Review of Studies on the Effect of Bile Acid Sequestrants in Patients with Type 2 Diabetes Mellitus

Abstract

Type 2 diabetes mellitus (T2DM) and prediabetes (or patients at risk for diabetes) have been increasing in epidemic proportions. Dyslipidemia and hypertension are cardiovascular risk factors frequently associated with diabetes and prediabetes. Bile acid sequestrants (BAS) were initially approved for the treatment of elevated low-density lipoprotein cholesterol (LDL-C), but they were subsequently found to have a glucose-lowering effect as well. Colesevelam hydrochloride (HCl), a BAS, has been approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM based on several studies that used it as an addition to sulfonylurea-based, metformin-based, and insulin-based therapies. Colesevelam HCl has not been approved for use for glycemic control in type 1 diabetes or for treating diabetic ketoacidosis and has not been studied in T2DM as monotherapy or in combination with dipeptidyl peptidase 4 inhibitors, or extensively with thiazolidinediones. A recent study has examined the combination of colesevelam HCl and metformin as an initial therapy for treatment-naïve patients with T2DM. Another recent study, which looked at colesevelam for the treatment of dyslipidemia of prediabetes, raised the possibility of the use of colesevelam therapy for both dyslipidemia and hyperglycemia of T2DM. This article reviews and summarizes the recent clinical studies regarding colesevelam as therapy for both diabetes and dyslipidemia. This dual mechanism of action is an attractive feature for the treatment of diabetes.