Boehringer Ingelheim is planning to conduct a large-scale study to look at the benefits of its anticoagulant Pradaxa in the prevention of recurrent stroke.
Specifically, the 6,000-patient study will look at the safety and efficacy of Pradaxa (dabigatran) in people who have already suffered an embolic stroke of undetermined source (ESUS), in other words when a blood clot forms elsewhere in the body but travels and lodges in the brain.
Dabigatran is already recommended for stroke prevention in patients with atrial fibrillation (AF) but approval for ESUS would markedly increase the number of patients eligible for treatment with the direct thrombin inhibitor as around a quarter of all strokes come under this category.
Boehringer announced the new trial – called RE-SPECT ESUS – at the European Stroke Conference in Nice, France, yesterday. It will enrol patients who have suffered an ESUS within the last three to six months and randomise them to treatment with either dabigatran or aspirin, with a follow-up period of three years.
Pradaxa is jostling for market share with two other novel anticoagulants – Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) – and has seen sales build steadily to knock on the door of $1bn this year, according to analyst estimates.
Having reached the market first in 2008, Pradaxa was the undisputed market leader among the new anticoagulants for some time. However, Xarelto’s rapid growth in the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism) and other indications saw it take pole position and break into the top 50 best-selling medicines for 2013, as seen in PMLiVE’s Top Pharma List, with Eliquis languishing a distant third.
Boehringer has started to claw back some ground thanks to recent approvals in DVT/PE in patients who have been treated with an injectable anticoagulant, and a positive trial in ESUS could add another big indication to its portfolio.
“The results obtained from the RE-SPECT ESUS study will help to address current gaps in knowledge, supporting physician choice of appropriate therapy and improving patient care,” commented its lead clinical investigator, Professor Hans-Christoph Diener of the University of Duisburg-Essen in Germany.