Twice-daily dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) was shown to be associated with lower rates of fatal and traumatic intracranial hemorrhage compared with warfarin, according to the results of a retrospective subanalysis published online, April 5, in Stroke, the Journal of the American Heart Association.
Twice-daily dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) was shown to be associated with lower rates of fatal and traumatic intracranial hemorrhage (ICH) compared with warfarin, according to the results of a retrospective subanalysis published online, April 5, in Stroke, the Journal of the American Heart Association.
“All anticoagulants carry an increased risk of bleeding that should be considered along with the benefit of stroke risk reduction when making treatment decisions,” said John Smith, MD, PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals.
“Intracranial hemorrhage can be a devastating complication of anticoagulation and is responsible for the majority of disability and death from treatment-related bleeding,” Dr Smith added. “These data further our understanding of the risk profile of Pradaxa compared to warfarin, showing a lower rate of both fatal and traumatic ICH with Pradaxa 150 mg in patients with non-valvular atrial fibrillation, including those who were older.”
In this study, Robert G. Hart, MD, from the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada, and colleagues looked at a group of patients who participated in the RE-LY trial, a multicenter, phase 3, randomized study that investigated whether dabigatran etexilate (2 blinded doses) was as effective as well-controlled warfarin for stroke prevention in 18,113 participants with atrial fibrillation.
The investigators followed patients for a mean of 2 years and noted 154 ICH events in 153 patients. Patients assigned to dabigatran 150 mg and 110 mg experienced fewer fatal ICH events (n=13 and n=11) and fewer traumatic ICH events (n=11 for both doses) than those who were taking warfarin (n=32 and n=24). Rates were 0.76% per year for those assigned to warfarin and 0.31% and 0.23% per year among those assigned to dabigatran 150 mg and dabigatran 110 mg, respectively (P<.001 for either dabigatran dose versus warfarin). It should be noted that, although studied, dabigatran 110 mg is a dose that has not been FDA-approved.
Consistent across treatment arms, patients who experienced ICH events tended to be older (mean age, 75 [with ICH] vs 71.5 [without ICH], relative risk, 1.1 per year; P<.001), had a history of stroke or transient ischemic attack (TIA) (relative risk, 1.8; P=.001), used aspirin concomitantly (relative risk, 1.6; P=.01), and were assigned to warfarin (relative risk, 2.9; P<.001).
“The key take-away based on the findings of this subanalysis is that in RE-LY there were fewer fatal (13 vs 32) and traumatic (11 vs 24) ICH events in patients treated with Pradaxa 150 mg compared to warfarin,” Dr Smith told Formulary. In addition, the results highlight critical predictors of ICH, which should be considered when prescribing anticoagulation therapy, including age, prior history of stroke or TIA, and aspirin use.
“These data add to the previously reported results of the pivotal RE-LY trial, which showed the overall rate of ICH was 59% lower with Pradaxa 150 mg [n=38] compared with warfarin [n=90],” he said.
Dabigatran is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The reasons that patients reported for discontinuing use of the drug in RE-LY were bleeding and gastrointestinal events.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.