Naslov
Empagliflozin in combination with oral agents in young and overweight/obese Type 2 diabetes mellitus patients: A pooled analysis of three randomized trials

Autori
Romera, Irene ; Gomis, Ramon ; Crowe, Susanne ; de Pablos-Velasco, Pedro ; Aranda, Unai ; García, Arantxa ; Giljanovic Kis, Sanja ; Naderali, Ebrahim

Izvornik
Journal of diabetes and its complications (1056-8727) 30 (2016), 8; 1571-1576

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Oral agents ; Type 2 diabetes mellitus ; Obesity ; Therapy ; Glycemic control ; Hba1c

Sažetak
Aims: This analysis aimed to evaluate efficacy and safety of empagliflozin in combination therapy in < 65 y.o.patients, overweight/obese, and with uncontrolled T2DM. Methods: Pooled analysis from three phase-III trials, in < 65 y.o. patients, with BMI 25–35 kg/m2, and HbA1c ≥8% at baseline. Patients (N = 439) were randomized to placebo (n = 138), empagliflozin 10 mg (n = 160), or empagliflozin 25 mg (n = 141) once daily (24 weeks) as add-on to metformin, to metformin plus sulfonylurea, or to pioglitazone ± metformin. Results:At week 24, adjusted mean (SE) changes from baseline in HbA1c were −0.19% (0.07) for placebo vs.−1.10% (0.07) and −1.10% (0.07) for empagliflozin 10 and 25 mg, respectively (both p b 0.001). Adjusted mean (SE) changes from baseline in weight were −0.33 kg (0.21) for placebo vs. -1.94 kg (0.19) and −2.14 kg (0.20) for empagliflozin 10 and 25 mg, respectively (both p b 0.001). Adverse events were reported in 57.2% on placebo, 64.4% on empagliflozin 10 mg and 59.6% on empagliflozin 25 mg. Genital infection AEs were reported in 1.4% on placebo, 3.8% on empagliflozin 10 mg, and 5.0% on empagliflozin 25 mg. Conclusions: In this specific population, empagliflozin in combination with other oral agents, significantly reduced HbA1c and body weight and was well tolerated.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

POVEZANOST RADA