Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study

Abstract

BackgroundImprovements 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.MethodsCHOICE 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.ResultsThere 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.ConclusionsThese 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 registrationClinicalTrials.gov, NCT00635492

The effects of exenatide twice daily compared to insulin lispro added to basal insulin in Latin American patients with type 2 diabetes: A retrospective analysis of the 4B trial

“…Future studies in Latin American patients would help to better establish the effects of exenatide BID in this population. Real-world studies have been conducted in American [20] and European [21] patients and support the efficacy and safety of exenatide BID. A prospective study or a registry study that specifically examines the effects of exenatide BID in a larger sample of Latin American patients, as well as additional randomized controlled trials, would help to validate the current findings.…”

Health-related quality of life in adults with type 2 diabetes mellitus starting with new glucose lowering drugs: An inception cohort study

“…Through these methods, the proportion of participants meeting MID ranged from 35.3% to 64.4% and from 46.1% to 66.6%, concerning index and VAS scores, respectively. Existent literature regarding MID is scarce, however we found a higher and a lower proportion of GLP-1 inception GLD treatment subgroup that had improved index and VAS scores by more than MID, respectively, when compared to the CHOICE study, where similar assumptions were used [4].…”

“…Characterization of the newer GLD users in real-life settings is needed, particularly the non-responders to metformin, where glycaemic management has become increasingly complex and, to some extent, controversial, creating uncertainties regarding the long-term benefits of intensive glycaemic control and impact on quality of life [2]. Many GLD randomized clinical trials (RCT) have investigated generic or specific health related quality of life (HRQoL) [3]; yet studies reporting comparisons of routine clinical practice HRQoL data across different groups of GLD users, specifically the newly marketed, have rarely been undertaken [4]. Moreover, assessing drug effects on experienced treated people with T2DM who use these newer therapies is lacking, since the population included in recent studies are often treatment naïve for T2DM or has come from selective groups with strict exclusion criteria related to prior treatment exposures [5].…”

The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Baseline Patient-Reported Outcomes

“…Real-world studies involving patients commencing their first injectable therapy with dulaglutide or liraglutide can help us to understand the impact of prescribing GLP-1 RAs on T2DM clinical outcomes in routine practice. Patient-reported outcome (PRO) measures can complement clinical outcomes and, beyond efficacy and safety data, enrich our understanding of the patients’ perspective of GLP-1 RA use in routine clinical practice [ 10 , 11 ].…”