PMID- 31073846
OWN - NLM
STAT- MEDLINE
DCOM- 20191125
LR  - 20200309
IS  - 1179-1969 (Electronic)
IS  - 1170-229X (Linking)
VI  - 36
IP  - 8
DP  - 2019 Aug
TI  - Did Generic Clopidogrel Commercialization Affect Trends of ER Consultations and 
      Hospitalizations in the Population Treated with Clopidogrel?
PG  - 759-768
LID - 10.1007/s40266-019-00679-4 [doi]
AB  - BACKGROUND: Clopidogrel has been widely used to prevent atherothrombotic events. 
      Since 2011, pharmacists have offered their patients the opportunity to switch to 
      generic clopidogrel, an economic alternative. Whether bioequivalence of generic 
      cardiovascular drugs translates into clinical equivalence at a population level 
      remains unclear and needs to be further documented. OBJECTIVE: We aimed to 
      evaluate the impact of generic clopidogrel commercialization on adverse events 
      (AEs): hospitalizations or emergency room (ER) consultations. METHODS: This is an 
      interrupted time series analysis using the Quebec Integrated Chronic Disease 
      Surveillance System. We included all patients >/= 66 years old who were users of 
      the brand-name clopidogrel or a generic version (n = 6) 24 months before and up 
      to 12 months after generics commercialization. Rates of AEs were computed, and 
      periods before and after generics commercialization were analyzed by segmented 
      regression models along with exploratory analyses (generic vs. brand name). 
      Sensitivity analyses were also performed using stratification of the time series 
      by (1) sex, (2) the number of prevalent cardiovascular comorbidities, and (3) 
      socioeconomic status. RESULTS: Time series were constituted of 89,525 clopidogrel 
      users (mean age 78 years, 45% women, 71% ischemic heart disease, 34% stroke). For 
      all users, there was a mean rate of 157 AEs per 1000 user-months, stable trend 
      before (-0.1% [95% confidence interval -0.3 to 0.1] and after (0.0% [- 0.5 to 
      0.6]) generics commercialization. In exploratory analyses, once generic 
      clopidogrel versions were commercialized, rates of AEs were 19.2% (95% CI 
      11.7-26.7) higher for generic versus brand-name users. This difference persisted 
      up to 1 year. Sensitivity analyses yielded similar results. CONCLUSIONS: The 
      population treated with clopidogrel had similar rates of hospitalizations or ER 
      consultations before and after generics commercialization. However, differences 
      in rates of hospitalizations or ER consultations between generic and brand-name 
      clopidogrel users may represent a drug safety signal which remains to be 
      validated. Using a different study design, permitting adjustment for potential 
      confounders, could be useful in this regard.
FAU - Leclerc, Jacinthe
AU  - Leclerc J
AD  - Institut national de sante publique du Quebec, Quebec City, Canada.
AD  - Nursing Department, Universite du Quebec a Trois-Rivieres, Trois-Rivieres, 
      Canada.
AD  - Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie 
      de Quebec, Quebec City, Canada.
FAU - Blais, Claudia
AU  - Blais C
AD  - Institut national de sante publique du Quebec, Quebec City, Canada.
AD  - Faculty of Pharmacy, Universite Laval, Quebec City, QC, Canada.
FAU - Rochette, Louis
AU  - Rochette L
AD  - Institut national de sante publique du Quebec, Quebec City, Canada.
FAU - Hamel, Denis
AU  - Hamel D
AD  - Institut national de sante publique du Quebec, Quebec City, Canada.
FAU - Guenette, Line
AU  - Guenette L
AD  - Faculty of Pharmacy, Universite Laval, Quebec City, QC, Canada.
AD  - Centre de recherche du CHU de Quebec-Universite Laval, Axe Sante des populations 
      et pratiques optimales en sante, Quebec City, Canada.
FAU - Poirier, Paul
AU  - Poirier P
AD  - Faculty of Pharmacy, Universite Laval, Quebec City, QC, Canada. 
      paul.poirier@criucpq.ulaval.ca.
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Drugs Aging
JT  - Drugs & aging
JID - 9102074
RN  - 0 (Drugs, Generic)
RN  - A74586SNO7 (Clopidogrel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Clopidogrel/adverse effects/economics/*therapeutic use
MH  - Comorbidity
MH  - Drug Costs
MH  - Drugs, Generic/adverse effects/economics/pharmacology/*therapeutic use
MH  - Emergency Service, Hospital/*trends
MH  - Female
MH  - Hospitalization/*trends
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quebec
MH  - Referral and Consultation/*trends
MH  - Regression Analysis
MH  - Therapeutic Equivalency
MH  - Treatment Outcome
EDAT- 2019/05/11 06:00
MHDA- 2019/11/26 06:00
CRDT- 2019/05/11 06:00
PHST- 2019/05/11 06:00 [pubmed]
PHST- 2019/11/26 06:00 [medline]
PHST- 2019/05/11 06:00 [entrez]
AID - 10.1007/s40266-019-00679-4 [pii]
AID - 10.1007/s40266-019-00679-4 [doi]
PST - ppublish
SO  - Drugs Aging. 2019 Aug;36(8):759-768. doi: 10.1007/s40266-019-00679-4.