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

Health and Quality of Life Outcomes

Bruno Guerci⁶  Michael Theodorakis⁷  Hélène Sapin⁵  Carole Salaun-Martin⁵  Jacek Kiljański³  Thure Krarup⁸  Stephan Matthaei¹  Claes-Göran Östenson⁹  Chantal Mathieu⁴  Matthew Reaney² 

[1] Diabetes-Center Quakenbrück, Quakenbrück, Germany;Eli Lilly, Windlesham, Surrey, UK;Eli Lilly, Warsaw, Poland;Department of Endocrinology, UZ Gasthuisberg, Leuven, Belgium;Eli Lilly, Neuilly Cedex, France;Diabetologie, Maladies Metaboliques & Nutrition, Hôpital Brabois, CHU de Nancy, et CIC Inserm, ILCV, 54500 Vandoeuvre Lès Nancy, France;Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece;Department of Endocrinology I, Bispebjerg Hospital, Copenhagen, Denmark;Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

关键词: Patient-reported outcomes;    Injectable therapy;    Insulin;    Exenatide;    Type 2;    Diabetes mellitus;   

Others  :  821904
DOI  :  10.1186/1477-7525-11-217

 received in 2013-02-19, accepted in 2013-12-02,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Reaney et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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