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Colesevelam for type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2012 Dec 12; 12:CD009361.CD

Abstract

BACKGROUND

Colesevelam is a second-generation bile acid sequestrant that has effects on both blood glucose and lipid levels. It provides a promising approach to glycaemic and lipid control simultaneously.

OBJECTIVES

To assess the effects of colesevelam for type 2 diabetes mellitus.

SEARCH METHODS

Several electronic databases were searched, among these The Cochrane Library (Issue 1, 2012), MEDLINE, EMBASE, CINAHL, LILACS, OpenGrey and Proquest Dissertations and Theses database (all up to January 2012), combined with handsearches. No language restriction was used.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) that compared colesevelam with or without other oral hypoglycaemic agents with a placebo or a control intervention with or without oral hypoglycaemic agents.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected the trials and extracted the data. We evaluated risk of bias of trials using the parameters of randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias.

MAIN RESULTS

Six RCTs ranging from 8 to 26 weeks investigating 1450 participants met the inclusion criteria. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effects of colesevelam with or without other antidiabetic drug treatments with placebo only (one study) or combined with antidiabetic drug treatments. Colesevelam with add-on antidiabetic agents demonstrated a statistically significant reduction in fasting blood glucose with a mean difference (MD) of -15 mg/dL (95% confidence interval (CI) -22 to - 8), P < 0.0001; 1075 participants, 4 trials, no trial with low risk of bias in all domains. There was also a reduction in glycosylated haemoglobin A1c (HbA1c) in favour of colesevelam (MD -0.5% (95% CI -0.6 to -0.4), P < 0.00001; 1315 participants, 5 trials, no trial with low risk of bias in all domains. However, the single trial comparing colesevelam to placebo only (33 participants) did not reveal a statistically significant difference between the two arms - in fact, in both arms HbA1c increased. Colesevelam with add-on antidiabetic agents demonstrated a statistical significant reduction in low-density lipoprotein (LDL)-cholesterol with a MD of -13 mg/dL (95% CI -17 to - 9), P < 0.00001; 886 participants, 4 trials, no trial with low risk of bias in all domains. Non-severe hypoglycaemic episodes were infrequently observed. No other serious adverse effects were reported. There was no documentation of complications of the disease, morbidity, mortality, health-related quality of life and costs.

AUTHORS' CONCLUSIONS

Colesevelam added on to antidiabetic agents showed significant effects on glycaemic control. However, there is a limited number of studies with the different colesevelam/antidiabetic agent combinations. More information on the benefit-risk ratio of colesevelam treatment is necessary to assess the long-term effects, particularly in the management of cardiovascular risks as well as the reduction in micro- and macrovascular complications of type 2 diabetes mellitus. Furthermore, long-term data on health-related quality of life and all-cause mortality also need to be investigated.

Authors+Show Affiliations

Endocrine Unit, Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia. cpooi07@gmail.com.No affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Review
Systematic Review

Language

eng

PubMed ID

23235674

Citation

Ooi, Cheow Peng, and Seng Cheong Loke. "Colesevelam for Type 2 Diabetes Mellitus." The Cochrane Database of Systematic Reviews, vol. 12, 2012, p. CD009361.
Ooi CP, Loke SC. Colesevelam for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2012;12:CD009361.
Ooi, C. P., & Loke, S. C. (2012). Colesevelam for type 2 diabetes mellitus. The Cochrane Database of Systematic Reviews, 12, CD009361. https://doi.org/10.1002/14651858.CD009361.pub2
Ooi CP, Loke SC. Colesevelam for Type 2 Diabetes Mellitus. Cochrane Database Syst Rev. 2012 Dec 12;12:CD009361. PubMed PMID: 23235674.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Colesevelam for type 2 diabetes mellitus. AU - Ooi,Cheow Peng, AU - Loke,Seng Cheong, Y1 - 2012/12/12/ PY - 2012/12/14/entrez PY - 2012/12/14/pubmed PY - 2013/2/22/medline SP - CD009361 EP - CD009361 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev VL - 12 N2 - BACKGROUND: Colesevelam is a second-generation bile acid sequestrant that has effects on both blood glucose and lipid levels. It provides a promising approach to glycaemic and lipid control simultaneously. OBJECTIVES: To assess the effects of colesevelam for type 2 diabetes mellitus. SEARCH METHODS: Several electronic databases were searched, among these The Cochrane Library (Issue 1, 2012), MEDLINE, EMBASE, CINAHL, LILACS, OpenGrey and Proquest Dissertations and Theses database (all up to January 2012), combined with handsearches. No language restriction was used. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared colesevelam with or without other oral hypoglycaemic agents with a placebo or a control intervention with or without oral hypoglycaemic agents. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the trials and extracted the data. We evaluated risk of bias of trials using the parameters of randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias. MAIN RESULTS: Six RCTs ranging from 8 to 26 weeks investigating 1450 participants met the inclusion criteria. Overall, the risk of bias of these trials was unclear or high. All RCTs compared the effects of colesevelam with or without other antidiabetic drug treatments with placebo only (one study) or combined with antidiabetic drug treatments. Colesevelam with add-on antidiabetic agents demonstrated a statistically significant reduction in fasting blood glucose with a mean difference (MD) of -15 mg/dL (95% confidence interval (CI) -22 to - 8), P < 0.0001; 1075 participants, 4 trials, no trial with low risk of bias in all domains. There was also a reduction in glycosylated haemoglobin A1c (HbA1c) in favour of colesevelam (MD -0.5% (95% CI -0.6 to -0.4), P < 0.00001; 1315 participants, 5 trials, no trial with low risk of bias in all domains. However, the single trial comparing colesevelam to placebo only (33 participants) did not reveal a statistically significant difference between the two arms - in fact, in both arms HbA1c increased. Colesevelam with add-on antidiabetic agents demonstrated a statistical significant reduction in low-density lipoprotein (LDL)-cholesterol with a MD of -13 mg/dL (95% CI -17 to - 9), P < 0.00001; 886 participants, 4 trials, no trial with low risk of bias in all domains. Non-severe hypoglycaemic episodes were infrequently observed. No other serious adverse effects were reported. There was no documentation of complications of the disease, morbidity, mortality, health-related quality of life and costs. AUTHORS' CONCLUSIONS: Colesevelam added on to antidiabetic agents showed significant effects on glycaemic control. However, there is a limited number of studies with the different colesevelam/antidiabetic agent combinations. More information on the benefit-risk ratio of colesevelam treatment is necessary to assess the long-term effects, particularly in the management of cardiovascular risks as well as the reduction in micro- and macrovascular complications of type 2 diabetes mellitus. Furthermore, long-term data on health-related quality of life and all-cause mortality also need to be investigated. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/23235674/Colesevelam_for_type_2_diabetes_mellitus_ L2 - https://doi.org/10.1002/14651858.CD009361.pub2 DB - PRIME DP - Unbound Medicine ER -