Key result
Following the 2009 FDA safety communication, the probability of using clopidogrel-PPI combination therapy among clopidogrel users fell by over 40% (OR 0.57, p<0.001), dropping from an average of 30.5% to 19.9%.
Why the study?
Does the FDA Safety Communication reduce the concomitant prescription of clopidogrel and CYP2C19-inhibiting PPIs in clopidogrel users?
Observational (n=483,074)
Does the FDA Safety Communication reduce the concomitant prescription of clopidogrel and CYP2C19-inhibiting PPIs in clopidogrel users?
Odds Ratio: 0.57
Absolute Event Rate: 19.9% vs 30.5%
p-value: p=<0.001
The 2009 FDA Safety Communication significantly reduced the concomitant prescription of clopidogrel and CYP2C19-inhibiting PPIs, though approximately one-third of patients still received combination therapy post-communication.
FDA warning was associated with reduced clopidogrel-PPI co-prescription; leaves open effects on ischemic or bleeding outcomes.
OBJECTIVES: In 2009, the FDA issued a warning that omeprazole--a proton pump inhibitor (PPI)--reduces the antithrombotic effect of clopidogrel by almost half when taken concomitantly. This study aims to analyze the impact of the FDA Safety Communications on prescribing clopidogrel together with PPIs. METHODS: This retrospective study identified clopidogrel users from the Truven Health Analytics MarketScan Databases (01/2006-12/2012). Rates of clopidogrel-PPI combination therapy were estimated in 6-month intervals for patients with ≥1 clopidogrel prescription fill, then were analyzed pre- and post-safety communication (11/17/2009). Analyses were also conducted by grouping PPIs into CYP2C19 inhibitors (omeprazole and esomeprazole) and CYP2C19 non-inhibitors (pantoprazole, lansoprazole, dexlansoprazole, and rabeprazole). RESULTS: Overall, 483,074 patients met the selection criteria; of these, 157,248 used a clopidogrel-PPI combination. On average, 30.5% of patients in the pre- and 19.9% in the post-communication period used a clopidogrel-PPI combination therapy. Among clopidogrel users, the probability of using clopidogrel-PPI combinations fell by over 40% in the post-communication period (OR = 0.57; p<0.001); the proportion of patients using esomeprazole fell from 12.9% to 5.3%, and the proportion using omeprazole fell from 10.1% to 6.3%. Among combination therapy users, the probability of patients using a combination with a CYP2C19 inhibitor decreased by 53% (OR = 0.47; p<0.001); however, 31.5% of patients were still prescribed a clopidogrel-PPI combination therapy. Trends were similar for all and newly treated patients, regardless of clopidogrel indication and physician specialty. CONCLUSIONS: The FDA Safety Communication resulted in a reduction in the number of patients undergoing combination therapy; however approximately one-third of patients still used combination therapy post-communication.
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Guérin et al. (2016) conducted an observational in Clopidogrel users (including patients with acute coronary syndrome, peripheral arterial disease, recent myocardial infarction, or recent stroke) (n=483,074). FDA Safety Communication (2009) vs. Pre-safety communication period was evaluated on Use of clopidogrel-PPI combination therapy (OR 0.57, p=<0.001). Following the 2009 FDA safety communication, the probability of using clopidogrel-PPI combination therapy among clopidogrel users fell by over 40% (OR 0.57, p<0.001), dropping from an average of 30.5% to 19.9%.
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