Randomised comparison of losartan vs. captopril on quality of life in elderly patients with symptomatic heart failure: The losartan heart failure ELITE quality of life substudy

Objective: To measure health-related quality-of-life (HRQoL) in elderly sym ptomatic heart failure patients following treatment with an angiotensin II receptor antagonist (losartan) vs. an angiotensin-converting-enzyme (ACE) i nhibitor (captopril). Methods: Patients (age greater than or equal to 65 ye ars) were randomised to losartan, titrated to 50 mg once daily, or captopri l, titrated to 50 mg three times daily, as tolerated. Sickness Impact Profi le (SIP) and Minnesota Living with Heart Failure (LIhFE) questionnaires wer e administered at baseline, weeks 12 and 48. Composite hypothesis testing o f change in HRQoL from baseline for completers, and withdrawal for unfavour able events (death, clinical/laboratory adverse experience) was used to acc ount for differential dropout rates. Results: In 203 patients completing th e substudy (week 48), significant and comparable improvements in HRQoL from baseline were observed for both treatment groups (p less than or equal to 0.001). Although there was a trend favouring losartan vs. captopril for the composite HRQoL endpoint (unadjusted p = 0.018, one-sided), this was not c onsidered significant after adjusting for multiple testing. Significantly m ore captopril patients in the substudy subset withdrew for unfavourable rea sons (19.6 vs. 10.9%, p = 0.038). Conclusions: Significant improvements in HRQoL were observed in elderly patients with symptomatic heart failure trea ted with losartan and captopril long-term. A trend favouring losartan in th e composite measure of drug tolerability/quality of life was not significan t, but losartan was generally better tolerated than captopril in that signi ficantly fewer losartan patients discontinued therapy.