Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study

Abstract Background Patients with low-to-normal body mass index (BMI; < 25.0 kg/m2) were underrepresented in major randomized controlled trials on sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes. The present study aims to investigate the effectiveness of SGLT2 inhibitors for...

Full description

Saved in:
Bibliographic Details
Main Authors: Yuichiro Mori, Toshiaki Komura, Motohiko Adomi, Ryuichiro Yagi, Shingo Fukuma, Naoki Kondo, Motoko Yanagita, O. Kenrik Duru, Katherine R. Tuttle, Kosuke Inoue
Format: Article
Language:English
Published: BMC 2024-10-01
Series:Cardiovascular Diabetology
Online Access:https://doi.org/10.1186/s12933-024-02478-7
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850203930680623104
author Yuichiro Mori
Toshiaki Komura
Motohiko Adomi
Ryuichiro Yagi
Shingo Fukuma
Naoki Kondo
Motoko Yanagita
O. Kenrik Duru
Katherine R. Tuttle
Kosuke Inoue
author_facet Yuichiro Mori
Toshiaki Komura
Motohiko Adomi
Ryuichiro Yagi
Shingo Fukuma
Naoki Kondo
Motoko Yanagita
O. Kenrik Duru
Katherine R. Tuttle
Kosuke Inoue
author_sort Yuichiro Mori
collection DOAJ
description Abstract Background Patients with low-to-normal body mass index (BMI; < 25.0 kg/m2) were underrepresented in major randomized controlled trials on sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes. The present study aims to investigate the effectiveness of SGLT2 inhibitors for cardiovascular outcomes among patients with type 2 diabetes and low-to-normal BMI, using finer stratification than previous trials. Methods This cohort study with a target trial emulation framework was conducted using insurance claims and health screening records of more than 30 million working-age citizens in Japan acquired from April 1, 2015 to March 31, 2022. 139,783 new users of SGLT2 inhibitors matched to 139,783 users of dipeptidyl protease (DPP) 4 inhibitors with stratification by BMI category (< 20.0, 20.0–22.4, 22.5–24.9, 25.0–29.9, 30.0–34.9, and 35.0 ≤ kg/m2). The primary outcome was a composite of all-cause death, myocardial infarction, stroke, or heart failure. Secondary outcomes were the components of the primary outcome. Cox proportional hazard models were used to compare SGLT2 inhibitors with DPP4 inhibitors in the whole population and subgroups defined by the BMI category. Results Among participants, 17.3% (n = 48,377) were female and 31.0% (n = 86,536) had low-to-normal BMI (< 20.0 kg/m2, 1.9% [n = 5,350]; 20.0–22.4 kg/m2, 8.5% [n = 23,818]; and 22.5–24.9 kg/m2, 20.5% [n = 57,368]). Over a median follow-up of 24 months, the primary outcome occurred in 2.9% (n = 8,165) of participants. SGLT2 inhibitors were associated with a decreased incidence of the primary outcome in the whole population (HR [95%CI] = 0.92 [0.89 to 0.96]), but not in patients with low-to-normal BMI (< 20.0 kg/m2, HR [95%CI] = 1.08 [0.80 to 1.46]; 20.0–22.4 kg/m2, HR [95%CI] = 1.04 [0.90 to 1.20]; and 22.5–24.9 kg/m2, HR [95%CI] = 0.92 [0.84 to 1.01]). Conclusions The protective effect of SGLT2 inhibitors on cardiovascular events among patients with type 2 diabetes appeared to decrease with lower BMI and was not significant among patients with low-to-normal BMI (< 25.0 kg/m2). These findings suggest the importance of considering BMI when initiating SGLT2 inhibitors. Graphical abstract
format Article
id doaj-art-bcd41e39ee9544bb85db4c1b289913d3
institution OA Journals
issn 1475-2840
language English
publishDate 2024-10-01
publisher BMC
record_format Article
series Cardiovascular Diabetology
spelling doaj-art-bcd41e39ee9544bb85db4c1b289913d32025-08-20T02:11:23ZengBMCCardiovascular Diabetology1475-28402024-10-0123111010.1186/s12933-024-02478-7Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort studyYuichiro Mori0Toshiaki Komura1Motohiko Adomi2Ryuichiro Yagi3Shingo Fukuma4Naoki Kondo5Motoko Yanagita6O. Kenrik Duru7Katherine R. Tuttle8Kosuke Inoue9Department of Human Health Sciences, Graduate School of Medicine, Kyoto UniversityDepartment of Epidemiology, Boston University School of Public HealthDepartment of Epidemiology, Harvard T.H. Chan School of Public HealthDivision of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s HospitalDepartment of Human Health Sciences, Graduate School of Medicine, Kyoto UniversityDepartment of Social Epidemiology, Graduate School of Medicine, Kyoto UniversityDepartment of Nephrology, Graduate School of Medicine, Kyoto UniversityDivision of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLAKidney Research Institute, University of WashingtonDepartment of Social Epidemiology, Graduate School of Medicine, Kyoto UniversityAbstract Background Patients with low-to-normal body mass index (BMI; < 25.0 kg/m2) were underrepresented in major randomized controlled trials on sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes. The present study aims to investigate the effectiveness of SGLT2 inhibitors for cardiovascular outcomes among patients with type 2 diabetes and low-to-normal BMI, using finer stratification than previous trials. Methods This cohort study with a target trial emulation framework was conducted using insurance claims and health screening records of more than 30 million working-age citizens in Japan acquired from April 1, 2015 to March 31, 2022. 139,783 new users of SGLT2 inhibitors matched to 139,783 users of dipeptidyl protease (DPP) 4 inhibitors with stratification by BMI category (< 20.0, 20.0–22.4, 22.5–24.9, 25.0–29.9, 30.0–34.9, and 35.0 ≤ kg/m2). The primary outcome was a composite of all-cause death, myocardial infarction, stroke, or heart failure. Secondary outcomes were the components of the primary outcome. Cox proportional hazard models were used to compare SGLT2 inhibitors with DPP4 inhibitors in the whole population and subgroups defined by the BMI category. Results Among participants, 17.3% (n = 48,377) were female and 31.0% (n = 86,536) had low-to-normal BMI (< 20.0 kg/m2, 1.9% [n = 5,350]; 20.0–22.4 kg/m2, 8.5% [n = 23,818]; and 22.5–24.9 kg/m2, 20.5% [n = 57,368]). Over a median follow-up of 24 months, the primary outcome occurred in 2.9% (n = 8,165) of participants. SGLT2 inhibitors were associated with a decreased incidence of the primary outcome in the whole population (HR [95%CI] = 0.92 [0.89 to 0.96]), but not in patients with low-to-normal BMI (< 20.0 kg/m2, HR [95%CI] = 1.08 [0.80 to 1.46]; 20.0–22.4 kg/m2, HR [95%CI] = 1.04 [0.90 to 1.20]; and 22.5–24.9 kg/m2, HR [95%CI] = 0.92 [0.84 to 1.01]). Conclusions The protective effect of SGLT2 inhibitors on cardiovascular events among patients with type 2 diabetes appeared to decrease with lower BMI and was not significant among patients with low-to-normal BMI (< 25.0 kg/m2). These findings suggest the importance of considering BMI when initiating SGLT2 inhibitors. Graphical abstracthttps://doi.org/10.1186/s12933-024-02478-7
spellingShingle Yuichiro Mori
Toshiaki Komura
Motohiko Adomi
Ryuichiro Yagi
Shingo Fukuma
Naoki Kondo
Motoko Yanagita
O. Kenrik Duru
Katherine R. Tuttle
Kosuke Inoue
Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study
Cardiovascular Diabetology
title Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study
title_full Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study
title_fullStr Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study
title_full_unstemmed Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study
title_short Sodium-glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low-to-normal body mass index: a nationwide cohort study
title_sort sodium glucose cotransporter 2 inhibitors and cardiovascular events among patients with type 2 diabetes and low to normal body mass index a nationwide cohort study
url https://doi.org/10.1186/s12933-024-02478-7
work_keys_str_mv AT yuichiromori sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT toshiakikomura sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT motohikoadomi sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT ryuichiroyagi sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT shingofukuma sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT naokikondo sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT motokoyanagita sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT okenrikduru sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT katherinertuttle sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy
AT kosukeinoue sodiumglucosecotransporter2inhibitorsandcardiovasculareventsamongpatientswithtype2diabetesandlowtonormalbodymassindexanationwidecohortstudy