title: Efficacy and safety of empagliflozin in combination with other oral hypoglycemic agents in patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  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 25mg 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 10mg: -0.58% [95% CI: -0.66; -0.49]; P<.0001, and with empagliflozin 25mg: -0.62% [95% CI: -0.70; -0.53], P<.0001), weight (adjusted mean reduction vs placebo with empagliflozin 10mg: -1.77kg [95% CI: -2.05; -1.48]; P<.0001, and with empagliflozin 25mg: -1.96kg [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 10mg, and 60.9% with empagliflozin 25mg. Documented episodes of hypoglycemia (≤70mg/dL and/or requiring care) occurred in 3.9% of patients with placebo, 6.9% of patients with empagliflozin 10mg, and 5.3% of patients with empagliflozin 25mg. Urinary tract infections developed in 9.4% of patients with placebo, 10.2% of patients with empagliflozin 10mg, and 8.3% of patients with empagliflozin 25mg. Genital infections were reported in 1.0% of patients with placebo, 4.6% of patients with empagliflozin 10mg, and 3.5% of patients with empagliflozin 25mg.
  
  
  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.
authors: Eli Lilly and Company España, Alcobendas, Madrid, España. Electronic address: romerai@lilly.com.
authors: Irene
authors: I
authors: Romera
authors: Hospital Clínico Universitario de Valencia, Valencia, España.
authors: Francisco Javier
authors: FJ
authors: Ampudia-Blasco
authors: Hospital de la Santa Creu i Sant Pau, Barcelona, España.
authors: Antonio
authors: A
authors: Pérez
authors: Boehringer Ingelheim Pharma GmbH & Co., España, Sant Cugat del Vallès, Barcelona, España.
authors: Bernat
authors: B
authors: Ariño
authors: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Alemania.
authors: Egon
authors: E
authors: Pfarr
authors: Eli Lilly (Suisse) SA Representative Office, Croatia, Zagreb, Croacia.
authors: Sanja
authors: S
authors: Giljanovic Kis
authors: Eli Lilly and Company, UK, Basingstoke, Reino Unido; Faculty of Science, Liverpool Hope University, Liverpool, Reino Unido.
authors: Ebrahim
authors: E
authors: Naderali
mesh_terms: D000368:Aged; D001559:Benzhydryl Compounds; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004198:Disease Susceptibility; D004359:Drug Therapy, Combination; D005260:Female; D005960:Glucosides; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007239:Infections / Q000209:etiology; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C570240:empagliflozin
keywords: Diabetes mellitus tipo 2; Empagliflozin; Empagliflozina; Inhibidores de transportador sodio glucosa tipo 2; SGLT-2 inhibitors; Type 2 diabetes mellitus