Biotech Values

[DewDiligence]

Plavix PCI Study Shows 6-Months Non-Inferior to 12

[But the lingering question is whether *any* specified length of antiplatelet treatment is non-inferior to “forever” for patients who receive a non-bioabsorbable DES.]

http://www.reuters.com/article/2011/04/05/heart-plavix-idUSN0513415820110405

›Tue Apr 5, 2011 2:09pm EDT
By Bill Berkrot

NEW ORLEANS, April 5 (Reuters) - Six months of therapy using Plavix and aspirin to prevent dangerous blood clots from forming in stents following artery-clearing procedures may be as effective as current guidelines calling for 12 months or longer, according to a study presented on Tuesday.

The data demonstrating the effectiveness of six months of so-called dual anti-platelet therapy could prove cost saving and reduce the risk of dangerous bleeding in patients in need of later emergency procedures should much larger clinical trials confirm the findings, researchers said.

However, any changes in practice or guidelines of Plavix use resulting from such a study would come too late to damage sales for Sanofi-Aventis (SNY) and Bristol-Myers Squibb Co. (BMY). The world's second-biggest prescription medicine, with annual sales of more than $9 billion, is expected to face competition from cheaper generic versions next year. Once multiple generic rivals reach the market, sales of branded drugs quickly lose 80 to 90 percent of sales.

Subjects in the 1,428-patient study had all received drug-coated stents to prop open their cleared arteries and were on standard therapy of aspirin and Plavix, known chemically as clopidogrel.

In those who received the blood clot preventing therapy for six months, 4.7 percent suffered target vessel failure -- defined as cardiac death, heart attack or need for repeat stenting procedure. That compared with 4.4 percent in the group who took Plavix and aspirin for 12 months.

The results for six months, which amounted to a difference of three patients, were deemed to be non-inferior, meeting the main goal of the study, researchers said.

"We have no data to support the current guidelines that recommend at least 12 months duration with clopidogrel, just observational studies," said Dr. Hyeon-Cheol Gwon, who presented the study at the American College of Cardiology scientific meeting in New Orleans.

Blood thinners such as Plavix increase the risk of major bleeding, so patients who might require urgent surgery are at much higher risk if they are on the drug at the time of such a procedure, explained Gwon, a cardiologist at Samsung Medical Center in Seoul.

If the duration of the dual anti-platelet therapy could be safely halved, that risk would be eliminated after six months instead of a year or more, he said.

"Our results may be very reassuring for many physicians who may need to discontinue clopidogrel before the routinely recommended 12-month duration for various reasons," Gwon said.‹