AstraZeneca's Toprol-XL cleared for CHF in USA

AstraZeneca has received approval from the US Food and DrugAdministration to launch a 25mg extended-release tablet of Toprol-XL (metoprolol succinate) for treatment of stable, symptomatic (New York Heart Association class II or III) heart failure of ischemic, hypertension, or cardiomyopathic origin. The new low-dose beta blocker tablet extends the 50mg, 100mg and 200mg Toprol-XL range for treating hypertension and angina pectoris. If the initial dose of 25mg in patients with NYHA class II heart failure and 12.5mg in patients with more severe heart failure is tolerated, it may be doubled every two weeks up to 200mg. The company warns abrupt cessation may be lead to myocardial infarction.

This extended release formulation of metoprolol is already marketed for heart failure in Europe. Its efficacy in this indication was demonstrated in the landmark MERIT-HF study (Marketletter November 23, 1998).