Eficacia y seguridad de empagliflozina en combinación con otros hipoglucemiantes orales en pacientes con diabetes mellitus tipo 2

Abstract

Introduction

To analyze the efficacy and safety of empagliflozin combined with other oral hypoglycemic agents in patients with type 2 diabetes mellitus.

Methods

Pooled analysis of three phase III trials in patients with type 2 diabetes mellitus (n = 1,801) who received placebo or empagliflozin 10 or 25 mg once daily for 24 weeks, in combination with metformin, metformin + sulphonylurea or pioglitazone ± metformin.

Results

Empagliflozin significantly decreased HbA1c (adjusted mean reduction vs placebo with empagliflozin 10 mg: –0.58% [95% CI: –0.66; –0.49]; P < .0001, and with empagliflozin 25 mg: –0.62% [95% CI: –0.70; –0.53], P < .0001), weight (adjusted mean reduction vs placebo with empagliflozin 10 mg: –1.77 kg [95% CI: –2.05; –1.48]; P < .0001, and with empagliflozin 25 mg: –1.96 kg [95% CI: –2.24; –1.67], P < .0001), and systolic and diastolic blood pressure (SBP/DBP). Adverse effect rates were 64% with placebo, 63.9% with empagliflozin 10 mg, and 60.9% with empagliflozin 25 mg. Documented episodes of hypoglycemia (≤ 70 mg/dL and/or requiring care) occurred in 3.9% of patients with placebo, 6.9% of patients with empagliflozin 10 mg, and 5.3% of patients with empagliflozin 25 mg. Urinary tract infections developed in 9.4% of patients with placebo, 10.2% of patients with empagliflozin 10 mg, and 8.3% of patients with empagliflozin 25 mg. Genital infections were reported in 1.0% of patients with placebo, 4.6% of patients with empagliflozin 10 mg, and 3.5% of patients with empagliflozin 25 mg.

Conclusions

Empagliflozin combined with other oral treatments decreased HbA1c, body weight, and SBP/DBP as compared to placebo, with a good safety and tolerability profile.