Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients

Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USAObjective: To evaluate the long-term safety, tolerability, and efficacy of colesevelam HCl (colesevelam) in type 2 diabetes mellitus patients receiving metformin monotherapy or metformin combination thera...

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Autor principal:	Bays HE
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/e3d6a34ccecb4e2cbc0af2f58703c244
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spelling	oai:doaj.org-article:e3d6a34ccecb4e2cbc0af2f58703c2442021-12-02T06:28:50ZLong-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients1178-7007https://doaj.org/article/e3d6a34ccecb4e2cbc0af2f58703c2442012-05-01T00:00:00Zhttp://www.dovepress.com/long-term-52ndash78-weeks-treatment-with-colesevelam-hcl-added-to-metf-a9979https://doaj.org/toc/1178-7007Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USAObjective: To evaluate the long-term safety, tolerability, and efficacy of colesevelam HCl (colesevelam) in type 2 diabetes mellitus patients receiving metformin monotherapy or metformin combination therapy.Methods: This post-hoc subgroup analysis examined data from type 2 diabetes mellitus patients aged 18 to 75 years with a hemoglobin A1c of 7.5% to 9.5%, who received metformin as part of their treatment via their participation in one of three randomized, double-blind base studies wherein colesevelam (3.75 g/day) or a placebo was added to existing metformin-, insulin-, or sulfonylurea-based treatment. After completing the base studies, the subjects who initially received blinded colesevelam (n = 196) or the placebo (n = 166) entered a 52-week extension study wherein they received open-label colesevelam (3.75 g/day).Results: This analysis describes the 362 patients receiving background metformin therapy who also received open-label colesevelam (3.75 g/day) during a 1-year extension study. From a safety perspective, hypoglycemia was reported by 11 patients (3.0%; none severe). Drug-related adverse events (AEs) occurred in 38 patients (10.5%). At least one serious AE occurred in 35 patients (9.7%), with only one being assessed by investigators as drug related (exacerbation of diverticulitis). Twenty-four patients (6.6%) discontinued open-label treatment because of an AE (10 due to a drug-related AE). Compared with baseline values obtained prior to the start of both the base and extension studies, colesevelam improved and maintained improvement in hemoglobin A1c and various lipid parameters.Conclusion: This analysis found colesevelam to be generally safe and effective for long-term therapy in type 2 diabetes mellitus patients with inadequately controlled glucose while treated with metformin monotherapy or metformin combination therapy.Keywords: bile acid sequestrant, open-label, safetyBays HEDove Medical PressarticleSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol 2012, Iss default, Pp 125-134 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Specialties of internal medicine RC581-951
spellingShingle	Specialties of internal medicine RC581-951 Bays HE Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients
description	Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USAObjective: To evaluate the long-term safety, tolerability, and efficacy of colesevelam HCl (colesevelam) in type 2 diabetes mellitus patients receiving metformin monotherapy or metformin combination therapy.Methods: This post-hoc subgroup analysis examined data from type 2 diabetes mellitus patients aged 18 to 75 years with a hemoglobin A1c of 7.5% to 9.5%, who received metformin as part of their treatment via their participation in one of three randomized, double-blind base studies wherein colesevelam (3.75 g/day) or a placebo was added to existing metformin-, insulin-, or sulfonylurea-based treatment. After completing the base studies, the subjects who initially received blinded colesevelam (n = 196) or the placebo (n = 166) entered a 52-week extension study wherein they received open-label colesevelam (3.75 g/day).Results: This analysis describes the 362 patients receiving background metformin therapy who also received open-label colesevelam (3.75 g/day) during a 1-year extension study. From a safety perspective, hypoglycemia was reported by 11 patients (3.0%; none severe). Drug-related adverse events (AEs) occurred in 38 patients (10.5%). At least one serious AE occurred in 35 patients (9.7%), with only one being assessed by investigators as drug related (exacerbation of diverticulitis). Twenty-four patients (6.6%) discontinued open-label treatment because of an AE (10 due to a drug-related AE). Compared with baseline values obtained prior to the start of both the base and extension studies, colesevelam improved and maintained improvement in hemoglobin A1c and various lipid parameters.Conclusion: This analysis found colesevelam to be generally safe and effective for long-term therapy in type 2 diabetes mellitus patients with inadequately controlled glucose while treated with metformin monotherapy or metformin combination therapy.Keywords: bile acid sequestrant, open-label, safety
format	article
author	Bays HE
author_facet	Bays HE
author_sort	Bays HE
title	Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients
title_short	Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients
title_full	Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients
title_fullStr	Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients
title_full_unstemmed	Long-term (52&ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients
title_sort	long-term (52&ndash;78 weeks) treatment with colesevelam hcl added to metformin therapy in type 2 diabetes mellitus patients
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/e3d6a34ccecb4e2cbc0af2f58703c244
work_keys_str_mv	AT bayshe longterm52ampndash78weekstreatmentwithcolesevelamhcladdedtometformintherapyintype2diabetesmellituspatients
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Long-term (52&amp;ndash;78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients

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