European guidelines back use of Multaq

Stockholm: Genetic tests won't be needed to determine whether AstraZeneca Plc's anti-clot drug Brilinta works, according to a study that may be used to differentiate the medicine from the best-selling Plavix treatment.

Two gene variations that may change how patients respond to Plavix didn't make Brilinta less effective, researchers said in a company-funded study presented yesterday at the European Society of Cardiology conference in Stockholm. One of the two variations also didn't reduce the effectiveness of Effient, another anti-clotting drug sold by Eli Lilly & Co with partner Daiichi Sankyo Co, researchers said in a second study. Both studies were published yesterday in The Lancet.

Plavix, which had $9.8 billion (Dh36 billion) in sales last year for Sanofi-Aventis SA and Bristol-Myers Squibb Co, faces generic competition in the US in 2012. Copies are already approved in Europe. While its low price may make the generic version, known chemically as clopidogrel, the treatment of choice, confirmation that newer medicines don't require gene testing may also influence doctors, Alfred Bove, immediate past president of the American College of Cardiology, told journalists in Stockholm.

"Physicians don't like complications," Bove said. "If I told you there was an alternative to clopidogrel that worked the same way without the variations, they would jump on it."

Brilinta cut the risk of heart attacks, strokes and death linked to heart disease more than Plavix, at a higher risk of spontaneous major bleeding, regardless of genetic variations, researchers said yesterday. The international team analysed gene variations in more than 10,000 patients who participated in the Plato study presented at last year's European cardiovascular conference.

AstraZeneca, based in London, won the backing of a US Food and Drug Administration advisory panel in July for Brilinta. An FDA decision on the drug is scheduled in September.

Further evidence

In the second study, funded by Lilly and Daiichi Sankyo, researchers analysed patients from the 2007 Triton trial to find that a genetic variation that diminished the effectiveness of Plavix didn't have the same effect on Effient's potency.

The FDA warned in March that in certain patients, known as "poor metabolisers", a genetic variant could reduce the effectiveness of Plavix. Some two per cent to 14 per cent of the population aren't able to metabolise the drug effectively, the agency said.

Doctors should take into account a range of factors that might change the way a patient responds to blood-thinning therapy, including age, sex and body-mass index, Betti Giusti and Rosanna Abbate, of the Department of Medical and Surgical Critical Care at Careggi Hospital in Florence, Italy, said in a comment published alongside the Lancet articles.

Doctors may decide against genetic tests anyway, especially for patients who need to take a drug immediately and can't wait weeks for test results, said David Holmes, president-elect of the American College of Cardiology.

Stockholm (Reuters) Sanofi-Aventis' new heart rhythm drug Multaq should be considered as a first-line treatment option for patients with atrial fibrillation, a common arrhythmia, according to medical guidelines released yesterday.

The recommendation from the European Society of Cardiology (ESC) is a fillip for a drug that has got off to a slow start commercially.

Multaq, or dronedarone, was designed as an improvement on the older drug amiodarone. It has a safer profile than the older medicine but has suffered from sluggish sales in the United States and Europe because studies suggest it is less effective.

The latest version of the ESC's guidelines on atrial fibrillation now includes Multaq, on the basis that it makes sense to choose a treatment that is safer, even though it may be less effective.

"In view of the better safety and potential outcome benefit, dronedarone may be preferable as the first antiarrhythmic option," according to the guidelines, which were released in Stockholm.