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)
| Autor: | Marie M. Michelsen, Anna Sandberg, Mark Warren, Esteban Jódar, Stephen C. Bain, William H. Polonsky, Rosangela Rea, Signe Harring, Uwe Ziegler, Tina Vilsbøll |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism Calidad de vida Enfermedad cardiovascular Glucagon-Like Peptides 030209 endocrinology & metabolism Type 2 diabetes 030204 cardiovascular system & hematology Placebo weight control 03 medical and health sciences 0302 clinical medicine Endocrinology Medicina preventiva Quality of life Risk Factors cardiovascular disease GLP‐1 analogue Internal medicine Heart rate Internal Medicine medicine Humans Hypoglycemic Agents Adverse effect GLP-1 analogue business.industry Semaglutide Standard of Care Original Articles medicine.disease Confidence interval humanities Blood pressure Treatment Outcome Diabetes mellitus tipo 2 Diabetes Mellitus Type 2 Cardiovascular Diseases Heart Disease Risk Factors Quality of Life Original Article incretin therapy type 2 diabetes business hypoglycaemia |
| Zdroj: | Diabetes, Obesity & Metabolism ABACUS. Repositorio de Producción Científica Universidad Europea (UEM) Jódar, E, Michelsen, M, Polonsky, W, Réa, R, Sandberg, A, Vilsbøll, T, Warren, M, Harring, S, Ziegler, U & Bain, S 2020, ' 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) ', Diabetes, Obesity and Metabolism, vol. 22, no. 8, pp. 1339-1347 . https://doi.org/10.1111/dom.14039 |
| DOI: | 10.1111/dom.14039 |
| Popis: | 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). Sin financiación 6.577 JCR (2020) Q1, 21/146 Endocrinology & Metabolism 2.445 SJR (2020) Q1, 6/122 Endocrinology No data IDR 2020 UEM |
| Databáze: | OpenAIRE |
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