Faiez Zannad, M.D., Ph generic levitra canada .D., John J.V. McMurray, M.D., Henry Krum, M.B., Ph.D., Dirk J. Van Veldhuisen, M.D., Ph.D., Karl Swedberg, M.D., Ph.D., Harry Shi, M.S., John Vincent, M.B., Ph.D., Stuart J. Pocock, Ph.D., and Bertram Pitt, M.D. For the EMPHASIS-HF Study Group: Eplerenone in Sufferers with Systolic Heart Failing and Mild Symptoms The activation of mineralocorticoid receptors by cortisol and aldosterone has deleterious effects in patients with cardiovascular disease.1 In the placebo-controlled Randomized Aldactone Evaluation Study ,2 adding the mineralocorticoid-receptor antagonist spironolactone to recommended therapy in sufferers with systolic heart failure and moderate-to-severe symptoms decreased the death rate from any cause and the chance of hospitalization for cardiovascular factors.
If noninferiority was set up for the primary efficacy final result, the secondary efficacy result would be tested for noninferiority by using a prespecified margin in which the maximum worth for the higher limit of the 95 percent confidence interval for relative risk was 1.5. Finally, if apixaban fulfilled the prespecified requirements for noninferiority with respect to both the principal and secondary efficacy outcomes, we would check for superiority using Pearson’s chi-square test. This sequential testing method maintained the one-sided alpha level at 0.025. We estimated that assigning 4022 individuals in a 1:1 ratio to apixaban or enoxaparin would supply the study 92 percent capacity to establish noninferiority with respect to the major efficacy outcome , assuming true event prices of 3.85 percent with apixaban and 5.50 percent with enoxaparin, and 80 percent capacity to establish noninferiority with regards to the secondary efficacy outcome .