Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.
Curr Med Res Opin
; 36(7): 1097-1106, 2020 07.
Article
en En
| MEDLINE
| ID: mdl-32324065
ABSTRACT
Objective:
To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM).Methods:
Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. Least-squares mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs).Results:
Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three placebo-controlled studies where ertugliflozin was initiated as a single agent, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 and 15 mg was -0.8 and -1.0%, respectively. In an active-comparator study, when initiated as a single agent, the change from baseline in HbA1c at week 52 was -0.5, -0.7, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and glimepiride, respectively. In a placebo-controlled study, when initiated in combination with sitagliptin, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin was -1.3 and -1.6%, respectively. In an active-comparator study, when initiated in combination with sitagliptin, the change from baseline in HbA1c at week 26 was -1.4, -1.6, and -0.9 for ertugliflozin 5 mg/sitagliptin, ertugliflozin 15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin. The incidences of overall and prespecified AEs in Hispanic/Latino patients were generally consistent with the known safety profile of ertugliflozin.Conclusion:
Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM. Clinicaltrials.gov identifiers NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Compuestos Bicíclicos Heterocíclicos con Puentes
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Diabetes Mellitus Tipo 2
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Inhibidores del Cotransportador de Sodio-Glucosa 2
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Hipoglucemiantes
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Curr Med Res Opin
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos