INDIRECT COMPARISONS OF NOVEL ORAL ANTICOAGULANTS FOR THE PREVENTION OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION- A SYSTEMATIC LITERATURE REVIEW
Author(s)
Claflin AB*1;Liu X2, Phatak H3 1Pfizer Inc, New York, NY, USA, 2Pfizer, Inc., New York, NY, USA, 3Bristol-Myers Squibb Company, Princeton, NJ, USA
Presentation Documents
OBJECTIVES: Given the absence of head-to-head studies, this review summarized indirect treatment comparison studies of oral anticoagulants (OACs) for the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). METHODS: Eligible English-language studies published up to May 31, 2013 were identified from electronic databases, Medline, EMBASE and Cochrane Library. Studies were included if the indirect comparison involved at least two OACs currently on the market with the common comparator warfarin. The search yielded ten published studies and one in press study was obtained. RESULTS: Eleven indirect comparison studies, based on data from three phase III (RE-LY, ROCKET-AF, and ARISTOTLE) and one phase II (PETRO) clinical trial, was reviewed. Six pairwise comparisons were reviewed across studies: any/all OACs vs. warfarin, apixaban vs. dabigatran 110mg, apixaban vs. dabigatran 150mg, apixaban vs. rivaroxaban, dabigatran 110mg vs. rivaroxaban, and dabigatran 110mg vs. rivaroxaban. OACs as a whole were found to have significantly better bleeding and efficacy endpoints when compared with warfarin. Apixaban and dabigatran 110mg were found to have significantly reduced risk of multiple bleeding endpoints when compared with rivaroxaban and dabigatran 150mg. Dabigatran 150mg was found to have significantly decreased risk of multiple efficacy endpoints when compared with rivaroxaban. Three studies compared discontinuation rates. Apixaban and rivaroxaban were found to have significantly lower discontinuation rates compared with both doses of dabigatran. Apixaban was also found to have a significantly lower discontinuation rate compared with rivaroxaban. CONCLUSIONS: Apixaban, dabigatran and rivaroxaban appear to have better safety and efficacy profiles when compared with warfarin. Apixaban and dabigatran 110mg consistently demonstrated reduced risk of bleeding when compared with rivaroxaban and dabigatran 150mg. Dabigatran150mg demonstrated increased efficacy on multiple endpoints when compared with rivaroxaban, while discontinuation rates were increased. Head-to-head studies would help clarify any differences among these medicines for efficacy and bleeding.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PCV16
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Cardiovascular Disorders, Respiratory-Related Disorders