Patients receiving dabigatran have high adherence rates, low risk of stroke, bleeding
A registry analysis found that patients with newly diagnosed non-valvular atrial fibrillation who received dabigatran (Pradaxa) had a 76.6 percent probability of remaining on treatment at one year and a 69.2 percent probability of remaining on treatment at two years.
Meanwhile, a real-world study found that patients receiving dabigatran had a lower risk of stroke and bleeding compared with patients receiving warfarin.
The results of both studies were presented on Dec. 4 at the American Society of Hematology annual meeting in San Diego.
The FDA has approved dabigatran to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Dabigatran is an oral anticoagulant.
Boehringer Ingelheim, which manufactures dabigatran, said in a news release that researchers examined 2,937 patients who received the medication at nearly 1,000 sites in 44 countries, including 88 percent who were considered at high risk for stroke. The registry is expected to enroll as many as 56,000 patients from 2,200 sites in nearly 50 countries.
In the real-world study, the researchers used a nationwide administrative U.S. claims database and identified adults who were newly diagnosed with non-valvular atrial fibrillation and treated with dabigatran or warfarin from 2011 to 2013. They used propensity scores to match dabigatran and warfarin users in a 1:1 ratio. In all, there were 18,980 patients in each group.
Strokes occurred in 0.5 percent of patients receiving dabigatran and 0.8 percent of patients receiving warfarin, while bleeding occurred in 1.2 percent and 1.6 percent of patients, respectively. The differences were statistically significant.
After adjustment, the hazard ratio of having a first stroke or bleed was significantly lower in the dabigatran group.
In addition, patients in the dabigatran group had a significantly lower number of stroke-specific hospitalizations and outpatient visits as well as significantly lower bleed-specific hospitalizations and outpatient visits.
The stroke-specific outpatient visit costs were $84 in the dabigatran group and $144 in the warfarin group, while the bleed-specific hospitalization costs were $360 and $612, respectively. Those differences were both statistically significant, as well, although the stroke-specific hospitalization costs and bleed-specific outpatient costs were similar between the groups.
Further, the mean length of hospital stay for stroke or bleeding was significantly lower in the dabigatran group.
Although the 30-day, stroke-related readmissions were similar between the groups, the odds of stroke-related readmissions were significantly lower in the dabigatran group. Meanwhile, the 30-day, bleed-related readmissions were significantly lower for patients receiving dabigatran.