Author information
Corresponding author: Ju‑Yeun Lee, Professor
Affiliation: College of Pharmacy and Research Institute of
Pharmaceutical Sciences, Seoul National University, 1, Gwanak-ro, Seoul,
08826, Republic of Korea
Tel: +82-02-3668-7473; E-mail: jypharm@snu.ac.kr
ORCiD ID: 0000-0002-2261-7330
First author: Suhyun Lee
Affiliation: College of Pharmacy and Research Institute of
Pharmaceutical Sciences, Seoul National University, 1, Gwanak-ro, Seoul,
08826, Republic of Korea
E-mail: sh198410@snu.ac.kr
ORCiD ID: 0000-0001-8481-4386
Second author: Kyu Nam Heo
Affiliation: College of Pharmacy and Research Institute of
Pharmaceutical Sciences, Seoul National University, 1, Gwanak-ro, Seoul,
08826, Republic of Korea
E-mail: bogopa8@snu.ac.kr
Third author: Mee Yeon Lee
Affiliation: College of Pharmacy and Research Institute of
Pharmaceutical Sciences, Seoul National University, 1, Gwanak-ro, Seoul,
08826, Republic of Korea
E-mail: lpeach@snu.ac.kr
Fourth author: Young-Mi Ah
Affiliation: College of Pharmacy, Yeungnam University, Gyeongsan,
Gyeongbuk, 38541, Republic of Korea
E-mail: ymah@ynu.ac.kr
Fifth author: Jaekyu Shin
Affiliation: Department of Clinical Pharmacy, School of Pharmacy,
University of California, San Francisco, 533 Parnassus Avenue, U585, Box
0622, San Francisco, CA 94143-0622, USA
E-mail:Jaekyu.Shin@ucsf.edu
Abstract
Aim: Although there is a high risk of gastrointestinal (GI) bleeding in
the elderly, 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
to identify high-risk elderly patients using NSAID for severe GI
complications. Methods: We used the following two Korean claims
datasets: customized data with an enrollment 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. Patients who experienced serious
GI complications, defined as hospitalizations or emergency department
visits, were diagnosed with GI bleeding or perforation. We derived a
model using logistic regression and cross-validation. Results: In the
external validation cohort, we identified 372 cases from 254,551
patients. We identified 8,176 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, NSAID type, complicated GI ulcer
history, male sex, concomitant gastroprotective agents, relevant
co-medications, severe renal disease, and cirrhosis. Area under the
receiver operating characteristic curves was 0.77 (95% confidence
interval, 0.75–0.80) in the external validation dataset. Conclusion:
The prediction model may be a useful tool for reducing the risk of
serious GI complications by identifying high-risk elderly patients.