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Published Online, 17 October 2006, www.theannals.com, DOI 10.1345/aph.1H183.
The Annals of Pharmacotherapy: Vol. 40, No. 11, pp. 1924-1931. DOI 10.1345/aph.1H183
© 2006 Harvey Whitney Books Company.
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ADVERSE DRUG REACTIONS

GI Risk Factors and Use of GI Protective Agents Among Patients Receiving Nonsteroidal Antiinflammatory Drugs

Crystal L Harris, PharmD

Assistant Center Director, Pharmaceutical Management and Research, Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM

Dennis W Raisch, PhD

Associate Center Director, Scientific Affairs, VA Cooperative Studies Program Cinical Research Pharmacy

Upendra Abhyankar, MS MBA

Medical Writer, Life Sciences Division of Cognizant Technology Solutions, Mumbai, India

Shalaka Marfatia, MS MPh

Project Manager, Center for Health Economics and Policy, MEDTAP International at United BioSource Corporation, Bethesda, MD

Heather M Campbell, PharmD

Pharmacoeconomics Fellow, VA Cooperative Studies Program Clinical Research Pharmacy

Mike R Sather, PhD FASHP

Center Director, VA Cooperative Studies Program Clinical Research Pharmacy

Reprints: Dr. Harris, VA Cooperative Studies Program Clinical Research Pharmacy, 2401 Centre, SE, Albuquerque, NM 87106-4180, fax 505/248-3205, crystal.harris{at}csp.research.med.va.gov

BACKGROUND: Patient characteristics increase the risk of gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAIDs). Patients at risk may not be prescribed protective therapies that might mitigate their risk of NSAID-associated GI complications.

OBJECTIVE: To assess GI risk among Veterans Affairs (VA) patients on NSAID therapy, determine whether therapy conformed to VA guidelines for lessening the risk of GI complications, and identify patient risk factors associated with conformance.

METHODS: Using databases from 3 VA medical centers, we retrospectively identified patients receiving NSAIDs and obtained data regarding age, history of GI bleed over 8 years, GI adverse effects associated with NSAIDs, diagnoses, and medication history over one year. We inferred health status from age-adjusted Charlson comorbidity index values. Each patient's risk of developing GI complications over one year was calculated using these data. Among patients at significant or substantial risk, we assessed conformance to VA guidelines. We used logistic regression to identify risk factors associated with conformance and determine adjusted ORs (AORs) with 95% CIs for each risk factor.

RESULTS: There were 19 122 patients receiving NSAIDs. Of 4589 patients at significant risk and 1246 at substantial risk, 1161 (25.3%) and 356 (28.6%), respectively, were prescribed guideline-conformant therapy. Risk factors associated with conformance (p ≤ 0.001) among patients at significant risk were rheumatoid arthritis (AOR 1.34; 95% CI 1.13 to 1.58) and GI adverse effects (AOR 1.53; 95% CI 1.42 to 1.64). For substantial risk patients, risk factors associated with conformance (p ≤ 0.031) were rheumatoid arthritis (AOR 1.65; 95% CI 1.37 to 1.98), concomitant corticosteroids (AOR 1.21; 95% CI 1.02 to 1.43), GI hospitalization (AOR 2.01; 95% CI 1.57 to 2.59), and GI adverse effects (AOR 1.79; 95% CI 1.47 to 2.18).

CONCLUSIONS: Many patients at risk for GI adverse events do not receive guideline-conformant therapy. Educational interventions to improve conformance could focus on specific risk factors for GI complications.

Key Words: gastrointestinal bleeding, nonsteroidal antiinflammatory agents

Published Online, October 17, 2006. www.theannals.com, DOI 10.1345/aph.1H183





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