Colesevelam effective in the treatment of bile acid Diarrhea: Lancet

Colesevelam outperformed placebo in causing remission of bile acid diarrhea with a Plasma 7a-hydroxy-4-cholesten-3-one (C4) concentration greater than 46 ng/mL, says an article published in The Lancet Gastroenterology & Hepatology.

Bile acid diarrhea is a prevalent yet underappreciated cause of prolonged watery diarrhea. The plasma 7-hydroxy-4-cholesten-3-one test can be used instead of the gold standard tauroselcholic [75Se] acid (SeHCAT) test. Sequestrant therapy, including colesevelam, is supported by evidence of low confidence. As a result, Christian Borup and his colleagues undertook this trial to assess the effectiveness and safety of colesevelam in bile acid diarrhea.

Consecutive patients aged 18-79 years were included in this randomized, placebo-controlled, double-blind, investigator-initiated phase 4 study of the sequestrant colesevelam in bile acid diarrhea (SINBAD) at four Danish secondary care facilities. Participants were randomly assigned to either colesevelam (overencapsulated tablets of 625 mg) or placebo for 12 days, with a starting dosage of two capsules twice daily titrated to effect over the first 5 days of therapy. Using block randomization, a pharmacist independent of the trial investigators developed a randomization list on the website randomization.com. During therapy, the C4 and SeHCAT test findings were kept hidden. Diarrhea was treated in all patients, with a daily mean of 30 or more bowel movements or 10 or more watery stool movements. On therapy days 6-12, remission was defined as the absence of both of these criteria. The primary outcome was the incidence of remission in patients with bile acid diarrhea identified by a C4 concentration more than 46 ng/mL. The intention-to-treat remission rate in bile acid diarrhea identified by SeHCAT retention of 10% or less was a secondary outcome.