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RE-LY trial results suggest Pradaxa capsule reduces risk of stroke in AF patients

September 22, 2017

Results from the CHA2DS2-VASc Subanalysis

In the subanalysis, patients were grouped into quartiles based on CHA2DS2-VASc score (0-2, n = 4,042; 3, n = 5,365; 4, n = 4,374; 5-9, n = 4,327). The results of the subanalysis showed that PRADAXA 150mg was associated with reductions in stroke risk compared to warfarin for all four quartiles (0-2: PRADAXA 150mg: 0.5%/yr, warfarin: 0.8%/yr; 3: PRADAXA 150mg: 0.8%/yr, warfarin: 1.4%/yr; 4: PRADAXA 150mg: 1.0%/yr, warfarin: 2.0%/yr; 5-9: PRADAXA 150mg: 2.1%/yr, warfarin: 2.8%/yr; interaction p-value = 0.60).

Results of the analysis showed there was a significant interaction between CHA2DS2-VASc score and rates of major bleeding, with lower rates for PRADAXA 150mg compared to warfarin for patients in the first three quartiles, but an increased rate of major bleeding for the quartile at greatest risk (0-2: PRADAXA 150mg: 1.8%/yr, warfarin: 2.4%/yr; 3: PRADAXA 150mg: 2.6%/yr, warfarin: 3.5%/yr; 4: PRADAXA 150mg: 3.2%/yr, warfarin: 3.9%/yr; 5-9: PRADAXA 150mg: 5.8%/yr, warfarin: 4.4%/yr; interaction p-value = 0.003).

Results from the Different Types of NVAF Subanalysis

In the subanalysis, patients were classified by type of NVAF - 6,375 had permanent NVAF, 5,943 had paroxysmal NVAF and 5,789 had persistent NVAF. Results showed that PRADAXA 150mg reduced the risk of stroke and systemic embolism compared to warfarin across all three subgroups (permanent: PRADAXA 150mg: 1.11%/yr, warfarin: 1.58%/yr; paroxysmal: PRADAXA 150mg: 1.09%/yr, warfarin: 1.77%/yr; persistent: PRADAXA 150mg: 1.14%/yr, warfarin: 1.80%/yr; interaction p-value = 0.88).

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.