Vorapaxar and Amyotrophic Lateral Sclerosis: Coincidence or Adverse Association?

Am J Ther

1HeartDrug Research, LLC, Towson, MD;2Johns Hopkins University, Baltimore, MD; and3Clinical Trials Unit, Dong-A University, Busan, Korea.

Published: March 2017

Background: Vorapaxar, a novel antiplatelet thrombin PAR-1 inhibitor, is currently approved for post myocardial infarction and peripheral artery disease indications with concomitant use of clopidogrel and/or aspirin. The vorapaxar safety profile was acceptable. However, aside from heightened bleeding risks, excesses of solid cancers and diplopia, there were more amyotrophic lateral sclerosis (ALS) diagnoses after vorapaxar.

Study Question: To assess the Food and Drug Administration (FDA) reviews on the potential association of vorapaxar with ALS.

Study Design: The review the public FDA records on reported adverse events after vorapaxar.

Measures And Outcomes: Incidence of ALS after vorapaxar and placebo.

Results: The ALS risk appears very small, about 1 case per 10,000 treated subjects, but quite probable. Indeed, there were overall 2 placebo and 4 vorapaxar ALS incidences in the Phase III clinical trials.

Conclusions: Potential adverse association of vorapaxar with ALS risks may be related to off-target neuronal PAR receptor(s) blockade beyond platelet inhibition.

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Source
http://dx.doi.org/10.1097/MJT.0000000000000395DOI Listing

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