Pradaxa Bleeding Risk Increased With Certain Statins: Study

Toronto, ONIn tandem with oft-cited Pradaxa bleeding associated with the frequently-prescribed blood thinner, a new concern has emerged from a Canadian study suggesting that Pradaxa use with certain statins can heighten the risk for bleeding for patients suffering from atrial fibrillation.

The latter, characterized by an irregular and rapid heartbeat, can lead to blood clots capable of inducing strokes. Anti-coagulants are routinely used to help thin the blood in an effort to avoid clotting.

For Pradaxa patients prescribed the statins Mevacor (lovastatin) or Zocor (simvastatin) for control of LDL cholesterol, the combination can further increase the risk for Pradaxa bleeding, according to the Canadian study.

Health Daily Digest (11/22/16) reports that researchers from St. Michael’s Hospital in Toronto analyzed data from 46,000 patients aged 65 and up suffering from atrial fibrillation. All were prescribed dabigatran Pradaxa to reduce the risk for stroke.

The study, ‘Association between statin use and ischemic stroke or major hemorrhage in patients taking dabigatran for atrial fibrillation’ by Tony Antoniou, PhD and colleagues determined that Pradaxa patients who also used Mevacor or Zocor for cholesterol control revealed an increased risk for Pradaxa bleeding events over Pradaxa patients prescribed a different statin.

The higher risk, the authors stated, translated to a 40 percent increased risk for Pradaxa bleeding. Patients were at greater risk for being hospitalized, or requiring emergency treatment.

All anti-coagulants carry a bleeding risk – thus the need for stringent monitoring to ensure that diet, dosage and other factors align in an effort to maintain the expected safety and efficacy of blood thinners.

Due to claims that Pradaxa requires less-stringent monitoring than Coumadin, patients and their health care providers embraced Pradaxa in spite of increased risk for Pradaxa heart attack and Pradaxa deaths, or so it has been alleged in Pradaxa lawsuits.

In related news, the manufacturer of Pradaxa – Boehringer Ingelheim Pharmaceuticals – announced today data from a new analysis of the GLORIA-AF Registry that reveals newly-diagnosed patients suffering from non-valvular atrial fibrillation (NVAF) and treated with dabigatran Pradaxa presented with a 76.6 percent probability of remaining on Pradaxa for 12 months, and a corresponding 69.2 percent probability for two years.

“Patients with NVAF are at a five times greater risk for stroke, and the goal of anticoagulant therapy is to reduce this risk. It is critical for patients and physicians to understand the benefits of staying on prescribed treatment and the potential risks of discontinuing,” said Jonathan Halperin, MD, the Robert and Harriet Heilbrunn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, study author and member of the GLORIA-AF steering committee, in a statement. “In general, nearly half of patients discontinue oral anticoagulant therapy after only a year, so it is promising to see high adherence rates with Pradaxa in this new analysis from the GLORIA-AF Registry.”

Unlike Xarelto, Pradaxa has a specific reversal agent available, described as the only novel oral anticoagulant to have one. An available antidote does not, however minimize the increased risk for Pradaxa bleeding in patients using lovastatin or simvastatin, as suggested by Canadian researchers.

According to reports from the European Medicines Agency, some 50 to 256 deaths have been allegedly linked to Pradaxa side effects. The GLORIA-AF data was presented to the Annual Meeting of the American Society of Hematology in San Diego, in early December.