Colesevelam Hydrochloride and Gastrointestinal disorders

• Generic Name: colesevelam
• Dosage Forms: n.a.
• Other Brand Names: Welchol, Colesevelam Hydrochloride

Adjunct to dietary therapy and exercise to decrease elevated serum LDL-cholesterol concentrations in the management of primary hypercholesterolemia (Frederickson type IIa).

May be used alone or combined with a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (i.e., statin).

Effect of colesevelam (alone or in combination with a statin on cardiovascular morbidity and mortality not established.

Safety and efficacy of colesevelam for management of Fredrickson type I, III, IV, and V dyslipidemias not established.

ACC/AHA cholesterol management guideline states that nonstatin drugs (e.g., bile acid sequestrants) do not provide acceptable atherosclerotic cardiovascular disease (ASCVD) risk reduction benefits compared to their potential for adverse effects in the routine prevention of ASCVD. May be useful as adjuncts to statin therapy in high-risk patients (e.g., patients with ASCVD, LDL-cholesterol concentrations ≥190 mg/dL, or diabetes mellitus) who have a less-than-anticipated response to statins, are unable to tolerate even a less-than-recommended intensity of a statin, or are completely intolerant to statin therapy. Select nonstatin drug based on favorable benefit-risk ratio (i.e., demonstrated benefit of ASCVD risk reduction outweighs risks of adverse effects and drug interactions) and patient preferences.

Diabetes Mellitus

Used in combination with metformin, sulfonylurea, or insulin monotherapy or in combinations with these and other oral antidiabetic agents as an adjunct to diet and exercise for the management of type 2 diabetes mellitus.

Safety and efficacy as monotherapy or in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor not established in type 2 diabetes mellitus; has not been studied extensively in combination with thiazolidinediones.

Not effective as sole therapy for type 1 diabetes mellitus or diabetic ketoacidosis.