JNJ Johnson and Johnson

By Ron Winslow 

NEW ORLEANS -- Researchers said a study involving reduced doses of Johnson & Johnson's anticoagulant Xarelto suggests it may be possible for patients with two types of heart disease to avoid the need for three different blood thinners to protect them from stroke and heart attack.

Between one million and two million patients in the U.S. and Europe suffer from both a heart rhythm disorder called atrial fibrillation and blockages in their coronary arteries that are propped open with stents to alleviate chest pain.

Currently, such patients often get a total of three different medicines -- aspirin and a drug called clopidogrel to keep heart-attack causing clots from forming in stents, and either warfarin or a new anticoagulant such as Xarelto to prevent stroke-causing clots in atrial fibrillation. Each drug hits a different target involved in formation of blood clots.

But so much blood-thinning causes more than 25% of patients to suffer major and even potentially life-threatening bleeding episodes.

"The concern this causes for patients is very big," said Michael Gibson, a cardiologist at Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, and principal investigator of the new trial.

The new, 2,100-patient study found that 16.8% patients treated with a two-drug regimen -- 15 milligrams of Xarelto plus clopidogrel -- suffered what researchers termed clinically significant bleeding events, compared with 26.7% of patients treated with warfarin, clopidogrel and aspirin. That amounts to a 41% reduction in risk of such bleeding.

Dr. Gibson said 18% of a third group of patients treated with a three-drug regimen -- 2.5 milligrams of Xarelto plus clopidogrel and aspirin -- suffered significant bleeding events.

The study also found that 5.6% of patients in the warfarin-treated group suffered a heart related death, heart attack or stroke, compared with 6% given 2.5 milligrams of Xarelto and 6.5% for those with the two-drug regimen including 15 milligrams of Xarelto. But the number of such events in the study was too small to enable researchers to conclude with confidence that the reduce blood thinning regimens didn't put patients at higher risk of heart attacks and strokes.

Dr. Gibson presented the data at the annual scientific meeting of the American Heart Association. The results also were published in separate papers in the New England Journal of Medicine and the journal Circulation.

"We've hated to put patients on triple therapy," said Vincent Bufalino, a cardiologist at Advocate Health Care, Oakland Terrace, Ill., who wasn't involved with the study. He said doctors are already treating some patients with just two drugs, generally dropping aspirin and using clopidogrel and either warfarin or a drug like Xarelto.

The study "makes us feel better about what we've been shifting towards," he said.

Gabriel Steg, a cardiologist at Hopital Bichat, Paris, said a previous, smaller study using a two-drug of warfarin and clopidogrel (and no aspirin) in stent patients who also have atrial fibrillation was effective in reducing bleeding. Though warfarin is a difficult drug to use, that regimen would be cheaper than ones involving Xarelto, he noted.

Write to Ron Winslow at ron.winslow@wsj.com

(END) Dow Jones Newswires

November 14, 2016 13:12 ET (18:12 GMT)

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