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
利拉鲁肽
病理
作者
Jakob Bue Bjørner,Sára Larsen,Christopher Lübker,Thomas Holst‐Hansen
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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