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Combined Incidence (combined + incidence)
Selected AbstractsSafety of nevirapine in pregnancyHIV MEDICINE, Issue 1 2007U Natarajan Background Nevirapine has been widely used in pregnancy for its efficacy, low pill burden, bioavailability and rapid transplacental transfer. Concern about nevirapine toxicity during pregnancy has emerged over recent years. Objectives The aims of the study were to document the frequency of cutaneous and hepatic toxicity secondary to nevirapine use during pregnancy and to compare rates in women starting nevirapine during the current pregnancy with those in women who had commenced nevirapine prior to the current pregnancy. Design This was a retrospective, comparative, five-centre study carried out in London, UK, in 1997,2003. Methods All HIV-1-infected women who received nevirapine as part of combination antiretroviral therapy (ART) during pregnancy were included in the study. Data on demographics, HIV infection risk, Centers for Disease Control and Prevention (CDC) status, surrogate markers at initiation of therapy, other medications hepatitis B and C virus coinfection and clinical data relating to potential toxicity were collated and analysed. Results Fifteen of 235 eligible women (6.4%) developed rash and eight (3.4%) developed hepatotoxicity, including four with coexistent rash, giving a combined incidence of 19 potential cases of nevirapine toxicity during pregnancy (8.1%). Alternative causes of rash/hepatotoxicity were suspected in seven cases and only 10 mothers (5.8%) discontinued nevirapine. Of the 170 women who commenced nevirapine during this pregnancy, 13 (7.6%) developed rash and eight (4.7%) hepatotoxicity, a combined incidence of 10%. Only two of 65 women with nevirapine exposure prior to this pregnancy developed rash (3.1%). Conclusions Nevirapine-containing ART was well tolerated in this cohort of pregnant women. Although pregnancy did not appear to increase the risk of nevirapine-associated toxicity compared to published adult data, CD4 count may be less predictive of toxicity in pregnancy. [source] Exercise is Superior to Pacing for T Wave Alternans Measurement in Subjects with Chronic Coronary Artery Disease and Left Ventricular DysfunctionJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 9 2002ERIC J. RASHBA M.D. Exercise vs Pacing for TWA Measurement.Introduction: T wave alternans (TWA) is a heart rate-dependent marker of vulnerability to ventricular arrhythmias. Atrial pacing and exercise both are used as provocative stimuli to elicit TWA. However, the prognostic value of the two testing methods has not been compared. The aim of this prospective study was to compare the prognostic value of TWA measured during bicycle exercise and atrial pacing in a large cohort of high-risk patients with ischemic heart disease and left ventricular dysfunction. Methods and Results: This was a prospective study of 251 patients with coronary artery disease and left ventricular dysfunction who were referred for electrophysiologic studies (EPS) for standard clinical indications. Patients underwent TWA testing using bicycle ergometry (exercise TWA, n = 144) and/or atrial pacing (pacing TWA, n = 178). The primary endpoint was the combined incidence of death, sustained ventricular arrhythmias, and appropriate implantable cardioverter defibrillator therapy. The predictive value of exercise and pacing TWA for EPS results and for endpoint events was determined. Exercise and pacing TWA both were significant predictors of EPS results (odds ratios 3.0 and 2.9 respectively, P < 0.02). Kaplan-Meier survival analysis of the primary endpoint revealed that exercise TWA was a significant predictor of events (hazard ratio 2.2, P = 0.03). In contrast, pacing TWA had no prognostic value for endpoint events (hazard ratio 1.1, P = 0.8). Conclusion: TWA should be measured during exercise when it is used for clinical risk stratification. EPS results may not be an adequate surrogate for spontaneous events when evaluating new risk stratification tests. [source] Drug-Eluting Stents Versus Bare Metal Stents Following Rotational Atherectomy for Heavily Calcified Coronary Lesions: Late Angiographic and Clinical Follow-Up ResultsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2007AHMED A. KHATTAB M.D. Objectives: To study the effectiveness of drug-eluting stents following rotablation of severely calcified lesions. Background: Drug-eluting stents are increasingly showing promising results in complex lesions and high-risk patients. Heavily calcified stenoses have not been adequately studied, and form a challenge both for the immediate and late outcomes. Methods: Single-center prospective study among 27 patients treated by rotablation followed by a drug-eluting stent implantation for angiographically heavily calcified lesions, compared with a historical control of 34 patients treated by rotablation followed by bare stent implantation for the same indication. The primary endpoint was the late lumen loss at 9 months; secondary endpoints were binary restenosis and major adverse cardiac events at 9 months. A 2-year follow-up directed to death and myocardial infarction was added. Results: Both groups were comparable regarding baseline and procedural characteristics. Angiographic success was 100% for both groups. At 9 months, there was a significant difference in the late lumen loss (0.11 ± 0.7 mm in the DES group and 1.11 ± 0.9 mm in the BMS group, P = 0.001). This difference was manifest in the clinical event rates at late follow-up (combined incidence of death due to any cause, MI, and TLR was 7.4% in the DES group and 38.2% in the BMS group; P = 0.004). At 2 years, there were 5 deaths in each group (P = 0.5) and 2 infarctions in the BMS group versus none in the DES group (P = 1.0). Conclusion: The combination of rotablation and drug-eluting stent implantation (Rota-DES) has a favorable effect on clinical and angiographic outcomes at 9 months when treating heavily calcified lesions compared to rotablation followed by bare metal stent implantation. No safety concerns are observed at 2 years. [source] GABRA2 and Alcohol Use Disorders: No Evidence of an Association in an Italian Case,Control StudyALCOHOLISM, Issue 4 2010Nicoletta Onori Background:, Alcoholism is a major health and social issue, a highly frequent disease and a cause of premature death. It is also the most expensive addictive disorder being related to high morbidity and mortality, violence, accidents, and social and legal problems. It is a quantitative disorder, where the combined incidence of environmental and multiple genetic factors varies from 1 subject to another. Recent association studies have identified several genes as candidates for alcoholism, including GABAA receptor genes, due to their role in mediating several behavioral effects of alcohol, such as motor incoordination, anxiolysis, sedation, and withdrawal. The proposed association between the 3, half of the gene encoding the alpha-2 subunit of GABA receptor (3,-GABRA2) and alcohol use disorders (AUDs) has received several independent confirmations. Methods:, In this study, 10 single nucleotide polymorphisms (SNPs) of the 3,-GABRA2 gene, previously reported to be implicated in alcohol dependence, were used to evaluate the linkage between selected SNPs and AUDs in an Italian sample and to compare findings with those of previous studies. Results:, No evidence of an association was found at the allele, genotype, haplotype, or diplotype levels between the 3,-GABRA2 polymorphisms investigated and alcoholism in 149 Italian alcoholics (98 alcohol dependents and 51 alcohol abusers) and 278 controls. Conclusions:, Despite previous reports, we did not find an association between AUDs and 3,-GABRA2 polymorphisms. This is probably due to the minimal comorbidity of our Italian sample suggesting that this gene is implicated in polysubstance dependence rather than in alcoholism alone. [source] Effects of stem canker (Leptosphaeria maculans) and light leaf spot (Pyrenopeziza brassicae) on yield of winter oilseed rape (Brassica napus) in southern EnglandPLANT PATHOLOGY, Issue 4 2000Y. Zhou The relationships between yield loss and incidence or severity of stem canker and light leaf spot in winter oilseed rape were analysed by correlation and regression analyses, using data from experiments at Rothamsted, England in 1992/93, 1994/95 and 1995/96. Growth stages (GS) 6,3/6,4 and 4,0/4,5 were identified as the critical points for relating percentage yield loss to stem canker and light leaf spot (on stems), respectively. Critical point (CP) and area under disease progress curve (AUDPC) models relating percentage yield loss to combined incidence or severity of stem canker and light leaf spot (stems) in each experiment were constructed by linear regression. There were no differences in the CP models for incidence between 1992/93, 1994/95 and 1995/96 experiments, or in the AUDPC models for incidence between 1992/93 and 1994/95 experiments. Therefore, a general CP model relating percentage yield loss (,Y) to combined incidence of stem canker (Si) at GS 6,3/6,4 and light leaf spot (stems) (Li) at GS 4,0/4,5 was constructed using data from the three experiments: ,Y = 0·85 + 0·079Si + 0·065Li (R2 = 43·7%, P < 0·001, 92 df). A general AUDPC model relating ,Y to the AUDPC of combined incidence of stem canker (Sia) from GS 5·7 to GS 6·5 and light leaf spot (stems) (Lia) from GS 4·0 to GS 6·3 was constructed using data from the 1992/93 and 1994/95 experiments: ,Y = 0·07 + 0·00096Sia + 0·0026Lia (R2 = 43·6%, P < 0·001, 68 df). These two general yield-loss models were tested with data from Rothamsted in 1993/94 and Boxworth in 1992/93. The predictive accuracy of the CP model based on combined incidence of stem canker and light leaf spot (stems) was better than that of the AUDPC model. Yield losses predicted by summing the estimates from individual models for incidence of stem canker alone (GS 6,3/6,4) and light leaf spot alone (on leaves at GS 3,3) were greater than observed yield losses in experiments at Rothamsted in 1992/93, 1993/94, 1994/95 and 1995/96 and at Boxworth in 1992/93. [source] Latest news and product developmentsPRESCRIBER, Issue 21 2007Article first published online: 3 DEC 200 NSAIDs and SSRIs increase GI bleeding Taking an NSAID and an SSRI increases the risk of GI bleeding more than six-fold compared with taking neither drug, a meta-analysis shows (Aliment Pharmacol Ther online: 5 Oct 2007; doi:10.1111/j.1365-2036.20 07.03541.x). The analysis included four observational studies involving a total of 153 000 patients, and 101 cases reported in postmarketing surveillance. Compared with nonuse, the odds ratio for upper GI haemorrhage in patients taking an SSRI alone was 2.36; the number needed to harm (NNH) was 411 for one year's treatment in patients aged over 50 with no risk factors. For those taking an SSRI and an NSAID, it was 6.33 (NNH 106). Of 22 cases where treatment duration was known, the median time to onset of bleeding was 25 weeks and five occurred within one month. The MHRA warns of this interaction in its latest issue of Drug Safety Update, noting: ,corticosteroids, antiplatelet agents, and SSRIs may increase the risk of GI ulceration or bleeding. NSAIDs may enhance the effects of anticoagulants, such as warfarin'. MHRA warning on NSAID safety The MHRA reminds prescribers of new restrictions on prescribing piroxicam and the risks associated with ketorolac and ketoprofen in its latest Drug Safety Update (2007;1:Issue 3). Treatment with piroxicam should now only be initiated by a specialist as a second-line drug; patients currently taking it should be reviewed at the next routine appointment. Piroxicam is no longer indicated for any acute indications. These restrictions do not apply to topical piroxicam (Feldene gel). Ketorolac and ketoprofen are associated with a higher risk of adverse GI effects than other NSAIDs. The MHRA advises prescribers to adhere to the licensed indications that limit oral ketorolac therapy to seven days (two days for continuous iv or im use) and the maximum dose of ketoprofen to 100-200mg. Inhaled steroids may increase the risk of pneumonia in patients with COPD. In the TORCH study (N Engl J Med 2007;356:775-89), fluticasone (Flixotide) and fluticasone plus salmeterol (Seretide) were associated with a significantly increased risk compared with salmeterol alone. The MHRA recommends vigilance for signs of pneumonia or bronchitis in patients with COPD who are treated with inhaled steroids; affected patients should have their treatment reconsidered. Other issues reviewed in Drug Safety Update include: a more intense reaction after revaccination with the pneumococcal vaccine, Pneumovax II; exacerbation of osteonecrosis of the jaw by dental surgery in patients taking a bisphosphonate; a lower maximum dose for lorazepam (4mg for severe anxiety, 2mg for severe insomnia) rare reactions with botulinum toxin; and the cardiovascular safety and risk of fractures with the glitazones. Antibiotic resistance GPs who reduce their antibiotic prescribing achieve a significant reduction in bacterial resistance, a study from Wales has shown (Br J Gen Pract 2007;57:785-92). The analysis of 164 225 coliform isolates from urine samples submitted from 240 general practices found a 5.2 per cent decrease in ampicillin resistance in practices with the greatest reductions in total antibiotic prescribing. Overall, ampicillin resistance decreased by 1 per cent for every reduction of 50 amoxicillin prescriptions per 1000 patients. Trimethoprim resistance showed a similar trend. Mortality risk with discontinuing statins Patients who discontinue statin therapy after acute stroke are almost three times more likely to die than those who do not, an Italian study shows (Stroke 2007;38:2652-7). Follow-up of 631 patients discharged after acute stroke revealed that 39 per cent discontinued statin therapy. The hazard ratio for all-cause mortality in the first 12 months was 2.78 compared with those who continued treatment; this compared with a hazard ratio of 1.81 for stopping antiplatelet therapy. The authors argue that patient care should be improved during the transition from hospital to outpatient primary care. ACEI ± ARB = ADRs Combining an ACE inhibitor and an angiotensin-II receptor blocker increases the risk of adverse effects in patients with symptomatic left ventricular dysfunction, according to a US study (Arch Intern Med 2007;167:1930-6). Meta-analysis of four trials involving a total of 17 337 patients followed up for about two years showed that, compared with therapy including an ACE inhibitor, combined treatment increased the risk of stopping treatment due to adverse events by 38 per cent in patients with heart failure and by 17 per cent in patients with MI. The authors estimate that, for every 1,000 patients treated, 25 will discontinue treatment due to adverse effects and 17 will develop renal dysfunction. WOSCOPS: statin protection continues Pravastatin reduces the risk of death years after treatment has stopped, according to a follow-up of the WOSCOPS study (N Engl J Med 2007;357:1477-86). The West of Scotland Coronary Prevention Study originally randomised men with hypercholesterolaemia but no history of myocardial infarction (MI) to treatment with pravastatin or placebo. After five years, the combined incidence of death from CHD or nonfatal MI was reduced from 7.9 to 5.5 per cent in the treatment group. During the 10 years after completion of the trial, the incidence of the combined end-point was 8.6 per cent in those originally assigned to pravastatin and 10.3 per cent in the placebo group. All- cause mortality was also reduced over the entire 15-year period. The proportions of patients still taking a statin in the middle of this period, ie five years after the trial ended, were 39 per cent of the placebo group. Prescribing policies on HRT need reappraisal Health authorities should reconsider their policy on prescribing HRT, the International Menopause Society (IMS) says. In an open letter, the IMS says current safety concerns over HRT use are founded, but have been misinterpreted in observational studies, such as the Women's Health Initiative, that led to changes in guidelines. The IMS says HRT is the most effective treatment for vasomotor and urogenital symptoms and the risk:benefit profile is favourable until age 60. Low-dose oestrogen or the transdermal route of administration may lead to a more favourable risk profile. Flu vaccine does cut morbidity and mortality Following The Lancet's commentary doubting the effectiveness of flu vaccination (Lancet Infectious Diseases 2007;7:658-66), a US cohort study has found that it does reduce morbidity and mortality (N Engl J Med 2007;357:1373-81). The observational study included 713 872 person-seasons in older people living in the community over a 10year period from 1990 to 2000. Vaccination was associated with a 48 per cent reduction in the risk of death and a 27 per cent reduction in admission for pneumonia or flu. These benefits changed little in subgroups or with age. Copyright © 2007 Wiley Interface Ltd [source] Outcome of endoscopy surveillance for Barrett's oesophagusANZ JOURNAL OF SURGERY, Issue 11 2009Tim Bright Abstract Background:, Endoscopic surveillance of individuals with Barrett's oesophagus is undertaken to detect early stage oesophageal malignancy. The impact of a surveillance programme on endoscopy resources and disease detection is uncertain. Methods:, In 2004, we commenced a structured Barrett's oesophagus surveillance programme. The surveillance protocol specifies surveillance interval and number of oesophageal biopsies required according to previous endoscopy and biopsy findings. The first 3 years of surveillance were reviewed to assess programme adherence, impact on endoscopy resources and the incidence of high-grade dysplasia and adenocarcinoma in patients undergoing surveillance. Results:, Four hundred five patients were enrolled in the surveillance programme, and 776 patient years of endoscopy follow-up were analysed. Four-quadrant biopsies every 2 cm throughout the Barrett's oesophagus were performed in 89.8% of endoscopies. A total of 93.7% of patients had surveillance endoscopy performed at the appropriate time interval. Formalizing surveillance was followed by a decrease in the mean time interval for endoscopy surveillance from 16 months to 15 months, although the mode endoscopy surveillance interval lengthened from 1 year to 2 years. The mean number of biopsies per endoscopy increased from 5.9 to 7. In four patients, T1 stage oesophageal adenocarcinoma was identified, and in six patients, high-grade dysplasia was identified (combined incidence of adenocarcinoma/high-grade dysplasia 1 per 77.6 endoscopy years of follow-up). Conclusions:, Structured Barrett's surveillance detects malignant progression at an early stage, which provides opportunities for curative surgical or endoscopic intervention. Formalizing surveillance resulted in a high rate of adherence to agreed guidelines and rationalized the use of endoscopy resources without significantly increasing workload. [source] Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents: The TAXi-LATE trialCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2007Alexandre Berger MD Abstract Goal: Analysis of the 3-year outcome of the original population of the TAXi trial which compared the efficacy of the paclitaxel (PES) and the sirolimus (SES) stents in a randomized "real world" investigation. History: The widespread use of drug-eluting stents strongly modified the world of interventional cardiology. The TAXi trial was a randomized comparison between PES and SES and showed similar efficacy between the two prostheses. Recently, emerging discussions raised questions about potential long-term risk with the use of DES. The present work attempts to describe the long-term outcome of the patients compared during the TAXi trial. Method: During April 2003 and January 2004, 202 patients were prospectively randomly assigned to the PES group (102 patients) and to the SES group (100 patients). The primary aim of the present investigation was the comparison of combined incidence of cardiac death, myocardial infarction, and target lesion revascularization within 36-months. Results: No difference in mortality of all causes was noted in the PES and the SES groups (3% vs. 7%, P = 0.98) or in major adverse cardiac event free survival (89% vs. 83%, P = 0.28). Four stent thromboses were observed, two in the PES group (205 and 788 days) and two in the SES group (210 and 772 days). Conclusion: The long-term outcome analysis of the TAXi trial confirms available published data showing the equivalence of PES and SES on clinical basis. © 2007 Wiley-Liss, Inc. [source] | ||||||||||