The improved health utility of once‐weekly subcutaneous semaglutide 2.4 mg compared with placebo in the STEP 1‐4 obesity trials

赛马鲁肽 安慰剂 医学 生活质量(医疗保健) 体质指数 随机对照试验 物理疗法 内科学 肥胖 2型糖尿病 糖尿病 替代医学 内分泌学 护理部 病理 利拉鲁肽
作者
Jakob Bue Bjørner,Sára Larsen,Christopher Lübker,Thomas Holst‐Hansen
出处
期刊:Diabetes, Obesity and Metabolism [Wiley]
卷期号:25 (8): 2142-2150 被引量:2
标识
DOI:10.1111/dom.15090
摘要

Abstract Aim To assess health utility values in the Semaglutide Treatment Effect in People with obesity (STEP) 1‐4 trials. Materials and Methods The STEP 1‐4 phase 3a, 68‐week, double‐blind randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with a body mass index (BMI) of 30 kg/m 2 or higher or a BMI of 27 kg/m 2 or higher and at least one comorbidity (STEP 1, 3 and 4), or a BMI of 27 kg/m 2 or higher and type 2 diabetes (STEP 2). Patients received lifestyle intervention plus intensive behavioural therapy in STEP 3. Health‐related quality of life was assessed using the Short Form 36‐item Health Survey version 2 (SF‐36v2) at baseline and week 68. Scores were converted into Short Form Six‐Dimension version 2 (SF‐6Dv2) utility scores or mapped onto the European Quality of Life Five‐Dimension Three‐Level (EQ‐5D‐3L) utility index using UK health utility weights. Results At week 68, semaglutide 2.4 mg was associated with minor health utility score improvements from baseline (all trials), while scores for placebo typically decreased. SF‐6Dv2 treatment differences by week 68 for semaglutide 2.4 mg versus placebo were significant in STEP 1 and 4 ( P ≤ .001), but not STEP 2 or 3. EQ‐5D‐3L treatment differences by week 68 for semaglutide 2.4 mg versus placebo were significant in STEP 1, 2 and 4 ( P < .001 for all), but not STEP 3. Conclusions Semaglutide 2.4 mg was associated with improvement in health utility scores compared with placebo, reaching statistical significance in STEP 1, 2 and 4.
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