title: Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study.
abstract: BACKGROUND
  Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study.
  
  
  METHODS
  CHOICE was a 24-month, prospective observational study conducted in six European countries. Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement. Clinical and PRO data were collected at baseline (injectable therapy initiation) and after approximately 3, 6, 12, 18 and 24 months. The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
  
  
  RESULTS
  There were 2388 patients eligible for analysis (exenatide BID cohort, n = 1114; insulin cohort, n = 1274). Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation. Patients who experienced weight loss (≥ 1 kg) at 24 months appeared to have higher mean improvements in IWQOL-Lite total score than did patients with weight gain or no weight change. Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤ 1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes.
  
  
  CONCLUSIONS
  These data from a clinical practice study support those from clinical trials, suggesting that PROs are not adversely affected, and may be improved, by injectable therapy initiation. PRO data may aid appropriate treatment selection for individual patients.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT00635492.
authors.forename: Matthew
authors.initials: M
authors.lastname: Reaney
authors.forename: Chantal
authors.initials: C
authors.lastname: Mathieu
authors.forename: Claes-Göran
authors.initials: CG
authors.lastname: Ostenson
authors.forename: Stephan
authors.initials: S
authors.lastname: Matthaei
authors.forename: Thure
authors.initials: T
authors.lastname: Krarup
authors.forename: Jacek
authors.initials: J
authors.lastname: Kiljański
authors.forename: Carole
authors.initials: C
authors.lastname: Salaun-Martin
authors.forename: Hélène
authors.initials: H
authors.lastname: Sapin
authors.affiliation: Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece. mtheod@ebie.gr.
authors.forename: Michael
authors.initials: M
authors.lastname: Theodorakis
authors.forename: Bruno
authors.initials: B
authors.lastname: Guerci
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D005060:Europe; D000077270:Exenatide; D005260:Female; D006115:Greece; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009010:Monte Carlo Method; D063868:Patient Outcome Assessment; D010455:Peptides / Q000008:administration & dosage*; D011446:Prospective Studies; D014688:Venoms / Q000008:administration & dosage*
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; D014688:Venoms; D000077270:Exenatide