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Dabigatran joins US atrial-fib guidelines
FEBRUARY 15, 2011 | Steve Stiles
Dallas, TX and Washington, DC - The oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), approved by the FDA only few months ago, as expected has entered the US atrial fibrillation (AF) management guidelines as an alternative to warfarin for preventing strokes and thromboembolism [1].
The drug received the highest class I recommendation, based primarily on its showing in the randomized RE-LY trial, according to the document posted online February 14, 2010 as an addendum to a guidelines update published jointly in late December [2] by the American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS).
Dabigatran's emergence as a second option for oral anticoagulation in AF has been covered in detail by heartwire.
The writing group for the December 2010 "focused update" on the management of AF had yanked the dabigatran section at the last minute: the drug's FDA approval, thought to be imminent, at press time had yet to come through. The approval was announced on October 20, after the document had been finalized but about two months before the document's public release.
Dr L Samuel Wann (Wisconsin Heart Hospital, Wauwatosa), chair of the writing group, told heartwire at the time that there was a plan to reinstate the dabigatran recommendation in early 2011 with another update that would support the drug as a warfarin alternative in most AF patients.
Exceptions, according to that latest update, include those with prosthetic heart valves or hemodynamically significant valve disease, severe renal failure, or advanced liver disease.
The December ACC/AHA/HRS document was itself an update to AF-management guidelines published in 2006 [3] and followed publication of new AF guidelines from the Canadian Cardiovascular Society (CCS) in September and the European Society of Cardiology (ESC) in October, as reported by heartwire. Interestingly, the CCS guidelines had also been finalized before dabigatran's approval, but their developers took the unusual step of including dabigatran as an anticoagulation option anyway, betting successfully that it would be soon approved in Canada.
With several other oral anticoagulants encroaching on likely FDA review for approval for the AF indication, dabigatran is for the time being the only available warfarin alternative in AF. Many patients and clinicians find warfarin difficult to manage and are welcoming another oral anticoagulation option.
But the new statement cautions that warfarin may still be appropriate for some patients. "Because of the twice-daily dosing and greater risk of nonhemorrhagic side effects with dabigatran, patients already taking warfarin with excellent [international normalized ratio] INR control may have little to gain by switching to dabigatran," it states.
Disclosures for the writing group are listed in the paper.
« PREVIOUS HEARTWIRE ARTICLE
MI and CHF readmission rates higher in black patients
FEB 15, 2011 16:00 EST NEXT HEARTWIRE ARTICLE »
Threshold for "high risk" reduced in new AHA guidance on CVD prevention for women
FEB 16, 2011 11:15 EST
Sources
Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS Focused update on the management of patients with atrial fibrillation (update on dabigatran). A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011. DOI:10.1161/CIR.0b013e31820f14c0. Available at: http://circ.ahajournals.org.
Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011; 123:104-123. J Am Coll Cardiol 2011; 57:223-242. Heart Rhythm 2011; 8:157-176.
Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114:e257-354.
Thrombosis
ARRHYTHMIA/EP
Dabigatran joins US atrial-fib guidelines
FEBRUARY 15, 2011 | Steve Stiles
Dallas, TX and Washington, DC - The oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), approved by the FDA only few months ago, as expected has entered the US atrial fibrillation (AF) management guidelines as an alternative to warfarin for preventing strokes and thromboembolism [1].
The drug received the highest class I recommendation, based primarily on its showing in the randomized RE-LY trial, according to the document posted online February 14, 2010 as an addendum to a guidelines update published jointly in late December [2] by the American College of Cardiology (ACC), American Heart Association (AHA), and Heart Rhythm Society (HRS).
Dabigatran's emergence as a second option for oral anticoagulation in AF has been covered in detail by heartwire.
The writing group for the December 2010 "focused update" on the management of AF had yanked the dabigatran section at the last minute: the drug's FDA approval, thought to be imminent, at press time had yet to come through. The approval was announced on October 20, after the document had been finalized but about two months before the document's public release.
Dr L Samuel Wann (Wisconsin Heart Hospital, Wauwatosa), chair of the writing group, told heartwire at the time that there was a plan to reinstate the dabigatran recommendation in early 2011 with another update that would support the drug as a warfarin alternative in most AF patients.
Exceptions, according to that latest update, include those with prosthetic heart valves or hemodynamically significant valve disease, severe renal failure, or advanced liver disease.
The December ACC/AHA/HRS document was itself an update to AF-management guidelines published in 2006 [3] and followed publication of new AF guidelines from the Canadian Cardiovascular Society (CCS) in September and the European Society of Cardiology (ESC) in October, as reported by heartwire. Interestingly, the CCS guidelines had also been finalized before dabigatran's approval, but their developers took the unusual step of including dabigatran as an anticoagulation option anyway, betting successfully that it would be soon approved in Canada.
With several other oral anticoagulants encroaching on likely FDA review for approval for the AF indication, dabigatran is for the time being the only available warfarin alternative in AF. Many patients and clinicians find warfarin difficult to manage and are welcoming another oral anticoagulation option.
But the new statement cautions that warfarin may still be appropriate for some patients. "Because of the twice-daily dosing and greater risk of nonhemorrhagic side effects with dabigatran, patients already taking warfarin with excellent [international normalized ratio] INR control may have little to gain by switching to dabigatran," it states.
Disclosures for the writing group are listed in the paper.
« PREVIOUS HEARTWIRE ARTICLE
MI and CHF readmission rates higher in black patients
FEB 15, 2011 16:00 EST NEXT HEARTWIRE ARTICLE »
Threshold for "high risk" reduced in new AHA guidance on CVD prevention for women
FEB 16, 2011 11:15 EST
Sources
Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS Focused update on the management of patients with atrial fibrillation (update on dabigatran). A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011. DOI:10.1161/CIR.0b013e31820f14c0. Available at: http://circ.ahajournals.org.
Wann LS, Curtis AB, January CT, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (updating the 2006 guideline): A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2011; 123:104-123. J Am Coll Cardiol 2011; 57:223-242. Heart Rhythm 2011; 8:157-176.
Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 2006; 114:e257-354.
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