Authors: Daphne Reinau, Matthias Schwenkglenks, Mathias Früh, Andri Signorell, Eva Blozik, Christoph R. Meier.
Journal: Drug Safety
Controversy exists as to whether glucocorticoids (GC) are ulcerogenic per se and may thus cause peptic ulcer bleeding (PUB) independent of concomitantly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs). The objective of the study was to investigate the association between GC use and PUB with or without co-medication with NSAIDs.
We conducted a case–control study using administrative claims data from the Swiss health insurance company Helsana. We identified 1191 cases with incident PUB between 2012 and 2016 and matched up to 10 PUBfree controls to each case on age, sex, region and number of years insured with Helsana. We compared prior GC exposure between cases and controls using multivariate conditional logistic regression analyses controlling for several potential confounders. Patients with or without concomitant NSAID exposure were analysed separately.
Patients with prior exposure to both GC and NSAIDs were five times more likely to experience PUB than patients who neither used GC nor NSAIDs (adjusted odds ratio [adj. OR] 4.80, 95% CI 3.55–6.71). Although the risk of PUB among patients who used NSAIDs without GC was increased threefold (adj. OR 3.20, 95% CI 2.59–3.95), we observed only a moderately increased risk among patients who used GC alone without NSAIDs (adj. OR 1.63, 95% CI 1.20–2.42).
The use of NSAIDs with or without GC was associated with a markedly higher risk of PUB compared with GC monotherapy. Use of GC alone was associated with a moderately increased risk of PUB, which might be causal or attributed to confounding by indication.