FDA study suggests dabigatran’s pros outweigh cons

Scientist in the lab

Credit: Darren Baker

After reviewing data from more than 134,000 patients, researchers at the US Food and Drug Administration (FDA) have concluded that dabigatran has a favorable risk-benefit profile.

Their research showed that, compared to warfarin, dabigatran decreased the risk of stroke, death, and intracranial hemorrhage in patients with atrial fibrillation.

On the other hand, dabigatran increased the risk of gastrointestinal bleeding, and the risk of myocardial infarction was similar for the 2 drugs.

This study was part of the FDA’s ongoing review of dabigatran. The agency has been investigating the safety of dabigatran since 2011, following reports of serious bleeding events associated with the drug.

A previous FDA study, announced in 2012, suggested dabigatran does not pose an increased risk of serious bleeding when compared to warfarin. But other studies have provided conflicting results, so the FDA decided to conduct additional research.

This study included information from more than 134,000 Medicare patients, aged 65 years or older. The researchers compared dabigatran and warfarin, evaluating the risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleeding, myocardial infarction, and death.

The FDA said this study is based on a much larger and older patient population than those used in the agency’s earlier review of post-market data, and researchers employed a more sophisticated analytical method to capture and analyze the events of concern.

The data showed that, among new users of anticoagulants, dabigatran was associated with a lower risk of ischemic stroke, intracranial hemorrhage, and death, when compared to warfarin.

The incidence rate of ischemic stroke per 1000 person-years was 11.3 among dabigatran users and 13.9 among warfarin users (hazard ratio [HR]=0.80).

The incidence of intracranial hemorrhage was 3.3 and 9.6, respectively (HR=0.34). And the incidence of death was 32.6 and 37.8, respectively (HR=0.86).

The study also showed an increased risk of major gastrointestinal bleeding with the use of dabigatran compared to warfarin. The incidence rate per 1000 person-years was 34.2 and 26.5, respectively (HR=1.28).

The risk of myocardial infarction was similar for the 2 drugs. The incidence rate per 1000 person-years was 15.7 for dabigatran users and 16.9 for warfarin users (HR=0.92).

These results, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for dabigatran’s approval.

The FDA said these findings suggest dabigatran has a favorable risk-benefit profile, so the agency has made no changes to the drug’s current label or recommendations for use.

The FDA is planning to publish detailed data from this study. Until then, some information is available on the agency’s website.

The FDA said it will continue to investigate the reasons for differences in major gastrointestinal bleeding rates for dabigatran and warfarin. And it will continue reviewing anticoagulant use and the risk of bleeding.

Scientist in the lab

Credit: Darren Baker

After reviewing data from more than 134,000 patients, researchers at the US Food and Drug Administration (FDA) have concluded that dabigatran has a favorable risk-benefit profile.

Their research showed that, compared to warfarin, dabigatran decreased the risk of stroke, death, and intracranial hemorrhage in patients with atrial fibrillation.

On the other hand, dabigatran increased the risk of gastrointestinal bleeding, and the risk of myocardial infarction was similar for the 2 drugs.

This study was part of the FDA’s ongoing review of dabigatran. The agency has been investigating the safety of dabigatran since 2011, following reports of serious bleeding events associated with the drug.

A previous FDA study, announced in 2012, suggested dabigatran does not pose an increased risk of serious bleeding when compared to warfarin. But other studies have provided conflicting results, so the FDA decided to conduct additional research.

This study included information from more than 134,000 Medicare patients, aged 65 years or older. The researchers compared dabigatran and warfarin, evaluating the risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleeding, myocardial infarction, and death.

The FDA said this study is based on a much larger and older patient population than those used in the agency’s earlier review of post-market data, and researchers employed a more sophisticated analytical method to capture and analyze the events of concern.

The data showed that, among new users of anticoagulants, dabigatran was associated with a lower risk of ischemic stroke, intracranial hemorrhage, and death, when compared to warfarin.

The incidence rate of ischemic stroke per 1000 person-years was 11.3 among dabigatran users and 13.9 among warfarin users (hazard ratio [HR]=0.80).

The incidence of intracranial hemorrhage was 3.3 and 9.6, respectively (HR=0.34). And the incidence of death was 32.6 and 37.8, respectively (HR=0.86).

The study also showed an increased risk of major gastrointestinal bleeding with the use of dabigatran compared to warfarin. The incidence rate per 1000 person-years was 34.2 and 26.5, respectively (HR=1.28).

The risk of myocardial infarction was similar for the 2 drugs. The incidence rate per 1000 person-years was 15.7 for dabigatran users and 16.9 for warfarin users (HR=0.92).

These results, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for dabigatran’s approval.

The FDA said these findings suggest dabigatran has a favorable risk-benefit profile, so the agency has made no changes to the drug’s current label or recommendations for use.

The FDA is planning to publish detailed data from this study. Until then, some information is available on the agency’s website.

The FDA said it will continue to investigate the reasons for differences in major gastrointestinal bleeding rates for dabigatran and warfarin. And it will continue reviewing anticoagulant use and the risk of bleeding.

Scientist in the lab

Credit: Darren Baker

After reviewing data from more than 134,000 patients, researchers at the US Food and Drug Administration (FDA) have concluded that dabigatran has a favorable risk-benefit profile.

Their research showed that, compared to warfarin, dabigatran decreased the risk of stroke, death, and intracranial hemorrhage in patients with atrial fibrillation.

On the other hand, dabigatran increased the risk of gastrointestinal bleeding, and the risk of myocardial infarction was similar for the 2 drugs.

This study was part of the FDA’s ongoing review of dabigatran. The agency has been investigating the safety of dabigatran since 2011, following reports of serious bleeding events associated with the drug.

A previous FDA study, announced in 2012, suggested dabigatran does not pose an increased risk of serious bleeding when compared to warfarin. But other studies have provided conflicting results, so the FDA decided to conduct additional research.

This study included information from more than 134,000 Medicare patients, aged 65 years or older. The researchers compared dabigatran and warfarin, evaluating the risk of ischemic stroke, intracranial hemorrhage, major gastrointestinal bleeding, myocardial infarction, and death.

The FDA said this study is based on a much larger and older patient population than those used in the agency’s earlier review of post-market data, and researchers employed a more sophisticated analytical method to capture and analyze the events of concern.

The data showed that, among new users of anticoagulants, dabigatran was associated with a lower risk of ischemic stroke, intracranial hemorrhage, and death, when compared to warfarin.

The incidence rate of ischemic stroke per 1000 person-years was 11.3 among dabigatran users and 13.9 among warfarin users (hazard ratio [HR]=0.80).

The incidence of intracranial hemorrhage was 3.3 and 9.6, respectively (HR=0.34). And the incidence of death was 32.6 and 37.8, respectively (HR=0.86).

The study also showed an increased risk of major gastrointestinal bleeding with the use of dabigatran compared to warfarin. The incidence rate per 1000 person-years was 34.2 and 26.5, respectively (HR=1.28).

The risk of myocardial infarction was similar for the 2 drugs. The incidence rate per 1000 person-years was 15.7 for dabigatran users and 16.9 for warfarin users (HR=0.92).

These results, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for dabigatran’s approval.

The FDA said these findings suggest dabigatran has a favorable risk-benefit profile, so the agency has made no changes to the drug’s current label or recommendations for use.

The FDA is planning to publish detailed data from this study. Until then, some information is available on the agency’s website.

The FDA said it will continue to investigate the reasons for differences in major gastrointestinal bleeding rates for dabigatran and warfarin. And it will continue reviewing anticoagulant use and the risk of bleeding.