利拉鲁肽或可帮助2型糖尿病肥胖患者减肥

  发表在JAMA上的一篇研究论文中，来自莱斯特大学的研究人员通过研究发现，对于2型糖尿病的肥胖或过重患者而言，利用新型修饰的胰岛素笔样装置每日注射糖尿病药物利拉鲁肽，并且结合饮食和锻炼，相比安慰剂而言或将有效降低患者体重。
  肥胖是一种慢性疾病，而且也是全球人口健康所要面临的巨大挑战；减肥被认为是2型糖尿病患者的一种简易，而适度的体重降低（5%-10%）可以改善机体的血糖控制及其它心血管代谢风险因素和障碍；体重降低对于2型糖尿病患者而言是一项巨大的挑战，因为相比非糖尿病患者而言，糖尿病病人往往对体重管理的药物疗法反应性较低，利拉鲁肽是一种用于治疗2型糖尿病的药物，此前有研究证实利拉鲁肽也可以有效降低机体的体重。
  研究者Melanie J. Davies博士表示，文章中我们随机对846名2型糖尿病的过重或肥胖个体进行研究，这些个体平均年龄为18岁及以上，研究者对进行如下注射策略：423名个体每日注射3mg剂量利拉鲁肽；211名个体每日注射1.8mg剂量利拉鲁肽；212名个体进行安慰剂治疗，治疗周期为56周；随后研究者对参与者进行12周的不服药随访来评估患者停止治疗后的效果（研究共计68周）。
  结果发现，利拉鲁肽3mg剂量组患者体重平均降低了6%（14.1磅），1.8mg剂量组患者体重平均降低了4.7%（11磅），而安慰剂组患者平均体重降低了2%（4.8磅）；研究者表示，相比21.4%的安慰剂组个体而言，54.3%的3mg剂量组的患者及40.4%的1.8mg剂量组患者的体重或许会降低5%甚至更多。
  这项研究中研究者首次调查了利拉鲁肽对于2型糖尿病的患者体重管理的效应，同时也揭示了高达3mg剂量的利拉鲁肽对2型糖尿病患者的效应；当前试验中，研究者将3mg利拉鲁肽作为附加物加入到减少卡路里饮食中，同时增加患者的体力运动，这或许是有效降低2型糖尿病患者的最佳策略。（转化医学网360zhyx.com）
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转化医学网推荐的原文摘要：

Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes
The SCALE Diabetes Randomized Clinical Trial
JAMA         doi:10.1001/jama.2015.9676
Melanie J. Davies, MD1; Richard Bergenstal, MD2; Bruce Bode, MD3; Robert F. Kushner, MD4; Andrew Lewin, MD5; Trine Vang Skjøth, MD6; Arne Haahr Andreasen, MSc6; Christine Bjørn Jensen, MD6; Ralph A. DeFronzo, MD7 ; for the NN8022-1922 Study Group
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.

Trial Registration  clinicaltrials.gov Identifier:NCT01272232