Breakthrough drug reduces stroke risk in patients with irregular heartbeat

MANILA, Philippines -  A stroke in the brain, with the heart as the source of the blood clot, has always been like a sword dangling over the heads of patients with an irregularly irregular heartbeat called atrial fibrillation (AF).

High-risk patients generally require use of potent blood thinners which have been associated with an increased rate of side effects — primarily bleeding — and inconvenience of blood testing.

A new blood thinner or oral anticoagulant with a more favorable effectiveness and safety profile has long been awaited in the market.

The Philippine Food and Drug Administration (FDA) has already approved dabigatran etexilate, Boehringer Ingelheim’s novel, anti-blood clot agent for the prevention of stroke, and reduction of clogged artery-related deaths in patients with atrial fibrillation.

Dabigatran is now available to a broad spectrum of patients, with 150 mg twice daily dose as the approved recommended dose for most patients.

For patients with moderate kidney impairment, elderly individuals aged 75 and older, or previous gastro-intestinal bleeding, a reduced daily dose of 110 mg twice daily may be considered.

The approval is based on findings from the Randomized Evaluation of Long-term anticoagulant therapY (RE-LY), the largest AF trial completed to date and is set to provide a breakthrough for stroke prevention in AF.

Dr. Dante Morales, one of the country’s most respected cardiologists and a participant in this international clinical trial, said the results demonstrated that dabigatran 150 mg significantly reduced the risk of stroke by 35 percent beyond the reduction achieved with warfarin, the longtime standard of care, in addition to reductions in life-threatening bleeding, including those inside the brain.

Based on the indirect comparison with placebo or dummy pills, these would translate to the prevention of three out of four AF-related strokes.

Besides providing superior efficacy compared to warfarin, dabigatran does not require blood monitoring or related dose adjustments, is not affected by food, and no dose adjustment is required for many common co-medications in AF patients.

“Many physicians believe that the findings of RE-LY has the potential to change the treatment paradigm in stroke prevention in AF,” Morales said.

Commenting on the clinical implications of the RE-LY results, Dr. Stuart Connolly, co-principal investigator of RE-LY and director of the Division of Cardiology at McMaster University, said, “Warfarin has been the standard therapy for stroke prevention in AF for many years. However, it is a very difficult treatment to use because of its interaction with various drugs, food types and the need for continuous monitoring to ensure that the drug is at the right therapeutic level.”