MONDAY, Jan. 9 (HealthDay News) -- The anticoagulant Pradaxa (dabigatran) is associated by a small increase in the endanger of heart attack, a new pass in ~ finds.

Researchers from the Cleveland Clinic in Ohio looked at seven trials involving Pradaxa that included besides than 30,000 patients. This step, called a meta-analysis, uses premises from published clinical trials to chafe out a pattern that might not elucidate up in a single study.

The researchers ground Pradaxa was associated with an increased hazard of heart attack or acute coronary syndrome (courage attack or angina), compared with couple other commonly used blood thinners, warfarin (Coumadin, Jantoven) and enoxaparin (Lovenox).

Among those apprehension Pradaxa, 1.19 percent had a core attack or suffered from acute coronary syndrome compared through 0.79 percent of those seizure either of the other drugs, they famous.

Although there was a 33 percent increase in relative risk for a will attack among those taking Pradaxa, the unrestricted increased risk -- that is, the added put to hazard for any one individual of having a kernel attack if on Pradaxa -- was 0.27 percent, researchers uttered.

Pradaxa was approved by the U.S. Food and deaden with narcotics Administration in October 2010 for persons with a common heart rhythm problem called atrial fibrillation. People with atrial fibrillation are at a higher hazard for stroke and are often prescribed medication to preclude clotting.

Pradaxa is often prescribed for the re~on that an alternative to warfarin, a medication that has been used notwithstanding a long time but which can raise the risk of bleeding and is herculean to dose properly.

Pradaxa is in like manner used to prevent blood clots in tribe who've had joint replacement surgery.

"For persons through atrial fibrillation, dabigatran has a beneficial benefit-risk profile, but for other uses the dare to undertake of heart attack has to be taken into account," said lead researcher Dr. Ken Uchino, director of the Vascular Neurology Fellowship Training Program at the Cleveland Clinic.

The discharge was published in the Jan. 9 online impression of the Archives of Internal Medicine.

In the large study that led to the approval of Pradaxa, in that place was a suggestion that Pradaxa main be associated with an increased exposure to harm of heart attacks, Uchino explained.

However, the unsalable article's benefit for patients with atrial fibrillation outweighs the jeopardize, he said.

"The increase of [inner part attack] risk associated with dabigatran is microscopic, and the benefit in prevention of affliction among persons with atrial fibrillation is greater," Uchino afore~.

Why Pradaxa is associated with one increased heart attack risk isn't undefiled, they say. It's possible Pradaxa doesn't greaten heart attack risk directly, but it may not exist as effective as warfarin and aspirin in preventing love attacks, he added.

Dr. John Smith, senior vice president for clinical development and of medicine affairs at Boehringer Ingelheim, the makers of Pradaxa, declared that "we don't agree with the conclusion and the method used beneficial to this meta-analysis. Based on totality the data, we conclude that seat of affection attack is not an adverse influence of Pradaxa treatment."

Another expert afore~ that the risk of heart run at does not outweigh the benefits of the physic, especially taking the risk of great bleeding with warfarin into account.

"I would have existence cautious about this meta-analysis. It doesn't persuade me," Dr. William O'Neill, a professor of cardiology and executive dean for clinical affairs at the University of Miami School of Medicine, uttered. "I am unimpressed by the data."

Warfarin, O'Neill added, "is a affectedly nice lousy drug."

Although he estimated relative to one in 10 patients can't tolerate Pradaxa because of severe gastrointestinal interest effects, "you don't have to overseer it the way you have to with warfarin. It's a big melioration over warfarin."

Dr. Jeremy Jacobs, a lecturer in geriatric remedial agent at Hebrew University Medical Center in Jerusalem and author of an accompanying editorial, said the study shows the weight of continuing to track new drugs following they've been approved and placed without ceasing the market.

"The dabigatran debate is a immaculate example which raises issues concerning post-marketing surveillance, and pharmaco-vigilance," Jacobs before-mentioned. "Who takes responsibility? Industry? Independent researchers? National bodies?"

"I personally mind to favor the latter, since the stakes are highly high for new drugs, and it is hard to manage for industry-backed research to overturn conflicts of interest that inevitably arise," he added.

As well-nigh as dabigatran is concerned, Jacobs reported that physicians should be cautious, especially at what time prescribing it to patients with known affection disease. The issue will only exist clarified as more data about the risk accumulates and how it measures up for the dangers of bleeding posed ~ means of warfarin, he said.

More information

For greater quantity on Pradaxa, visit the U.S. National Library of Medicine.

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