Cardio Trial Files Throwback Thursday: Carvedilol vs. Metoprolol in HFrEF, Fibrate Add-On to Statins in T2DM, and Spironolactone for Resistant HTN
Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure (COMET)
Poole-Wilson PA et al. The Lancet (July 2003)
Bottom Line: This randomized, double-blind, parallel-group trial enrolled 3029 patients with chronic heart failure, a previous cardiovascular admission, an ejection fraction of less than 0.35, and to have been treated optimally with diuretics and angiotensin-converting enzyme inhibitors unless not tolerated. The primary endpoints were all-cause mortality and the composite endpoint of all-cause mortality or all-cause admission. Patients were assigned to receive carvedilol (target dose 25 mg twice daily) or metoprolol (target dose 50 mg twice daily). The mean study duration was 58 months and the mean age of participants was 62 years. All-cause mortality was significantly lower in the carvedilol group (34% vs 40%, hazard ratio 0.83, 95% CI 0.74-0.93, p=0.0017). The composite endpoint of mortality or all-cause admission was not significantly different between the two groups (0.94, 95% CI 0.86-1.02, p=0.122). Incidence of side effects and drug withdrawals did not differ by much between the two study groups.
Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus
ACCORD Study Group et al. NEJM (April 2010)
Bottom Line: This randomized, double-blind, placebo-controlled study of 5518 patients with type 2 diabetes mellitus compared the effects of combination therapy with a statin plus a fibrate versus statin monotherapy. The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. Mean follow-up was 4.7 years. The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32). Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (hazard ratio, 0.91; 95% CI, 0.75 to 1.10; P=0.33). In conclusion, the combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke, as compared with simvastatin alone.
Spironolactone versus placebo, bisoprolol, and doxazosin to determine the optimal treatment for drug-resistant hypertension (PATHWAY-2)
Williams B et al. The Lancet (September 2015)
Bottom Line: This double-blind, placebo-controlled, crossover trial enrolled 285 patients aged 18-79 years with resistant hypertension, who were rotated in a preassigned, randomized order of 12-week periods of spironolactone (25-50 mg), bisoprolol (5-10 mg), doxazosin modified release (4-8 mg), and placebo, in addition to their baseline blood pressure drugs. The average reduction in home systolic blood pressure by spironolactone was superior to placebo, the mean of the other two active treatments, and each of the other two drugs. All treatments were well tolerated, with six of the 285 patients who received spironolactone having serum potassium exceeding 6·0 mmol/L on one occasion. The results suggest that spironolactone is the most effective add-on drug for the treatment of resistant hypertension, supporting a primary role of sodium retention in this condition.
Cardio Trial Files Issue #CRD-2024-17
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