Incretin-based drugs and the risk of gallbladder or biliary tract diseases among patients with type 2 diabetes across categories of body mass index: a nationwide cohort study

IF 7.6 1区医学 Q1 HEALTH CARE SCIENCES & SERVICES

The Lancet Regional Health: Western Pacific Pub Date : 2025-03-01 DOI:10.1016/j.lanwpc.2024.101242

Hwa Yeon Ko , Sungho Bea , Dongwon Yoon , Bin Hong , Jae Hyun Bae , Young Min Cho , Ju-Young Shin

{"title":"Incretin-based drugs and the risk of gallbladder or biliary tract diseases among patients with type 2 diabetes across categories of body mass index: a nationwide cohort study","authors":"Hwa Yeon Ko , Sungho Bea , Dongwon Yoon , Bin Hong , Jae Hyun Bae , Young Min Cho , Ju-Young Shin","doi":"10.1016/j.lanwpc.2024.101242","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Despite emerging evidence of gallbladder or biliary tract diseases (GBD) risk regarding incretin-based drugs, population-specific safety profile considering obesity is lacking. We aimed to assess whether stratification by body mass index (BMI) modifies the measures of association between incretin-based drugs and the risk of GBD.</div></div><div><h3>Methods</h3><div>We conducted an active-comparator, new-user cohort study using a nationwide claims data (2013–2022) of Korea. We included type 2 diabetes (T2D) patients stratified by Asian BMI categories: Normal, 18.5 to <23 kg/m<sup>2</sup>; Overweight, 23 to <25 kg/m<sup>2</sup>; Obese, ≥25 kg/m<sup>2</sup>. The primary outcome was a composite of GBD, including cholelithiasis, cholecystitis, obstruction of the gallbladder or bile duct, cholangitis, and cholecystectomy. We used 1:1 propensity score (PS) matching and estimated hazard ratios (HR) with 95% confidence intervals (CI) using Cox models.</div></div><div><h3>Findings</h3><div>New users of DPP4i and SGLT2i were 1:1 PS matched (n = 251,420 pairs; 186,697 obese, 39,974 overweight, and 24,749 normal weight pairs). The overall HR for the risk of GBD with DPP4i vs. SGLT2i was 1.21 (95% CI 1.14–1.28), with no effect modification by BMI (p-value: 0.83). For the second cohort, new users of GLP1RA and SGLT2i were 1:1 PS matched (n = 45,443 pairs; 28,011 obese, 8948 overweight, and 8484 normal weight pairs). The overall HR for the risk of GBD with GLP1RA vs. SGLT2i was 1.27 (1.07–1.50), with no effect modification by BMI (p-value: 0.73).</div></div><div><h3>Interpretation</h3><div>The increased risks of GBD were presented in both cohorts with no evidence of effect heterogeneity by BMI.</div></div><div><h3>Funding</h3><div><span>Ministry of Food and Drug Safety</span>, Health Fellowship Foundation.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"56 ","pages":"Article 101242"},"PeriodicalIF":7.6000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Lancet Regional Health: Western Pacific","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666606524002360","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Despite emerging evidence of gallbladder or biliary tract diseases (GBD) risk regarding incretin-based drugs, population-specific safety profile considering obesity is lacking. We aimed to assess whether stratification by body mass index (BMI) modifies the measures of association between incretin-based drugs and the risk of GBD.

Methods

We conducted an active-comparator, new-user cohort study using a nationwide claims data (2013–2022) of Korea. We included type 2 diabetes (T2D) patients stratified by Asian BMI categories: Normal, 18.5 to <23 kg/m²; Overweight, 23 to <25 kg/m²; Obese, ≥25 kg/m². The primary outcome was a composite of GBD, including cholelithiasis, cholecystitis, obstruction of the gallbladder or bile duct, cholangitis, and cholecystectomy. We used 1:1 propensity score (PS) matching and estimated hazard ratios (HR) with 95% confidence intervals (CI) using Cox models.

Findings

New users of DPP4i and SGLT2i were 1:1 PS matched (n = 251,420 pairs; 186,697 obese, 39,974 overweight, and 24,749 normal weight pairs). The overall HR for the risk of GBD with DPP4i vs. SGLT2i was 1.21 (95% CI 1.14–1.28), with no effect modification by BMI (p-value: 0.83). For the second cohort, new users of GLP1RA and SGLT2i were 1:1 PS matched (n = 45,443 pairs; 28,011 obese, 8948 overweight, and 8484 normal weight pairs). The overall HR for the risk of GBD with GLP1RA vs. SGLT2i was 1.27 (1.07–1.50), with no effect modification by BMI (p-value: 0.73).

Interpretation

The increased risks of GBD were presented in both cohorts with no evidence of effect heterogeneity by BMI.

Funding

Ministry of Food and Drug Safety, Health Fellowship Foundation.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

The Lancet Regional Health: Western Pacific Medicine-Pediatrics, Perinatology and Child Health

CiteScore

8.80

自引率

2.80%

发文量

305

审稿时长

11 weeks

期刊介绍： The Lancet Regional Health – Western Pacific, a gold open access journal, is an integral part of The Lancet's global initiative advocating for healthcare quality and access worldwide. It aims to advance clinical practice and health policy in the Western Pacific region, contributing to enhanced health outcomes. The journal publishes high-quality original research shedding light on clinical practice and health policy in the region. It also includes reviews, commentaries, and opinion pieces covering diverse regional health topics, such as infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, aging health, mental health, the health workforce and systems, and health policy.