Is there an association between liraglutide use and female breast cancer in a real-world setting?

Donnie Funch,1 Kathleen Mortimer,1 Ling Li,1 Heather Norman,1 Atheline Major-Pedersen,2 Anne Helene Olsen,3 Margit S Kaltoft,4 David D Dore1,5 1Optum Epidemiology, Boston, MA, USA; 2Global Safety, Novo Nordisk A/S, Copenhagen, Denmark; 3Epidemiology, Novo Nordisk A/S, Copenhagen, Denmark; 4Global De...

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Autores principales:	Funch D, Mortimer K, Li L, Norman H, Major-Pedersen A, Olsen AH, Kaltoft MS, Dore DD
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Glucagon-like peptide-1 receptor agonist type 2 diabetes administrative claims intention-to-treat time-on-drug Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/e936f0198d98452b809e9267a0daf4a8
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spelling	oai:doaj.org-article:e936f0198d98452b809e9267a0daf4a82021-12-02T01:41:20ZIs there an association between liraglutide use and female breast cancer in a real-world setting?1178-7007https://doaj.org/article/e936f0198d98452b809e9267a0daf4a82018-11-01T00:00:00Zhttps://www.dovepress.com/is-there-an-association-between-liraglutide-use-and-female-breast-canc-peer-reviewed-article-DMSOhttps://doaj.org/toc/1178-7007Donnie Funch,1 Kathleen Mortimer,1 Ling Li,1 Heather Norman,1 Atheline Major-Pedersen,2 Anne Helene Olsen,3 Margit S Kaltoft,4 David D Dore1,5 1Optum Epidemiology, Boston, MA, USA; 2Global Safety, Novo Nordisk A/S, Copenhagen, Denmark; 3Epidemiology, Novo Nordisk A/S, Copenhagen, Denmark; 4Global Development, Novo Nordisk A/S, Copenhagen, Denmark; 5Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI, USA Background: Liraglutide is a human glucagon-like peptide-1 receptor agonist approved for treatment of adults with type 2 diabetes mellitus at a maximum dose of 1.8 mg/day (Victoza®) and more recently at 3.0 mg/day for weight management (Saxenda®). During the evaluation of liraglutide for approval in weight management, a minor imbalance in the numbers of reported breast neoplasms was observed, motivating the present study. Our objective was to quantify the association between liraglutide and incidence of breast cancer (BC) among women in a real-world setting. Patients and methods: Women initiating liraglutide or other antidiabetic therapies and who were enrolled in a large US health plan (2010–2014) were included. Comparisons of BC incidence rates were made between matched cohorts of initiators of liraglutide and cohorts of initiators of exenatide, metformin, pioglitazone, sulfonylureas, and dipeptidyl peptidase-4 inhibitors separately and as two “all comparators” groupings: with or without exenatide. Women with two or more claims with BC diagnosis codes within 61days of each other were identified as possible cases, with additional confirmation by clinician review of comprehensive claims listings. Propensity score matched intention-to-treat (ITT) and time-on-drug (TOD) analyses were completed via Poisson regression. A latency analysis was performed. Results: Relative risks for BC for liraglutide vs comparators from the ITT analyses ranged from 0.90 (95% CI: 0.67–1.22) for both the “all comparator” and “all comparator except exenatide” cohorts to 1.46 (95% CI: 0.96–2.22) relative to exenatide. Latency analyses excluding the first year of follow-up yielded slightly attenuated point estimates. The TOD analyses of cumulative use of liraglutide suggested no increased risk of BC. Conclusion: Neither the ITT (overall or latency analysis) nor cumulative TOD analyses suggested an elevated risk of BC among liraglutide initiators. Short length of follow-up and the potential for confounding by unmeasured factors limit the full assessment of long-term risk. Keywords: glucagon-like peptide-1 receptor agonist, type 2 diabetes, administrative claims, intention-to-treat, time-on-drugFunch DMortimer KLi LNorman HMajor-Pedersen AOlsen AHKaltoft MSDore DDDove Medical PressarticleGlucagon-like peptide-1 receptor agonisttype 2 diabetesadministrative claimsintention-to-treattime-on-drugSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol Volume 11, Pp 791-806 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Glucagon-like peptide-1 receptor agonist type 2 diabetes administrative claims intention-to-treat time-on-drug Specialties of internal medicine RC581-951
spellingShingle	Glucagon-like peptide-1 receptor agonist type 2 diabetes administrative claims intention-to-treat time-on-drug Specialties of internal medicine RC581-951 Funch D Mortimer K Li L Norman H Major-Pedersen A Olsen AH Kaltoft MS Dore DD Is there an association between liraglutide use and female breast cancer in a real-world setting?
description	Donnie Funch,1 Kathleen Mortimer,1 Ling Li,1 Heather Norman,1 Atheline Major-Pedersen,2 Anne Helene Olsen,3 Margit S Kaltoft,4 David D Dore1,5 1Optum Epidemiology, Boston, MA, USA; 2Global Safety, Novo Nordisk A/S, Copenhagen, Denmark; 3Epidemiology, Novo Nordisk A/S, Copenhagen, Denmark; 4Global Development, Novo Nordisk A/S, Copenhagen, Denmark; 5Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, RI, USA Background: Liraglutide is a human glucagon-like peptide-1 receptor agonist approved for treatment of adults with type 2 diabetes mellitus at a maximum dose of 1.8 mg/day (Victoza®) and more recently at 3.0 mg/day for weight management (Saxenda®). During the evaluation of liraglutide for approval in weight management, a minor imbalance in the numbers of reported breast neoplasms was observed, motivating the present study. Our objective was to quantify the association between liraglutide and incidence of breast cancer (BC) among women in a real-world setting. Patients and methods: Women initiating liraglutide or other antidiabetic therapies and who were enrolled in a large US health plan (2010–2014) were included. Comparisons of BC incidence rates were made between matched cohorts of initiators of liraglutide and cohorts of initiators of exenatide, metformin, pioglitazone, sulfonylureas, and dipeptidyl peptidase-4 inhibitors separately and as two “all comparators” groupings: with or without exenatide. Women with two or more claims with BC diagnosis codes within 61days of each other were identified as possible cases, with additional confirmation by clinician review of comprehensive claims listings. Propensity score matched intention-to-treat (ITT) and time-on-drug (TOD) analyses were completed via Poisson regression. A latency analysis was performed. Results: Relative risks for BC for liraglutide vs comparators from the ITT analyses ranged from 0.90 (95% CI: 0.67–1.22) for both the “all comparator” and “all comparator except exenatide” cohorts to 1.46 (95% CI: 0.96–2.22) relative to exenatide. Latency analyses excluding the first year of follow-up yielded slightly attenuated point estimates. The TOD analyses of cumulative use of liraglutide suggested no increased risk of BC. Conclusion: Neither the ITT (overall or latency analysis) nor cumulative TOD analyses suggested an elevated risk of BC among liraglutide initiators. Short length of follow-up and the potential for confounding by unmeasured factors limit the full assessment of long-term risk. Keywords: glucagon-like peptide-1 receptor agonist, type 2 diabetes, administrative claims, intention-to-treat, time-on-drug
format	article
author	Funch D Mortimer K Li L Norman H Major-Pedersen A Olsen AH Kaltoft MS Dore DD
author_facet	Funch D Mortimer K Li L Norman H Major-Pedersen A Olsen AH Kaltoft MS Dore DD
author_sort	Funch D
title	Is there an association between liraglutide use and female breast cancer in a real-world setting?
title_short	Is there an association between liraglutide use and female breast cancer in a real-world setting?
title_full	Is there an association between liraglutide use and female breast cancer in a real-world setting?
title_fullStr	Is there an association between liraglutide use and female breast cancer in a real-world setting?
title_full_unstemmed	Is there an association between liraglutide use and female breast cancer in a real-world setting?
title_sort	is there an association between liraglutide use and female breast cancer in a real-world setting?
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/e936f0198d98452b809e9267a0daf4a8
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Is there an association between liraglutide use and female breast cancer in a real-world setting?

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