Randomized trial of loperamide versus dose escalation of octreotide acetate for chemotherapy‐induced diarrhea in bone marrow transplant and leukemia patients

Abstract

This study compares maximal daily doses of loperamide to escalating doses of continuous intravenous (CI) octreotide acetate in bone marrow transplant (BMT) and leukemia patients. Following chemotherapy, BMT and leukemia patients who developed > or = 600 ml of stool volume in a 24-hr period were randomized to receive loperamide 4 mg po q6h or octreotide 150 micrograms mixed in hyperalimentation solution or normal saline and administered CI. Patients were assessed at 48 hr intervals for decrease in stool volume from baseline. Complete response (CR) was defined as > or = 50% from baseline stool volume (BSV). Patients receiving octreotide who did not achieve a CR at 48 hr were dose escalated by doubling the dose to a maximum of 2,400 micrograms with evaluations at 48 hr intervals. Patients receiving loperamide who did not achieve a CR at 48 hr had treatment discontinued. A total of 36 patients were enrolled in the study. Of these, all were evaluable for intention to treat, and 31 were evaluable for initial response. Based on intent to treat at the initial 48 hr, patients receiving loperamide had a higher complete response rate (86% vs. 45%, P = 0.033) than did those who received octreotide. By treatment analysis (patients who actually received the drug), patients receiving loperamide had a higher complete response rate (92% vs. 56%, P = 0.0448) than did those who received octreotide at the 150 micrograms dosage level. Additional octreotide patients eventually achieved a CR at a higher dosage level (78%). Loperamide at maximal doses of 4 mg po q6h is more effective than octreotide 150 micrograms CI in treating diarrhea following chemotherapy in BMT and leukemia patients. Higher doses of octreotide may be required in a significant number of patients not responding to lower doses.

The Palliative Effects of Octreotide in Cancer Patients

“…If conventional measures such as use of opioids and drugs such as loperamide fail, then it is my view that octreotide is certainly worth a trial. Some sources suggest that loperamide is at least as effective as low dose octreotide (150 Ìg/day) [44]. In my experience doses from 300-600 Ìg daily are usually effective in controlling difficult diarrheal states.…”

Control of irinotecan-induced diarrhea by octreotide after loperamide failure

“…Octreotide given in various doses was more effective than loperamide given in standard doses in the control of diarrhea [9,10,11]. However, loperamide has been shown to be superior to octreotide by continuous intravenous infusion given in the hyperalimentation solution.…”

Systematic review: the use of somatostatin or octreotide in refractory diarrhoea

“…The results of our search disclosed a total of 30 publications containing at least five patients each 11–42 . Of these, 18 were case series with a total of 324 patients 11–28 .…”