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De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: Procoralan(R) (Ivabradine), the First
Pure Heart Rate-Lowering Agent, Receives
Marketing Authorization in Europe
16 de novembro de 2005 09:09 HORALOCAL
Procoralan(R) (Ivabradine), the First Pure Heart
Rate-Lowering
Agent, Receives Marketing Authorization in
Europe
EMEA Approves New Treatment for Chronic Stable
AnginaPARIS, 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
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
BRASIL-NÉLIA GARCIA
TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469
E-MAILS: nelia_garcia@prnewswire.com.br
mary_dleon@prnewswire.com
PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: INDÚSTRIA
FARMACÊUTICA
PALAVRA-CHAVE/EMPRESA: SERVIER
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