BN003644  16 de novembro de 2005  09:09 HORALOCAL


EMEA Approves New Treatment for Chronic Stable Angina

    PARIS, Nov. 16 /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)

SOURCE  Servier
                              11/16/2005
    CONTACT:  Kristen O'Leary, +1-207-798-9900, 
kristen.o'leary@toniclc.com, or Moira Gitsham, +33-6-20-74-01-92 - 
mobile, moira.gitsham@toniclc.com, both for Servier


BNED: NG

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