Merck KGaA’s beta blocker Cardicor/Concor (bisoprolol) cuts the risk of sudden death by 46% when used ahead of an ACE inhibitor in the initial treatment of patients with chronic heart failure.
The CIBIS III study, results from which were first reported a year ago, is designed to evaluate whether there are any advantages to starting treatment of heart failure patients with a beta blocker first, and then move onto use of an ACE inhibitor.
Current treatment guidelines indicate the reverse, with ACE inhibitors recommended in the first instance and beta blockers added in later.
The results of the 1,010-patient trial showed that, after one year’s follow-up, there was no difference between the two study groups in terms of efficacy or tolerability, indicating that bisoprolol was just as good an option as an ACE inhibitor – enalapril - for initial treatment.
But, during the first six months of therapy, there were 23 deaths among the bisoprolol group, eight of which were sudden, compared to 32 deaths (16 sudden) with enalapril. Sudden death remains the most common cause of death in the earlier stages of mild-to-moderate CHF.
At one year, the rates were 16 out of 42 deaths for bisoprolol and 29 out of 60 deaths for the ACE inhibitor, although there was no statistical difference in overall mortality between the two groups. There was also a trend towards higher hospitalisation rates with Merck’s drug, which could be a result of doctors’ lack of experience with using beta blockers as a first-line treatment in heart failure patients.
The data could give a lift to sales of bisoprolol, which fell 3% to 84 million euros in the second quarter of 2006.