The quality of evidence is downgraded by study limitations (lack of/unclear allocation concealment) and by indirectness (only surrogate outcomes reported).
A Cochrane review included 6 RTCs with a total of 1450 participants to assess the effects of colesevelam, a second-generation bile acid sequestrant, for type 2 diabetes mellitus. Duration of the trials varied between 8 to 26 weeks.
Colesevelam added on to antidiabetic agents demonstrated a significant reduction in fasting blood glucose (MD -15 mg/dL; 95% CI -22 to -8, P < 0.0001; n = 1075, 4 trials). There was also a reduction in HbA1c in favour of colesevelam (MD -0.5%; 95% CI -0.6 to -0.4, P < 0.00001; n = 1315, 5 trials). The single trial comparing colesevelam to placebo only (n = 33) did not reveal a statistically significant difference between the two arms; in both arms HbA1c increased.
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.
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