The RE-LY clinical safety study (Randomized Evaluation of Long-Term Anticoagulant Therapy) evaluated the risks and benefits of Pradaxa (dabigatran) compared to warfarin. Researchers found that Pradaxa was associated with a slightly increased risk of heart attacks. Now, researchers have found that people taking Pradaxa may be 33% more likely to suffer a heart attack compared to people taking warfarin.
The researchers analyzed data collected from seven different safety studies. The studies compared Pradaxa to control drugs (warfarin, enoxaparin, or a placebo). In total, there were 30,514 patients involved in the studies. The researchers’ analysis found the following results:
- Pradaxa patients were 33% more likely to suffer a heart attack compared to people taking a control
- 1.2% of people on Pradaxa had a heart attack, compared with 0.8% of control patients
- The researchers limited the data to the RE-LY study, comparing warfarin to Pradaxa. They found that Pradaxa patients had a 27% increased risk of heart attack
In conclusion, the researchers found that Pradaxa patients have a higher risk of heart attack, compared with the people who were taking other blood-thinning medications.
What is the increased risk? The researchers estimated that for every year of Pradaxa use, the risk of heart attack increases by 0.25%. While this increase is not large, it could be significant for people who have multiple other risk factors with increase their chance of a heart attack. Over 10 years of treatment, the risk of a heart attack increases by about 5%.
Other researchers published a study in February 2012 which also found Pradaxa linked to a 33% increased risk of heart attack. These researchers determined that the increased risk was “nonsignificant,” and they also found that the benefits of Pradaxa still outweigh its risks compared to warfarin.
Pradaxa heart attacks are one of the most life-threatening side effects of this medication. They can occur suddenly, without warning, and can cause severe heart damage, heart failure, permanent disability, or death. A heart attack (“myocardial infarction”) occurs when something gets stuck in a coronary artery, which carries oxygenated blood to the heart. The clog is usually due to a blood clot, though it may also be caused by soft plagues in the arterial wall that rupture — when a vulnerable plaque ruptures, it releases substances into the bloodstream that can clog a coronary artery.
If the clog in the heart is not cleared immediately, a person can suffer heart failure. This life-threatening complication occurs when the heart muscle is too severely damaged to pump efficiently. The heart is unable to supply the body with enough blood. Heart failure is often fatal.
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