Safety evaluation of colesevelam therapy to achieve glycemic and lipid goals in type 2 diabetes

• Published in: Expert opinion on drug safety Vol. 10; no. 2; p. 305
• Main Authors: Avitabile, Nicholas, Banka, Ajaz, Fonseca, Vivian A
• Format: Journal Article
• Language: English
• Published: England 01.03.2011
• Subjects: Adult; Allylamine - administration & dosage; Allylamine - adverse effects; Allylamine - analogs & derivatives; Allylamine - therapeutic use; Animals; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - therapeutic use; Colesevelam Hydrochloride; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Drug Therapy, Combination; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia - complications; Hypercholesterolemia - drug therapy; Randomized Controlled Trials as Topic
• ISSN: 1744-764X
• DOI: 10.1517/14740338.2011.548320

Patients with hypercholesterolemia and type 2 diabetes mellitus often require multiple medications to attain their LDL-C and A1C goals. Colesevelam, a bile acid sequestrant (BAS), which was FDA approved 10 years ago for the reduction of LDL-C in patients with dyslipidemia is also the only BAS that is approved for glycemic control in adults with type 2 diabetes to date. From both the physician and patient standpoint, safety and tolerability are the most important factors when considering initiating pharmacological therapy. Several randomized controlled studies have examined the safety, tolerability and efficacy of colesevelam over the last decade. This manuscript focuses on the safety and tolerability based on the evaluation of data obtained from several human randomized controlled studies. In addition, the pharmacology, pharmacodynamics and key clinical efficacy data are reviewed using research articles accessed through MEDLINE/PubMed (2000 - 2010). Current data suggest that colesevelam is safe, well tolerated and offers the potential for improved adherence. Colesevelam is a valid option for long-term therapy for patients with hypercholesterolemia and type 2 diabetes. It can be used in combination with HMG-CoA reductase inhibitors for hypercholesterolemia, not controlled at their cholesterol goals with HMG-CoA reductase inhibitors, and should be considered in patients with type 2 diabetes mellitus with concomitant hypercholesterolemia to improve both risk factors.