The Clopidogrel Medco Outcomes Study

A series of studies exploring the impact of concomitant use of proton pump inhibitors (PPIs) and clopidogrel on major adverse cardiovascular events and related hospitalization costs.

Investigators: Eric J. Stanek, PharmD^1, Ronald E. Aubert, PhD¹, David A. Flockhart, MD,PhD², Rolf P. Kreutz, MD², Jianying Yao, MS¹, Jeffrey A. Breall, MD,PhD², Zeruesenay Desta, PhD², Todd C. Skaar, PhD², Felix W. Frueh, PhD¹, J. Russell Teagarden, DMHS¹, Robert S. Epstein, MD¹.

Study in Brief:

- The sample included 16,690 patients adherent to clopidogrel therapy and compared CV event-related hospitalizations for patients concurrently taking PPIs to patients not using PPIs over a 12-month period.

- Results showed that patients taking PPIs with clopidogrel increased their relative risk of a major adverse CV event by 51 percent.

- Evidence that this effect is most likely due to an interaction between PPIs and clopidogrel was strengthened by findings that PPIs taken without clopidogrel do not independently increase CV event risks.

- Individual PPI agents including omeprazole (Prilosec), esomeprazole (Nexium), pantoprazole (Protonix) and lansoprazole (Prevacid) taken with clopidogrel were each independently associated with a significantly higher risk of a major adverse CV event.

- Overall, the incidence of hospitalization for upper gastrointestinal bleeding at 1 year was low, at about 1 percent.

- One-year hospitalization costs for patients on PPIs and clopidogrel were 38 percent higher than for patients not using a PPI.

¹Medco Health Solutions, Inc., Franklin Lakes, NJ
²Indiana University School of Medicine