Fujioka Ken, O'Neil Patrick M, Davies Melanie, Greenway Frank, C W Lau David, Claudius Birgitte, Skjøth Trine Vang, Bjørn Jensen Christine, P H Wilding John
Scripps Clinic, La Jolla, California, USA.
Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, Charleston, South Carolina, USA.
Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.
To identify an early response criterion for predicting ≥5% weight loss with liraglutide 3.0 mg at week 56 and to compare efficacy outcomes in early responders (ERs) and early nonresponders (ENRs).
Using pooled data from the SCALE Obesity and Prediabetes and SCALE Diabetes trials, weight loss of ≥4% at 16 weeks best predicted ≥5% weight loss after 56 weeks. Weight loss and changes in cardiometabolic risk factors and health-related quality of life were evaluated in ERs (≥4% weight loss at week 16) and ENRs (<4% weight loss at week 16) completing 56 weeks' treatment.
Proportions of ERs/ENRs to liraglutide 3.0 mg were 77.3%/22.7% (individuals without type 2 diabetes, T2D) and 62.7%/37.3% (those with T2D). Greater mean weight loss was observed in ERs versus ENRs: 10.8% versus 3.0% (without T2D) and 8.5% versus 3.1% (T2D). In both trials, greater proportions of ERs versus ENRs achieved ≥5%, >10%, and >15% weight loss at week 56 with liraglutide 3.0 mg. Greater improvements in cardiometabolic risk factors and health-related quality of life scores were observed in ERs versus ENRs.
The early response criterion was clinically useful to identify individuals who would achieve clinically meaningful weight loss at 56 weeks.
确定一个早期反应标准,以预测使用3.0毫克利拉鲁肽在第56周时体重减轻≥5%,并比较早期反应者(ERs)和早期无反应者(ENRs)的疗效结果。
使用来自SCALE肥胖与糖尿病前期试验和SCALE糖尿病试验的汇总数据,16周时体重减轻≥4%最能预测56周后体重减轻≥5%。对完成56周治疗的ERs(第16周体重减轻≥4%)和ENRs(第16周体重减轻<4%)的体重减轻情况以及心血管代谢危险因素和健康相关生活质量的变化进行了评估。
使用3.0毫克利拉鲁肽时,ERs/ENRs的比例在无2型糖尿病(T2D)个体中为77.3%/22.7%,在T2D患者中为62.7%/37.3%。与ENRs相比,ERs的平均体重减轻更多:无T2D者为10.8%对3.0%,T2D患者为8.5%对3.1%。在两项试验中,使用3.0毫克利拉鲁肽时,第56周时达到体重减轻≥5%、>10%和>15%的ERs比例均高于ENRs。与ENRs相比,ERs的心血管代谢危险因素和健康相关生活质量评分改善更大。
早期反应标准在临床上有助于识别那些在56周时将实现具有临床意义的体重减轻的个体。