PMID- 21856592
OWN - NLM
STAT- MEDLINE
DCOM- 20120517
LR  - 20221207
IS  - 1934-2403 (Electronic)
IS  - 1530-891X (Linking)
VI  - 17
IP  - 6
DP  - 2011 Nov-Dec
TI  - Colesevelam hydrochloride added to background metformin therapy in patients with 
      type 2 diabetes mellitus: a pooled analysis from 3 clinical studies.
PG  - 933-8
LID - 10.4158/EP11218.OR [doi]
AB  - OBJECTIVE: To evaluate the glucose- and lipid-altering efficacy of colesevelam 
      hydrochloride (HCl) when added to background metformin therapy in patients with 
      inadequately controlled type 2 diabetes mellitus (T2DM). METHODS: This post hoc 
      analysis included patients with T2DM from 3 randomized, double-blind, 
      placebo-controlled pivotal studies who received metformin as part of their 
      background antidiabetes therapy. In the pivotal studies, patients with T2DM were 
      randomly assigned to receive colesevelam HCl (3.75 g/d) or placebo added to 
      existing metformin (26 weeks), sulfonylurea (26 weeks), or insulin (16 weeks) 
      monotherapy or combination therapy, wherein the combination therapies may have 
      included metformin. RESULTS: In this pooled analysis of 696 patients with T2DM 
      who were receiving metformin monotherapy or metformin combined with other 
      antidiabetes therapies, 355 were randomly assigned to receive colesevelam HCl and 
      341 to receive placebo. In comparison with placebo, colesevelam HCl significantly 
      reduced hemoglobin A1c (A1C) and fasting plasma glucose (mean treatment 
      difference: -0.50% and -15.7 mg/dL, respectively; P<.001 for both), as well as 
      significantly reduced levels of low-density lipoprotein cholesterol (LDL-C; mean 
      treatment difference: -16.5%), total cholesterol (TC; -5.8%), non-high-density 
      lipoprotein cholesterol (non-HDL-C; -8.2%), and apolipoprotein (apo) B (-7.6%) 
      (P<.0001 for all). Median triglyceride levels were increased with colesevelam HCl 
      (median treatment difference: +12.8%; P<.0001). In comparison with placebo, 
      colesevelam HCl significantly increased apo A-I (mean treatment difference: 
      +3.3%; P<.0001), whereas the mean increase in HDL-C with colesevelam HCl was not 
      significant. Colesevelam HCl therapy was generally well tolerated. CONCLUSION: 
      When added to metformin-including therapy, colesevelam HCl significantly reduced 
      A1C and fasting glucose, as well as levels of LDL-C, TC, non-HDL-C, and apo B in 
      patients with inadequately controlled T2DM.
FAU - Bays, Harold E
AU  - Bays HE
AD  - Louisville Metabolic and Atherosclerosis Research Center, Inc., Louisville, 
      Kentucky 40213, USA. HBaysMD@aol.com
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Endocr Pract
JT  - Endocrine practice : official journal of the American College of Endocrinology 
      and the American Association of Clinical Endocrinologists
JID - 9607439
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Apolipoprotein A-I)
RN  - 0 (Apolipoproteins B)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 48G762T011 (Allylamine)
RN  - 9100L32L2N (Metformin)
RN  - 97C5T2UQ7J (Cholesterol)
RN  - P4SG24WI5Q (Colesevelam Hydrochloride)
SB  - IM
MH  - Aged
MH  - Allylamine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Anticholesteremic Agents/adverse effects/*therapeutic use
MH  - Apolipoprotein A-I/blood
MH  - Apolipoproteins B/blood
MH  - Cholesterol/blood
MH  - Cholesterol, LDL/blood
MH  - Colesevelam Hydrochloride
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypercholesterolemia/*prevention & control
MH  - Hyperglycemia/*prevention & control
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Insulin/therapeutic use
MH  - Intention to Treat Analysis
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Patient Dropouts
MH  - Sulfonylurea Compounds/therapeutic use
EDAT- 2011/08/23 06:00
MHDA- 2012/05/18 06:00
CRDT- 2011/08/23 06:00
PHST- 2011/08/23 06:00 [entrez]
PHST- 2011/08/23 06:00 [pubmed]
PHST- 2012/05/18 06:00 [medline]
AID - S1530-891X(20)43285-9 [pii]
AID - 10.4158/EP11218.OR [doi]
PST - ppublish
SO  - Endocr Pract. 2011 Nov-Dec;17(6):933-8. doi: 10.4158/EP11218.OR.