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.

Trial registration: ClinicalTrials.gov, NCT00635492.

Figures

Figure 1

Changes in patient-reported outcomes (PROs) over 24 months in the CHOICE study. Changes from baseline in PRO measures over 24 months after initiation of exenatide twice daily (BID) or insulin are presented. The number of patients with change data at each time point is presented below the time point. a) Mean change in standardised Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score. b) Mean change in EuroQoL-5-Dimension (EQ-5D) index score. c) Mean change in EuroQoL-visual analogue scale (EQ-VAS) score. d) Mean changes in standardised Diabetes Health Profile-18 (DHP-18) scores. e) Mean change in Hospital Anxiety and Depression Scale (HADS) scores.

Figure 2

CDF of IWQoL-Lite questionnaire total score change from baseline to 24 months. CDF = cumulative distribution function; IWQOL-Lite = Impact of Weight on Quality of Life-Lite Higher scores indicate higher quality of life. IWQOL-Lite was not applied in Germany.

Figure 3

CDF of HADS score change from baseline to 24 months. a) CDF for HADS anxiety score change from baseline. b) CDF for HADS depression score change from baseline to 24 months. CDF = cumulative distribution function; HADS = Hospital Anxiety and Depression Scale Lower scores indicate lower levels of emotional distress. HADS Anxiety and Depression were not applied in Germany.