Cardio Trial Files Throwback Thursday: Dabigatran vs. Warfarin in AFib, Eplerenone in HFrEF, and Canakinumab in Patients with Previous MI
Dabigatran versus Warfarin in Patients with Atrial Fibrillation
Connolly SJ et al. NEJM (September 2009)
Bottom Line: This randomized, noninferiority trial included 18,113 patients with atrial fibrillation and a risk of stroke who were assigned to receive either dabigatran (110 mg or 150 mg twice daily) or warfarin in a blinded and unblinded fashion, respectively. The median follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Dabigatran 110 mg was noninferior to warfarin, and dabigatran 150 mg was superior to warfarin. Major bleeding rates were lower with dabigatran 110 mg compared to warfarin, and similar between dabigatran 150 mg and warfarin. Hemorrhagic stroke rates were significantly lower with both doses of dabigatran compared to warfarin. Mortality rates were similar between both dabigatran 110 mg and warfarin, and dabigatran 150 mg compared to warfarin.
Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms
Zannad F et al. NEJM (January 2011)
Bottom Line: This randomized, double-blind trial evaluated the effects of eplerenone vs. placebo on 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% over a median follow-up period of 21 months. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure, which occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% CI, 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008). Serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001).
Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease
Ridker PM et al. NEJM (September 2017)
Bottom Line: This randomized, double-blind trial of 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary endpoint was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. At a median follow-up of 3.7 years, only the 150-mg dose of canakinumab led to a significantly lower rate of the primary endpoint than placebo (hazard ratio 0.85, 95% CI 0.74 to 0.98, P=0.021). Canakinumab was associated with a higher incidence of fatal infection than placebo, but there was no significant difference in all-cause mortality (hazard ratio 0.94, 95% CI 0.83 to 1.06, P=0.31).
Cardio Trial Files Issue #CRD-2024-19
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