近日，来自英国莱斯特大学的研究人员在国际学术期刊JAMA上发表了一项最新研究进展，他们发现对患有2型糖尿病的超重或肥胖人群使用改造过的胰岛素笔每天注射糖尿病治疗药物利拉鲁肽可以促进减重。
肥胖是一种慢性疾病，并且正在逐渐成为一个全球性的公共健康问题。医生建议患有2型糖尿病的患者减重，适当的减重可以改善血糖控制能力，并降低其他心血管代谢紊乱疾病的发生风险。但减重对于2型糖尿病患者来说更具挑战，因为相比于非糖尿病人群，他们对减肥药物的应答能力更差。
在这项研究中，研究人员随机挑选了846名患有2型糖尿病的超重或肥胖参与者，他们平均年龄都在18岁以上，然后分组分别给予每天一次的3.0mg利拉鲁肽，1.8mg利拉鲁肽和安慰剂注射，共持续56周，之后再进行12周的不给药跟踪观察。研究人员还要求参与者减少饮食中的卡路里摄入，并增加身体活动以进行体重管理。
结果表明3.0mg利拉鲁肽组的参与者平均减重6%，1.8mg利拉鲁肽组的参与者平均减重4.7%，安慰剂组为2%。并且3.0mg利拉鲁肽组的参与者中减重超过5%的人数占到该组的54.3%，超过10%的人数为该组的25.2%，而1.8mg利拉鲁肽组达到这一指标的分别为40.4%和15.9%，安慰剂组达到这一指标的分别为21.4%和6.7%。但相比于1.8mg利拉鲁肽组和安慰剂组，3.0mg利拉鲁肽组参与者出现胃肠道紊乱的情况也更多。
研究人员指出，这可能是首次关于利拉鲁肽对2型糖尿病病人体重管理效率影响的研究，以目前的临床案例来看，高剂量的利拉鲁肽作为低卡路里饮食和高活动量的辅助方法用以管理2型糖尿病病人的体重是非常有效的，但这种方法的长期作用效果和安全性问题仍需要进一步研究。
Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes
Melanie J. Davies, MD1; Richard Bergenstal, MD2; Bruce Bode, MD3; Robert F. Kushner, MD4; Andrew Lewin, MD5; Trine Vang Skj?th, MD6; Arne Haahr Andreasen, MSc6; Christine Bj?rn Jensen, MD6; Ralph A. DeFronzo, MD7
importance Weight loss of 5% to 10% can improve type 2 diabetes and related comorbidities. Few safe, effective weight-management drugs are currently available.
Objective To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type 2 diabetes.
Design, Setting, and Participants Fifty-six-week randomized (2:1:1), double-blind, placebo-controlled, parallel-group trial with 12-week observational off-drug follow-up period. The study was conducted at 126 sites in 9 countries between June 2011 and January 2013. Of 1361 participants assessed for eligibility, 846 were randomized. Inclusion criteria were body mass index of 27.0 or greater, age 18 years or older, taking 0 to 3 oral hypoglycemic agents (metformin, thiazolidinedione, sulfonylurea) with stable body weight, and glycated hemoglobin level 7.0% to 10.0%.
Interventions Once-daily, subcutaneous liraglutide (3.0 mg) (n?=?423), liraglutide (1.8 mg) (n?=?211), or placebo (n?=?212), all as adjunct to 500 kcal/d dietary deficit and increased physical activity (≥150 min/wk).
Main Outcomes and Measures Three coprimary end points: relative change in weight, proportion of participants losing 5% or more, or more than 10%, of baseline weight at week 56.
Results baseline weight was 105.7 kg with liraglutide (3.0-mg dose), 105.8 kg with liraglutide (1.8-mg dose), and 106.5 kg with placebo. Weight loss was 6.0% (6.4 kg) with liraglutide (3.0-mg dose), 4.7% (5.0 kg) with liraglutide (1.8-mg dose), and 2.0% (2.2 kg) with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, ?4.00% [95% CI, ?5.10% to ?2.90%]; liraglutide [1.8 mg] vs placebo, ?2.71% [95% CI, ?4.00% to ?1.42%]; P?<?.001 for both). Weight loss of 5% or greater occurred in 54.3% with liraglutide (3.0 mg) and 40.4% with liraglutide (1.8 mg) vs 21.4% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 32.9% [95% CI, 24.6% to 41.2%]; for liraglutide [1.8 mg] vs placebo, 19.0% [95% CI, 9.1% to 28.8%]; P?<?.001 for both). Weight loss greater than 10% occurred in 25.2% with liraglutide (3.0 mg) and 15.9% with liraglutide (1.8 mg) vs 6.7% with placebo (estimated difference for liraglutide [3.0 mg] vs placebo, 18.5% [95% CI, 12.7% to 24.4%], P?<?.001; for liraglutide [1.8 mg] vs placebo, 9.3% [95% CI, 2.7% to 15.8%], P?=?.006). More gastrointestinal disorders were reported with liraglutide (3.0 mg) vs liraglutide (1.8 mg) and placebo. No pancreatitis was reported.
Conclusions and Relevance Among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide (3.0 mg) daily, compared with placebo, resulted in weight loss over 56 weeks. Further studies are needed to evaluate longer-term efficacy and safety.