Concomitant Use of Clopidogrel and PPIs Still Prescribed Despite Safety Warnings

MedicalResearch.com Interview with:
Willemien J. Kruik-Kollöffel, PharmD
Medisch Spectrum Twente in Enschede
Netherlands,

MedicalResearch.com: What is the background for this study?

Response: Safety concerns of the concomitant use of clopidogrel and proton pump inhibitors (PPIs) were published in 2009 and 2010 by the medicines regulatory agencies, including a direct healthcare professional communication. Those publications caused a lot of turmoil. We examined the association between various safety statements and prescription behavior for gastroprotective drugs in naïve patients in the Netherlands during the years 2008–2011.


MedicalResearch.com: Would you discuss the study design?

Response: Data from the PHARMO Database Network were analyzed with interrupted time series analyses to estimate the impact of each communication on drug prescriptions. Dispensings were used as a proxy variable for prescription behavior.

MedicalResearch.com: What are the main findings?

Response: After the early communication in January 2009, 15.5% (95% CI 7.8, 23.4) more patients started concomitantly with (es)omeprazole and 13.8% (95% CI 6.5, 21.2) less with other PPIs. Directly after the first statement in June 2009, we found a steep increase in histamine 2-receptor antagonists (H2RA) peaking at 25%, placing those patients at risk for gastrointestinal events. This effect for H2RA faded away after a few months. In February 2010, when the official advice via an adjusted statement was to avoid (es)omeprazole, we found a decrease of 11.9% (95% CI 5.7, 18.2) for (es)omeprazole and an increase of 16.0% (95% CI 10.3, 21.7) for other PPIs. Still 22.6% (95% CI 19.5, 25.7) of patients started on (es)omeprazole in February 2010, placing them at risk for cardiovascular events.

MedicalResearch.com: What should readers take away from your report?

Response: Advices of regulatory authorities were followed, however, reluctantly and not fully, probably partly because of the existing scientific doubt about the interaction. Although the place in therapy of clopidogrel will be repositioned to specific – smaller – groups of patients, prescribing the drug still needs to be done in a safe way, taking into account all available safety information and weighing pros and cons of the message. Lessons learned in this study should be applied to managing drug safety information in general.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:
Prescription behavior for gastroprotective drugs in new users as a result of communications regarding clopidogrel – proton pump inhibitor interaction
Willemien J. Kruik-Kollöffel,Jo b van der Palen,H. Joost Kruik,Myrthe P. P. van Herk-Sukel,Kris L. L. Movig

First published: 18 July 2016 DOI: 10.1002/prp2.242

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