FDA to assess safety of Pradaxa for nonvalvular AF

The FDA has announced plans to conduct a safety assessment of dabigatran, as compared with warfarin, for the treatment of patients with nonvalvular atrial fibrillation, according to an agency announcement.

The intention of the protocol is to evaluate safety outcomes among new users of dabigatran (Pradaxa, Boehringer Ingelheim) or warfarin who have nonvalvular AF.

“Dabigatran is given as a fixed-dose, twice-daily regimen and requires no therapeutic monitoring, but does require dose adjustments for severe kidney dysfunction and cannot be used in patients with mechanical prosthetic heart valves and does not currently have any specific antidote,” according to the FDA statement. “Questions remain, however, about the outcomes associated with dabigatran outside of the clinical trial setting and in typical clinical practice populations.”

The evaluated population will include patients aged 21 years or older, and subgroup analysis will be performed according to sex and age. The primary outcomes for analysis will include ischemic stroke and intracranial/major extracranial hemorrhage. The secondary outcome will be the incidence of hospitalization for acute MI.

Follow-up will be conducted for as long as patients receive medication or until the incidence of death, disenrollment, initiation of a comparator therapy or another anticoagulant, or admission to a nursing home or skilled nursing facility, according to the protocol documentation. The analysis will be adjusted for confounders including risk factors for bleeding, MI and stroke/thromboembolism, medication use and overall health status measurements.

The FDA posted the planned study protocol for public comment on the website for its Mini-Sentinel project, a database of patient electronic health records for users to monitor the safety of already-approved products.

The FDA has announced plans to conduct a safety assessment of dabigatran, as compared with warfarin, for the treatment of patients with nonvalvular atrial fibrillation, according to an agency announcement.

The intention of the protocol is to evaluate safety outcomes among new users of dabigatran (Pradaxa, Boehringer Ingelheim) or warfarin who have nonvalvular AF.

“Dabigatran is given as a fixed-dose, twice-daily regimen and requires no therapeutic monitoring, but does require dose adjustments for severe kidney dysfunction and cannot be used in patients with mechanical prosthetic heart valves and does not currently have any specific antidote,” according to the FDA statement. “Questions remain, however, about the outcomes associated with dabigatran outside of the clinical trial setting and in typical clinical practice populations.”

The evaluated population will include patients aged 21 years or older, and subgroup analysis will be performed according to sex and age. The primary outcomes for analysis will include ischemic stroke and intracranial/major extracranial hemorrhage. The secondary outcome will be the incidence of hospitalization for acute MI.

Follow-up will be conducted for as long as patients receive medication or until the incidence of death, disenrollment, initiation of a comparator therapy or another anticoagulant, or admission to a nursing home or skilled nursing facility, according to the protocol documentation. The analysis will be adjusted for confounders including risk factors for bleeding, MI and stroke/thromboembolism, medication use and overall health status measurements.

The FDA posted the planned study protocol for public comment on the website for its Mini-Sentinel project, a database of patient electronic health records for users to monitor the safety of already-approved products.

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