Risk of gastrointestinal bleeding and cardiovascular events due to NSAIDs in the diabetic elderly population

BMJ Open Diabetes Res Care. 2015 Dec 18;3(1):e000133. doi: 10.1136/bmjdrc-2015-000133. eCollection 2015.


Objective: We assessed gastrointestinal bleeding (GIB) and cardiovascular (CV) risks such as myocardial infarction or stroke associated with non-steroidal anti-inflammatory drug (NSAID) use among elderly patients with diabetes.

Methods: Using a nationwide claims database covering 2008-2012, we conducted a cohort study of patients with diabetes aged ≥65 years. Among the 117 610 patients, NSAID users and non-users were propensity score matched, excluding any who had experienced a potentially confounding event in the year prior to cohort entry. Multivariate Cox regression models treating death as competing risk were used.

Results: There were 2184 (1.86%) cases of GIB and NSAID users had an adjusted HR (aHR) of 1.68 (95% CI 1.54 to 1.83) of GIB risk after adjusting for age, sex, comorbidities and recent medications compared to NSAID non-users. There were 9333 (7.94%) cases of myocardial infarction or stroke with an aHR of 1.20 (95% CI 1.15 to 1.25). The risk of GIB was higher in patients with liver disease and renal failure, while that of CV events was higher in patients who received anticoagulants, antiplatelet agents, aspirin and selective serotonin reuptake inhibitors. The number needed to harm was 111 for GIB and 77 for CV events. Among different NSAIDs, nimesulide increased the risk of GIB and ketorolac increased the risk of CV events compared to celecoxib (aHR 2.60 and 3.13, respectively).

Conclusions: Elderly patients with diabetes treating NSAIDs had a significantly higher risk of both upper GIB and CV events compared to NSAID non-users, and the risk varied among different NSAIDs regardless of cyclooxygenase-2 activity.

Keywords: COX-2 Inhibitors; Cardiovascular Complications; Cardiovascular Pharmacotherapy; Drug-Related Problems.