Despite a reassuring overall short-term risk, we could neither refute nor verify that individual anti-TNF therapies affect the short-term clinical emergence of cancer. Despite representing the best available evidence, statistical precision, and differences in baseline cancer risk and reporting detail between trials of adilumumab, etanercept, and infliximab hampered distinction of drug-specific from trial effects, illustrating the challenges in safety-assessments using RCT meta-analyses. Long-term risk assessment requires observational studies.
Objectives: To quantify the incidence of major adverse events (AEs) occurring in hospital or within 30 days after surgery in patients undergoing coronary artery bypass graft (CABG) surgery and to identify risk factors for these AEs. Methods: Systematic review and analysis of studies published in English since 1990. Studies of isolated standard CABG reporting postoperative incidence of myocardial infarction (MI), stroke, gastrointestinal bleeding, renal failure, or death in hospital or within 30 days were eligible for inclusion. Incidence of these events was calculated overall and for selected patient groups defined by all elective CABG versus mixed (some non-elective); mean ejection fraction < 50% versus > 50%; mean age < 60 versus > 60 years; primary CABG versus some reoperations; randomised controlled trials versus cohort studies; and single centre versus multicentre studies. Odds ratios of selected AEs were computed according to group risk factors. Results: 176 studies (205 717 patients) met all inclusion criteria. The average incidence of major AEs occurring in-hospital was death (1.7%); non-fatal MI (2.4%); non-fatal stroke (1.3%); gastrointestinal bleeding (1.5%); and renal failure (0.8%). Thirty day mortality was 2.1%. Meta-analyses show that age > 70, female sex, low ejection fraction, history of stroke, MI, or heart surgery, and presence of diabetes or hypertension are all associated with increased 30 day mortality after CABG. Conclusion: The incidence of major AEs in patients after CABG varies widely across studies and patient populations, and this heterogeneity must be controlled when using the literature to benchmark safety.
Objective: To determine the risk of cardiovascular events and death in patients receiving statin treatment for cholesterol regulation.Methods: Systematic review and meta-analysis of all randomized controlled trials that were published as of April 15, 1997. Primary or secondary prevention trials or regression trials were eligible.Main Outcome Measures: All-cause mortality, fatal myocardial infarction (MI) or stroke, nonfatal MI or stroke, angina, and withdrawal from the studies. Both random-and fixed-effects models were run for the outcomes of interests, and results are expressed as odds ratios (ORs). Sensitivity analyses tested the impact of the study type and duration, statin treatment type, and control arm event rates. Intent-to-treat denominators were used whenever they were available, and the number needed to treat was calculated when appropriate.Results: Seventeen studies (21 303 patients) were included (2 secondary prevention studies, 5 mixed primarysecondary prevention population studies, and 10 regression trials). Treatment groups included lovastatin (t = 5), pravastatin (t = 10), and simvastatin (t = 3). For all-cause mortality, the OR was 0.76 (95% confidence interval [CI], 0.67-0.86) in favor of receiving statin treatment; for fatal MI, the OR was 0.61 (95% CI, 0.48-0.78); for nonfatal MI, the OR was 0.69 (0.54-0.88); for fatal stroke, the OR was 0.77 (95% CI, 0.57-1.04); for nonfatal stroke, the OR was 0.69 (95% CI, 0.54-0.88); and for angina, the OR was 0.70 (95% CI, 0.65-0.76). Conclusions:Patients who received statin treatment demonstrated a 20% to 30% reduction in death and major cardiovascular events compared with patients who received placebo. This advantage was generally present across study types and statin treatment types and for patients with less severe dyslipidemias. The benefit in clinical outcomes was noticeable as early as 1 year.
Bisphosphonate drugs for treating osteoporosis are excreted by the kidney. However, many of the major trials on efficacy and safety of the bisphophonates for treating osteoporosis excluded patients with significant renal compromise. Since both osteoporosis and renal insufficiency become more prevalent with age, it seems prudent for physicians to be aware of the prevalence of renal dysfunction in patients with osteoporosis who are candidates for treatment with bisphosphonates. Data on 13,831 men and women aged 20+ from the Third National Health and Nutrition Examination Survey, 1988-1994 (NHANES III) were used to study the occurrence of compromise in renal clearance function in men and women with osteopenia and osteoporosis. To estimate creatinine clearance (CCr), a measure of renal function, serum creatinine (sCr), weight and age were inserted into the Cockcoft-Gault (C-G) formula. The World Health Organization gender specific bone mineral density (BMD) cut-offs were used to define the populations with osteopenia and osteoporosis. For women ages 20-80+ with osteoporosis, the percent prevalence (95% CI) for mild to moderate compromise of CCr =60 ml/min is estimated to be 85% (79%, 91%) and for severe renal compromise of CCr <35 ml/min to be 24% (19%, 29%). In women with osteoporosis and severe compromise, the age specific prevalence is negligible through ages 50-59 and then rises steeply to 54% (46%, 62%) for ages 80+. Similarly, in women with osteopenia and severe renal compromise, the age specific prevalence is also negligible through ages 50-59 and then rises to 37% (28%, 45%) for ages 80+. Lower prevalence estimates hold for men with about 11% of men with osteoporosis having severe renal compromise as compared to 24% for women. These data suggest that there is a substantial prevalence of candidates for treatment of osteoporosis and osteopenia who have significant renal compromise but for whom there is a dearth of clinical trial data on the impact of treatment.
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