Sex-related clinical outcomes following generic clopidogrel commercialization: a population-based comparative safety study
Author(s): ,
Claudia Blais
Affiliations:
PhD
,
Louis Rochette
Affiliations:
MSc
,
Denis Hamel
Affiliations:
MSc
,
Line Guénette
Affiliations:
BPharm PhD
Paul Poirier
Affiliations:
MD PhD FRCPC FCCS FACC FA
Canadian Pharmacists Conference ePoster Library. Leclerc J. Jun 3, 2017; 174245
Ms. Jacinthe Leclerc
Ms. Jacinthe Leclerc
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Abstract
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Objectives
Clopidogrel is widely used to prevent atherothrombotic events in secondary prevention. Generic drugs are licensed through comparative bioavailability studies and mostly conducted in men. No systematic post-marketing surveillance studies are conducted once generic drugs are commercialized. We evaluated the sex-related impact of generic clopidogrel commercialization on adverse events: emergency room consultations (ER) or hospitalizations.

Methods
This interrupted time series analysis conducted using data from the Quebec Integrated Chronic Disease Surveillance System. Rates of adverse events for clopidogrel users at risk (n=74,925; 45% women and 55% men) aged ≥ 66 years were calculated monthly, 12 months before and 12 months after generics commercialization. Monthly periods before and after generics commercialization were compared by segmented regression models with a specific variable for generic and brand-name users, stratified by sex and including a sex-related interaction term.

Results
During the 2-year period, there was a monthly mean rate for 1000 users-month of 157 adverse events for all users (range: 147-177): 167 for women (151-183) vs. 149 for men (136-173). In sex-stratified models, there was an increase in adverse events rates of 24.9% and 19.3% for generic women and men users respectively the month of generics commercialization, both higher vs. brand-name users (p<0.0006). In models including sex and its interaction term, women had 14.5% more adverse events vs. men over the observed period (p<0.0001), independently of generic or brand-name usage at the moment of generics commercialization (p=0.7625).

Conclusion
Among generic clopidogrel users, similar patterns of increased rates of adverse events were observed soon after generics commercialization for women and men. Women had consistently higher adverse events rates compared to men either on brand-name or generic clopidogrel. Further population-based post-marketing surveillance studies, such as cohort studies controlling for potential confounders, would be required to test potential causality.

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