Servier Release: Procoralan(R) (Ivabradine), The First Pure Heart Rate-Lowering Agent, Receives Marketing Authorization In Europe

PARIS, November 15 /PRNewswire/ -- Procoralan (ivabradine, Servier), the first selective and specific If inhibitor, has received marketing authorization in 27 European countries from the European Medicines Evaluation Agency (EMEA) for the symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm who have a contraindication or intolerance to beta-blockers.

Procoralan has been discovered and developed by Servier and represents one of the most important advances in cardiovascular treatment over the last two decades. Procoralan is the first pure heart rate-lowering agent and acts by selective inhibition of the cardiac pacemaker If current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. Procoralan's effects are selective to the sinus node and the new agent has no effect on intracardiac conduction, myocardial contractility or ventricular repolarization. Unlike beta-blockers, the most common current treatment for angina, Procoralan is free from sexual disturbances, respiratory side effects caused by constriction or spasm of the airways, bradycardia or rebound phenomena.

Procoralan and heart rate reduction

"Heart rate reduction is widely recognized as an important approach for the prevention and treatment of angina and pure heart rate reduction with ivabradine provides a promising new alternative to current treatment," says Professor Kim Fox, MD, from the Royal Brompton Hospital, London, UK.

Heart rate reduction is one of the main therapeutic goals in angina treatment. However, existing treatments do not exclusively reduce heart rate and their use is often associated with unwanted pharmacological actions and poor tolerability. Moreover, stable angina patients very often have a high heart rate.

Procoralan provides an effective and significant, dose-dependent reduction in heart rate, which is also reflected in a reduction in the rate pressure product leading to a reduction in myocardial oxygen consumption.

A large clinical program including almost 5000 patients has demonstrated the efficacy and tolerability of Procoralan. The antianginal and anti-ischemic efficacy of Procoralan was evaluated using a standardized exercise tolerance test in four double-blind randomized trials (two versus placebo, and one each versus the beta-blocker atenolol and the calcium channel blocker amlodipine) involving 3222 patients with chronic stable angina. Procoralan (5 mg and 7.5 mg twice daily) was associated with a significant decrease in angina attacks, and the twice-daily dosage regimen provided uniform efficacy over 24 hours. A sustained reduction in heart rate was demonstrated in patients treated for at least one year (n=713) and no rebound effect occurred following the withdrawal of treatment. Moreover, no influence on glucose or lipid metabolism was observed.

The recommended starting dose of Procoralan is 5 mg twice daily followed by uptritration to 7.5 mg. The new drug will be available as film-coated tablets containing 5 mg and 7.5 mg ivabradine and will be launched over the next few months in European countries.

Future perspectives

Beyond the clinical program in stable angina, different indications for Procoralan will also be investigated. In this context, the morbidity/mortality trial BEAUTIFUL has recently been initiated. This large study will include more than 10 000 coronary patients with left ventricular dysfunction from 33 different countries. The aim of the study is to demonstrate the prognostic benefits of Procoralan in this population, with the study results expected in 2008. In addition, the efficacy of Procoralan in other indications such as heart failure or acute coronary syndrome will also be explored in the future.

Servier and cardiovascular medicine

Servier has a long-standing interest in the field of cardiovascular disease and is unique among global pharmaceutical companies in that all the cardiovascular products it has introduced have stemmed from its own research efforts.

Servier's cardiovascular profile also includes Coversyl(R) (perindopril) for the treatment of patients with hypertension, heart failure and stable coronary artery disease, Vastarel MR(R) (trimetazidine 35 mg) for stable angina, and Natrilix(R) SR (indapamide), Preterax(R) ( perindopril/indapamide) and Hyperium(R) (rilmenidine) for the treatment of hypertension.

Data source: Procoralan summary of product characteristics (SPC)


CONTACT: For further information, please contact: Kristen O'Leary, tel+44-207-798-9900, kristen.o' Moira Gitsham, tel:+33-6-20-74-01-92 (mobile)

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