New Anticlotting Drug May Extend Heart Patients' Lives
Study Shows Xarelto Helps Treat People Who Had Heart Attacks or Chest Pain
By Charlene Laino
WebMD Health News
Reviewed By Laura J. Martin, MD
Nov. 14, 2011 (Orlando, Fla.) -- People recently hospitalized for heart attack or the severe chest pain of angina may live longer if they take the new anticlotting pill Xarelto in addition to standard treatment, a large study shows.
There was a drawback to taking Xarelto: an increased risk of serious, but non-deadly, bleeding, including bleeding in the brain.
Still, "death trumps nonfatal bleeding in most people's mind," so overall Xarelto is a substantial advance for these people, says Paul Armstrong, MD, a cardiologist at the University of Alberta in Edmonton, Canada. Armstrong was not involved with the study.
The study was presented here at the American Heart Association (AHA) annual meeting. It was also published online by The New England Journal of Medicine.
Targeting Acute Coronary Syndrome
The study involved more than 15,500 people who had been hospitalized for acute coronary syndrome within the past week. Acute coronary syndrome (ACS) describes conditions such as heart attacks and angina (heart-related chest pain) that occur because of reduced blood flow to the heart.
Xarelto (rivaroxaban) is approved by the FDA to prevent strokes in people with an abnormal heart rhythm called atrial fibrillation (AF) and to prevent the formation of blood clots after hip and knee replacement surgeries.
Based on the new findings, Johnson & Johnson, which makes the drug and funded the study, plans to apply for FDA approval for use in people with acute coronary syndrome by the end of the year.
At least 671,000 Americans were discharged from the hospital with ACS in 2007, the latest year for which figures are available, according to the AHA.
A price for use of Xarelto in treating ACS has not been set. A much higher dose used for stroke prevention in people with AF costs about $7 a day, according to Johnson & Johnson.
Xarelto for Acute Coronary Syndrome
In the study, everyone got low-dose aspirin, usually with the standard anticlotting drug Plavix. One-third also got a low dose of Xarelto, one-third got a very low dose of the drug, and the rest got a placebo. The pills were given twice daily for an average of 13 months.
Overall, 9% of those given Xarelto had a heart attack or stroke or died from heart disease or stroke vs. 11% given standard therapy alone. This translates to a 16% lower risk of suffering one of these events if you take Xarelto.
People taking the very low dose were also more likely to still be alive two years later. A total of 3% died vs. 5% in the standard treatment group.
One death would be prevented if 56 people on standard anticlotting therapies were also given very low-dose Xarelto twice daily for two years, says researcher C. Michael Gibson, MD, of Harvard Medical School. Gibson has received consulting fees from Johnson & Johnson.
But people taking Xarelto were nearly four times more likely to have serious bleeding: 2.1% vs. 0.6% on placebo. About one-third were bleeds into the brain, which can be disabling. Most of the rest were gastrointestinal bleeds.
However, there was no increase in fatal bleeding or other side effects with the new drug. All patients benefited from the new drug, including the elderly and people with diabetes, Gibson says.
Other Drugs for Acute Coronary Syndrome
Drugs already used to treat ACS, including Brilinta, Effient, and Plavix, block platelets (blood components involved in clotting) in the blood from sticking together and forming clots. Xarelto affects clotting in a different way, by blocking a protein involved in clotting.
Pradaxa and Eliquis are from the same family of drugs as Xarelto. Although Eliquis failed to prevent heart attacks and deaths while causing more serious bleeding in a recent study, Armstrong tells WebMD that is likely because too high a dose was tested.
The findings were generally met with enthusiasm, although questions remain.
Doctors have been searching for better anticlotting drugs for heart patients for years, but efforts typically failed because of too much bleeding, Matthew T. Roe, MD, and E. Magnus Ohman, MD, both of Duke University Medical Center in Durham, N.C., write in an editorial accompanying the study.
Xarelto and drugs similar to it may represent "a new standard of [anticlotting] treatment in ACS," Armstrong says.
AHA President Gordon Tomaselli, MD, head of cardiology at Johns Hopkins, was more tempered. "I'm cautiously optimistic that [Xarelto] will find a niche in the treatment of ACS," he tells WebMD.
Doctors need better ways of predicting which patients are at risk for drug-related bleeding, Tomaselli says.
Among the questions that remain are whether patients who at the highest risk of another heart attack or dying would benefit from taking Xarelto.
American Heart Association Scientific Session 2011, Orlando, Fla., Nov. 12-16, 2011.
Paul Armstrong, MD, professor of medicine, division of cardiology, University of Alberta, Edmonton, Canada.
Gordon Tomaselli, MD, president, American Heart Association; director of cardiology, Johns Hopkins University, Baltimore.
C. Michael Gibson, MD, chief of clinical research, cardiovascular division, Beth Israel Hospital, Harvard Medical School, Boston.
Mega, J. The New England Journal of Medicine, published online Nov. 13, 2011.
Roe, M. and Ohman, E. The New England Journal of Medicine, published online Nov. 13, 2011.
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