The presentation of the RE-LY results at the 2009 ESC meeting, showing that dabigatran safely and significantly cut the risk of stroke or peripheral embolic events compared with warfarin over two years, quickly let to speculation that a new era in anticoagulation therapy had arrived. The path to approval around the globe has not been entirely without controversy.
The European Medicines Agency has nevertheless recommended that the bleeding risk continues to be kept under close review and that the product information is updated with further advice and warnings about bleeding.
Two separate experiences with dabigatran from different US centers showing very different results, and new cost-effectiveness analyses with the new drugs were reported in a poster session at last week's ACC meeting.
NICE has concluded that the "most plausible" incremental cost-effectiveness ratios for all patients eligible for dabigatran are within the range considered cost-effective for use in the UK National Health Service.
The Australian regulatory authority has issued a "safety advisory" on the new oral anticoagulant dabigatran because of an increase in the number of bleeding-related adverse events reports received since it was approved for use in AF patients.
According to Boehringer Ingelheim, treatment with Prazaxa, as it is known in Japan, could not be completely ruled out as a cause of death in five patients, one of whom had kidney failure (a contraindication) and four of whom were aged over 80.
Two new case reports are highlighting inaccuracies in the point-of-care INRs in patients treated with dabigatran. In these instances, the point-of-care INR in patients taking dabigatran was falsely elevated, thereby raising concerns that such inaccuracies might affect patient care.
It also was closely related to the degree of INR control patients might be expected to achieve were they to use warfarin instead, according to a new analysis; dabigatran was more appealing with greater stroke or hemorrhage risk and looser INR control.
Expectedly, the new oral thrombin inhibitor received a class I recommendation as a warfarin alternative for preventing stroke/thromboembolism in patients with atrial fibrillation in a guidelines update jointly released by the AHA, ACC, and HRS.
Healthcare professionals say that patients in the US taking the new anticoagulant dabigatran should be aware that if their prescription comes in a bottle, it should be used within 30 days of opening. This is unusualmost medications are stable for at least a year after package opening. In all other markets, dabigatran comes only in blister packs, which are not affected by the expiry issue, the company says.
With a neurologist at the helm at the AHA, a decision was taken this year to highlight separately the top 10 research advances in the fields of heart disease and stroke. There is some crossover, however, says AHA president Dr Ralph Sacco. He picks out new anticoagulants for stroke prevention in AF as perhaps the most important new topic for both disciplines.
UPDATED// The FDA approval of dabigatran came late in the game, so the drug wasn't included in a new "focused update" to guidelines for managing atrial fibrillation, released jointly by the ACC, AHA, and HRS. But the authors have something up their sleeve to address that.
It seems likely that there will be two new oral anticoagulants available in the not-too-distant future that can be used as an alternative to warfarin in the prevention of stroke in AF patients. But how do the two new agents compare with each other, and what about other possible indications and the host of other similar agents in development?
The drug-safety watchdog Therapeutic Initiative, in Vancouver, BC, says available dabigatran data don't adequately show whether it's likely to be safe in patients with atrial fibrillation; RE-LY trial investigators respond and unveil updated adverse-event numbers.
Dr Valentin Fuster sits down with Drs C Noel Bairey Merz, Roger Blumenthal, Sunil Rao, Renu Virmani, Lars Wallentin, and James Young for an in-depth discussion on the important trials presented at the AHA 2010 Scientific Sessions.