Is there an inter-manufacturer difference in generic clopidogrel response?

Abstract Background Differences in platelet aggregation response to generic clopidogrel by manufacturer has not been investigated. Purpose Compare rates of among patients receiving medication produced two different manufacturers after acute coronary syndrome and/or percutaneous intervention. Methods This quality improvement project included 515 adult for or ischemic heart disease and referred angiography/percutaneous intervention at a large, public hospital. The was divided into phases: 1. retrospective collection baseline data; 2. 12-week, prospective phases which all the hospital restricted single time. primary outcome measured function testing defined as ADP <40% on light transmission aggregometry between groups. Aspirin arachidonic acid <20% also measured. Results Of total both (mean [SD] age, 64.5 [11.4] years; 351 [68.2%] men; 450 [87.4%] ACS), 52% were found be responders based results (Table 1 – select variables). Among 135 phase, there significantly lower proportion who Manufacturer group compared 2 (34.8% vs. 55.1%, p=0.03) After adjustment sex, BMI, aspirin response, therapeutic hypothermia, LHC indication, loading dose, time dose lab measurement, manufacturer, (OR [95% CI]: 0.96 [0.95–0.97], p<0.001) 2.45 [1.18–5.22], p=0.02) associated with response. Conclusions In large hospital, we observed that pharmacodynamic varied drug manufacturer. Further investigation regulation is needed minimize inter-manufacturer variability. Funding Acknowledgement Type funding sources: None.