Merck Short Press Release

Bisoprolol

Bisoprolol: continuing innovation in cardiovascular care

Bisoprolol is a beta1-selective blocker, developed by Merck KGaA, Darmstadt, Germany. It was originally introduced for the treatment of hypertension and coronary artery disease (angina pectoris), where it provides reliable efficacy over 24 hours with a single daily dose. More recently, however, bisoprolol has come to the forefront of cardiovascular medicine as a treatment for congestive heart failure (CHF).

CIBIS II: a landmark study

CHF was once thought to be a contra-indication for beta-blockers, but is now recognised as a major indication. This remarkable reversal of expert opinion is based on three major mortality trials published in the last three years. The first study to show a significant mortality benefit of a beta-blocker in CHF was the landmark Cardiac Insufficiency Bisoprolol Study II (CIBIS II).1Bisoprolol reduced total mortality (the primary endpoint) by 34%, sudden deaths by 44%, and total hospitalisations for worsening of heart failure by 363%. Subsequent trials (MERIT-HF and COPERNICUS) confirmed that metoprolol or carvedilol also reduced CHF mortality by 34-35%.

Studies in France, German and the UK show bisoprolol to be cost-effective in CHF, as the costs of the medication are more than offset by the reduction in hospitalization. Subgroup analyses show that patients who have diabetes, renal impairment, NYHA class IV symptoms, are elderly, or taking digitalis, amiodarone or aldosterone antagonists benefit as much from bisoprolol as patients without these complications or drugs.

Beta-blockers underused

New guidelines from the European Society of Cardiology stipulate that, unless contra-indicated, all patients in NYHA classes II to IV should receive a beta-blocker as first-line therapy, in addition to standard treatment. Long-term beta-blockade is also recommended in all patients with left ventricular systolic dysfunction following an acute MI, whether or not they have symptomatic heart failure.

However, the recent Euro Heart Failure survey, including over 11,000 patients in 25 European countries, found that fewer than 40% received a beta-blocker. Clearly, more education is needed to bring the benefits of beta-blockade to the millions of patients with CHF who could benefit from this potentially life-saving treatment.

Bisoprolol is available for the treatment of CHF in Europe as: Cardicor (Denmark, Ireland, UK); Cardensiel (France); Concor COR (Austria, Germany, Switzerland); Emconcor CHF (Finland, Sweden); Emcor DECO (Netherlands); Emconcor minor (Belgium); Emconcor COR (Spain).

For further information, please contact: Patricia Verkenne, Merck KGaA, Clinical R&D/Clinical Sciences, Phone: +49-6151-727187, email: sert names and addresses of Merck contact

1. CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13.