The relevance of subgroup-specific treatment effects: The Studies Of Left Ventricular Dysfunction (SOLVD) revisited

摘要: Abstract Background The overall effect sizes estimated from randomized clinical trials may not apply similarly to all patients. Univariate subgroup analyses are often used help determine the generalizability of a trial's results, but themselves be misleading. We reanalyzed Studies Left Ventricular Dysfunction (SOLVD) whether treatment depended on patients' baseline prognosis, defined basis multiple variables. Methods SOLVD prevention (4228 patients) and (2569 were randomized, double-blind that studied enalapril in patients with reduced left-ventricular function or congestive heart failure. combined both populations compared results univariate analysis multivariate approach which 3 patient subgroups according risks for end point death hospitalization Results Enalapril resulted 24% fewer events. strongest predictors an event ejection fraction, New York Heart Association classification age, antiplatelet agents, history diabetes mellitus, digoxin diuretics, race. Only fraction produced significant interaction ( P =.004). Consistent original reports, this was also demonstrable when scaled into tertiles examined its own =.012). However, there no present divided multifactorial risk. Conclusions confirmed enalapril, impact systolic function, negative prognostic importance mellitus population. Although led subgroup-treatment main publications, grouping abolished interaction. These findings highlight limitations illustrate risk group complementary method assessing effects observed trials. (Am J 2002;144:941-7.)