PMID- 19344229
OWN - NLM
STAT- MEDLINE
DCOM- 20090814
LR  - 20221207
IS  - 1557-8518 (Electronic)
IS  - 1540-4196 (Print)
IS  - 1540-4196 (Linking)
VI  - 7
IP  - 3
DP  - 2009 Jun
TI  - Concomitant reduction in low-density lipoprotein cholesterol and glycated 
      hemoglobin with colesevelam hydrochloride in patients with type 2 diabetes: a 
      pooled analysis.
PG  - 255-8
LID - 10.1089/met.2009.0007 [doi]
AB  - Colesevelam hydrochloride (COL), a bile acid sequestrant indicated as an adjunct 
      to diet and exercise for reducing low-density lipoprotein cholesterol (LDL-C) in 
      patients with primary hypercholesterolemia, was shown in a pilot study to reduce 
      both glycated hemoglobin (HbA1c) and LDL-C in patients with type 2 diabetes 
      mellitus (T2DM). Three double-blind, placebo-controlled trials in T2DM have now 
      independently confirmed the HbA1c and LDL-C reductions with COL. In each of the 
      primary studies, a significant mean treatment difference in HbA1c (-0.54%, 
      -0.50%, and -0.54%) and LDL-C (-15.9%, -12.8%, and -16.7%) resulted from the 
      addition of 3.75 grams/day of COL to existing metformin, insulin, or 
      sulfonylurea-based therapy, respectively, in patients with T2DM inadequately 
      controlled on their current antidiabetic regimen. Here we report the results of a 
      pooled analysis of data for the 1018 patients included in the three primary 
      studies. By study end, HbA1c, fasting plasma glucose (FPG), LDL-C, total 
      cholesterol (TC), non-high-density lipoprotein cholesterol (HDL-C), 
      apolipoprotein B (ApoB), and high-sensitivity C-reactive protein (hsCRP) were 
      significantly reduced with COL versus placebo. Triglyceride (TG) and ApoA-I were 
      significantly increased in the COL group relative to placebo. HDL-C did not 
      change in either group, and the between-group treatment difference was small and 
      not significant. Results of this pooled analysis are consistent with results 
      reported previously in each of the primary COL studies and indicate that the 
      HbA1c and LDL-C-lowering effects of COL are consistent, occurring regardless of 
      whether COL is added to metformin, insulin, or sulfonylurea-based therapy. In 
      conclusion, COL represents a novel therapeutic option by significantly lowering 
      both LDL-C and HbA1c in patients with T2DM, two important treatment goals to 
      forestall vascular complications.
FAU - Jialal, Ishwarlal
AU  - Jialal I
AD  - Laboratory for Atherosclerosis and Metabolic Research, University of California, 
      Davis Medical Center, Sacramento, California 95817, USA. 
      ishwarlal.jialal@ucdmc.ucdavis.edu
FAU - Abby, Stacey L
AU  - Abby SL
FAU - Misir, Soamnauth
AU  - Misir S
FAU - Nagendran, Sukumar
AU  - Nagendran S
LA  - eng
GR  - K24 AT 00596/AT/NCCIH NIH HHS/United States
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - Metab Syndr Relat Disord
JT  - Metabolic syndrome and related disorders
JID - 101150318
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 48G762T011 (Allylamine)
RN  - 9100L32L2N (Metformin)
RN  - P4SG24WI5Q (Colesevelam Hydrochloride)
SB  - IM
MH  - Aged
MH  - Allylamine/administration & dosage/*analogs & derivatives/therapeutic use
MH  - Anticholesteremic Agents/administration & dosage/*therapeutic use
MH  - Cardiovascular Diseases/prevention & control
MH  - Cholesterol, LDL/*blood
MH  - Cohort Studies
MH  - Colesevelam Hydrochloride
MH  - Diabetes Mellitus, Type 2/*blood/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/*metabolism
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & 
      dosage/therapeutic use
MH  - Hypoglycemic Agents/administration & dosage/therapeutic use
MH  - Insulin/administration & dosage/therapeutic use
MH  - Male
MH  - Metformin/administration & dosage/therapeutic use
MH  - Middle Aged
MH  - Sulfonylurea Compounds/administration & dosage/therapeutic use
PMC - PMC3135892
EDAT- 2009/04/07 09:00
MHDA- 2009/08/15 09:00
PMCR- 2010/06/01
CRDT- 2009/04/07 09:00
PHST- 2009/04/07 09:00 [entrez]
PHST- 2009/04/07 09:00 [pubmed]
PHST- 2009/08/15 09:00 [medline]
PHST- 2010/06/01 00:00 [pmc-release]
AID - 10.1089/met.2009.0007 [pii]
AID - 10.1089/met.2009.0007 [doi]
PST - ppublish
SO  - Metab Syndr Relat Disord. 2009 Jun;7(3):255-8. doi: 10.1089/met.2009.0007.