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Relative Risk Reduction (relative + risk_reduction)
Selected AbstractsStatin Use Is Associated With Improved Survival in Patients With Advanced Heart Failure Receiving Resynchronization TherapyCONGESTIVE HEART FAILURE, Issue 4 2009Andrew D. Sumner MD It is unknown whether statin use improves survival in patients with advanced chronic heart failure (HF) receiving cardiac resynchronization therapy (CRT). The authors retrospectively assessed the effect of statin use on survival in patients with advanced chronic HF receiving CRT alone (CRT-P) or CRT with implantable cardioverter-defibrillator therapy (CRT-D) in 1520 patients with advanced chronic HF from the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial database. Six hundred three patients (40%) were taking statins at baseline. All-cause mortality was 18% in the statin group and 22% in the no statin group (hazard ratio [HR] 0.85; confidence interval (CI), 0.67,1.07; P=.15). In a multivariable analysis controlling for significant baseline characteristics and use of CRT-P/CRT-D, statin use was associated with a 23% relative risk reduction in mortality (HR, 0.77; CI, 0.61,0.97; P=.03). Statin use is associated with improved survival in patients with advanced chronic HF receiving CRT. No survival benefit was seen in patients receiving statins and optimal pharmacologic therapy without CRT. [source] Treatment of diabetic nephropathy in its early stagesDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 2 2003Giacomo Deferrari Abstract Diabetic nephropathy is one of the most frequent causes of end-stage renal disease (ESRD), and, in recent years, the number of diabetic patients entering renal replacement therapy has dramatically increased. The magnitude of the problem has led to numerous efforts to identify preventive and therapeutic strategies. In normoalbuminuric patients, optimal glycemic control (HbA1c lower than 7.5%) plays a fundamental role in the primary prevention of ESRD [weighted mean relative risk reduction (RRR) ,37% for metabolic control versus trivial renoprotection for intensive anti-hypertensive therapy or ACE-inhibitors (ACE-I)]. In the microalbuminuric stage, strict glycemic control probably reduces the incidence of overt nephropathy (weighted mean RRR ,50%), while blood pressure levels below 130/80 mmHg are recommended according to the average blood pressure levels obtained in various studies. In normotensive patients, ACE-I markedly reduce the development of overt nephropathy almost regardless of blood pressure levels; in hypertensive patients, ACE-I are less clearly active (weighted mean RRR ,23% versus other drugs), whereas angiotensin-receptor blockers (ARB) appear strikingly renoprotective. Once overt proteinuria appears, it is uncertain whether glycemic control affects the progression of nephropathy. In type 1 diabetes, various anti-hypertensive treatments, mainly ACE-I, are effective in slowing down the progression of nephropathy; in type 2 diabetes, two recent studies demonstrate that ARB are superior to conventional therapy or calcium channel blockers (CCB). In clinical practice, pharmacological tools are not always used to the best benefit of the patients. Therefore, clinicians and patients need to be educated regarding the renoprotection of drugs inhibiting the renin-angiotensin system (RAS) and the overwhelming importance of achieving target blood pressure. Copyright © 2003 John Wiley & Sons, Ltd. [source] The collaborative atorvastatin diabetes study: preliminary results,INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2005Olwen Glynn Owen Summary The Collaborative AtoRvastatin Diabetes Study (CARDS) is the first large primary prevention study to focus specifically on the role of a statin in patients aged 40,75 years with type 2 diabetes, but no signs or symptoms of pre-existing vascular disease and who had only average or below average cholesterol levels. The trial was a prospective double-blind randomised trial with 2383 type 2 diabetic subjects randomised to either 10-mg atorvastatin daily or placebo. Originally designed to run for 5 years, the trial was terminated over a year early in June 2003 on account of a clear benefit demonstrated for the intervention group. Over half of patients had a low-density lipoprotein cholesterol (LDL-C) below 3.3 mmol/l at entry and a quarter had an LDL-C <2.6 mmol/l. Atorvastatin 10 mg reduced LDL-C by 40% (1.2 mmol/l) on average. Results at 4 years showed a 37% relative risk reduction (p < 0.001) for atorvastatin 10 mg in the primary endpoint (acute coronary heart disease death, fatal or non-fatal myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, coronary revascularisation procedures and stroke). Among the secondary endpoints, total mortality was reduced by 27% (p = 0.05), acute coronary events by 36%, coronary revascularisation by 31% and stroke by 48%. The same magnitude of benefit was observed among patients with LDL-C above or below 3 mmol/l. Results observed were against a background where 9% of placebo patients had been permitted to start statin therapy after enrolment and 15% of patients on active treatment had discontinued atorvastatin. The true benefit of the intervention is therefore probably around 25% greater than the intention to treat analysis reports. [source] Long-Term Follow-Up After Radiofrequency Catheter Ablation of Ventricular Tachycardia: A Successful Approach?JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2002ALIDA E. BORGER VAN DER BURG M.D. RF Catheter Ablation of VT.Introduction: Radiofrequency ablation (RFCA) of ventricular tachycardia (VT) is a potential curative treatment modality. We evaluated the results of RFCA in patients with VT. Methods and Results: One hundred fifty-one consecutive patients (122 men and 29 women; age 57 ± 16 years) with drug-refractory VT were treated. Underlying heart disease was ischemic heart disease in 89 (59%), arrhythmogenic right ventricular cardiomyopathy (ARVC) in 32 (21%), and idiopathic VT in 30 (20%; left ventricle in 9 [30%]; right ventricle in 21 [70%]). Ablation was performed using standard ablation techniques. Three hundred six different VTs were treated (cycle length 334 ± 87 msec, 2.0 ± 1.4 VTs per patient). Procedural success (noninducibility of VT after RFCA) was achieved in 126 (83%) patients (70 ischemic heart disease [79%]; 28 ARVC [88%]; 27 idiopathic VT [93%]). Procedure-related complications (< 48 hours) occurred in 11 (7%) patients: death 3 (2.0%), cerebrovascular accident 2 (1.3%), complete heart block 4 (2.6%), and pericardial effusion 3 (2.0%). Thirty-three (22%) patients received an implantable cardioverter defibrillator (because of hemodynamic unstable VT, failure of the procedure, or aborted sudden death). During follow-up (34 ± 11 months), VT recurrences occurred in 38 (26%) patients (recurrence rate: 19% in successfully ablated patients and 64% in nonsuccessfully ablated patients; P < 0.001). During follow-up, 12 (8%) patients died (heart failure 8, unknown cause 1, noncardiac cause 3). Conclusion: RFCA of VT can be performed with a high degree of success (83%). The long-term outcome of successfully ablated patients is promising, with a 75% relative risk reduction compared with nonsuccessfully ablated patients. During follow-up, only one patient died suddenly, supporting a selective ICD placement approach in patients with hemodynamically stable VT. [source] A systematic review on communicating with patients about evidenceJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 1 2006Lyndal J Trevena MBBS (Hons) MPhilPH Abstract Objective, To conduct a systematic search for (1) the effectiveness of evidence-based communication tools to increase patient understanding of evidence, (2) effective formats for representing probabilistic information and (3) effective strategies for eliciting patient preferences about evidence. A case scenario is used to illustrate some of the difficulties of putting these results into practice., ,Data sources, Systematic search of The Cochrane Library, Medline, Psychinfo, Embase and Cancerlit. Review methods, Systematic reviews of randomized controlled trials (RCTs) and high quality RCTs were included. Studies were excluded if they did not address the question, were focused on behavioural outcomes without attempting to increase understanding, were concerned with counselling as a therapeutic intervention, or were specific to communication regarding clinical trial participation., ,Results, We found 10 systematic reviews of RCTs and 30 additional RCTs addressing our questions. Communication tools in most formats (verbal, written, video, provider-delivered, computer-based) will increase patients' understanding but are more likely to do so if structured, tailored and/or interactive. Probabilistic information is best represented as event rates (natural frequencies) in relevant groups of people, rather than words, probabilities or summarized as effect measures such as relative risk reduction. Illustrations such as cartoons, or graphs (vertical bar charts) appear to aid understanding. Values clarification exercises may be better than standard utility techniques for eliciting preferences in individual decision making. Looking for effective evidence-based communication tools for prostatic specific antigen testing highlighted the challenges for clinicians and consumers in accessing tools that are evidence-based in design as well as content. Conclusion, There is an increasing body of evidence supporting the design of effective evidence-based communication tools but variable access to such tools in practice. [source] Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillationJOURNAL OF INTERNAL MEDICINE, Issue 1 2003N. Edvardsson Abstract. Edvardsson N, Juul-Möller S, Ömblus R, Pehrsson K (Sahlgrenska University Hospital, Malmö University Hospital, Bristol-Myers Squibb Bromma; and Karolinska University Hospital; Stockholm, Sweden). Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation. J Intern Med 2003; 254: 95,101. Objectives. To assess the optimal stroke prevention treatment for patients with atrial fibrillation (AF) and a low,medium risk (,4%) of stroke. Design. A total of 668 patients with persistent or permanent AF, without an indication for full dose and with adequate rate control on sotalol, were randomized to warfarin 1.25 mg + aspirin 75 mg daily (W/A, 334 patients) or no anticoagulation (C, 334 patients). The mean follow-up period was 33 months. The protocol intended to verify a 37% relative risk reduction provided a 4% stroke incidence in the C group. Results. The stroke incidence was less in the W/A group, although the reduction was not statistically significant (W/A 9.6% versus C 12.3%). Four haemorrhagic strokes were identified, two in each group. Secondary end-points were transient ischaemic attacks (TIA) (W/A 3.3% versus C 4.5%), all cause mortality (W/A 9.3% versus C 10.8%), cardiovascular morbidity (W/A 17.7% versus C 22.2%) and the combination of stroke + TIA (W/A 11.7% versus C 16.5%). Bleedings were documented in 19 versus four patients (W/A 5.7% versus C 1.2%) (P = 0.003), although none fatal. Sinus rhythm (SR) was recorded occasionally in 68 patients (W/A 9.6% versus C 10.8%). The stroke incidence tended to be higher in those with SR than without, 16.2% versus 10.4%. Conclusions. Our results were inconclusive, but consistent with a small beneficial effect of W/A for reduction of stroke and major vascular events in AF patients at moderate risk. The low-dose regiment produced, however, a significantly increased risk of bleedings. Documented SR occasionally recorded may represent a subpopulation that warrants full dose warfarin. [source] Integrating the Principles of Evidence-Based Practice Into Clinical PracticeJOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS, Issue 3 2004Kathleen A. Klardie RN Column Editor Comment This series of articles illustrates many considerations relevant to the application of clinical practice guidelines (CPGs). This particular column describes the actions of a nurse practitioner (NP) striving to understand the foundations of recommendations that are based largely on expert opinion. Although application of CPGs does not generally require this degree of investigation, it is essential that providers understand the processes used to interpret the basis of recommendations, including the application of the basic statistical concepts, when making decisions about how recommendations apply to individual patient scenarios. Utilizing evidence-based practice when providing patient care requires a range of skills that allows the NP to locate appropriate research evidence, to develop an understanding of the statistics used in interpreting and reporting research, and to evaluate the effects of interventions on patient outcomes. The application of the key concepts of evidenced-based practice within the primary care setting is explored through a hypothetical patient scenario, which was created as the focal point for three articles that illustrate principles of evidence-based practice. The goal of this series of articles is to provide a basic understanding of evidence-based practice and its application in clinical practice. This article explores the use of interventions selected from CPGs and investigates the potential effects of recommended interventions on patient outcomes. Commonly encountered statistical concepts are reviewed, and examples of their application in interpreting and reporting research are demonstrated. The principles of relative risk, relative risk reduction, absolute risk reduction, and numbers needed to treat are described. This review provides the NP with some basic skills to determine both the quality and usefulness of research. [source] The role of selective digestive decontamination for reducing infection in patients undergoing liver transplantation: A systematic review and meta-analysis,LIVER TRANSPLANTATION, Issue 7 2004Nasia Safdar Selective digestive decontamination (SDD) refers to the use of antimicrobials to reduce the burden of aerobic gram-negative bacteria and/or yeast in the intestinal tract to prevent infections caused by these organisms. Liver transplant patients are highly vulnerable to bacterial infection particularly with gram-negative organisms within the first month after transplantation, and SDD has been proposed as a potential measure to prevent these infections. However, the benefit of this procedure remains controversial. We undertook a systematic review and meta-analysis to determine whether SDD is beneficial in reducing infections overall and those caused by gram-negative bacteria in patients following liver transplantation. All studies that evaluated the efficacy of SDD in liver transplant patients were included. Randomized trials that included liver transplant patients given SDD versus either placebo or no treatment or minimal treatment (e.g., oral nystatin alone), and that provided adequate data to calculate a relative risk ratio, were included in the meta-analysis. Our review shows that most studies found SDD to be effective in reducing gram-negative infection. The nonrandomized and uncontrolled trials also showed benefit with SDD in reducing overall infection; however, the effect on overall infection was limited in the 4 randomized trials, in which the pooled relative risk was 0.88 (95% CI, 0.7-1.1), indicating no statistically significant reduction in infection with the use of SDD. The summary risk ratio for the association between SDD and gram-negative infection was 0.16 (95% CI, 0.07-0.37), indicating an 84% relative risk reduction in the incidence of infection caused by gram-negative bacteria in patients receiving SDD in randomized trials. In conclusion, the available literature supports a beneficial effect of SDD on gram-negative infection following liver transplantation; however, the risk of antimicrobial resistance must be considered. Larger multicenter randomized trials in this patient population to assess the effect of SDD in reducing infection and mortality, while assessing the risk of antimicrobial resistance, are needed. (Liver Transpl 2004;10:817,827.) [source] A small dose of droperidol decreases postoperative nausea and vomiting in adults but cannot improve an already excellent patient satisfactionACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 4 2001A. Hechler Background: We evaluated whether or not 1) a routine prophylaxis with 20 ,g ,· ,kg,1 body weight of droperidol would efficiently prevent postoperative nausea and vomiting (PONV) after elective surgery in adults and 2) an efficient prophylaxis would improve patient satisfaction. Methods: With approval of the local ethics committe and after having obtained informed written consent, 1334 patients in a randomised, single-blinded fashion either received droperidol (group 1, n=665) or saline intravenously (group 2, n=669) 20 min before the end of a standard O2/N2O/fentanyl/isoflurane anaesthesia of at least 30 min duration. End points: incidence of PONV during the first 24 h; individual episodes of nausea or vomiting, overall patient satisfaction with the procedure. Results: Compared to saline, intravenous injection of droperidol substantially and significantly reduced the incidence of PONV from 30% to 20% (P<0.0001). Women suffered three times more frequently from PONV (10.5% vs. 30%, P<0.0001). Droperidol significantly reduced the incidence of PONV from 35.4% to 24.4% in women (relative risk reduction: 31%, P=0.0002), but not in men (13.1% vs. 8.2%, relative risk reduction: 37%, P=0.159) , without impact on overall patient satisfaction (98.8% vs. 97.1%, P=0.439). Distribution of surgical procedures, sex, age, height, weight and anaesthetic duration were not different between groups. To prevent one woman from suffering PONV, nine had to be treated prophylactically at an individual drug cost (German prices) of about 0.80 per woman. Conclusion: Routine PONV prophylaxis with 20 ,g ,· ,kg,1 body weight of droperidol is cost-efficient and appropriate in women but not in men. [source] Early intervention of recent onset mild persistent asthma in children aged under 11 yrs: the Steroid Treatment As Regular Therapy in early asthma (START) trialPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 2006Yu-Zhi Chen Inhaled corticosteroids are known to be effective in persistent asthma, but their long-term effect in mild persistent disease of recent onset, which is particularly relevant in children, requires clarification. The objective of this study was to determine the long-term efficacy of regular inhaled low-dose budesonide in children aged <11 yrs with mild persistent asthma with onset within 2 yrs of enrollment. Children aged 5,10 yrs formed part of the population of the inhaled Steroid Treatment As Regular Therapy in early asthma (START) study, and they were randomized in a double-blind manner to treatment with once daily budesonide 200 ,g or placebo via TurbuhalerTM in addition to usual clinical care and other asthma medication. The double-blind treatment phase continued for 3 yrs. Of the 1974 children, 1000 in the budesonide group and 974 in the placebo group, were analyzed for efficacy. Addition of once-daily budesonide to usual care was associated with a significant increase in the time to first severe asthma-related event (SARE) and significantly reduced risk of SARE over 3 yrs. The hazard ratio relative to usual care (placebo) was 0.60 (95% confidence interval: 0.40,0.90; p = 0.012), with a relative risk reduction of 40%. Children receiving budesonide also needed significantly less intervention with other inhaled corticosteroids (12.3% vs. 22.5% over 3 yrs; p < 0.01), with trends towards decreased usage of oral/systemic corticosteroids and inhaled short-acting ,2 -agonists. Budesonide treatment also had a significant beneficial effect on lung function relative to placebo. In conclusion, early intervention adding once-daily budesonide to usual care in children with mild, persistent asthma of recent onset reduces the long-term risk and frequency of SAREs and improves lung function compared with usual care alone. [source] A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2007Charles M. Gerrits PharmD Abstract Background Recent studies have raised concerns about potential increased cardiovascular (CV) risk in type 2 diabetes patients treated with some peroxisome proliferator-activated receptor gamma (PPAR-gamma) agonists. Objective To ascertain the risk of hospitalization for acute myocardial infarction (AMI) in type 2 diabetes patients treated with pioglitazone relative to rosiglitazone. Methodology Using data covering 2003,2006 from a large health care insurer in the US, a retrospective cohort study was conducted in patients who initiated treatment with pioglitazone or rosiglitazone. The hazard ratio (HR) of incident hospitalization for AMI after initiation of treatment with these drugs was estimated from multivariate Cox's proportional hazards survival analysis; similarly, the HR was ascertained for hospitalization for the composite endpoint of AMI or coronary revascularization (CR). Results A total of 29,911 eligible patients were identified in the database; 14,807 in the pioglitazone and 15,104 in the rosiglitazone group. Baseline demographics, medical history, and dispensed medications were generally well balanced between groups. The unadjusted HR for hospitalization for AMI was 0.82, 95%CI: 0.67,1.01. After adjustment for baseline covariates the HR was 0.78, 95%CI: 0.63,0.96. The adjusted HR for the composite of AMI or CR was 0.85, 95%CI: 0.75,0.98. Conclusion This retrospective cohort study showed that pioglitazone, in comparison with rosiglitazone, is associated with a 22% relative risk reduction of hospitalization for AMI in patients with type 2 diabetes. Copyright © 2007 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 8 2007Article first published online: 23 JUL 200 Lamotrigine for partial, valproate for generalised A large UK trial has shown that lamotrigine is the most effective choice in the treatment of partial epilepsy (Lancet 2007;369: 1000-15). The SANAD trial, commissioned by the National Institute for Health Research's Health Technology Assessment programme, randomised 1721 patients (for whom carbamazepine monotherapy would have been the treatment of choice) to treatment with carbamazepine, gabapentin, lamotrigine, oxcarbazepine (Trileptal) or topiramate (Topamax). Lamotrigine was associated with a longer time to treatment failure, though time to 12-month remission favoured carbamazepine. Over four years' follow-up, lamotrigine was numerically but not significantly superior. The authors concluded lamotrigine is clinically superior to carbamazepine for partial epilepsy A second arm of the trial, yet to be published, evaluated the treatment of generalised epilepsy and found valproate to be clinically most effective, though topiramate was cost effective for some patients. Chronic pain common in nursing homes Most residents in nursing homes say they have long- term pain but only one in seven say a health professional has ever discussed its treatment with them, according to a report by the Patients' Association (www.patients-association.org.uk). Pain in Older People ,A Hidden Problem was a qualitative study of 77 older residents in care homes in England. Most were frail and suffered long-term illness. The study found that 85 per cent of residents said they were often troubled by aches or pains and these lasted over a year in 74 per cent. Most described their pain as moderate (33 per cent) or severe (38 per cent) but 8 per cent said it was excruciating. Many reported limitations on mobility and social activities despite a high level of stoicism. All but one were taking medication to relive pain; one-third experienced adverse effects but 78 per cent believed drugs offered the most effective treatment. One-quarter said a doctor or nurse had discussed how to stop their pain worsening, and 15 per cent said they had discussed how to treat their pain. Visits from GPs appeared to be uncommon. Atherothrombotic events despite treatment Between one in five and one in seven of high-risk patients experience atherothrombotic events despite evidence-based treatment, the REACH study has shown (J Am Med Assoc 2007;297:1197-1206). REACH (REduction of Atherothrombosis for Continued Health) is an international observational study involving 68 236 patients with atherothrombotic disease or at least three risk factors. Most were taking conventional evidence-based medication. After one year, the incidence of the combined endpoint of cardiovascular death, myocardial infarction, stroke or hospitalisation for atherothrombotic events was approximately 15 per cent for patients with coronary artery disease or cardiovascular disease, and 21 per cent in patients with peripheral artery disease and established coronary disease. Event rates increased with the number of vascular beds affected, rising to 26 per cent in patients with three symptomatic arterial disease locations. Extended CD prescribing by nurses and pharmacists The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on expanding the prescribing of controlled drugs (CDs) by nonmedical prescribers. Currently, nurse independent prescribers can prescribe 12 CDs, including diamorphine and morphine, but pharmacist independent prescribers may not prescribe any CDs. The proposal is to allow both professions to prescribe any CDs within their competence, with the exception of cocaine, diamorphine or dipipanone for the management of addiction. The closing date for consultation is 15 June. Consultation is also underway on expanding the range of CDs nurses and pharmacists can prescribe under a patient group direction (PGD), and their use for pain relief. The closing date for consultation is 20 April. Intrinsa: transdermal testosterone for women A transdermal formulation of testosterone has been introduced for the treatment of low sexual desire associated with distress in women who have experienced an early menopause following hysterectomy involving a bilateral oophorectomy and are receiving concomitant oestrogen therapy. Manufacturer Procter & Gamble says that Intrinsa, a twice-weekly patch, delivers testosterone 300µg every 24 hours, achieving premenopausal serum testosterone levels. Clinical trials showed that Intrinsa reduced distress in 65-68 per cent and increased satisfying sexual activity in 51-74 per cent of women. A month's treatment (eight patches) costs £28.00. Fish oil for secondary ,not primary ,prevention of CHD Supplementing statin therapy with eicosapentaenoic acid (EPA) reduces the risk of major coronary events in patients with coronary heart disease (CHD) ,but not in patients with no history of CHD Lancet 2007;369:1090-8). The five-year study in 18 645 patients with total cholesterol levels of 6.5mmol per litre or greater found that the incidence of sudden cardiac death, fatal and nonfatal myocardial infarction in CHD patients treated with EPA plus a statin was 8.7 per cent compared with 10.7 per cent with a statin alone (relative risk reduction 19 per cent). A similar relative risk reduction in patients with no CHD was not statistically significant. There was no difference in mortality between the groups but EPA did reduce unstable angina and nonfatal coronary events. Department pilots information prescriptions The Department of Health has announced 20 sites to pilot information prescriptions prior to a nationwide roll-out in 2008. The prescriptions will guide people with long-term conditions such as diabetes and cancer to sources of support and information about their condition. The Department hopes the project will increase patients' understanding of their discussions with health professionals, empower them to locate the information they need, and provide long-term support. NPSA guidelines for safer prescribing The National Patient Safety Agency (www.npsa.nhs.uk) has published five guidelines to improve medication safety in the NHS. Targeting ,high-risk issues', the guidance covers anticoagulant prescribing, liquid medicines for oral or enteral administration, injectable medicines, epidural injections and infusions, and paediatric intravenous infusions. The implementation of each guide is supported by additional tools and resources. Better adherence not matched to outcomes A systematic review has found that interventions can increase adherence to prescribed medication but there is no evidence that clinical outcomes also improve (Arch Intern Med 2007;167:540-9). The review of 37 trials identified 20 reporting increased adherence. The most effective interventions were behavioural changes to reduce dose demands and those involving monitoring and feedback. Improvements in clinical outcomes were variable and did not correspond to changes in adherence. Antidepressant plus mood stabiliser no better US investigators have found that combining a mood stabiliser with an antidepressant is no more effective than a mood stabiliser alone in preventing mood changes (N Engl J Med 2007; published online 28 March, doi.10.1056/NEJMoa064135). The study found durable recovery occurred in 23.5 per cent of patients treated with a mood stabiliser and adjunctive antidepressant therapy for six months compared with 27.3 per cent of those taking a mood stabiliser plus placebo. [source] Ondansetron has similar clinical efficacy against both nausea and vomitingANAESTHESIA, Issue 2 2009R. M. Jokela Summary Ondansetron is widely believed to prevent postoperative vomiting more effectively than nausea. We analysed data from 5161 patients undergoing general anaesthesia who were randomly stratified to receive a combination of six interventions, one of which was 4 mg ondansetron vs placebo. For the purpose of this study a 20% difference in the relative risks for the two outcomes was considered clinically relevant. Nausea was reduced from 38% (969/2585) in the control to 28% (715/2576) in the ondansetron group, corresponding to a relative risk of 0.74, or a relative risk reduction of 26%. Vomiting was reduced from 17% (441/2585) to 11% (293/2576), corresponding to a relative risk of 0.67, or a relative risk reduction of 33%. The relative risks of 0.67 and 0.74 were clinically similar and the difference between them did not reach statistical significance. We thus conclude that ondansetron prevents postoperative nausea and postoperative vomiting equally well. [source] Balancing absolute and relative risk reduction in tobacco control policy: the example of antenatal smoking in Victoria, AustraliaAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2010Nathan Grills Abstract Objective: This descriptive epidemiological analysis aims to explore the benefits, risks and policy balance between a whole-of-population and high-risk reduction approach to reducing antenatal smoking prevalence. Methods: Using Victorian hospital antenatal statistics the rate-ratio for smoking in each hypothesised high prevalence group was calculated and combined with the absolute number of births in each high-risk group. The effect on smoking prevalence of whole-of-population reductions and high-risk group reductions was then modelled. Results: In Victoria, there were higher rates of antenatal smoking among single [RR = 4.67 (3.46,4.42)], teenage women [RR (95%CI) = 3.26 (3.00,3.54)] of indigenous ethnicity [RR = 4.39 (3.94, 4.88)] with low income [RR = 4.67 (4.17,5.22)] and low education attainment [RR = 3.89 (3.47,4.36)] who lived in less accessible areas [RR = 2.14 (1.92,2.39)]. However, as each of these high-risk groups represents a relatively small proportion of mothers, most antenatal smokers are aged 25,34, educated, city-based, non-Indigenous and non-impoverished. Conclusions: The majority of Victorian women who smoke in pregnancy do not belong to traditional high-risk groups. Implications: Absolute reductions in smoking prevalence in high-risk groups can potentially be achieved by whole-of-population prevalence reductions, despite a potential continuance in high relative risk among these groups. Conversely, an exclusive focus on smoking reduction in high-risk groups may fail to reduce the whole-of-population antenatal smoking prevalence. [source] Some Methods of Propensity-Score Matching had Superior Performance to Others: Results of an Empirical Investigation and Monte Carlo simulationsBIOMETRICAL JOURNAL, Issue 1 2009Peter C. Austin Abstract Propensity-score matching is increasingly being used to reduce the impact of treatment-selection bias when estimating causal treatment effects using observational data. Several propensity-score matching methods are currently employed in the medical literature: matching on the logit of the propensity score using calipers of width either 0.2 or 0.6 of the standard deviation of the logit of the propensity score; matching on the propensity score using calipers of 0.005, 0.01, 0.02, 0.03, and 0.1; and 5 , 1 digit matching on the propensity score. We conducted empirical investigations and Monte Carlo simulations to investigate the relative performance of these competing methods. Using a large sample of patients hospitalized with a heart attack and with exposure being receipt of a statin prescription at hospital discharge, we found that the 8 different methods produced propensity-score matched samples in which qualitatively equivalent balance in measured baseline variables was achieved between treated and untreated subjects. Seven of the 8 propensity-score matched samples resulted in qualitatively similar estimates of the reduction in mortality due to statin exposure. 5 , 1 digit matching resulted in a qualitatively different estimate of relative risk reduction compared to the other 7 methods. Using Monte Carlo simulations, we found that matching using calipers of width of 0.2 of the standard deviation of the logit of the propensity score and the use of calipers of width 0.02 and 0.03 tended to have superior performance for estimating treatment effects (© 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Adherence level of antihypertensive agents in coronary artery diseaseBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 1 2010Sylvie Perreault WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Non-adherence is probably an important source of preventable cardiovascular morbidity and mortality. , However, until now there have been very few large effectiveness studies assessing the relationship between adherence levels to antihypertensive medication and major cardiovascular outcomes for primary prevention of cardiovascular disease. WHAT THIS STUDY ADDS , The study results suggest that there is an association between better adherence to antihypertensive agents and a relative risk reduction of coronary artery disease. , Adherence to antihypertensive agents needs to be improved so that patients can benefit from the full protective effects of antihypertensive therapies. AIMS Antihypertensive (AH) agents have been shown to reduce the risk of cardiovascular events, including coronary artery disease (CAD). Previous surveys have shown that a substantial number of patients with diagnosed hypertension remain uncontrolled. Non-adherence to AH agents may reduce the effectiveness. The aim was to evaluate the impact of better adherence to AH agents on the occurrence of CAD in a real clinical setting. METHODS A cohort of 83 267 patients was reconstructed using the Régie de l'assurance maladie du Québec databases. Patients were eligible if they were between 45 and 85 years of age without indication of cardiovascular disease, and had been newly treated with AH agents between 1999 and 2004. A nested case,control design was used to study the incidence of CAD. Every case of CAD was matched for age and duration of follow-up to up to 15 randomly selected controls. The adherence level was measured by calculating the medication possession ratio. Cases' adherence was calculated from the start of follow-up to the time of the CAD (index date). For controls, adherence was calculated from the start of follow-up to the time of selection (index date). Rate ratios of CAD were estimated by conditional logistic regression adjusting for covariables. RESULTS The mean patient age was 65 years, 37% were male, 8% had diabetes and 18% had dyslipidaemia. High adherence level (96%) to AH therapy compared with lower adherence level (59%) was associated with a relative risk reduction of CAD events (rate ratios 0.90; 0.84, 0.95). Risk factors for CAD were male gender, diabetes, dyslipidaemia and developing a cardiovascular condition disease during follow-up. CONCLUSION Our study suggests that better adherence to AH agents is associated with a risk reduction of CAD. Adherence to AH agents needs to be improved so that patients can benefit from the full protective effects of AH therapies. [source] Risks and benefits of continued aggressive statin therapyCLINICAL CARDIOLOGY, Issue S3 2003Antonio M. Gotto Jr. M.D., D.PHIL Abstract The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins, are a well-tolerated, effective class of medications for the reduction of low-density lipoprotein cholesterol (LDL-C) and total cholesterol levels. Extensive data from clinical trials demonstrate that these agents reduce fatal and nonfatal cardiovascular risk in primary and secondary prevention patients, including women and the elderly. A threshold value for LDL-C reduction below which there is no further clinical benefit has not yet been identified. In the Heart Protection Study (HPS), significant relative risk reduction occurred even among patients with LDL-C levels < 2.6 mmol/l (100 mg/dl). Statin therapy also produced reductions in cardiovascular disease in a wide range of high-risk patients regardless of baseline cholesterol levels. Rhabdomyolysis, typically defined as muscle pain or weakness associated with creatine kinase levels higher than 10 times the upper limit of normal and the presence of myoglobulinuria, is a rare but potentially serious complication of statins. Although dose-dependent transaminase elevations occur in 0.5 to 2% of cases, it has not been determined whether these elevations qualify as true drug-related hepatotoxicity. Management of myopathy and elevated transaminases is addressed in a joint publication from the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Heart, Lung, and Blood Institute (NHLBI). Because statins have significant potential benefits and a low risk for serious adverse effects, aggressive therapy should be considered in patients at high risk for coronary heart disease. [source] Vaccines modulating lipoprotein autoimmunity as a possible future therapy for cardiovascular diseaseJOURNAL OF INTERNAL MEDICINE, Issue 3 2009J. Nilsson Abstract. Current strategies for prevention of cardiovascular disease focus on risk factor intervention. Although these have been proven both safe and effective results from randomized clinical trials suggest that it is difficult to achieve relative risk reductions exceeding 40% with this approach. To further improve efficacy future therapies must aim at targeting the actual disease process in the arterial wall. Emerging evidence have identified an important role of the immune system in atherosclerosis and suggest that modulation of autoimmune responses against oxidized LDL and other antigens in the atherosclerotic plaque represent one possible new approach to disease prevention. Oxidized LDL is targeted by both antibody-mediated and cellular immune responses and as much as 10% of the T cells in atherosclerotic plaques are oxidized LDL-specific. Immune activation in the atherosclerotic plaque is primarily of the pro-inflammatory Th1-type and inhibition Th1 immunity reduces atherosclerosis in experimental animals. Atherosclerosis vaccines based on antigens derived from LDL have been developed to modulate these processes. Their mechanisms of action remain to be full characterized but may involve expression of protective antibodies that facilitate the removal of oxidized LDL and antigen-specific regulatory T cells that counteract Th1 autoimmunity against oxidized LDL. In this review we will discuss the possibilities and challenges encountering the translation of immune-modulatory therapy for atherosclerosis from the experimental stage into the clinic. [source] | |||||||||||||||||||||||||