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Dabigatran: A chronology
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.
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Medscape Medical News
Label update for dabigatran
Jun 7, 2012 10:45 EDT
Boehringer Ingelheim announced the label will now reflect the 150-mg twice-daily dose was "superior" to warfarin to prevent ischemic and hemorrhagic stroke in nonvalvular atrial fibrillation.
Dabigatran fatal bleeding less than in clinical trials
Thrombosis
Dabigatran fatal bleeding less than in clinical trials
1 COMMENT - May 25, 2012 10:30 EDT
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.
Oral anticoagulants in the real world: Bleeding rates and medical costs compared
Thrombosis
Oral anticoagulants in the real world: Bleeding rates and medical costs compared
Apr 2, 2012 11:45 EDT
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.
Medscape Medical News
Dabigatran cost-effective compared with warfarin
1 COMMENT - Mar 7, 2012 17:00 EST
A new analysis shows the drug is cost effective in secondary stroke prevention in patients with atrial fibrillation.
Arrhythmia/EP
More bleeding, thromboembolic events with dabigatran in AF ablation
Feb 8, 2012 16:45 EST
Dabigatran was stopped the morning of the procedure; its long half-life combined with the use of unfractionated heparin during the procedure likely explains the increased risk of bleeding.
Arrhythmia/EP
US bleeding ADRs higher with dabigatran than warfarin
14 COMMENTS - Jan 12, 2012 15:40 EST
There is particular concern over use of dabigatran in the elderly, in whom there has been a high number of bleeds, including intracranial hemorrhages, reported to the FDA.
Thrombosis
RECOVER II confirms benefit of dabigatran in treatment of VTE
Dec 19, 2011 16:45 EST
The new study adds another 2500 patients tested with dabigatran in the setting of VTE, confirming the results observed in the first RECOVER study.
Arrhythmia/EP
NICE gives dabigatran thumbs-up after getting "plausible" cost estimates
Nov 1, 2011 12:45 EDT
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.
Dabigatran: Australia issues bleeding warning
Arrhythmia/EP
Dabigatran: Australia issues bleeding warning
1 COMMENT - Oct 7, 2011 08:15 EDT
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.
Novel anticoagulants in AF: A guide for the clinical practitioner
Editorial series
Novel anticoagulants in AF: A guide for the clinical practitioner
2 COMMENTS - Sep 15, 2011 10:47 EDT
Join Drs Samuel Goldhaber, Jean-Pierre Bassand, Stavros Konstantinides, and Alexander GG Turpie as they guide the clinical practitioner through the landscape of novel anticoagulants in AF.
The Paris review: ARISTOTLE, dal-VESSEL, and PURE at ESC 2011
The Cardiology Show
The Paris review: ARISTOTLE, dal-VESSEL, and PURE at ESC 2011
4 COMMENTS - Aug 31, 2011 09:54 EDT
Share the excitement from the blockbuster ESC 2011 Congress with Drs Valentin Fuster, Mariell Jessup, Adnan Kastrati, Magnus Ohman, Terje Pedersen, Silvia Priori, and Bryan Williams.
Arrhythmia/EP
Deaths prompt dabigatran safety advisory in Japan
8 COMMENTS - Aug 17, 2011 10:45 EDT
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.
Caution needed with dabigatran in the elderly
Arrhythmia/EP
Caution needed with dabigatran in the elderly
16 COMMENTS - Aug 4, 2011 09:45 EDT
Caution must be exercised when prescribing the new anticoagulant dabigatran to prevent stroke in atrial-fibrillation patients who are elderly and frail, say doctors.
RE-MEDY: Dabigatran noninferior to warfarin for extended treatment of VTE
Thrombosis
RE-MEDY: Dabigatran noninferior to warfarin for extended treatment of VTE
Jul 27, 2011 19:30 EDT
Whether dabigatran equals warfarin in the extended treatment of venous thromboembolism is addressed in the RE-MEDY trial.
Arrhythmia/EP
Falsely elevated point-of-care INR values in dabigatran-treated patients
1 COMMENT - Jul 7, 2011 15:15 EDT
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.
Dabigatran cost-effectiveness in AF tied to patient stroke and bleeding risks
Arrhythmia/EP
Dabigatran cost-effectiveness in AF tied to patient stroke and bleeding risks
7 COMMENTS - Jun 7, 2011 10:15 EDT
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.
Time to revisit dabigatran dose in the US?
Medscape Medical News
Time to revisit dabigatran dose in the US?
6 COMMENTS - May 31, 2011 15:00 EDT
Researchers say new bleeding-risk data from the RE-LY trial suggest that the 110-mg dose may be best for patients older than 75 years and provide a rationale for the FDA to revisit this issue.
Dabigatran joins US atrial-fib guidelines
Arrhythmia/EP
Dabigatran joins US atrial-fib guidelines
4 COMMENTS - Feb 15, 2011 17:00 EST
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.
Arrhythmia/EP
Pradaxa in bottles must be used within 30 days
9 COMMENTS - Feb 4, 2011 13:30 EST
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 unusual—most 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.
Arrhythmia/EP
RE-LY: Stroke risk at AF cardioversion similar on dabigatran or warfarin
3 COMMENTS - Jan 7, 2011 16:30 EST
The newly available oral anticoagulant dabigatran appears to be "at least as good" as warfarin for prevention of stroke or peripheral embolism in the setting of cardioversion of atrial fibrillation.
Clinical cardiology
Top 10 CVD advances from AHA for 2010 include stroke
Dec 24, 2010 13:43 EST
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.
US societies bring atrial-fib guidelines almost up-to-date
Arrhythmia/EP
US societies bring atrial-fib guidelines almost up-to-date
2 COMMENTS - Dec 23, 2010 09:45 EST
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.
Experts compare new oral anticoagulants preparing to battle for the warfarin market
Features
Experts compare new oral anticoagulants preparing to battle for the warfarin market
22 COMMENTS - Dec 14, 2010 16:30 EST
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?
New dabigatran safety data from RE-LY unveiled as watchdog group seeks answers
Arrhythmia/EP
New dabigatran safety data from RE-LY unveiled as watchdog group seeks answers
3 COMMENTS - Dec 8, 2010 18:30 EST
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.
ROCKET AF, EMPHASIS-HF, and DEFINE: AHA 2010 Overview from Chicago
The Cardiology Show
ROCKET AF, EMPHASIS-HF, and DEFINE: AHA 2010 Overview from Chicago
4 COMMENTS - Nov 17, 2010 16:00 EST
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.

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