EFFECT OF GASTROINTESTINAL ADVERSE EVENTS ON TREATMENT SATISFACTION IN SEMAGLUTIDE TREATMENT OF TYPE 2 DIABETES
Author(s)
Jendle J1, Birkenfeld AL2, Silver R3, Uusinarkaus K4, Højbjerre L5, Thomsen HF5, Davies M6
1Örebro University, Örebro, Sweden, 2Technical University Dresden, Dresden, Germany, 3Southern New Hampshire Diabetes and Endocrinology, Nashua, NH, USA, 4CSHP / DaVita Clinical Research, Colorado Springs, CO, USA, 5Novo Nordisk A/S, Søborg, Denmark, 6Diabetes Research Centre, University of Leicester, Leicester, UK
OBJECTIVES: Semaglutide, a GLP-1 analogue in development for type 2 diabetes (T2D), demonstrated superior glycaemic control and weight loss across the phase 3a SUSTAIN 2–5 trials vs placebo (on a background of insulin) and active comparators, but higher rates of gastrointestinal adverse events (GI AEs). Treatment satisfaction (TS), the subjective appraisal of an individual’s treatment experience, is an important outcome measure associated with improved adherence. In SUSTAIN 2–5, TS improvement had been consistently significantly higher for semaglutide 0.5 mg (2.7–5.3 points) and 1.0 mg (3.5–5.9) vs comparators (1.3–4.5) in all trials, based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ). This post hoc analysis of SUSTAIN 2–5 reviewed the impact of GI AEs on TS changes. METHODS: In SUSTAIN 2–5, subjects with inadequately controlled T2D were randomised to subcutaneous semaglutide 0.5 mg or 1.0 mg once weekly, or to a comparator (sitagliptin, exenatide extended release, insulin glargine or placebo). TS was assessed with the DTSQ at baseline and end of treatment, using the overall satisfaction component (36-point scale). Subjects were grouped by whether or not they reported any GI AE. RESULTS: A total of 3530 subjects were randomised (semaglutide, n=2214; comparators, n=1316). Among 1774 semaglutide-treated subjects who completed treatment and had available data on TS changes from baseline, 659 (37.1%) experienced GI AEs. TS improvements in subjects who did not experience GI AEs (2.7–5.5 and 3.7–5.9 with semaglutide 0.5 mg and 1.0 mg, respectively) were higher than in those who experienced GI AEs (2.8–4.7 and 3.1–5.7, respectively), although the difference was not significant (p>0.08). CONCLUSIONS: Treatment satisfaction was significantly greater with semaglutide vs comparators and was not significantly affected by the presence of GI AEs. Thus, the patient-perceived beneficial effects of semaglutide appear to outweigh the negative impact of GI AEs.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PDB54
Topic
Patient-Centered Research
Topic Subcategory
Stated Preference & Patient Satisfaction
Disease
Diabetes/Endocrine/Metabolic Disorders