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Dabigatran shows promise in unselected cohort
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Cardiovascular events occurred in less than 2% of unselected patients in daily care who received dabigatran to prevent stroke in atrial fibrillation.
Results of the RE-LY trial indicated that dabigatran (Pradaxa, Boehringer Ingelheim) offered similar safety and efficacy as warfarin in the prevention of stroke in atrial fibrillation. Patients in randomized controlled trials are under close surveillance and protocol, so researchers wanted to confirm the efficacy of dabigatran in a cohort of unselected patients.
The current investigation included 938 patients from a network of 200 physicians in Germany. Eligible participants had been indicated for new oral anticoagulant therapy for more than 3 months, were aged at least 18 years, had written informed-consent and were available for follow-up.
Patients received prospective follow-up by phone on day 30 and quarterly thereafter.
The final analysis included 201 patients who were treated with dabigatran for atrial fibrillation.
Patients in the current registry were aged 74.2 years vs. 71.5 years among patients in the RE-LY trial. The current study also included patients with a higher CHADS2 score (2.7 vs. 2.1).
More than half (55.7%) of patients in the current registry received a 110-mg daily dose of dabigatran. Patients who took this dose had higher CHADS2 scores than those who received the 150-mg dose (2.3 vs. 2.9).
Two-thirds of the study population were new to anticoagulant therapy, and the other portion had switched from vitamin K agonists. The most common reason for the switch was due to poor international normalized ratio control or bleeding complications, according to researchers.
Major cardiovascular events occurred in 1.5% of the study population, and minor cardiovascular events occurred in 1%. No deaths have been reported.
Bleeding complications occurred in 14.9% of the study population, but only 1.5% of patients experienced major bleeding.
Ninety-three percent of patients were still receiving dabigatran by the 3-month mark. However, between 3 and 6 months, side effects or noncompliance caused an increasing percentage of patients to change to other anticoagulants.
“In unselected patients in daily care, [dabigatran] is effective and safe with low rates of cardiovascular or major bleeding events,” the researchers wrote. “However, within 6 months, about 20% of patients are switched to other anticoagulants.”
For more information:
Gelbricht V. Abstract #502. Presented at: the 2012 ASH Annual Meeting and Exposition; Dec. 8-11, 2012; Atlanta.
Disclosure: Gelbricht reports no relevant financial disclosures.