Derivation and validation of a risk prediction score for nonsteroidal anti‐inflammatory drug‐related serious gastrointestinal complications in the elderly

• Published in: British journal of clinical pharmacology Vol. 89; no. 7; pp. 2216 - 2223
• Main Authors: Lee, Suhyun, Heo, Kyu‐Nam, Lee, Mee Yeon, Ah, Young‐Mi, Shin, Jaekyu, Lee, Ju‐Yeun
• Format: Journal Article
• Language: English
• Published: England 01.07.2023
• Subjects: clinical pharmacology; drug utilization; epidemiology; gastroenterology; geriatrics; patient safety; pharmacovigilance; epidemiology; geriatrics; patient safety; drug utilization; clinical pharmacology; gastroenterology; pharmacovigilance
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.15696

Aims Few studies have quantified the impact of risk factors on GI complications in elderly nonsteroidal anti‐inflammatory drug (NSAID) users. This study aimed to develop and validate a risk prediction score for severe GI complications to identify high‐risk elderly patients using NSAID. Methods We used the following two Korean claims datasets: customized data with an enrolment period 2016–2017 for model development, and the sample data in 2019 for external validation. We conducted a nested case–control study for model development and validation. NSAID users were identified as the elderly (≥65 years) who received NSAIDs for more than 30 days. Serious GI complications were defined as hospitalizations or emergency department visits, with a main diagnosis of GI bleeding or perforation. We applied the logistic least absolute shrinkage and selection operator (LASSO) regression model for variable selection and model fitting. Results We identified 8176 cases and 81 760 controls with a 1:10 matched follow‐up period in the derivation cohort. In the external validation cohort, we identified 372 cases from 254 551 patients. The risk predictors were high‐dose NSAIDs, nonselective NSAID, complicated GI ulcer history, male sex, concomitant gastroprotective agents, relevant co‐medications, severe renal disease and cirrhosis. Area under the receiver operating characteristic curve was 0.79 (95% confidence interval, 0.77–0.81) in the external validation dataset. Conclusions The prediction model may be a useful tool for reducing the risk of serious GI complications by identifying high‐risk elderly patients.