New Results in Angina Patients: Fewer Heart Attacks With Procoralan(R) (ivabradine)*

Tuesday 01 September 2009 09:33
Important new findings in patients with angina participating in the BEAUTIFUL study show that there is a 42% reduction in heart attack with Procoralan(R) (ivabradine)*, as presented today at the European Society of Cardiology (ESC) Congress. This benefit was particularly marked in patients with a resting heart rate (greater than or equal to) 70 beats per minute (bpm), where Procoralan cut the risk of hospitalisation for heart attack by nearly three quarters and the rate of coronary revascularisation by more than half.

These findings set Procoralan apart as an antianginal agent documented to be able to reduce major cardiovascular events in angina patients. "Procoralan is already known to relieve angina. These new results demonstrated that it may also prevent cardiovascular events," said Professor Tendera, Medical University of Silesia, Katowice, Poland.

These impressive efficacy results stem from a subgroup analysis of patients in the BEAUTIFUL study with limiting angina. Angina is the most common manifestation of coronary artery disease (CAD) and can have a profound impact on patients' quality of life, as well as adversely affecting prognosis. In this analysis, Procoralan reduced the primary endpoint - a combination of cardiovascular death, myocardial infarction (MI) and heart failure - in all angina patients by 24% with an improvement on all parameters. Hospitalisations for fatal or non-fatal MI were also reduced by 42% with Procoralan. This benefit was even more striking in angina patients

with a heart rate (greater than or equal to) 70 bpm, where the risk of MI was cut by 73%. The need for coronary revascularisation was also reduced with Procoralan treatment, decreasing by 30% in all angina patients and 59% in those with a heart rate (greater than or equal to) 70 bpm.

A total of 1,507 patients with angina were included in this BEAUTIFUL subgroup analysis and half of them had a heart rate more than 70 bpm at baseline. Nearly all patients were receiving conventional treatment aimed at protecting against cardiovascular events, with approximately 9 out of every 10 patients on beta-blockers.

Previously released results from the BEAUTIFUL study have already shown in 10,917 patients with CAD and associated left ventricular dysfunction, that Procoralan reduces both fatal and non-fatal heart attack by 36% (P=0.001) and need for revascularisation by 30% (P=0.016) in coronary patients with a heart rate higher than 70 bpm.(1)

Angina is a presenting symptom in half of all coronary patients and the presence of angina can adversely affect their prognosis. Procoralan is one of the most important advances in stable angina treatment in the last two decades. The antianginal and anti-ischaemic efficacy of Procoralan has been very well documented in monotherapy(2) and in combination with beta-blocker.

In angina patients already receiving beta-blockers, the addition of Procoralan significantly prolongs total exercise duration.(3) "These new results on the prevention of cardiovascular events with Procoralan in angina

patients, further reinforce the place of Procoralan as a step further in the management of angina patients," commented Professor K. Fox, Co-Chairman of the BEAUTIFUL Executive Committee study.

The study is funded by Servier, France's leading independent pharmaceutical company.

*Depending on the country, ivabradine is available as Procoralan(R), Coralan(R), Coraxan(R), or Corlentor(R).

Notes to editors

Coronary artery disease (CAD)

Coronary artery disease, also known as ischaemic heart disease, is the most common type of heart disease. CAD is the leading cause of death worldwide and is predicted to remain so for the next 20 years.(4)

approximately 3.8 million men and 3.4 million women die from CAD each year,(5) and in 2020, it is estimated that this disease will be responsible for a total of 11.1 million deaths globally.(4)

CAD could remain undetected for years and can manifest suddenly as an acute heart attack. Although CAD might be a silent disease, in the majority of patients it is symptomatic. It causes angina - chest pain evoked by exercise and other factors, and may lead to heart failure, placing a huge impact on quality of life. Despite lifestyle modifications and advances in the medical management, CAD remains a global health problem and there is a need for new and effective preventative treatments.

References

(1) Fox K, Ford I, Steg P G et al. Ivabradine for patients with stable

coronary artery disease and left ventricular dysfunction (Beautiful): a

randomized, double-blind, placebo-controlled trial. Lancet 2008, 372,

807-816.

(2) Tardif J-C, Ford I, Tendera M, et al. Efficacy of ivabradine, a new

selective If inhibitor, compared with atenolol in patients with chronic

stable angina. Eur Heart J. 2005 ; 26 : 2529-36.

(3) Tardif JC, Ponikowski P, Kahan T; ASSOCIATE study investigators.

Efficacy of the If current inhibitor ivabradine in patients with chronic

stable angina receiving beta blocker therapy: a 4 month, randomized,

placebo-controlled trial. Eur Heart J. 2009;30:540-548.

(4) Mathers CD, Loncar D. Projections of global mortality and

burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3:e442.

(5) WHO. The global burden of disease: 2004 update. Available at:

http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en

/index.html.

SOURCE: Servier

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