Table 2

Summary of AEs associated with colesevelam in patients with type 2 diabetes

StudynDuration (weeks)Background therapyTreatmentAEs
Bays et al. (17)31626Metformin-based therapyColesevelam 3.75 g/day (n = 159); placebo (n = 157)•Eight patients receiving colesevelam (four receiving placebo) withdrew because of AEs; of the AEs in the colesevelam group, six were considered drug-related.
•Constipation was the most common drug-related AE with colesevelam.
•No weight gain occurred with colesevelam.
•One patient reported (mild) hypoglycemia with colesevelam.
Fonseca et al. (18)46126Sulfonylurea-based therapyColesevelam 3.75 g/day (n = 230); placebo (n = 231)•Eighteen patients receiving colesevelam (nine receiving placebo) withdrew because of AEs. 
•Constipation was the most common drug-related AE in both treatment groups. 
•No weight gain occurred with colesevelam. 
•Six patients receiving colesevelam (two receiving placebo) reported hypoglycemia.
Goldberg et al. (19,26)28716Insulin-based therapyColesevelam 3.75 g/day (n = 147); placebo (n = 140)•Five patients receiving colesevelam (two receiving placebo) withdrew because of AEs. 
•Constipation, dyspepsia, hypoglycemia, flatulence, and nausea were the most common drug-related AEs with colesevelam. 
•No weight gain occurred with colesevelam. 
•Nine patients receiving colesevelam (eleven receiving placebo) reported hypoglycemia.
Goldfine et al. (25)50952Metformin-, sulfonylurea-, or insulin-based therapyColesevelam 3.75 g/day (n = 509)•Thirty-five patients receiving colesevelam withdrew because of AEs. 
•Constipation and flatulence were the most common drug-related AEs. 
•No weight gain occurred with colesevelam. 
•Seventeen patients reported hypoglycemia (one episode of severe hypoglycemia).
Rigby et al. (42)16916Metformin monotherapyColesevelam 3.75 g/day (n = 57); rosiglitazone 4 mg/day (n = 56); sitagliptin 100 mg/day (n = 56)•Three patients receiving colesevelam withdrew because of AEs. 
•Eighteen patients receiving colesevelam reported drug-related AEs; the most common were gastrointestinal in nature. 
•No weight gain occurred with colesevelam.