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Vorapaxar and Amyotrophic Lateral Sclerosis: Coincidence or Adverse Association?

Abstract 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.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title american journal of therapeutics
Publication Year Start




PMID- 28267691
OWN - NLM
STAT- MEDLINE
DA  - 20170307
DCOM- 20170314
LR  - 20170314
IS  - 1536-3686 (Electronic)
IS  - 1075-2765 (Linking)
VI  - 24
IP  - 2
DP  - 2017 Mar/Apr
TI  - Vorapaxar and Amyotrophic Lateral Sclerosis: Coincidence or Adverse Association?
PG  - e139-e143
LID - 10.1097/MJT.0000000000000395 [doi]
AB  - 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.
FAU - Serebruany, Victor L
AU  - Serebruany VL
AD  - 1HeartDrug Research, LLC, Towson, MD;2Johns Hopkins University, Baltimore, MD;
      and3Clinical Trials Unit, Dong-A University, Busan, Korea.
FAU - Fortmann, Seth D
AU  - Fortmann SD
FAU - Hanley, Daniel F
AU  - Hanley DF
FAU - Kim, Moo Hyun
AU  - Kim MH
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Am J Ther
JT  - American journal of therapeutics
JID - 9441347
RN  - 0 (Lactones)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (Pyridines)
RN  - 0 (Receptor, PAR-1)
RN  - 3KX376GY7L (Glutamic Acid)
RN  - EC 3.4.21.5 (Thrombin)
RN  - ZCE93644N2 (vorapaxar)
SB  - IM
MH  - Amyotrophic Lateral Sclerosis/*epidemiology/metabolism
MH  - Glutamic Acid/metabolism
MH  - Humans
MH  - Incidence
MH  - Lactones/*therapeutic use
MH  - Platelet Aggregation Inhibitors/*therapeutic use
MH  - Pyridines/*therapeutic use
MH  - Receptor, PAR-1/*antagonists & inhibitors/metabolism
MH  - Risk Factors
MH  - Thrombin/metabolism
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2017/03/08 06:00
MHDA- 2017/03/16 06:00
CRDT- 2017/03/08 06:00
AID - 10.1097/MJT.0000000000000395 [doi]
AID - 00045391-201703000-00005 [pii]
PST - ppublish
SO  - Am J Ther. 2017 Mar/Apr;24(2):e139-e143. doi: 10.1097/MJT.0000000000000395.

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