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MEDICATION SAFETY

Reducing Clinically Significant Gastrointestinal Toxicity Associated with Nonsteroidal Antiinflammatory Drugs

at time of writing, Specialized Resident in Primary Care, University of Iowa Hospitals and Clinics; now, Pharmacy Practice Specialist, Ambulatory Care, University of Iowa Hospitals and Clinics, Iowa City, IA

Beth Bryles Phillips, PharmD BCPS

Clinical Pharmacy Specialist, Ambulatory Care, University of Iowa Hospitals and Clinics; Assistant Professor (Clinical), College of Pharmacy, University of Iowa

Reprints: Beth Bryles Phillips PharmD BCPS, Department of Pharmaceutical Care, University of Iowa Hospitals and Clinics, 200 Hawkins Dr., Iowa City, IA 52242-1009, fax 319/353-8443, beth-phillips{at}uiowa.edu

OBJECTIVE: To evaluate the efficacy of treatment strategies to reduce clinically significant gastrointestinal adverse effects associated with nonsteroidal antiinflammatory drugs (NSAIDs).

DATA SOURCES: A MEDLINE search (1966–November 2003) was performed to identify relevant articles. Key search terms included proton-pump inhibitors, histamine H₂ antagonists, misoprostol, cyclooxygenase-2 (COX-2) selective inhibitors, nonsteroidal antiinflammatory agents, stomach ulcer, prevention, and economics. Additional references were obtained from cross-referencing the bibliographies of selected articles.

STUDY SELECTION AND DATA EXTRACTION: All information obtained from the MEDLINE search was reviewed. To provide the most clinically relevant information, only randomized controlled trials are included in this review.

DATA SYNTHESIS: Clinically significant upper gastrointestinal adverse events, such as ulcers and ulcer complications, associated with NSAIDs are a cause of significant morbidity and mortality in the US. Interest in strategies to reduce the risk of these adverse events is high among clinicians and patients. Misoprostol, high-dose H₂-receptor antagonists, proton-pump inhibitors, and COX-2 inhibitors have been shown to reduce this risk. Misoprostol and proton-pump inhibitors are more effective than H₂-receptor antagonists; dose-related diarrhea limits the clinical utility of misoprostol. These strategies may not provide enough protection in patients taking concomitant low-dose aspirin therapy or patients with a history of ulcer complications.

CONCLUSIONS: COX-2 inhibitors and proton-pump inhibitors are effective and well-tolerated therapies to reduce clinically significant upper gastrointestinal adverse events associated with NSAIDs.

Key Words: adverse effects, COX-2 inhibitors, H₂-receptor antagonists, misoprostol, nonsteroidal antiinflammatory drugs, proton-pump inhibitors, ulcer complications, ulcers

Published Online, June 22, 2004. www.theannals.com, DOI 10.1345/aph.1D621

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-04-028-H01

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