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.

Abstract:

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.

journal_name

Diabetes Care

journal_title

Diabetes care

authors

Hegedüs L,Sherman SI,Tuttle RM,von Scholten BJ,Rasmussen S,Karsbøl JD,Daniels GH,LEADER Publication Committee on behalf of the LEADER Trial Investigators.

doi

10.2337/dc17-1956

subject

Has Abstract

pub_date

2018-03-01 00:00:00

pages

620-622

issue

3

eissn

0149-5992

issn

1935-5548

pii

dc17-1956

journal_volume

41

pub_type

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