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Trial Findings Mark "Significant Advance" In Angina Treatment

September 05, 2003

Results from the INITIATIVE study(1), the largest phase III trial ever carried out for the treatment of stable angina, herald what has been described as a "significant advance" in the management of the condition, which afflicts 4% of adults in the UK and costs the NHS some £700 million per year(2).

Findings from the 4-month, multi-centre study, presented for the first time at the European Society of Cardiology (ESC) Congress in Vienna, show that ivabradine (Procoralan® , Servier), a new chemical entity, was at least as effective as the beta blocker atenolol but did not display any of the side-effects commonly associated with beta-blockers, such as sexual dysfunction, asthenia or bronchospasm.

Ivabradine is the first selective and specific If inhibitor, a new class of compound, which exclusively reduces heart rate by specific action on the sino-atrial node. Unlike some other treatments which also reduce heart rate, ivabradine does not influence myocardial contractility or blood pressure, and it preserves atrioventricular conduction and vascular repolarisation.(3)

This is a significant factor, since according to a recent survey of cardiologists(4) carried out for the newly formed Angina Forum, beta blockers are contraindicated or not tolerated in around one in five angina patients. Others suffer side-effects but continue on the medication.

Results presented earlier this year had already shown that ivabradine had significant anti-anginal and anti-ischaemic efficacy compared to placebo(3); the aim of INITIATIVE was to demonstrate its "non-inferiority" to a beta blocker in a larger trial.

INITIATIVE, a multi-centre trial involving nine countries, was a 4-month randomized, double blind comparative (ivabradine versus atenolol) study of 939 patients with a 3-month history of stable angina and documented coronary artery disease(1).

Ivabradine significantly increased total exercise duration and was shown to be at least as effective as atenolol after both 1 month and 4 months of treatment in all treatment groups. All exercise test criteria were similarly improved, including time to limiting angina, time to angina onset and time to 1-mm ST-segment depression (an electrocardiographic indication of ischaemia).

Commenting on the findings, Kim Fox, Professor of Clinical Cardiology, Royal Brompton Hospital, said:

"This trial shows that ivabradine represents a significant advance; it not only demonstrates good efficacy by exclusively reducing heart rate, but it also has a good safety profile. The absence of a negative inotropic effect makes ivabradine easy to use in the management of ischaemia and angina, offering an alternative to conventional therapies that are currently available, which have restrictions due to contraindications.

"As the global prevalence of ischaemic heart disease continues to increase, ivabradine represents one the most important advances in cardiovascular treatment over the last two decades."

Ivabradine, which is expected to be available on the UK market within the next two years, is currently in Phase III trials as part of the largest clinical programme ever carried out to evaluate anti-ischaemic efficacy with exercise tests. The ongoing clinical development programme conducted by Servier involves more than 4,000 patients.

Phase IV Communications

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