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 |