M-001 A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED STUDY EVALUATING THE EFFECTS OF TWO DOSES OF LOSARTAN ON MORBIDITY AND MORTALITY IN CHINESE PATIENTS WITH SYMPTOMATIC HEART FAILURE INTOLERANT OF ACE INHIBITOR TREATMENT (HEAAL)

Background Symptomatic heart failure is a common clinical problem associated with a poor prognosis and is a major growing public health problem worldwide. Methods This was a post hoc subgroup analysis of Chinese subjects with heart failure from Mainland China, Hong Kong and Taiwanenrolled in the HEAAL trial (N = 545). Adults with symptomatic heart failure (NYHA II-IV) and intolerant of treatment with ACE inhibitors were randomized to losartan 50 mg or 150 mg once daily. The primary endpoint was the composite event rate of all cause death or hospitalization for heart failure. Safety was assessed by clinical evaluations, laboratory measurements, and adverse experience reports. Results Mean(median) follow-up was 4.2 (4.8) years and baseline characteristics were generally similar to the overall HEAAL cohort. In the losartan 50 mg group,50.2%of the patients died or were hospitalized for heart failure vs 44.1% in the losartan 150 mg group (20% reduction, HR = 0.807; 95% CI: 0.631–1.031). In the losartan 50 mg group 59.3% of the patients died (any cause) or were admitted for CV hospitalization vs 50.4% in the losartan 150 mg group (13.5% reduction, HR = 0.765; 95% CI: 0.609–0.961). There were no notable differences between treatment groups in the %of subjects with clinical or laboratory AEs, drug-related AEs, serious AEs, or AEs leading to discontinuation. Conclusion In the total HEAAL cohort, compared with losartan 50 mg daily, losartan 150 mg significantly reduced the risk of all cause death or hospitalization for heart failure (HR = 0.90; 95% CI: 0.82, 0.99), supporting the use of the higher dose for optimum clinical benefit. The efficacy and safety results of this subgroup analysis in Chinese subjects, although not powered to show significance, were generally consistent with the main study results.