Suboptimal gastroprotective coverage of NSAID use and the risk of upper gastrointestinal bleeding and ulcers: an observational study using three European databases. Issue 12 (2nd June 2011)

• Record Type: Journal Article
• Authors: van Soest, Eva M; Valkhoff, Vera E; Mazzaglia, Giampiero; Schade, René; Molokhia, Mariam; Goldstein, Jay L; Hernández-Díaz, Sonia; Trifirò, Gianluca; Dieleman, Jeanne P; Kuipers, Ernst J; Sturkenboom, Miriam C J M
• Is Part Of: Gut. Volume 60:Issue 12(2011)
• Page Start: 1650
• Page End: 1659
• Publication Date: 2011-06-02
• Subjects: Anti-ulcer agents -- bleeding peptic ulcer -- gastric and duodenal ulcers -- multi-database study -- non-steroidal anti-inflammatory agents -- peptic ulcer -- peptic ulcer haemorrhage -- proton pump inhibitors; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gut.2011.239848
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : Background: Gastro-protective agents (GPA) are co-prescribed with non-steroidal anti-inflammatory drugs (NSAID) to lower the risk of upper gastrointestinal (UGI) events. It is unknown to what extent the protective effect is influenced by therapy adherence. Aim: To study the association between GPA adherence and UGI events among non-selective (ns) NSAID users. Methods: The General Practice Research Database (UK 1998–2008), the Integrated Primary Care Information database (the Netherlands 1996–2007) and the Health Search/CSD Longitudinal Patient Database (Italy 2000–2007) were used. A nested case-control design was employed within a cohort of nsNSAID users aged ≥50 years, who also used a GPA. UGI event cases (UGI bleeding and/or symptomatic ulcer with/without obstruction/perforation) were matched to event-free members of the cohort for age, sex, database and calendar time. Adherence to GPA was calculated as the proportion of nsNSAID treatment days covered by a GPA prescription. Adjusted OR with 95% CI were calculated. Results: The cohort consisted of 618 684 NSAID users, generating 1 107 266 nsNSAID episodes. Of these, 117 307 (10.6%) were (partly) covered by GPA, 4.9% of which with a GPA coverage <20% (non-adherence), and 68.1% with a GPA coverage >80% (full adherence). 339 patients experienced an event. Among non-adherers, the OR was 2.39 (95% CI 1.66 to 3.44) for all UGI events and 1.89 (95% CI 1.09 to 3.28) for UGI bleeding alone, compared to full adherers. Conclusions: The risk of UGI events was significantly higher in nsNSAID users with GPA non-adherence. This underlines the importance of strategies to improve GPA adherence.