Effectiveness and tolerability of colesevelam hydrochloride for bile-acid malabsorption in patients with cancer: a retrospective chart review and patient questionnaire.

BACKGROUND: Commercially available bile-acid sequestrants are not well tolerated by >80% of patients.
OBJECTIVE: The aim of the present study was to assess the effectiveness and tolerability of colesevelam hydrochloride in patients who developed bile-acid malabsorption after cancer therapy.
METHODS: The present study comprised 2 parts: a retrospective chart review of the electronic patient records and a patient questionnaire assessing outcome measures. All patients included in this study had a diagnosis of cancer and were being followed up in a cancer clinic at The Royal Marsden Hospital. In addition, all had symptoms of bile-acid malabsorption for >3 months and had been prescribed colesevelam in the gastroenterology clinic at the hospital. The electronic records of patients who were prescribed colesevelam between 2004 and 2007 were obtained from the hospital pharmacy. Those patients who were prescribed colesevelam and did not take any of the prescribed medication or did not return for a follow-up clinical review were excluded. To help further assess outcomes, a questionnaire was mailed to patients who were still residing in the United Kingdom, were not terminally ill, and were not lost to follow-up. The questionnaire comprised questions that assessed medication history (ie, whether patients were still taking colesevelam or not [and the reason for not taking colesevelam]), dosage, effectiveness for symptom relief, and adverse events.
RESULTS: In total, 45 patients (37 women and 8 men; median age, 58 years [range, 32-89 years]) who received treatment with colesevelam between 2004 and 2007 were included. Of these, 36 were sent a questionnaire and 30 responded. Identifiable causes of bile acid malabsorption in this sample population were pelvic radiotherapy (n = 29), small-bowel resection (12), upper gastrointestinal surgery (2), high-dose chemotherapy (1), and new-onset Crohn's disease (1). Of these patients, 67% (30/45) had not previously responded to cholestyramine treatment, but following treatment with colesevelam, this group had a recorded improvement in: diarrhea, 83% (25/30); urgency of defecation, 74% (20/27); frequency of defecation, 72% (21/29); steatorrhea, 71% (12/17); abdominal pain, 68% (15/22); and fecal incontinence, 62% (13/21). Based on the medical chart review and the patient questionnaire, after colesevelam treatment, the following proportions of all 45 patients studied experienced improvement in symptoms: loose stool (diarrhea), 88% (medical chart) and 80% (questionnaire); frequency of defecation, 77% and 83%, respectively; steatorrhea, 76% and 80%; urgency of defecation, 76% and 80%; abdominal pain, 74% and 58%; and fecal incontinence, 69% and 74%. During the study period, 15 patients discontinued colesevelam: ineffectiveness, 5; adverse events, 5 (because >or=1 of the following: bloating, constipation, heartburn, abdominal pain, flatulence, or perianal soreness); and other reasons, 7 (too many tablets or tablets difficult to swallow [3]; symptoms resolved [2]; colesevelam replaced with another medication [1]; and lost to follow-up [1]). Sixty-seven percent (30/45) of patients continued using colesevelam for up to 4 years.
CONCLUSION: In view of the data found in this retrospective chart review and patient questionnaire, prospective, double-blind, placebo-controlled trials of colesevelam for bile acid malabsorption are warranted. Copyright 2009 Excerpta Medica Inc. All rights reserved.