Abstract
PurposeTo assess the risk of gastrointestinal perforation, ulcers, or bleeding (PUB) associated with the use of conventional nonsteroidal anti‐inflammatory drugs (NSAIDs) with proton pump inhibitors (PPIs) and selective COX‐2 inhibitors, with or without PPIs compared with conventional NSAIDs.MethodsA case–control study was performed within conventional NSAIDs and/or selective COX‐2 inhibitors users identified from the Dutch PHARMO Record Linkage System in the period 1998–2012. Cases were patients aged ≥18 years with a first hospital admission for PUB. For each case, up to four controls were matched for age and sex at the date a case was hospitalized (index date). Logistic regression analysis was used to calculate odds ratios (ORs).ResultsAt the index date, 2634 cases and 5074 controls were current users of conventional NSAIDs or selective COX‐2 inhibitors. Compared with conventional NSAIDs, selective COX‐2 inhibitors with PPIs had the lowest risk of PUB (adjusted OR 0.51, 95% confidence interval [CI]: 0.35–0.73) followed by selective COX‐2 inhibitors (adjusted OR 0.66, 95%CI: 0.48–0.89) and conventional NSAIDs with PPIs (adjusted OR 0.79, 95%CI: 0.68–0.92). Compared with conventional NSAIDs, the risk of PUB was lower for those aged ≥75 years taking conventional NSAIDs with PPIs compared with younger patients (adjusted interaction OR 0.79, 95%CI: 0.64–0.99). However, those aged ≥75 years taking selective COX‐2 inhibitors, the risk was higher compared with younger patients (adjusted interaction OR 1.22, 95%CI: 1.01–1.47).ConclusionsSelective COX‐2 inhibitors with PPIs, selective COX‐2 inhibitors, and conventional NSAIDs with PPIs were associated with lower risks of PUB compared with conventional NSAIDs. These effects were modified by age. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.
Highlights
Our study revealed that conventional Nonsteroidal anti-inflammatory drugs (NSAIDs) with pump inhibitors (PPIs), selective COX-2 inhibitors alone, and selective COX-2 inhibitors with PPIs decreased the relative risk of PUB compared with conventional NSAIDs alone as we found in our main analyses
This study demonstrated that compared with conventional NSAIDs, conventional NSAIDs with PPIs, selective COX-2 inhibitors alone, and selective COX-2 inhibitors with PPIs decreased the risk of PUB with 21%, 34%, and 49%, respectively
Our study showed that age modified the risk of PUB for conventional NSAIDs with PPIs and selective COX-2 inhibitors alone compared with conventional NSAIDs alone
Summary
Nonsteroidal anti-inflammatory drugs (NSAIDs) are extensively used to treat pain-related musculoskeletal diseases such as osteoarthritis, rheumatoid arthritis, and chronic low back pain.[1,2,3] Conventional NSAIDs inhibit the cyclooxygenase (COX) isoenzymes, COX-1 and COX-2, while the selective COX-2 inhibitors mainly inhibit the latter.[4]Two meta-analyses of clinical trials showed that conventional NSAIDs increase the risk of Several evidence-based strategies are implemented to lower the risk of GI adverse events when a NSAID is needed, such as substitution of conventionalNSAIDs for selective COX-2 inhibitors or coadministration of proton pump inhibitors (PPIs) with conventional NSAIDs.[8,9,10,11] When conventional NSAIDs are combined with PPIs, the risk of symptomatic GI ulcers is lower than with conventional NSAIDs alone,[11,12] in particular for patients with risk factors for GI complications and long-term use.[13]. Two meta-analyses of clinical trials showed that conventional NSAIDs increase the risk of Several evidence-based strategies are implemented to lower the risk of GI adverse events when a NSAID is needed, such as substitution of conventional. Risk of upper GI toxicity for the combined treatment of a conventional NSAID and a PPI is similar for selective COX-2 inhibitors alone.[14]. Another strategy to reduce GI toxicity is by combining selective COX-2 inhibitors with PPIs.[15] Several studies showed that this combination is associated with a lower risk of GI adverse events compared with conventional NSAIDs16–18 or selective COX-2 inhibitors alone.[19,20]
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