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Title: Initiating Treatment for Chronic Heart Failure With Bisoprolol Leads to 46% Reduction in Sudden Death After 1 Year

"Initiating Treatment for Chronic Heart Failure With Bisoprolol Leads to 46% Reduction in Sudden Death After 1 Year"

New Results of the CIBIS III Trial BARCELONA, SPAIN and DARMSTADT, GERMANY -- September 6, 2006 -- Initiating chronic heart failure (CHF) therapy with the beta1-receptor selective beta-blocker, Concor®COR (bisoprolol), prevents early sudden deaths when compared with an ACE inhibitor. Sudden death remains the most common cause of death in the earlier stages of mild-to-moderate CHF. These new findings, gleaned from additional analysis of data from the third Cardiac Insufficiency Bisoprolol Study (CIBIS III), provide a further challenge to the current guidelines that treatment of CHF should begin with an ACE inhibitor subsequently followed by a beta-blocker. CIBIS III is the first large prospective study to compare the two drug initiation strategies in CHF. A total of 1,010 patients aged 65 years and older (mean age 72 years) were randomized to 6 months' treatment with bisoprolol (n=505) or enalapril (n=505), followed by combination therapy for all patients for 6–24 months. By the end of the study (mean follow up 1.2 years), there was no significant difference in the efficacy or tolerability of the treatment strategies.(1) This means that starting with Concor®COR first is as efficacious and safe as starting with an ACE inhibitor first. These initial landmark data were presented at last year's European Society of Cardiology (ESC) congress in Stockholm, Sweden. Professor Ronnie Willenheimer (Department of Clinical Sciences at the University Hospital, Malmö, Sweden), the study's principal investigator, presented the latest sudden death data today at the World Congress of Cardiology/European Congress of Cardiology) in Barcelona. During the first 6 months of monotherapy, 8 of 23 deaths in the bisoprolol-first group were sudden, compared to 16 of 32 in the enalapril-first group (Hazard ratio 0.50, [P =.107). During the first year, 16 of 42 deaths in the bisoprolol-first group were sudden versus 29 of 60 deaths in the enalapril-first group, representing a significant 46% reduction (Hazard ratio 0.54, P =.049).

Since the sudden death reduction was accompanied by a non-significant reduction in all-cause mortality of similar magnitude in the bisoprolol-first group, treatment initiation with Concor®COR did not simply shift the mode of death from sudden death to other forms. Although the number of early sudden deaths was reduced by bisoprolol, the mortality rates levelled out over the course of the study.

Alongside the early improvement in sudden death rates with bisoprolol treatment there was also an increase in early CHF hospitalization rates. During the first six months, 39 patients in the bisoprolol-first group versus 25 patients in the enalapril-first group were hospitalized for worsening of CHF. This was not statistically significant and the study authors suggested that improved familiarity with a beta-blocker-first strategy would improve these figures. In any case, hospitalization was not associated with a worse prognosis and Professor Willenheimer said, "This may well be a reasonable price to pay for the dramatic reduction seen in early sudden deaths in patients initially treated with Concor®COR."

About Concor®COR
Merck KGaA is the maker of Concor®COR (bisoprolol), one of the world's leading beta1-selective beta-blockers. It is indicated in chronic heart failure (CHF) management. Concor®COR has pioneered clinical development of beta-blockers in CHF. In 2005, Merck's sales of bisoprolol, the active ingredient in the beta-blocker Concor®COR, increased by 14% to EUR 331 million.

REFERENCE:
1. Willenheimer R, van Veldhuisen DJ, Silke B, et al., on behalf of the CIBIS III investigators. Effect on survival and hospitalization of initiating treatment for chronic heart failure with bisoprolol followed by enalapril, as compared with the opposite sequence. Results of the randomized cardiac insufficiency bisoprolol study (CIBIS) III. Circulation 2005; 112: 2426-35.

SOURCE: Merck KGaA

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