, and 45.2 years in the control groups. In the inhaled corticosteroid cohort, 54.5% were female. The relative rates (RRs) of nonvertebral, hip, and vertebral fractures during inhaled corticosteroid treatment compared with control were 1.15 (95% CI, 1.10,1.20), 1.22 (95% CI, 1.04,1.43), and 1.51 (95% CI, 1.22,1.85), respectively. No differences were found between the inhaled corticosteroid and bronchodilator groups (nonvertebral fracture RR = 1.00; 95% CI, 0.94,1.06). The rates of nonvertebral fractures among users of budesonide (RR = 0.95; 95% CI, 0.85,1.07) and fluticasone propionate (RR = 1.03; 95% CI, 0.71,1.49) were similar to the rate determined for users of beclomethasone dipropionate. We conclude that users of inhaled corticosteroids have an increased risk of fracture, particularly at the hip and spine. However, this excess risk may be related more to the underlying respiratory disease than to inhaled corticosteroid. [source] Use of Oral Corticosteroids and Risk of FracturesJOURNAL OF BONE AND MINERAL RESEARCH, Issue 6 2000T. P. Van Staa Abstract Treatment with oral corticosteroids is known to decrease bone density but there are few data on the attendant risk of fracture and on the reversibility of this risk after cessation of therapy. A retrospective cohort study was conducted in a general medical practice setting in the United Kingdom (using data from the General Practice Research Database [GPRD]). For each oral corticosteroid user aged 18 years or older, a control patient was selected randomly, who was matched by age, sex, and medical practice. The study comprised 244,235 oral corticosteroid users and 244,235 controls. The average age was 57.1 years in the oral corticosteroid cohort and 56.9 years in the control cohort. In both cohorts 58.6% were female. The most frequent indication for treatment was respiratory disease (40%). The relative rate of nonvertebral fracture during oral corticosteroid treatment was 1.33 (95% confidence interval [CI], 1.29,1.38), that of hip fracture 1.61 (1.47,1.76), that of forearm fracture 1.09 (1.01,1.17), and that of vertebral fracture 2.60 (2.31,2.92). A dose dependence of fracture risk was observed. With a standardized daily dose of less than 2.5 mg prednisolone, hip fracture risk was 0.99 (0.82,1.20) relative to control, rising to 1.77 (1.55,2.02) at daily doses of 2.5,7.5 mg, and 2.27 (1.94,2.66) at doses of 7.5 mg or greater. For vertebral fracture, the relative rates were 1.55 (1.20,2.01), 2.59 (2.16,3.10), and 5.18 (4.25,6.31), respectively. All fracture risks declined toward baseline rapidly after cessation of oral corticosteroid treatment. These results quantify the increased fracture risk during oral corticosteroid therapy, with greater effects on the hip and spine than forearm. They also suggest a rapid offset of this increased fracture risk on cessation of therapy, which has implications for the use of preventative agents against bone loss in patients at highest risk. [source] Systematic review: the epidemiology of gastro-oesophageal reflux disease in primary care, using the UK General Practice Research DatabaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2009H. EL-SERAG Summary Background, Gastro-oesophageal reflux disease (GERD) is a common diagnosis in primary care; however, there has been no comprehensive review of the epidemiology of GERD in this setting. Aim, To review systematically articles that used the General Practice Research Database to study the epidemiology of GERD. Methods, Systematic literature searches. Results, Seventeen articles fulfilled the inclusion criteria. The incidence of GERD in primary care was 4.5 new diagnoses per 1000 person-years in 1996 (95% CI: 4.4,4.7). A new diagnosis of GERD was associated with being overweight, obese or an ex-smoker. Prior diagnoses of ischaemic heart disease, peptic ulcer disease, nonspecific chest pain, nonspecific abdominal pain, chronic obstructive pulmonary disease and asthma were associated with a subsequent new GERD diagnosis. A first diagnosis of GERD was associated with an increased risk of a subsequent diagnosis of oesophageal adenocarcinoma, oesophageal stricture, chronic cough, sinusitis, chest pain, angina, gallbladder disease, irritable bowel syndrome or sleep problems. Mortality may be higher in patients with a GERD diagnosis than in those without in the first year after diagnosis, but not long term. Conclusion, The General Practice Research Database is an effective way of studying the epidemiology of GERD in a large population-based primary care setting. [source] The epidemiology of haemochromatosis: a population-based studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2009C. J. CROOKS Summary Background, The discovery of the HFE genotype has revolutionized the diagnosis of haemochromatosis, changing the associated mortality and morbidity. Aim, To investigate the clinical significance of a diagnosis of haemochromatosis. Methods, In a cohort study, we identified 501 people with haemochromatosis and 4950 age- and gender-matched controls from the UK General Practice Research Database between 1987 and 2002. Results, The incidence of a diagnosis of haemochromatosis increased approximately 2-fold over the study period and was associated with a 2.2-fold increase in mortality [hazard ratio, 95% confidence interval (95% CI), 1.6,3.0]. There was no increase in extra hepatic malignancy, but an absolute risk excess of liver cancer of 0.89% per year. Diabetes, impotence, osteoarthritis and crystal arthritis were associated with haemochromatosis with odds ratios of 5.4 (95% CI, 4.1,7.0), 2.7(95% CI, 1.8,4.0), 1.9(95% CI, 1.5,2.4) and 2.1(95% CI, 1.4,3.1) respectively. Conclusion, Increasing numbers of people are being diagnosed with haemochromatosis, and the mortality associated with this disease remains high. However, people are living with considerably lower levels of morbidity than previously reported. This encouragingly suggests earlier diagnoses are being made, prior to the development of complications. [source] Risk of schizophrenia in people with coeliac disease, ulcerative colitis and Crohn's disease: a general population-based studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2006J. WEST Summary Background Recently, interest has been revived in whether people with coeliac disease, in contrast to other inflammatory gastrointestinal diseases, have an increased risk of schizophrenia. Aim To compare the risk of schizophrenia in people diagnosed with coeliac disease, ulcerative colitis and Crohn's disease with the general population. Methods We used data from the UK General Practice Research Database. People with coeliac disease, Crohn's disease and ulcerative colitis were matched individually with five age-, sex- and general practice-matched controls. The prevalence of schizophrenia was calculated and compared between disease groups and their respective controls. We calculated odds ratios for schizophrenia using conditional logistic regression adjusting for smoking status. Results In people with coeliac disease, Crohn's disease and ulcerative colitis the prevalence of schizophrenia was 0.25%, 0.27% and 0.24%, respectively, compared with a general population prevalence of 0.37%. The adjusted odds ratios showed no association between schizophrenia and gastrointestinal disease (coeliac disease vs. controls 0.76, 95% CI: 0.41,1.4; Crohn's disease vs. controls 0.74, 95% CI: 0.44,1.3; ulcerative colitis 0.71, 95% CI: 0.44,1.1). Conclusions Contrary to recent findings we found no evidence of an increased risk of schizophrenia in people with coeliac disease compared with the general population. [source] Autoimmune cholestatic liver disease in people with coeliac disease: a population-based study of their associationALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2005A. Lawson Summary Background :,Population data supporting an association between the autoimmune cholestatic liver diseases, primary biliary cirrhosis and primary sclerosing cholangitis and coeliac disease, is limited and at times contradictory. Aim :,To explore the relationship between coeliac disease and both primary biliary cirrhosis and primary sclerosing cholangitis within the General Practice Research Database, a UK-based longitudinal primary care database. Methods :,We identified 4732 people with diagnosed coeliac disease and 23 620 age- and sex-matched controls within the General Practice Research Database. We calculated the prevalence of primary biliary cirrhosis and primary sclerosing cholangitis for both the coeliac disease and control group. Results :,There was a higher prevalence of primary biliary cirrhosis in adults with coeliac disease, compared with controls [0.17% vs. 0.05%, odds ratio 3.63 (95% confidence interval: 1.46,9.04)]. Primary sclerosing cholangitis was also more common in the coeliac disease group [0.04% vs. 0%, fishers exact test (P = 0.03)]. Conclusions :,There was a threefold or greater increase in risk of both primary biliary cirrhosis and primary sclerosing cholangitis in people with coeliac disease compared with the general population. The association with primary biliary cirrhosis was weaker than in some reports and it is difficult on the basis of this study to justify screening patients with coeliac disease for either primary biliary cirrhosis or primary sclerosing cholangitis. [source] Risk of vascular disease in adults with diagnosed coeliac disease: a population-based studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2004J. West Summary Background :,It has been suggested that vascular disease mortality may be reduced in coeliac disease because of lower levels of blood pressure, cholesterol and body mass. Aim :,To examine whether people with coeliac disease are at reduced risk of various vascular diseases. Methods :,We identified 3790 adults with diagnosed coeliac disease and 17 925 age- and sex-matched controls in the General Practice Research Database. We estimated odds ratios for diagnosed hypertension, hypercholesterolaemia and atrial fibrillation and hazard ratios for myocardial infarction and stroke. Results :,Adults with coeliac disease, compared with controls, were less likely to have had a diagnosis of hypertension [11% vs. 15%, odds ratio 0.68 (95% confidence interval: 0.60,0.76)] or hypercholesterolaemia [3.0% vs. 4.8%, odds ration 0.58 (95% confidence interval: 0.47,0.72)] but slightly more likely to have had atrial fibrillation [2.1% vs. 1.7%, odds ratio 1.26 (95% confidence interval: 0.97,1.64)]. The hazard ratio for myocardial infarction was 0.85 (95% confidence interval: 0.63,1.13), while the hazard ratio for stroke was 1.29 (95% confidence interval: 0.98,1.70). Conclusions :,Although rates of myocardial infarction and stroke were not substantially different, adults with coeliac disease do have a lower prevalence of hypertension and hypercholesterolaemia compared with the general population. The effect of a gluten-free diet on cardiovascular risk factors should be determined before any screening programmes for coeliac disease are instituted. [source] Combination therapy with sulfonylureas and metformin and the prevention of death in type 2 diabetes: a nested case-control study,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2010Laurent Azoulay PhD Abstract Purpose To determine whether combination of sulfonylureas and metformin increases the risk of death from any cause in patients with type 2 diabetes. Methods A nested case-control study was conducted within a population-based cohort from the UK General Practice Research Database (GPRD). The cohort included patients over the age of 40 who were prescribed a first oral hypoglycaemic agent between 1 January 1988 and 30 June 2008. Cases included all patients who deceased during follow-up. Up to 10 controls were matched to each case on year of birth, date of cohort entry (±1 year) and duration of follow-up. Conditional logistic regression was used to estimate rate ratios (RRs) of death from any cause associated with the use of combination of sulfonylureas and metformin, relative to sulfonylurea monotherapy. Results The cohort comprised 84,231 users of oral hypoglycaemic agents, of whom 14,996 died from any cause during a mean of 4.3 years of follow-up (mortality rate 4.1 per 100 per year). Patients currently exposed to a combination of sulfonylureas and metformin were at a decreased risk of death from any cause compared to patients exposed to sulfonylurea monotherapy (adjusted RR: 0.77, 95%CI: 0.70, 0.85). Similar results were obtained for patients currently exposed to metformin monotherapy (adjusted RR: 0.70, 95%CI: 0.64, 0.75) when compared to sulfonylurea monotherapy. Patients had to be exposed to the combination therapy for at least 4 months prior to index date to experience a lower risk of mortality compared to sulfonylurea monotherapy. Conclusions The combination of sulfonylureas and metformin does not increase the risk of death. In contrast, it may moderately reduce this risk compared to sulfonylurea monotherapy. Copyright © 2010 John Wiley & Sons, Ltd. [source] Thiazolidinediones and the risk of incident strokes in patients with type 2 diabetes: a nested case-control study,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2010Laurent Azoulay PhD Abstract Purpose To determine whether the use of thiazolidinediones (TZDs) decreases the risk of incident strokes in patients with type 2 diabetes. Methods We conducted a nested case-control study within a population-based cohort from the UK General Practice Research Database (GPRD). The cohort comprised patients over the age of 40 who were prescribed a first oral hypoglycemic agent between 1 January 1988 and 30 June 2008. Cases included all subjects who experienced a first stroke during follow-up. Up to 10 controls were matched to each case on age (±2 years), sex, date of cohort entry (±1 year), and duration of follow-up. Rate ratios (RRs) of stroke associated with TZD use, including rosiglitazone and pioglitazone, relative to combinations of other oral hypoglycemic agents, were estimated using conditional logistic regression. Results The cohort comprised 75,717 users of oral hypoglycemic agents, of whom 2417 had a stroke during follow-up. The rate of stroke in users of TZDs given as monotherapy (RR: 1.20, 95%CI: 0.77, 1.86) or in combination with other oral hypoglycemic agents (RR: 0.78, 95%CI: 0.58, 1.04) was not lower than combinations of other oral hypoglycemic agents. The RRs were similar for rosiglitazone and pioglitazone. Conclusions The results of this study indicate that TZDs do not appear to decrease the incidence of first strokes. Copyright © 2009 John Wiley & Sons, Ltd. [source] Trends in the prescription of anti-diabetic medications in the United Kingdom: a population-based analysis,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2009Kristian B. Filion MSc Abstract Purpose Over the last decade, guidelines for the treatment of type 2 diabetes have increasingly favored tighter glycemic control, necessitating the use of more aggressive pharmacological therapy. The objective of this study was to describe trends in the prescription of anti-diabetic medications among patients with type 2 diabetes in the United Kingdom (UK). Methods Using the General Practice Research Database, we constructed a cohort of patients with type 2 diabetes. Diabetes was defined as the presence of a diagnosis of diabetes, HbA1c , 7%, or ,,2 prescriptions for anti-diabetic medications. Analyses were conducted for the full cohort as well as a sub-cohort with incident diabetes. Results Our full cohort involved 67,981 patients and a total of 320,089 patient-years, and our sub-cohort involved 30,234 patients with incident diabetes and 111,890 patient-years. From 2000 to 2006, there was a substantial increase in the prescription rate of anti-diabetic medications. Overall, there were 9.6,prescriptions/patient-year in 2000, and this had increased to 14.8,prescriptions/patient-year in 2006. The greatest relative increase occurred in the prescription of thiazolidinediones. The greatest absolute increase occurred in the prescription of metformin, which surpassed sulfonylureas as the most commonly prescribed anti-diabetic medication among patients with type 2 diabetes in 2002. Among those with incident diabetes, overall prescription rates were 4.6,prescriptions/patient-year in 2000 and 13.6,prescriptions/patient-year in 2006. Conclusions There was a substantial increase between 2000 and 2006 in the UK in the prescription of anti-diabetic medications. This increasingly aggressive pharmacological management is consistent with recent practice guidelines. Copyright © 2009 John Wiley & Sons, Ltd. [source] The safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2008Luis Alberto García-Rodríguez MD Abstract Purpose To compare mortality and the incidence of hospitalization for myopathy, rhabdomyolysis, acute renal failure and acute liver injury in patients receiving rosuvastatin and those taking other statins. Methods Patients prescribed a statin that they had not used before were selected from the UK General Practice Research Database (GPRD) and followed up from 1 April 2003 to 31 December 2005. Results We studied 10,289 patients on rosuvastatin and 117,102 taking other statins. No cases of myopathy, rhabdomyolysis or acute liver injury occurred among rosuvastatin users. In those taking statins other than rosuvastatin, the incidence of myopathy was 0.4 (95% confidence interval (CI): 0.1,0.9), of rhabdomyolysis was 0.4 (95%CI: 0.1,0.9) and of acute liver injury was 0.4 (95%CI: 0.2,1.0), per 10,000 person-years. Fourteen cases of acute renal failure were identified (two among rosuvastatin users and 12 among other statin users). Among current users, the relative risk (RR) of acute renal failure in rosuvastatin users compared with other statin users was 1.16 (95%CI: 0.15,9.03). We identified 3232 deaths during the study period (173 in the rosuvastatin-treated group and 3059 in the other statin group). The RR of death associated with current use of rosuvastatin compared with other statins was 0.55 (95%CI: 0.44,0.68). Conclusions We found no evidence that patients prescribed rosuvastatin were at greater risk of these outcomes than patients prescribed other statins. There was no evidence of increased mortality among patients taking rosuvastatin, even after allowing for age, sex and prior statin use. Copyright © 2008 John Wiley & Sons, Ltd. [source] Chronic statin therapy and the risk of colorectal cancer,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 9 2008MSCE, Yu-Xiao Yang MD Abstract Background and Aims Epidemiologic studies on a potential chemopreventive effect of statin therapy have yielded conflicting results. We sought to clarify whether long-term statin therapy has a chemopreventive effect on the risk of colorectal cancer (CRC) in a large, population-representative cohort. Methods A nested case,control study was conducted among patients ,50 years of age and with ,5 years of CRC-free initial follow-up in the General Practice Research Database (GPRD; 1987,2002). Cases consisted of all patients with incident CRC. Up to 10 controls were matched with each case on practice site and both duration and calendar time of follow-up prior to the index date. The primary exposure of interest was ,5 years of cumulative statin use. Results We identified 4432 incident CRC cases and 44,292 controls. The adjusted odds ratio (OR) for ,5 years of statin exposure was 1.1 (95% confidence interval (CI): 0.5,2.2). Chronic NSAID/aspirin use did not modify this primary association (test for interaction, p,=,0.5). Compared to statin non-users, the adjusted OR for 10 years of statin exposure was 1.3 (95% CI: 0.6,2.7), and the adjusted OR associated with the highest quartile of cumulative statin dose was 1.2 (95% CI: 0.9,1.7). There was a non-statistically significant trend towards a possible reduction in CRC risk among users of high daily statin dose. Conclusion Long-term statin therapy at usual doses was not associated with a significantly reduced risk of CRC. A chemopreventive effect at high daily doses cannot be excluded. Copyright © 2008 John Wiley & Sons, Ltd. [source] Replication of the Scandinavian Simvastatin Survival Study using a primary care medical record database prompted exploration of a new method to address unmeasured confoundingPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2008Mark G. Weiner M.D. Abstract Purpose To examine whether identifiable study characteristics and/or analytic methods used determine observational study validity, as assessed by replicating randomized controlled trials using observational data. Methods A cohort from the United Kingdom General Practice Research Database (GPRD) was used to replicate the Scandinavian Simvastatin Survival Study RCT, which investigated statin treatment of hypercholesterolemic subjects with coronary heart disease. All aspects of the RCT except randomization were replicated to the extent possible in the GPRD study, which included 2,871 Unexposed and 1,280 statin-treated Exposed subjects. Results Overall mortality [adjusted hazard ratio 0.71 (0.53,0.96)] and myocardial infarction [adjusted HR 0.79 (0.61,1.02)] decreased in the GPRD study similar to the RCT. Coronary revascularization increased two-fold in the GPRD study, whereas it decreased significantly in the RCT [0.63 (0.54,0.74)]. This latter disparity prompted use of a new methodology to adjust for unmeasured confounding, which yielded an adjusted HR [1.0 (0.75,1.33)] more comparable to the RCT. Conclusions This study provides additional evidence that a replicated GPRD observational study can yield results reasonably similar to a RCT. More important, it provides preliminary evidence suggesting that a new analytic methodology may adjust for unmeasured confounding, the major limitation to research using observational data. Copyright © 2008 John Wiley & Sons, Ltd. [source] Onset of acute myocardial infarction after use of non-steroidal anti-inflammatory drugs,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2008Tarek A. Hammad MD Abstract Purpose To examine the association between cyclooxygenase-2 (COX-2) selective and traditional nonsteroidal anti-inflammatory drugs (NSAIDs) and incident acute myocardial infarction (AMI), and to address unanswered questions regarding the contour of risk over time. Methods A cohort of new NSAID users aged 40,84 years was followed for the occurrence of first AMI. Data were collected within the General Practice Research Database (GPRD) from 1 January 1997 to 31 December 2004. Results The study population included 1185 AMI events (889 probable and 296 possible) from a cohort of 283,136 patients. After adjustment for demographic and cardiovascular risk factors, the hazard ratio (HR) for AMI was significantly increased for both coxib (2.11, 95% confidence interval (CI) 1.04,4.26) and non-coxib (2.24, 95%CI 1.13,4.42) COX-2 selective NSAIDs when compared to remote exposure to NSAIDs, but was not increased for traditional NSAIDs. Stratifying exposure into the first month of use versus use beyond 1 month, the risk of AMI was increased during the first month of COX-2 selective NSAIDs use, but not later (3.43, 95%CI 1.66,7.07 and 1.88, 95%CI 0.82,4.31, respectively p -value for interaction,=,0.6). Conclusions The results suggest that the use of coxib and non-coxib COX-2 selective NSAIDs was associated with an elevated risk of AMI within the first month of exposure. Recent past exposure to NSAID was not associated with a similar increase in risk. Copyright © 2008 John Wiley & Sons, Ltd. [source] Systemic lupus erythematosus prevalence in the U.K.: methodological issues when using the General Practice Research Database to estimate frequency of chronic relapsing-remitting disease,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007A. L. Nightingale BSc (Hons) Abstract Purpose The purpose of this study was to calculate the prevalence of systemic lupus erythematosus (SLE) between 1992 and 1998 using the General Practice Research Database (GPRD) Methods We identified all individuals who had contributed at least 3 years of data to the GPRD and who had a diagnosis of SLE with supporting evidence of their diagnosis. We calculated the annual age- and sex-specific prevalence of SLE. Additionally, we stratified the prevalence by years of data contributed to the GRPD. Results In males the point estimate of the prevalence of SLE increased from 7.5/100,000 (CI95 6.3, 8.8) to 10.1/100,000 (CI95 7.8, 12.2) but this rise was not statistically significant. However, prevalence appeared to increase significantly amongst females from 42.6/100,000 (CI95 39.6, 45.6) in 1992 to 70.8/100,000 (CI95 65.1, 76.6) in 1998. This increase was mainly amongst women aged 50,79 and in those contributing more than 5 years of data and could not be explained by increasing incidence of SLE or decreasing mortality during the study period. Conclusions We found an increasing prevalence of SLE that could not be explained by increasing incidence or decreasing mortality. This is almost certainly an artefact caused by the increased likelihood of detecting or confirming cases of chronic relapsing-remitting diseases with increasing time contributed to the GPRD. Copyright © 2006 John Wiley & Sons, Ltd. [source] The impact of over-the-counter simvastatin on the number of statin prescriptions in the United Kingdom: a view from the General Practice Research Database,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 1 2007Kristian B. Filion MSc Abstract Purpose The United Kingdom (UK) government changed the prescription policy of statins, making low-dose simvastatin (10 mg) available as an over-the-counter (OTC) drug in August 2004. We assessed the impact of this policy change on statin prescribing. Methods We examined all statin prescriptions in the General Practice Research Database (GPRD), a well-validated database of approximately 3.5 million patients, from the first quarter of 2001 to the second quarter of 2005. Results From 2001, the number of statin prescriptions written for GPRD patients was increasing by approximately 437 prescriptions per 100,000 people per quarter until the time of the policy change. Over the four quarters post-policy implementation, however, this trend changed abruptly (p,<,0.0001) with a decrease of 281 prescriptions per 100,000 people per quarter. This decrease was not restricted to prescriptions of 10,mg statins but was also observed for statin prescriptions of ,20,mg. Several other cardiovascular medications displayed a similar trend as that observed in the number of statin prescriptions. This trend was not observed among non-cardiovascular control medications. Conclusions Our study suggests that the policy allowing the OTC sale of 10,mg simvastatin has had a significant impact on statin prescriptions by general practitioners. However, this new policy may also be leading to less aggressive statin therapy. An alternative explanation for the observed decrease in statin prescriptions may be related to the unknown factors responsible for the overall decrease observed with other cardiovascular prescription drugs. Copyright © 2006 John Wiley & Sons, Ltd. [source] Safety of medications prescribed before and during early pregnancy in a cohort of 81,975 mothers from the UK General Practice Research Database,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2006Janet R. Hardy PhD Abstract Purpose To demonstrate a linkage methodology for mother and baby automated medical records, and describe frequency, type, and pregnancy risk level of medications prescribed during pregnancy in a GPRD cohort, 1991,1999. Methods We linked records using a two-stage algorithm and selected pairs with ,7 months prenatal records and ,2 records in baby's first year of life. Periods of interest were: 90 days prior to a woman's earliest identified pregnancy record (Period I), and this record plus 70 days (Period II, approximate early pregnancy). Medications were classified using the British National Formulary and US Food and Drug Administration Pregnancy Risk Categories. Results We achieved over 80% record linkage and defined a cohort of 81,975. Sixty-five per,cent of mothers had ,1 prescription during both periods combined. Most frequent medications in Period I were anti-bacterial, contraceptive, topical steroid, and bronchodilator. In Period II, they were folic acid, anti-bacterial, antacid, and gynecological anti-infective. In Period I, 4% were FDA category A (considered safest), 34% B, and 49% C and D combined. By Period II, prescription of category A medications increased (folic acid, iron) while other categories declined. Category X medications, with potential teratogenic risk that outweighs maternal benefit, were prescribed to 5714 (7%) women in Period I, and 501 (0.6%) women in Period II (46% progesterone). Conclusions One in every 164 women received a category X prescription in early pregnancy. The visit when pregnancy is first medically recognized represents an opportunity to review prescribed medications in light of contraindication and/or fetal risk. Copyright © 2006 John Wiley & Sons, Ltd. [source] The relationship between time since registration and measured incidence rates in the General Practice Research Database,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2005James D. Lewis MD, MSCE Abstract Background The General Practice Research Database (GPRD) is widely used to study incidence rates. This study examines whether incidence rates are overestimated during the first year after registration, how long one needs to wait to obtain accurate incidence rates, and whether the time period of overestimation differs among disease types. Methods We measured incidence rates of nine acute, eight chronic, and eight neoplastic outcomes in 3-month intervals through month 36 after enrollment in GPRD. The incidence rates in months 13,36 were used to estimate baseline incidence rates for each diagnosis. Results For patients registering with practices that were already UTS, incidence rates were highest in the first 3 months after registration. In eight of nine acute diagnoses, the incidence rate was within 20% of baseline by months 4,6; and in seven of eight cancers, the incidence rate was within 20% of baseline by months 7,9. For chronic conditions, the incidence rate in months 10,12 differed from baseline by more than 20% for five of the eight outcomes, respectively. For patients registering prior to UTS, incidence rates during the first quarter were within 20% of baseline for all acute and cancer diagnoses and six of eight chronic diagnoses. Conclusions Reported incidence rates are highest in the first 3 months after registration with an UTS practice and decline to baseline over the first year, more quickly for acute conditions than chronic conditions. For patients who registered prior to UTS, incidence rates are near the baseline level at the start of follow-up. Copyright © 2005 John Wiley & Sons, Ltd. [source] Prevalence of risk factors for suicide in patients prescribed venlafaxine, fluoxetine, and citalopram,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2005Daniel Mines MD Abstract Purpose Three recent observational studies reported that the risk of fatal overdose is greater with venlafaxine than SSRI use. It is not clear whether patient factors could account for this finding. We evaluated whether risk factors for suicide are more prevalent among patients prescribed venlafaxine than patients prescribed fluoxetine or citalopram. Methods Using data from the UK General Practice Research Database (GPRD), we identified patients who were first prescribed any of the three drugs between January 1995 and April 2002. We ascertained risk factors for suicide documented in the 1 year before that first prescription. Separate analyses compared venlafaxine (N,=,27,096) and fluoxetine (N,=,134,996) cohorts, and venlafaxine and citalopram (N,=,52,035) cohorts. Results Previous suicidal behaviors were documented for 1.0% of the venlafaxine cohort compared to 0.4% of the fluoxetine cohort (OR 2.8, 95%CI: 2.4, 3.2) and 0.4% citalopram cohorts (OR 2.4, 95%CI: 2.0, 2.9). 72.5% of venlafaxine patients had been prescribed at least one other antidepressant compared to 27.6% of fluoxetine (OR 6.9, 95%CI: 6.7, 7.1) and 39.5% of citalopram (OR 4.0, 95%CI: 3.9, 4.2) patients. Venlafaxine patients were also four to six times as likely to have been previously hospitalized for depression. Conclusion In the UK, venlafaxine has been selectively prescribed to a patient population with a higher burden of suicide risk factors than patients prescribed fluoxetine and citalopram. Unless baseline population differences are accounted for, observational studies that compare the risk of suicide in patients receiving these agents may produce biased results. Copyright © 2005 John Wiley & Sons, Ltd. [source] Strategies for identifying pregnancies in the automated medical records of the General Practice Research Database,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 11 2004Janet R. Hardy Abstract Purpose To develop a method for identifying the beginning and ending records of pregnancies in the automated medical records of the General Practice Research Database (GPRD). Methods Women's records from 1991 to 1999 were searched for codes from 17 pregnancy marker and 7 pregnancy outcome categories. Using the retrieved records, all possible pregnancy marker-outcome combinations were formed per woman. For each combination, the difference in days between record event dates was calculated. Restrictions were applied to select the combination with the earliest pregnancy marker mapped to the first outcome for each pregnancy. Iterations of the algorithm identified multiple pregnancies per woman when present. The algorithm was evaluated by analyzing time between marker and outcome event dates of mapped pregnancies and by analyzing unmapped pregnancy markers and outcomes. Results A total of 297,082 pregnancies were identified: 80% by general practitioner (GP) visit codes as the earliest pregnancy marker and 14% by laboratory or procedure codes. Limiting pregnancies to one per woman aged 15,44 years yielded 209,266 pregnancies. Pregnancy mapping success was greater than 80%. Plotting the pregnancies by weeks from earliest pregnancy marker to outcome and by pregnancy marker category showed two peaks in the distribution: 2,3 weeks and 33 weeks. Conclusions Arranging codes and time into algorithms provides a useful tool for pregnancy identification in databases whose size prohibits the audit of printed records. Evaluation of our algorithm confirmed a high degree of mapping success and a sensible time distribution from pregnancy marker to outcome. Copyright © 2004 John Wiley & Sons, Ltd. [source] Venous thromboembolism associated with cyproterone acetate in combination with ethinyloestradiol (Dianette®): observational studies using the UK General Practice Research Database,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2004H. E. Seaman Abstract Purpose To derive risk estimates for venous thromboembolism (VTE) in women prescribed cyproterone acetate combined with ethinyloestradiol (CPA/EE), a drug licensed in the UK for the treatment of women with acne or hirsutism. CPA/EE provides a treatment option for women with polycystic ovary syndrome (PCOS). CPA/EE has been associated with an increased risk of VTE. Methods Using the General Practice Research Database, we conducted cohort and case-control analyses in all women aged 15,39 and then nested in a population of women of the same age with acne, hirsutism or PCOS. Results The incidence rate ratio (IRR) for VTE in women exposed to CPA/EE versus conventional combined oral contraceptives (COCs) was significantly raised (all women: 1.92; 95%,CI: 1.22,2.88; nested: 2.51; 95%,CI: 1.07,5.75). Using exposure to conventional COCs as the reference, the adjusted odds ratio (ORadj) for VTE associated with CPA/EE was 1.45 (95%,CI: 0.80,2.64) in all women and 1.71 (95%,CI: 0.31,9.49) in women with acne, hirsutism or PCOS. Conclusions The risk of VTE associated with CPA/EE use does not differ significantly from that associated with the use of conventional COCs. These data are reassuring and together with knowledge of the risks associated with other treatments for acne, in particular, should influence prescribing practice. Copyright © 2003 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 17 2008Article first published online: 15 SEP 200 Small AED suicide risk Antiepileptic drugs (AEDs) are associated with a small increase in the risk of suicidal thoughts, the MHRA has warned. In the latest Drug Safety Update (2008;2:Issue 1) the MHRA says that, compared with placebo, AEDs are associated with an additional two cases of suicidal thoughts and behaviour per 1000 patients (0.43 vs 0.22 per cent). This may occur as early as one week after starting treatment. It is unclear whether the risk varies among AEDs. Also in this issue, the MHRA warns of an increased risk of tumour progression and reduced survival in patients with cancer treated with recombinant erythropoietin. Other topics include the use of lenalidomide (Revlimid) and thalidomide for multiple myeloma; new restrictions on the use of moxifloxacin (Avelox) due to adverse effects; and a reminder that metronidazole should be administered orally, not by intravenous injection, for the treatment of C. difficile -associated diarrhoea. Low-fat diet least effective option? A low-fat diet is associated with less weight loss and less favourable metabolic changes over two years than a low-carbohydrate (Watkins) diet or a Mediterranean diet in 322 moderately obese patients (mean BMI 30kg per m2; N Eng J Med 2008;359:229,41). Estimated energy intake was similar for all diets. Mean weight loss in all randomised patients was 2.9kg for the low fat diet, 4.4kg for the Mediterranean diet and 4.7kg for the low-carbohydrate diet. The low-carbohydrate diet was associated with greater increases in HDL-cholesterol and greater reductions in triglycerides and total cholesterol/HDL-C ratio compared with the low-fat diet. Among people with diabetes, fasting plasma glucose and insulin resistance were decreased only in those assigned to the Mediterranean diet, and only the low carbohydrate diet significantly decreased HbA1c. Stopping post-MI statins Patients who stop taking a statin first prescribed after an acute MI almost double their risk of death compared with nonusers, a new study shows (Eur Heart J; published online 29 July 2008; doi: 10.1093/eurheartj/ehn346). The analysis of 9939 MI survivors in the General Practice Research Database showed that, compared with patients who had never used a statin, the risk of death was unchanged for those previously taking a statin who continued treatment after MI. The risk was reduced by 28 per cent for those who started a statin post-MI and continued it but, in those who started a statin but then stopped it, the hazard ratio for death was 1.88 (CI 95% 1.13-3.07). Stopping control medication (aspirin, beta-blockers or proton pump inhibitors) did not alter the risk of death. Smoking quit rates with NRT and varenicline Differences in quit rates between nicotine replacement therapy (NRT) and varenicline (Champix) are small, according to a multinational study (Thorax 2008;63:717,24). The trial compared transdermal NRT (21mg to 7mg per day over 10 weeks) with varenicline (1mg twice daily for 12 weeks). Over the final four weeks of treatment, the abstinence rate was significantly higher with varenicline (56 vs 43 per cent). After one year, the four-week abstinence rates were 26 and 20 per cent respectively (p = 0.056) and seven-day point prevalence abstinence rates at 6 or 12 months were not significantly different. Varenicline reduced craving, withdrawal symptoms and smoking satisfaction compared with NRT but at the cost of a higher incidence of nausea (37 vs 10 per cent). Azithromycin goes OTC The MHRA has announced that azithromycin will be available without prescription for the treatment of Chlamydia infection. Under the brand Clamelle, azithromycin will be supplied from pharmacies to over-16s who have tested positive for infection but have no symptoms; their partners may also be treated. A urine testing kit will be marketed to pharmacists. Product news Sodium valproate (Epilim Chronosphere) is now available as modified-release granules to be taken with food or a drink; 30 sachets, in five strengths from 50750mg, cost £30. Boehringer Ingelheim has introduced a higher strength of its telmisartan/hydrochlorothiazide combination (Micardis Plus) for hypertension; 80mg/25mg costs £14.18 for a month's supply. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 10 2008Article first published online: 3 JUN 200 Glitazones more than double fracture risk An analysis of the UK General Practice Research Database has found that both glitazones increase the risk of fracture more than two-fold (Arch Intern Med 2008;168:820-5). Compared with nonusers, the odds ratio for fracture (mostly hip and wrist) was 2.59 for pioglitazone and 2.38 for rosiglitazone. The risk increased with dose but was unrelated to age and sex. Reduce antipsychotics in dementia patients Antipsychotics should be prescribed for patients with dementia only as a last resort at times of severe distress or critical need, the All-Party Parliamentary Group on Dementia has concluded. Its inquiry (available at www.alzheimers.org.uk) found that antipsychotics are being prescribed for patients with mild behavioural symptoms and for prolonged periods despite the limited benefits they offer and the risk of serious adverse effects such as stroke. Contributory factors include lack of training for staff, inadequate leadership and exclusion of family and friends from decisions about treatment. High-dose atorvastatin in chronic kidney disease High-dose atorvastatin (Lipitor) reduces cardiovascular events in patients with chronic kidney disease (CKD) more than a low dose , despite similar reductions in LDL-C (J Am Coll Cardiol 2008;51:1448-54). A post hoc subgroup analysis of the Treating-to-New-Targets study involving 10 001 patients with CHD, with or without CKD, found that atorvastatin 10 and 80mg per day reduced LDLC and triglycerides to similar levels; there was no change in HDL-C. After a median follow-up of five years, the incidence of cardiovascular events in patients with CKD was 9.3 per cent at 80mg per day and 13.4 per cent at 10mg per day (number needed to treat to prevent one event, NNT, 24). In patients with no CKD, the corresponding figures were 7.9 vs 9.2 per cent (NNT 74). There was no difference in all-cause mortality; adverse events were more frequent at the higher dose. COX-2 NSAIDs not more cost-effective An economic analysis of COX-2 selective NSAIDs has concluded that they are not more cost effective than older agents plus a proton pump inhibitor (PPI) in the treatment of osteoarthritis and rheumatoid arthritis (Health Technology Assessment 2008;12:No. 11). The analysis concluded that selective and nonselective NSAIDs were similarly effective but selective agents were associated with a lower risk of upper GI events and a higher risk of cardiovascular events. However, the available evidence includes only low numbers of events and further studies are needed. Compared with ibuprofen or diclofenac plus a PPI, the COX-2 selective NSAIDs look ,generally unattractive from a cost effectiveness point of view', even in high-risk patients with a history of peptic ulcer. There were insufficient data to allow a reliable comparison within the COX-2s. Naftidrofuryl helps intermittent claudication Naftidrofuryl increases pain-free walking distance (PFWD) in patients with intermittent claudication, a new Cochrane review has shown (Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001368. DOI: 10.1002/ 14651858.CD001368.pub3; also see page 49 in this issue). The meta-analysis of six trials involving a total of 1083 patients found that, compared with placebo, naftidrofuryl increased PFWD by over a third with a proportion successfully treated of 20 per cent (NNT 4.5). Coversyl Arginine To clarify any confusion following our recent news item (Perindopril brand switch, 19 April issue, page 12), Servier has asked us to reiterate that the new formulations Coversyl Arginine 2.5, 5 and 10mg are equivalent to 2, 4 and 8mg of the discontinued Coversyl formulation. Coversyl Arginine contains perindopril arginine, a salt that offers greater stability and a longer shelf-life. Prescriptions for the Coversyl brand of perindopril must in future be written as Coversyl Arginine in its revised strengths. Coversyl Plus has also been replaced by Coversyl Arginine Plus and the same revised dosages apply. Generic formulations of perindopril remain unaffected. Copyright © 2008 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 3 2007Article first published online: 14 MAR 200 PPIs and hip fracture Treatment with a PPI may increase the risk of hip fracture, with longer use associated with higher risk according to a study in UK patients (J Am Med Assoc 2006;297:2947-53). The case control study compared use of PPIs by 13 556 patients with hip fracture and 135 386 controls in the UK General Practice Research Database. Use of a PPI for more than one year was associated with an increase of 44 per cent in the odds of hip fracture. The risk was higher for longer- term use (59 per cent after four years) and at higher doses (more than doubled with long-term high doses). The mechanism for this possible effect may be impaired calcium absorption associated with hypochlorhydria and reduced bone resorption. CHD NSF Statin prescribing has increased by 30 per cent every year since the publication of the Coronary Heart Disease NSF, the Department of Health says. The estimated number of lives saved attributable to statins had risen to 9700 in 2005. The proportion of patients with acute MI who were given thrombolysis within 30 minutes of admission has increased to 83 per cent. Flu jabs cut pneumonia deaths A US study suggests that flu vaccine protects against death during the flu season in patients admitted with community-acquired pneumonia (Arch Intern Med 2007;167:53-9). Nineteen per cent of patients admitted with pneumonia during the winters of 1999-2003 were known to have been vaccinated against flu. Their risk of death during their hospital stay was 70 per cent lower than that of nonvaccinated individuals. After adjustment for antipneumococcal vaccination and comorbidity, the odds of death were still 39 per cent lower. Model to predict admissions The King's Fund, together with New York University and Health Dialog, has published a model that predicts the risk of emergency hospital admission (see www.kingsfund.org.uk). The model is intended for use by PCTs and draws on data from secondary and primary care to define clinical profiles, allowing patients whose condition is deteriorating to be identified before they need admission. Problem drinking The National Treatment Agency for Substance Misuse (NTA), a special authority within the NHS, has published a critical appraisal of the evidence for various treatments for alcohol problems (www.nta.nhs.uk). The 212-page document estimates that over seven million hazardous or harmful drinkers may benefit from brief interventions by any health workers, and over one million dependent drinkers may benefit from specialist intervention. It concludes that cognitive behavioural approaches to specialist treatment are most effective and that treatment probably accounts for about one-third of improvements made in problem drinking. of patients remained on the same treatment after one year, falling to half at two years and about 40 per cent at three years. Treatment was more frequently stopped for lack of efficacy than for adverse effects. Stopping anti-TNFs Discontinuation of treatment with anti-TNF agents is more common in clinical practice than in clinical trial populations, a French study has found (J Rheumatol 2006;33:2372-5). The retrospective analysis of a single centre's experience of treating 770 patients with etanercept (Enbrel), infliximab (Remicade) or adalimumab (Humira) found that fewer than two-thirds of patients remained on the same treatment after one year, falling to half at two years and about 40 per cent at three years. Treatment was more frequently stopped for lack of efficacy than for adverse effects. There were no statistically significant differences between the three agents but there was a trend for infliximab to be least well tolerated. Generic statin savings The Department of Health has estimated that prescribing simvastatin and pravastatin generically would save £85 million per year. Its analysis of the ,Better care, better value' indicators (see www.productivity.nhs.uk) shows that statin prescribing has increased by 150 per cent in the past five years, with costs totalling £600 million in 2005. The Department says that if every PCT prescribed pravastatin and simvastatin by generic name in only 69 per cent of cases ,the level achieved by the top quarter of trusts ,the savings would be over £85 million a year. Herceptin reporting Press reports of a two-year trial of trastuzumab (Herceptin) were generally accurate in reporting its effectiveness but few reported an increased risk of adverse effects, according to the NHS National Library for Health (www.library.nhs.uk). The Herceptin Adjuvant (HERA) trial (Lancet 2007;369:29-36) found that, after an average follow-up of two years, 3 per cent of women treated with trastuzumab died compared with 5 per cent of controls; estimated three-year survival rates were 92.4 and 89.7 per cent respectively. All four press articles reported these findings accurately, but only two mentioned the increased risk of adverse effects. Updated guidance on CDs The Department of Health has published updated guidance on the strengthened governance requirements for managing controlled drugs, taking into account new regulations that came into force on 1 January (seewww.dh.gov.uk/asset Root/04/14/16/67/04141667.pdf). Statin adherence lowers MI mortality Patients with acute myocar- dial infarction (MI) who take their statins as prescribed are significantly more likely to survive for two to three years than those with low adherence (J Am Med Assoc 2007;297: 177-86). The four-year observational study of 31 455 patients with acute MI found that, compared with those who had taken at least 80 per cent of prescribed daily doses, the risk of death in those with less than 40 per cent adherence was 25 per cent greater over 2.4 years. For individuals with intermediate adherence (40-79 per cent), the risk was 12 per cent greater. Both differences were statistically significant after adjustment for potential confounding factors. The authors believe their finding is explained by differences in adherence rather than healthier behaviour because the excess risk of low adherence was less marked with beta-blockers and not significant for calcium-channel blockers. Improving community medicines management Mental health trusts need to improve medicines management by their community teams and improve information sharing with GPs, the Healthcare Commission has found (www.healthcare commission.org.uk). Its national report revealed limited evidence of pharmacist involvement in community mental health teams, even though 90 per cent of patients were cared for in the community. Only 11 per cent of assertive outreach patients had the tests necessary to ensure safe use of their medicines. Medication reviews found that 46 per cent of patients in mental health trusts and 12 per cent of those in acute trusts were not taking their medication appropriately. The Commission also reported that acute trusts received a complete drug history from GPs for fewer than half of audited patients when they were admitted to hospital, and only 30 per cent of PCTs reported that GPs received adequate information on patients' medicines on discharge. Copyright © 2007 Wiley Interface Ltd [source] Latest news and product developmentsPRESCRIBER, Issue 2 2007Article first published online: 1 MAR 200 Venlafaxine: same suicide risk Venlafaxine (Efexor) is probably not associated with a higher risk of suicide than citalopram, fluoxetine or dosulepin, even when prescribed for patients at higher risk, according to an analysis of the UK General Practice Research Database (BMJ, doi:10.1136/bmj.39041.445104.BE. Published 12 December 2006). The retrospective cohort study found that venlafaxine was associated with a significantly higher risk of completed and attempted suicide in adults than the other antidepressants but, after adjusting for risk factors, the authors concluded that much, if not all, of the difference could be explained by confounding. Raised glucose with thiazides not clinically significant? A new analysis of the ALLHAT trial suggests that the small increase in blood glucose levels associated with long-term thiazide therapy is not associated with an increased risk of cardiovascular events (Arch Intern Med 2006;166:2191-201). The ALLHAT trial compared cardiovascular outcomes in over 18 000 patients with hypertension who were treated with chlortali- done (Hygroton), amlodipine and lisinopril. After two years, fasting blood glucose had increased in all groups (by 0.47, 0.31 and 0.19mmol per litre respectively); compared with chlortalidone, the odds of developing diabetes were 45 per cent lower with lisinopril and 27 per cent lower with amlodipine. However, there was no significant link between fasting blood glucose levels and cardiovascular events, end-stage renal disease or death; developing diabetes was associated with an increased risk of CHD overall but this was not statistically significant for chlortalidone in particular. Withdrawing alendronate after five years' treatment Discontinuing treatment of osteoporosis with alendronate after five years does not significantly increase fracture risk for many women, a US study has shown (J Am Med Assoc 2006;296:2927-38). In this five-year extension to the Fracture Intervention Trial, 1099 women who had taken alendronate for five years were randomised to continue treatment or switch to placebo for a further five years. In those taking placebo, bone mineral density decreased by 2.4 per cent at the hip and 3.7 per cent in the spine but remained above pre- treatment levels. Continuing with alendronate was associated with a lower risk of clinical vertebral fractures (2.4 vs 5.3 per cent) but no significant reduction in morphometric vertebral fractures (9.8 vs 11.3 per cent respectively). The cumulative risk of nonvertebral fractures was 19 per cent in each group. The authors conclude that women at very high risk of clinical vertebral fractures may benefit from continuing alendronate, but for many discontinuation does not appear to increase fracture risk. Instructions on labels Patients with low levels of literacy are at high risk of not understanding medicines labelling (Ann Intern Med 2006;145:887-94). In 395 English-speaking adults, 71 per cent correctly repeated simple label instructions, but only 35 per cent could demonstrate the correct number of tablets involved. Low literacy levels were associated with a twofold increased risk of misunderstanding labelling. Statins campaign The National Prescribing Centre (NPC) has launched a campaign to increase prescribing of low-cost statins. Resources available from its website at www.npc.co.uk/statins.htm are divided into four categories: policy and guidance, therapeutics, implementation resources and monitoring tools. Formats include documents and case studies, Powerpoint presentations and E-learning workshops. patients feeling rested on waking and daytime functioning. The Z-drugs were also believed to cause fewer adverse effects. GPs believe in ,Z' drugs A survey of GPs in Lincolnshire has revealed that their beliefs about nonbenzodiazepine hypnotics are inconsistent with NICE guidance and published evidence (Br J Gen Pract 2006; 56:964-7). Responders believed that zaleplon (Sonata), zopiclone and zolpidem were superior to benzodiazepines in increasing sleep time, patients feeling rested on waking and daytime functioning. The Z-drugs were also believed to cause fewer adverse effects. The authors note that, while benzodiazepine prescribing is declining, that of the Z-drugs is increasing, and they suggest this may be explained by misplaced beliefs about their relative effectiveness and safety. Pharmacy EHC guidance Pharmacists can supply emergency hormonal contraception (EHC) in advance but should consider when it is clinically appropriate to do so, according to revised guidance from the Royal Pharmaceutical Society. The move follows support for advance supply from the British Pregnancy Advisory Service and Marie Stopes International. Pharmacists are advised to decline repeated requests and recommend contraception instead, and to counsel users on using EHC safely and appropriately. More support from NICE NICE has developed two databases to support implementation of its recommendations. The shared learning database (www.nice.org.uk/ sharedlearning) includes experiences of implementing NICE guidance. The second, known as ERNIE (Evaluation and Review of NICE Implementation Evidence), includes data provided by NICE on uptake of its advice and external information (www.nice.org.uk/ernie). Mental health briefings The DoH (www.dh.gov.uk) has published several briefing documents to explain the main changes to mental health legislation, covering professional roles, criteria for detention and supervised community treatment (SCT). SCT applies to patients with a stable chronic mental disorder who have been discharged from hospital and who, but for their treatment, may pose a risk to themselves or others. Patients remain the responsibility of the mental health team. Copyright © 2007 Wiley Interface Ltd [source] Inhaled tiotropium bromide and risk of strokeBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 5 2009Anthony Grosso WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Conflicting studies have raised uncertainty over the vascular effects of the long-acting anticholinergic, tiotropium bromide. WHAT THIS STUDY ADDS , Our results show no increased risk of stroke with tiotropium bromide, or with inhaled anticholinergics in general. AIMS A recent communication from the United States Food and Drug Administration highlighted a possible increased risk of stroke associated with use of the relatively new inhaled anticholinergic drug, tiotropium bromide. Using the United Kingdom General Practice Research Database, we set out to assess the risk of stroke in individuals exposed to inhaled tiotropium bromide and two other inhaled treatments for airways disease. METHODS We used the self-controlled case-series that reduces confounding and minimizes the potential for biases in the quantification of risk estimates. RESULTS Of 1043 people with a diagnosis of incident stroke who had had at least one prescription for tiotropium bromide, 980 satisfied inclusion criteria. The age-adjusted incidence rate ratio for all-cause stoke in individuals exposed to tiotropium bromide (n= 980), ipratropium bromide (n= 4181) and fluticasone propionate/salmeterol xinafoate (n= 1000) was 1.1 [95% confidence interval (CI) 0.9, 1.3], 0.8 (95% CI 0.7, 0.9) and 1.0 (95% CI 0.9, 1.2), respectively. CONCLUSIONS We found no evidence of an increased risk of all-cause stroke for individuals exposed to commonly prescribed inhaled treatments for chronic obstructive pulmonary disease. [source] | ||||||||||