Paris, November 16 (ots/PRNewswire) -
- Emea Approves New Treatment for Chronic Stable Angina
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
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.
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)
ots Originaltext: Servier
Im Internet recherchierbar: http://www.presseportal.ch
For further information, please contact: Kristen O'Leary, tel
+44-207-798-9900, firstname.lastname@example.org Moira Gitsham, tel:
+33-6-20-74-01-92 (mobile) email@example.com