Researchers today published promising results for a drug that could lead to a replacement for the very effective but difficult-to-use blood thinner Coumadin® (sold generically as Warfarin), currently taken by millions of Americans to reduce their risk of stroke. Writing in the New England Journal of Medicine, lead U.S. researcher, active clinical cardiologist and Vice President of the Lankenau Institute for Medical Research, Dr. Michael Ezekowitz hailed the study results as “the first breakthrough in 60 years for preventing stroke in patients with atrial fibrillation.”
The three-year study by German pharmaceutical manufacturer Boehringer Ingelheim (BI) was the largest stroke prevention trial ever conducted among patients with atrial fibrillation. Involving 18,113 patients in 44 countries, the clinical trial compared results of the new drug against those of Coumadin / Warfarin. About 5,000 of these patients were from the U.S., including participants recruited from Lankenau Hospital.
“The magnitude of these results cannot be understated,” Dr. Ezekowitz said. “For years, the primary drug option cardiologists have had in preventing strokes in patients with atrial fibrillation is the anticoagulant Warfarin. Although it is highly effective, it is a very difficult drug to control in most patients. Many factors, including food, prescription drugs and over-the-counter medication, can interfere with its effectiveness. In addition, patients on Warfarin must be closely monitored through monthly blood tests.
“This study points to another anticoagulant solution that is potentially more effective and safer. This should be welcome news for any patient with atrial fibrillation who has been identified as being at risk for stroke.”
Atrial fibrillation, estimated to affect as many as three million people in the U.S. alone, is the leading heart arrhythmia. It is caused by a malfunction of the electrical signals that direct the heart’s pumping action. The result is a rapid and chaotic contraction of the atria, or upper chamber of the heart. Individuals with the condition often experience shortness of breath, fatigue and palpitations. In some cases, atrial fibrillation can lead to stroke. Because blood does not move normally through the heart, clots can form. If a clot breaks off, a stroke can occur.
According to Dr. Ezekowitz, clinical trial results for the new drug, Dabigatran, established it as a user-friendly, effective treatment for atrial fibrillation – one that favorably impacts patient care.
“While highly effective at reducing the incidence of stroke, Warfarin can be problematic in many patients. Patients need to be careful about eating salads, drinking alcohol or taking over-the-counter cold medications, all of which can interfere with the drug’s effectiveness.
“Another remarkable aspect of this trial is that we identified precisely the correct dosage of Dabigatran to give to patients. If the dosage of a blood thinner is too high, the patient can experience bleeding. If it’s too low, a stroke can occur. This trial not only identified a drug that is more effective than Warfarin, it also revealed the precise dosage that needs to be administered to prevent strokes.”
Dr. Ezekowitz listed the following attractive features of Dabigatran:
- Like Coumadin / Warfarin, it can be taken by mouth, but unlike Coumadin / Warfarin – which takes about four days to have an effect – Dabigatran acts within hours after ingestion
- Dabigatran, as compared to Coumadin / Warfarin, has fewer drug-to-drug interactions and, unlike Coumadin / Warfarin, does not require monitoring
- In addition, the trial shows that Dabigatran is superior to Coumadin / Warfarin at the higher dose without compromising safety, and is a lot safer than Coumadin / Warfarin at the lower dose without compromising effectiveness
As one of the trial’s leading research institutions, the Lankenau Institute for Medical Research brings a unique “community of science” approach to research, combining bench researchers, physician and nurse researchers, as well as incubating biotechnology companies – all working towards finding new and better ways to treat patients with diseases and conditions such as atrial fibrillation. In addition to Dr. Ezekowitz and the Lankenau Institute, other trial leaders included Stewart Connolly and Salim Yusuf, of Canada’s McMaster University and Lars Wallentin, of Uppsala in Sweden.
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