Brilinta Increases Stent Patients' Survival in Large Clinical Trial
Daniel J. DeNoon
WebMD Health News
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Reviewed By Louise Chang, MD
Jan. 13, 2010 -- A new anticlotting drug works better than Plavix, one of the most prescribed and most profitable drugs in the world, a huge clinical trial finds.
The new kid on the block is AstraZeneca's ticagrelor, to be named Brilinta if the experimental drug gets FDA approval.
That approval seems likely, given the results of a new clinical trial that compared Plavix to Brilinta in patients with acute coronary syndromes who had stents placed in their arteries to improve blood flow. Such patients need anticlotting drugs because blood clots can be a deadly complication of getting a stent.
Plavix is the drug most often used to prevent this complication. But there's a problem with Plavix, and with a newer, stronger drug in the same class called Effient.
Both drugs increase the risk of dangerous bleeding. And since the drugs irreversibly bind to blood-clotting platelets, a patient has to stop taking these drugs for five to seven days before the body can make enough new platelets.
Brilinta lets go of platelets more quickly than Plavix -- in about two or three days. And in the new study, patients had less bleeding after stent installation.
That's probably why the 6,732 study patients who got Brilinta were 16% less likely to die, or have a heart attack or stroke, than were the 6,676 patients who got Plavix. Brilinta reduced overall death rates by 1.1%.
"We estimate that use of [Brilinta] instead of [Plavix] for one year in 1,000 patients with acute coronary syndromes and who are planning to undergo an invasive strategy at the start of drug treatment would lead to 11 fewer deaths, 13 fewer myocardial infarctions, and six fewer cases of stent [clotting] without an increase in the rates of major bleeding or transfusion," conclude study researcher Christopher P. Cannon, MD, and colleagues.
The findings impress Columbia University researcher Gregg W. Stone, MD. Stone has in the past received honoraria from the makers of both Plavix and Brilinta and serves on the advisory boards of Boston Scientific and Abbott Vascular.
"These compelling results support [Brilinta] as a new standard of care in acute coronary syndromes," Stone concludes in an editorial accompanying the Cannon report in the Jan. 14 issue of The Lancet.
"This is a blockbuster paper. ... [Brilinta] looks like the next big thing," Kirk Garratt, MD, clinical director of Lenox Hill Hospital in New York, says in a news release. Garratt has no affiliation with AstraZeneca but is on the speakers' bureau for Sanofi-Aventis, which makes Plavix, and Daiichi-Sankyo, which makes Effient.
Garratt notes, however, that Brilinta must be taken twice a day and that missing a dose can be very dangerous since the drug wears off so quickly.
Jeffrey S. Berger, MD, director of cardiovascular thrombosis at NYU Langone Medical Center, predicts that Brilinta will change the practice of medicine.
Brilinta "will have a large impact on how we treat patients with acute coronary syndrome once the drug is approved," Berger says in a news release.
The Cannon study was funded by Brilinta maker AstraZeneca.
SOURCES: Cannon, C.P. The Lancet, published online Jan. 14, 2010.
Stone, G.W. The Lancet, published online Jan. 14, 2010.
News release, Lenox Hill Hospital, New York.
News release, NYU Langone Medical Center.
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