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MEDICATION SAFETY

Inadequate Prevention of NSAID-Induced Gastrointestinal Events

Director, PHARMO Institute for Drug Outcomes Studies, Utrecht, Netherlands

Wim G Goettsch, PhD

Research Manager, PHARMO Institute for Drug Outcomes Studies

Reprints: Ron MC Herings PharmD PhD, PHARMO Institute for Drug Outcomes Studies, PO Box 85222, NL-3508 TB Utrecht, Netherlands, fax 31 30 2345568, Ron.Herings{at}PHARMO.NL

BACKGROUND: Use of nonsteroidal antiinflammatory drugs (NSAIDs) is a well-known cause of gastrointestinal (GI) adverse events. To protect patients at risk, several strategies are advised, including concomitant treatment with proton-pump inhibitors or switching to cyclooxygenase (COX)-2 selective NSAIDs. It is as yet unknown how many patients at risk for NSAID-induced events are protected.

OBJECTIVE: To estimate the number of patients using GI preventive treatment while at risk for NSAID-induced GI events.

METHODS: Records of patients using NSAIDs consecutively for at least 100 days (from 2001 to 2002) were obtained from the PHARMO system in the Netherlands (N = 1 000 000). GI preventive treatments were classified as adequate or inadequate based on evidence-based criteria. Adequate treatment was defined as concomitant use of misoprostol (>400 µg daily), histamine₂-antagonists (2 times recommended dose) or proton-pump inhibitors (1 recommended dose), or alternative treatment with COX-2 selective inhibitors.

RESULTS: A total of 10 121 patients met the study inclusion criteria; 70% were women. One or more preventive strategies were prescribed in 4340 patients (42.9%), of which 2799 (64.5%) were adequate and 1541 (35.5%) inadequate. Prescribing of adequate preventive treatments increased with the number of risk factors, from 13.3% among those with no additional risk factors to 61.9% for those with 4 risk factors.

CONCLUSIONS: Although risk factors for GI damage were recognized, a large number of patients in the Netherlands were not or were inadequately protected against potential NSAID-associated GI damage. Despite recommendations, and even in the presence of 4 risk factors, almost 40% of these patients were not prescribed adequate GI preventive treatment.

Key Words: gastroprotective agents, nonsteroidal antiinflammatory drugs

Published Online, March 23, 2004. www.theannals.com, DOI 10.1345/aph.1D068