This article is more than 5 years old. Information may no longer be current.
Lubiprostone safe, effective in patients with opioid-induced bowel dysfunction
Click Here to Manage Email Alerts
LAS VEGAS — Patients with opioid-induced bowel dysfunction experiencing chronic, non-cancer pain reported few and mild side effects when treated with lubiprostone during a 9-month period, according to data presented at the 2012 American College of Gastroenterology Annual Scientific Meeting.
In an open-label, phase-3 clinical trial, researchers evaluated 439 patients with opioid-induced bowel dysfunction (OBD) who received 24 mcg lubiprostone (Amitiza, Sucampo Pharmaceuticals) twice a day for up to 9 months. OBD was defined as a mean of three or fewer spontaneous bowel movements per week, with hard to very hard stool consistency in 25% or more bowel movements causing a feeling of incomplete evacuation and/or moderate-to-severe straining. All participants had previously been enrolled in prior placebo-controlled, double blind lubiprostone studies.
Adverse events related to treatment occurred in 24.6% of patients, with nausea (5.0% of cases), diarrhea (4.6%) and headache (1.6%) most commonly reported. Nausea and diarrhea each caused five patients to withdraw from the study, with two cases of each event considered severe. No serious adverse events occurred within the cohort.
SBM frequency increased from a mean of 1.4 per week to between 4.9 and 5.3 per week over the course of the study (P<.001 for difference at all months). Participants indicated improvements to irregularity, stool consistency, straining, feelings of abdominal bloating and discomfort and severity of constipation compared with baseline (P<.001 for all treated months). Investigators also noted that reliance on rescue medication declined from 33.0% of cases in the first month to 18.6% at 9 months.
“Lubiprostone at 25 mg twice a day in patients with OBD is well-tolerated over a period of 9 months,” researcher Egilius L. Spierings, MD, PhD, director and principal inspector of MedVadis Research Corp. in Watertown, MA, told Healio.com. “Nausea is a side-effect that is quite common with this particular medication, but we found that to occur in only about 5% of patients, and in only a quarter of them was that a reason to discontinue the medication. Diarrhea, in the same way, [occurred in] about 5%, and only in a quarter of patients was it bad enough to cause discontinuation.”
Disclosure: Investigators received grant money from Sucampo to conduct the study. Researchers Elizabeth Lindner, Fasil Woldegeorgis and Taryn Joswick are employees of Sucampo. Spierings serves as a consultant and advisory committee/board member for Sucampo, and researcher Ryuji Ueno is an employee and patent holder with the company, and also reports stockholder/ownership interest.
For more information:
Spierings EL. P1259: Long-term Safety and Efficacy of Lubiprostone in Opioid-induced Bowel Dysfunction in Patients with Chronic, Non-Cancer Pain: Results of a Phase 3, Open-label Clinical Trial. Presented at: the 2012 American College of Gastroenterology Annual Scientific Meeting; Oct. 19-24, Las Vegas.