Dataset Information

Sodium-glucose cotransporter 2 inhibitors do not increase the risk of fractures in real-world clinical practice in Korea: A national observational cohort study.

ABSTRACT:

Aims/introduction

This study aimed to determine whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) were related to increased fracture risk in adults with type 2 diabetes compared with dipeptidyl peptidase-4 inhibitors (DPP-4i).

Materials and methods

Between 1 May 2016 and 31 December 2018, we carried out a new-user cohort study using the Korean National Health Insurance Service database. Propensity score matching was carried out on 478,826 new users of an SGLT2i or DPP-4i. After propensity score matching on >80 covariates, 84,460 individuals were initiated on SGLT2i or DPP-4i, with 42,230 individuals in each treatment group. The time to first fracture event was compared between the SGLT2i and DPP-4i groups using Cox proportional hazards models, and the results are reported as hazard ratios with 95% confidence intervals for fracture occurrence. Subgroup analyses investigated fractures between treatment groups according to baseline characteristics.

Results

Individuals who were started on SGLT2i were not linked with increased fracture risk in both as-treated and intention-to-treat analyses (as-treated: hazard ratio 0.98, 95% confidence interval 0.92-1.04; intention-to-treat: hazard ratio 0.94, 95% confidence interval 0.89-1.00). We identified no significant interaction between the individuals' age, sex, fracture history or thiazolidinedione use in any subgroup analyses, showing that none of these variables appeared to be impact modifiers in the connection between SGLT2i and fractures.

Conclusions

Our study found no increase in the risk of fracture among individuals treated with SGLT2i in a real-world clinical setting for type 2 diabetes.

SUBMITTER: Ha KH

PROVIDER: S-EPMC9153829 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Sodium-glucose cotransporter 2 inhibitors do not increase the risk of fractures in real-world clinical practice in Korea: A national observational cohort study.

Ha Kyoung Hwa KH Kim Dae Jung DJ Choi Yong Jun YJ

Journal of diabetes investigation 20220304 6

<h4>Aims/introduction</h4>This study aimed to determine whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) were related to increased fracture risk in adults with type 2 diabetes compared with dipeptidyl peptidase-4 inhibitors (DPP-4i).<h4>Materials and methods</h4>Between 1 May 2016 and 31 December 2018, we carried out a new-user cohort study using the Korean National Health Insurance Service database. Propensity score matching was carried out on 478,826 new users of an SGLT2i or DPP-4i. ...[more]

PMID: 35132815

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Project description:ImportancePostmenopausal individuals with type 2 diabetes are susceptible to fractures due to the interaction of elevated blood glucose levels and a deficiency of the hormone estrogen. Despite continued concerns of fracture risks associated with sodium-glucose cotransporter 2 inhibitors (SGLT2i), existing evidence in this high-risk population is lacking.ObjectiveTo assess the risk of fractures associated with SGLT2i vs incretin-based drugs of dipeptidyl-peptidase 4 inhibitors (DPP4i) and glucagon-like peptide 1 receptor agonists (GLP1RA), separately, in postmenopausal individuals with type 2 diabetes.Design, setting, and participantsThis active-comparator, new-user cohort study used nationwide claims data of Korea and took place from January 1, 2013, to December 31, 2020. Postmenopausal individuals (aged ≥45 years) with type 2 diabetes were included.ExposuresNew users of SGLT2i or comparator drugs.Main outcomes and measuresThe primary outcome was overall fractures, comprising vertebral, hip, humerus, and distal radius fractures. Patients were followed up from the day after drug initiation until the earliest of outcome occurrence, drug discontinuation (90-day grace period) or switch, death, or end of the study period. After propensity score fine stratification, hazard ratios (HRs) with 95% CIs were estimated using weighted Cox models.ResultsAmong 37 530 (mean [SD] age, 60.6 [9.7] years) and 332 004 (mean [SD] age, 60.6 [9.9] years) new users of SGLT2i and DPP4i, respectively, a lower rate of incident overall fractures was presented with SGLT2i vs DPP4i (weighted HR, 0.78; 95% CI, 0.72-0.84). Among 111 835 (mean [SD] age, 61.4 [9.8] years) and 8177 (mean [SD] age, 61.1 [10.3] years) new users of SGLT2i and GLP1RA, respectively, no association with an increased risk of overall fractures was presented with SGLT2i vs GLP1RA (weighted HR, 0.92; 95% CI, 0.68-1.24). Results from several subgroup and sensitivity analyses presented consistent results from main analysis.Conclusions and relevanceThis population-based cohort study suggests that SGLT2i was not associated with an increased rate of incident fractures compared with DPP4i and GLP1RA, separately, among postmenopausal individuals with type 2 diabetes.

Dataset Information

Sodium-glucose cotransporter 2 inhibitors do not increase the risk of fractures in real-world clinical practice in Korea: A national observational cohort study.

Aims/introduction

Materials and methods

Results

Conclusions

Publications

Sodium-glucose cotransporter 2 inhibitors do not increase the risk of fractures in real-world clinical practice in Korea: A national observational cohort study.

Similar Datasets

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