Sodium-glucose co-transporter-2 inhibitor use and risk of lower-extremity amputation: Evolving questions, evolving answers.
Adolescent
Adult
Amputation, Surgical
/ statistics & numerical data
Canagliflozin
/ therapeutic use
Cohort Studies
Diabetes Mellitus, Type 2
/ drug therapy
Diabetic Foot
/ epidemiology
Dipeptidyl-Peptidase IV Inhibitors
/ therapeutic use
Female
Humans
Hypoglycemic Agents
/ therapeutic use
Incidence
Lower Extremity
/ pathology
Male
Middle Aged
Retrospective Studies
Risk Factors
Sodium-Glucose Transporter 2 Inhibitors
/ therapeutic use
Sulfonylurea Compounds
/ therapeutic use
United States
/ epidemiology
Young Adult
SGLT2 inhibitor
cohort study
database research
lower extremity amputation
pharmacoepidemiology
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
21
10
2018
revised:
11
01
2019
accepted:
24
01
2019
pubmed:
31
1
2019
medline:
31
3
2020
entrez:
31
1
2019
Statut:
ppublish
Résumé
To examine whether sodium-glucose co-transporter-2 (SGLT2) inhibitors are associated with a higher risk of lower-extremity amputation than dipeptidyl-peptidase-4 (DPP-4) inhibitors and sulphonylureas. We conducted a retrospective cohort study, using the MarketScan Commercial Claims and Encounters Database (2013-2015), to compare the incidence of lower-extremity amputation (LEA) between initiators of SGLT2 inhibitors and initiators of two second-line drugs, DPP-4 inhibitors and sulphonylureas (SUs). We estimated crude incidence rates (IRs) and adjusted hazard ratios (aHR), with 95% confidence intervals (CIs), before and after propensity-score weighting. We additionally conducted sensitivity analyses using a comparator group of all non-metformin, non-SGLT2 inhibitor glucose-lowering drugs, as previous studies used this approach. In a cohort of 328 150 individuals aged 18 to 64 years, the IR of LEA ranged from 1.5 to 2.4 per 1000 person-years. In as-treated analysis, the estimated hazard of LEA was increased among SGLT2 inhibitor initiators compared to DPP-4 inhibitor initiators (aHR 1.69, 95% CI 1.20-2.38), but not compared to SU initiators (aHR 1.02, 95% CI 0.67-1.55) or non-metformin, non-SGLT2 inhibitor initiators (aHR 1.02, 95% CI 0.54-1.93). Results were consistent in intention-to-treat analysis and across a number of sensitivity analyses. Among commercially insured patients in the United States, our results suggest that initiation of SGLT2 inhibitors may increase the risk of LEA compared to initiation of DPP-4 inhibitors. Contrasting results when comparing SGLT2 inhibitor initiators to DPP-4 inhibitor and SU initiators highlight the importance of choosing appropriate comparator drugs when addressing comparative effectiveness and safety questions that can inform clinical decision-making.
Identifiants
pubmed: 30697897
doi: 10.1111/dom.13647
pmc: PMC6459697
mid: NIHMS1013484
doi:
Substances chimiques
Dipeptidyl-Peptidase IV Inhibitors
0
Hypoglycemic Agents
0
Sodium-Glucose Transporter 2 Inhibitors
0
Sulfonylurea Compounds
0
Canagliflozin
0SAC974Z85
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1223-1236Subventions
Organisme : HSRD VA
ID : IK2 HX001514
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL118255
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002489
Pays : United States
Organisme : NICHD NIH HHS
ID : R21 HD080214
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA174453
Pays : United States
Organisme : NIDDK NIH HHS
ID : T32 DK007634
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG056479
Pays : United States
Informations de copyright
© 2019 John Wiley & Sons Ltd.
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