The licence for Cozaar (losartan) in the treatment of heart failure has been extended to include patients aged less than 60 years. The recommended maximum dose in this setting has been increased from 50mg to 150mg once daily.
Approval for use in the 18-60 year age group was based on the findings of the Heart Failure Endpoint Evaluation of Angiotensin II Antagonist Losartan (HEAAL) study, which involved 3834 patients aged 18-98 years with NYHA class II-IV heart failure and an intolerance to ACE inhibitors. Investigators randomised participants to receive losartan 50mg once daily or 150mg once daily plus conventional therapy (excluding ACE inhibitors). Follow-up continued for a median of 4.7 years.
The 150mg dose was associated with a 10.1% reduction in the risk of all-cause death or hospitalisation for heart failure relative to the 50mg dose (p=0.027). The risk reduction was attributable mainly to a lower incidence of hospitalisation for heart failure in the 150mg group (13.5% risk reduction relative to the 50mg group; p=0.025).
Renal impairment, hypotension and hyperkalaemia were more common at the higher dose but were not associated with a significantly higher rate of treatment discontinuation in the 150mg group than in the 50mg group.
Further information: Merck Sharp & Dohme Ltd