Cardiorenal outcomes with ertugliflozin assessed according to baseline glucose-lowering agent: An analysis from VERTIS CV.
Diabetes Obes Metab
; 24(7): 1245-1254, 2022 07.
Article
em En
| MEDLINE
| ID: mdl-35266296
ABSTRACT
AIM:
To assess selected cardiorenal outcomes with ertugliflozin according to use of baseline glucose-lowering agent. MATERIALS ANDMETHODS:
VERTIS CV was a cardiovascular (CV) outcome trial for ertugliflozin versus placebo, conducted in patients with type 2 diabetes and established atherosclerotic CV disease. The primary outcome was time to the first event of CV death, myocardial infarction or stroke (major adverse CV events [MACE]), with other CV outcomes also assessed. Outcomes were analysed using Cox proportional hazards models stratified by baseline use of metformin, insulin, sulphonylureas (SUs) and dipeptidyl peptidase-4 (DPP-4) inhibitors, with interaction testing to assess for treatment effect modification. Changes from baseline in glycaemic, metabolic and haemodynamic variables were also assessed.RESULTS:
Of 8246 randomized patients, at baseline 6286 (76%) were on metformin, 3898 (47%) were on insulin, 3383 (41%) were on SUs and 911 (11%) were on DPP-4 inhibitors, alone or in combination therapy (67% used >1 glucose-lowering agent at baseline). For each glucose-lowering agent evaluated, no evidence for effect modification was observed for MACE by baseline use of metformin (with hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.790, 1.073; without 1.13, 95% CI 0.867, 1.480), insulin (with HR 0.91, 95% CI 0.765, 1.092; without 1.06, 95% CI 0.867, 1.293), SUs (with HR 1.11, 95% CI 0.890, 1.388; without 0.90, 95% CI 0.761, 1.060) or DPP-4 inhibitors (with HR 0.77, 95% CI 0.502, 1.173; without 1.00, 95% CI 0.867, 1.147) (all Pinteraction > 0.05). Similar results were observed for all secondary outcomes analysed.CONCLUSION:
In VERTIS CV, the effects of ertugliflozin on cardiorenal outcomes were consistent across subgroups of patients stratified by baseline glucose-lowering agent. CLINICALTRIALS gov identifier NCT01986881.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doenças Cardiovasculares
/
Diabetes Mellitus Tipo 2
/
Inibidores da Dipeptidil Peptidase IV
/
Inibidores do Transportador 2 de Sódio-Glicose
/
Metformina
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Diabetes Obes Metab
Assunto da revista:
ENDOCRINOLOGIA
/
METABOLISMO
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Estados Unidos