title: Comparative effectiveness of vildagliptin in combination with other oral anti-diabetes agents in usual-care conditions: the EDGE-Latin America study.
abstract: OBJECTIVE
  To assess the proportion of patients on vildagliptin add-on dual therapy who respond to treatment over a 12 month follow-up, relative to comparator oral anti-diabetes dual therapy, in a usual care setting.
  
  
  METHODS
  Participants were patients with type 2 diabetes (T2DM) aged 18 years and older from 311 centers in Argentina, Colombia, Ecuador, Mexico and Venezuela. Patients were taking monotherapy with an oral anti-diabetes drug (OAD), and were prescribed a new add-on OAD based on the judgment of their personal physician. According to this choice, patients were assigned to one of the two cohorts: vildagliptin or comparator OADs.
  
  
  METHODS
  The primary endpoint was the proportion of patients achieving an A1c drop >0.3% without edema, hypoglycemia, weight gain or discontinuation due to gastrointestinal (GI) events. The secondary endpoint was the proportion of patients with baseline A1c ≥7% who reached the goal of an A1c <7% without hypoglycemia or weight gain.
  
  
  RESULTS
  The per-protocol population (a subset of the intention-to-treat population that excluded patients with pre-specified protocol deviations) comprised 3773 patients, 3002 in the vildagliptin cohort and 771 in the comparator cohort. The proportion of patients reaching the primary endpoint was higher in the vildagliptin cohort (60.3%) than the comparator cohort (50.7%), OR 1.48 (95% CI: 1.25-1.73). The same was observed for the secondary endpoint (44.8 versus 33.1%) OR 1.64 (95% CI: 1.37-1.98). The incidence of adverse events was low and similar between treatment cohorts.
  
  
  CONCLUSIONS
  In a usual care setting, patients treated with a vildagliptin combination succeeded in lowering A1c to <7%, without weight gain, hypoglycemia or peripheral edema more often than patients treated with comparator combinations, without increased risk of adverse events. Key limitations are the observational nature of the study and its relatively limited 12 month timeframe.
authors.affiliation: Universidad de los Andes, School of Medicine , Bogotá , Colombia.
authors.forename: Carlos O
authors.initials: CO
authors.lastname: Mendivil
authors.forename: Eduardo
authors.initials: E
authors.lastname: Márquez-Rodríguez
authors.forename: Iván D
authors.initials: ID
authors.lastname: Angel
authors.forename: Gustavo
authors.initials: G
authors.lastname: Paz
authors.forename: Cruz
authors.initials: C
authors.lastname: Rodríguez
authors.forename: Jorge
authors.initials: J
authors.lastname: Almada
authors.forename: Ofelia
authors.initials: O
authors.lastname: Szyskowsky
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D057186:Comparative Effectiveness Research; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007843:Latin America; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011446:Prospective Studies; D011759:Pyrrolidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D015415:Biomarkers; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin
keywords: Anti-diabetics; Diabetes; Dipeptidyl peptidase-IV inhibitors; Vildagliptin