No evidence of increase in calcitonin concentrations or development of C-cellmalignancy in response to liraglutide for up to 5 years in the LEADER trial Journal Article


Authors: Hegedüs, L.; Sherman, S. I.; Tuttle, R. M.; von Scholten, B. J.; Rasmussen, S.; Karsbøl, J. D.; Daniels, G. H.; for the LEADER Publication Committee on behalf of the LEADER Trial Investigators
Article Title: No evidence of increase in calcitonin concentrations or development of C-cellmalignancy 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 ResultsdA 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 36months, patients randomized to liraglutide versus placebo showed no evidence of increase in calcitonin concentrations inmale (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-cellmalignancies occurred in the liraglutide group. © 2017 by The American Diabetes Association.
Keywords: adult; controlled study; middle aged; major clinical study; placebo; treatment duration; randomized controlled trial; calcitonin; high risk patient; cardiovascular risk; drug response; non insulin dependent diabetes mellitus; thyroid tumor; thyroid medullary carcinoma; thyroid disease; calcitonin blood level; liraglutide; thyroid hyperplasia; human; male; female; article; thyroid parafollicular cell cancer; thyroid parafollicular cell hyperplasia
Journal Title: Diabetes Care
Volume: 41
Issue: 3
ISSN: 0149-5992
Publisher: American Diabetes Association  
Date Published: 2018-03-01
Start Page: 620
End Page: 622
Language: English
DOI: 10.2337/dc17-1956
PROVIDER: scopus
PUBMED: 29279300
DOI/URL:
Notes: Article -- Export Date: 2 April 2018 -- Source: Scopus
Altmetric
Citation Impact
BMJ Impact Analytics
MSK Authors
  1. Robert M Tuttle
    481 Tuttle