Semaglutide improves health‐related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk (SUSTAIN 6)

Abstract

Aim To assess what drives change in health‐related quality of life (HRQoL) in type 2 diabetes in the SUSTAIN 6 trial and identify potential mediators of the treatment effect of semaglutide on HRQoL scores. Materials and Methods The Short Form (SF)‐36v2® questionnaire [comprising physical component summary (PCS) and mental component summary (MCS)] was used to assess changes in HRQoL from baseline to week 104, by treatment, in a prespecified analysis. This post‐hoc analysis assessed change in PCS and MCS using the following factors as parameter/covariate, using descriptive statistics and linear regressions: major adverse cardiac events, hypoglycaemia, gastrointestinal adverse events, at least one episode of nausea, vomiting or diarrhoea, and change in glycated haemoglobin (HbA1c), body weight, blood pressure, heart rate and estimated glomerular filtration rate. Results Mean change in overall PCS score was +1.0 with semaglutide versus +0.4 with placebo, and +0.5 versus −0.2 for MCS. The treatment effect of semaglutide versus placebo (unadjusted estimate) was 0.7 [(95% confidence interval 0.1, 1.2); P = 0.018] on PCS and this was reduced when adjusted for change in HbA1c [0.4 (−0.2, 1.0), P = .167] and body weight [0.3 (−0.3, 0.9), P = .314]. The unadjusted treatment effect on MCS [0.7 (−0.0, 1.5), P = .054] was only reduced when adjusted for change in HbA1c [0.3 (−0.4, 1.1), P = .397]. When adjusting for all other parameters separately, the estimated effect of semaglutide on PCS and MCS qualitatively did not change. Conclusions Semaglutide improved HRQoL versus placebo; greater improvements with semaglutide versus placebo were possibly mediated, in part, by change in HbA1c and body weight. Clinicaltrials.gov : NCT01720446 (SUSTAIN 6).

Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: A systematic review of longitudinal studies

“…One of these studies did find that treatment-related improvements in mental health were blunted among those experiencing three or more hypoglycaemic episodes, 29 but the other reported no change in Mental Component scores. 24 Moreover, the latter was consistent with a study examining mental health using a subscale of the RAND Corporation 36-item (RAND-36) survey-a measure that parallels the SF-36-which found no change in mental health following self-treated hypoglycaemia. 22 Taken as a whole, findings from health status studies (n = 9) indicated perceptions of health worsened among those experiencing hypoglycaemic over a period of 6-36 months, but only for events severe enough to require assistance.…”

“…Database searches identified 12,571 records. Abstract and title screening excluded 12,096 records, and full‐text screening eliminated 460 records, leaving 15 studies 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 that satisfied inclusion criteria. Backward and forward citation searches of these studies identified 3 additional studies, 35 , 36 , 37 and hand searches identified 2 studies, 38 , 39 resulting in 20 total studies selected for extraction and synthesis (Figure 1 ).…”

Self-Reported Satisfaction to Treatment, Quality of Life and General Health of Type 2 Diabetes Patients with Inadequate Glycemic Control from North-Eastern Romania

“…In our study, the lowest reported SF-36 subscale score was for physical functioning (and vitality), and the highest was for bodily pain. Our mean PCS and MCS values were similar to those reported by clinical trials investigating the cardiovascular and subjective outcomes of new medication [ 52 ].…”

Effect of once‐weekly semaglutide versus thrice‐daily insulin aspart, both as add‐on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open‐label, multinational, phase 3b trial

“…Additionally, CV benefits and positive effects on some kidney outcomes have been shown with OW semaglutide in participants with T2D 22,23 . Compared with BBI, the lower number of injections required with OW semaglutide may also enhance treatment adherence and QoL 8,24,25 …”