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No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial
Diabetes Care ( IF 14.8 ) Pub Date : 2018-03-01 , DOI: 10.2337/dc17-1956
Laszlo Hegedüs 1 , Steven I. Sherman 2 , R. Michael Tuttle 3 , Bernt J. von Scholten 4 , Søren Rasmussen 4 , Julie D. Karsbøl 4 , Gilbert H. Daniels 5 ,
Affiliation  

OBJECTIVE To describe the changes in serum levels of calcitonin in liraglutide- and placebo-treated patients in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation (LEADER) trial over a 3.5–5-year period.

RESEARCH DESIGN AND METHODS Patients (n = 9,340) with type 2 diabetes and high risk for cardiovascular events were randomized 1:1 to liraglutide or placebo. We analyzed calcitonin levels, thyroid and C-cell adverse events, and neoplasms.

RESULTS At 36 months, patients randomized to liraglutide versus placebo showed no evidence of increase in calcitonin concentrations in male (estimated treatment ratio [ETR] 1.03 [95% CI 1.00, 1.06]; P = 0.068) and female (ETR 1.00 [95% CI 0.97, 1.02]; P = 0.671) subgroups. There were no episodes of C-cell hyperplasia or medullary thyroid carcinoma in liraglutide-treated patients.

CONCLUSIONS There was no evidence of a difference in calcitonin concentrations between the liraglutide and placebo groups, and no C-cell malignancies occurred in the liraglutide group.



中文翻译:

在LEADER试验中,长达5年没有证据显示降钙素浓度升高或C细胞恶性反应对利拉鲁肽有影响。

目的为了描述利拉鲁肽和安慰剂治疗的患者血清降钙素在糖尿病患者的利拉鲁肽的作用和作用中的变化:评估心血管结果-一项3.5-5年的长期评估(LEADER)试验。

研究设计和方法将2例糖尿病和心血管事件高风险患者(n = 9,340)1:1随机分配给利拉鲁肽或安慰剂。我们分析了降钙素水平,甲状腺和C细胞不良事件以及肿瘤。

结果在36个月时,随机接受利拉鲁肽和安慰剂治疗的患者没有证据显示男性(估计治疗率[ETR] 1.03 [95%CI 1.00,1.06];P = 0.068)和女性(ETR 1.00 [95%] CI 0.97,1.02];P = 0.671)亚组。利拉鲁肽治疗的患者无C细胞增生或甲状腺髓样癌发作。

结论没有证据表明利拉鲁肽组和安慰剂组之间降钙素浓度存在差异,利拉鲁肽组中没有发生C细胞恶性肿瘤。

更新日期:2018-02-21
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