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Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects.
Arch Intern Med. 2008 Oct 13; 168(18):1975-83.AI

Abstract

BACKGROUND

Bile acid sequestrants are a well-accepted class of cholesterol-lowering drugs. Over the last decade, small studies have indicated that these agents may also lower glucose levels in patients with type 2 diabetes mellitus (T2DM).

METHODS

This 26-week, randomized, double-blind, placebo-controlled, parallel-group study was conducted between August 2004 and July 2006 at 54 sites in the United States and 2 in Mexico to determine the effects of colesevelam hydrochloride, a bile acid sequestrant, in patients with inadequately controlled T2DM (hemoglobin A(1c) [HbA(1c)] level, 7.5%-9.5% [baseline HbA(1c) level, 8.1%]), who were receiving metformin monotherapy or metformin combined with additional oral anti-diabetes mellitus drugs. In total, 316 subjects were randomized (159 to colesevelam hydrochloride, 3.75 g/d, and 157 to matching placebo). The primary efficacy parameter was mean placebo-corrected change in HbA(1c) level from baseline to week 26 (analysis was on an intent-to-treat population using a last-observation-carried-forward approach).

RESULTS

Colesevelam lowered the mean HbA(1c) level compared with placebo at week 26 (-0.54%; P < .001). Similar results were observed in the metformin monotherapy (-0.47%; P = .002) and combination therapy cohorts (-0.62%; P < .001). In addition, colesevelam significantly (1) lowered fasting plasma glucose (-13.9 mg/dL P = .01), fructosamine (-23.2 micromol/L; P < .001), total cholesterol (TC) (-7.2%; P < .001), low-density lipoprotein cholesterol (LDL-C) (-15.9%; P < .001), apolipoprotein B (-7.9%; P < .001), non-high-density lipoprotein cholesterol (HDL-C) (-10.3%; P < .001), and high-sensitivity C-reactive protein (-14.4%; P = .02) levels and (2) improved other measures of glycemic response, as well as TC/HDL-C, LDL-C/HDL-C, non-HDL-C/HDL-C, and apolipoprotein B/apolipoprotein A-I ratios (P < .003 for all). Triglyceride, HDL-C, and apolipoprotein A-I levels were not statistically significantly increased.

CONCLUSION

Colesevelam improves glycemic and lipid parameters in patients with T2DM inadequately controlled with metformin-based therapy.

Authors+Show Affiliations

Louisville Metabolic and Atherosclerosis Research Center Inc, 3288 Illinois Ave, Louisville, KY 40213, USA. hbaysmd@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18852398

Citation

Bays, Harold E., et al. "Colesevelam Hydrochloride Therapy in Patients With Type 2 Diabetes Mellitus Treated With Metformin: Glucose and Lipid Effects." Archives of Internal Medicine, vol. 168, no. 18, 2008, pp. 1975-83.
Bays HE, Goldberg RB, Truitt KE, et al. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008;168(18):1975-83.
Bays, H. E., Goldberg, R. B., Truitt, K. E., & Jones, M. R. (2008). Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Archives of Internal Medicine, 168(18), 1975-83. https://doi.org/10.1001/archinte.168.18.1975
Bays HE, et al. Colesevelam Hydrochloride Therapy in Patients With Type 2 Diabetes Mellitus Treated With Metformin: Glucose and Lipid Effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. PubMed PMID: 18852398.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. AU - Bays,Harold E, AU - Goldberg,Ronald B, AU - Truitt,Kenneth E, AU - Jones,Michael R, PY - 2008/10/15/pubmed PY - 2008/10/29/medline PY - 2008/10/15/entrez SP - 1975 EP - 83 JF - Archives of internal medicine JO - Arch Intern Med VL - 168 IS - 18 N2 - BACKGROUND: Bile acid sequestrants are a well-accepted class of cholesterol-lowering drugs. Over the last decade, small studies have indicated that these agents may also lower glucose levels in patients with type 2 diabetes mellitus (T2DM). METHODS: This 26-week, randomized, double-blind, placebo-controlled, parallel-group study was conducted between August 2004 and July 2006 at 54 sites in the United States and 2 in Mexico to determine the effects of colesevelam hydrochloride, a bile acid sequestrant, in patients with inadequately controlled T2DM (hemoglobin A(1c) [HbA(1c)] level, 7.5%-9.5% [baseline HbA(1c) level, 8.1%]), who were receiving metformin monotherapy or metformin combined with additional oral anti-diabetes mellitus drugs. In total, 316 subjects were randomized (159 to colesevelam hydrochloride, 3.75 g/d, and 157 to matching placebo). The primary efficacy parameter was mean placebo-corrected change in HbA(1c) level from baseline to week 26 (analysis was on an intent-to-treat population using a last-observation-carried-forward approach). RESULTS: Colesevelam lowered the mean HbA(1c) level compared with placebo at week 26 (-0.54%; P < .001). Similar results were observed in the metformin monotherapy (-0.47%; P = .002) and combination therapy cohorts (-0.62%; P < .001). In addition, colesevelam significantly (1) lowered fasting plasma glucose (-13.9 mg/dL P = .01), fructosamine (-23.2 micromol/L; P < .001), total cholesterol (TC) (-7.2%; P < .001), low-density lipoprotein cholesterol (LDL-C) (-15.9%; P < .001), apolipoprotein B (-7.9%; P < .001), non-high-density lipoprotein cholesterol (HDL-C) (-10.3%; P < .001), and high-sensitivity C-reactive protein (-14.4%; P = .02) levels and (2) improved other measures of glycemic response, as well as TC/HDL-C, LDL-C/HDL-C, non-HDL-C/HDL-C, and apolipoprotein B/apolipoprotein A-I ratios (P < .003 for all). Triglyceride, HDL-C, and apolipoprotein A-I levels were not statistically significantly increased. CONCLUSION: Colesevelam improves glycemic and lipid parameters in patients with T2DM inadequately controlled with metformin-based therapy. SN - 1538-3679 UR - https://www.unboundmedicine.com/medline/citation/18852398/Colesevelam_hydrochloride_therapy_in_patients_with_type_2_diabetes_mellitus_treated_with_metformin:_glucose_and_lipid_effects_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinte.168.18.1975 DB - PRIME DP - Unbound Medicine ER -