Impact of the FDA Safety Communication on Prescription Trends of Clopidogrel in Combination with Proton Pump Inhibitors: Presidential Poster

Abstract

Purpose: In 2009, FDA's safety communication warned that omeprazole reduced the antithrombotic effect of clopidogrel by almost half. The aim of this study was to assess the impact of the FDA safety communication on prescription trends of clopidogrel in combination with PPIs. Methods: Adult clopidogrel users were identified from a large retrospective U.S. claims database. Rates of combination therapy were estimated in 6-month intervals between Jan 2006 to Mar 2012 for patients with ≥1 clopidogrel prescription fill and continuous plan enrollment for the previous and current 6-month intervals. Combination therapy was defined as clopidogrel-PPI use for ≥30 consecutive days during the interval. The probability of combination therapy pre- and post-safety communication period (11/17/2009) was compared. Results: 327,368 pre-safety and 277,821 post-safety communication patient intervals were identified. On average, 34.1% of patients in the pre-period and 15.9% in the post-period used a PPI-clopidogrel combination therapy; the probability of combination use fell almost two thirds (odds ratio [OR] 0.36; p<0.001; Figure 1). Among patients using combination therapy, the percentage using omeprazole changed insignificantly (33.9% vs. 34.39%), the percentage using esomeprazole decreased (48.7% vs. 32.9%), and the percentage of those using pantoprazole increased the most (9.9% vs. 24.0%). Trends were similar for all and newly treated patients, regardless of indication and physician specialty. But, among new combination therapy patients, the percentage using omeprazole increased (34.3% vs. 38.2%; p<0.001).FigureConclusion: The FDA safety communication resulted in an overall decrease of PPI use by patients using clopidogrel. However, among patients receiving combination therapy, about one third still used omeprazole and a similar proportion still used esomeprazole after the FDA safety communication. Disclosure - Annie Guerin, senior economist, is an employee of Analysis Group, inc, which has received consulting fees from Takeda Pharmaceuticals Valerie Carter, economist, is an employee of Analysis Group, inc, which has received consulting fees from Takeda Pharmaceuticals Eric Q Wu, Managing Principal, is an employee of Analysis Group, inc, which has received consulting fees from Takeda Pharmaceuticals Reema Moody, Associate Director, is an employee of Takeda Pharmaceuticals International Inc. This research was supported by an industry grant from Takeda Pharmaceuticals.