"Lubiprostone a New Option for Treatment of Constipation: Presented at WCOG"
By Danny Kucharsky
MONTREAL, CANADA -- September 16, 2005 -- Lubiprostone 24 mcg twice daily is significantly more effective than placebo in providing relief from chronic idiopathic constipation, according to a phase 3 study presented here September 14[th at the World Congress of Gastroenterology (WCOG).
Researchers conducted the multicentre, randomised, placebo-controlled study at 20 sites in the United States and involving 242 subjects with constipation. Subjects were randomly assigned to receive either 24 mcg twice daily of lubiprostone or matching placebo twice daily for 4 weeks.
Lubiprostone is a novel chloride channel activator that enhances fluid secretion into the intestinal lumen, according to presenter Christopher Holland, PharmD, director of biostatistics and clinical data, Sucampo Pharmaceuticals Inc., Research and Development, Bethesda, Maryland, United States.
After the 4 weeks of treatment, patients underwent a 2-week follow-up period. Throughout the treatment and follow-up periods, patients documented bowel activity, bowel movement assessments, and rescue medication use.
An intent-to-treat analysis found a significant increase in spontaneous bowel movements in the lubiprostone group compared with the placebo group. The increased weekly spontaneous bowel movements with lubiprostone continued throughout the study, with frequencies ranging from 5.1 to 5.7 in the lubiprostone group compared with 2.8 to 3.5 in the placebo group (P < .0020 at all weeks).
Bowel movements occurred within a shorter time after the initial lubiprostone dose compared with placebo. Within 24 hours of the first dose, 57% of lubiprostone patients had a spontaneous bowel movement compared with 37% in the placebo group (P = .0024).
Patient global assessment of treatment effectiveness was significantly better in the lubiprostone group than in the placebo for the 4-week treatment period (P < .001 at all weeks).
There was 1 serious adverse event in the placebo treatment group. Nine patients in the lubiprostone group withdrew due to adverse events. The majority of adverse events were mild with nausea experienced by 31.7% of the 120 patients (P < .001) and headache by 11.7% in the lubiprostone group (P = .015).
The primary endpoint for the study was spontaneous bowel movements at week 1 and "we saw a statistically significant difference there," Dr. Holland said.
The study was previously presented at Digestive Disease Week 2003. The drug is now in prelaunch activities.
Support for the study was provided by Sucampo Pharmaceuticals. The company submitted a new drug application to the United States Food and Drug Administration (FDA) on March 31, 2005 to market the compound for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults.
[Presentation title: Phase III Efficacy and Safety of Lubiprostone, a Novel Chloride Channel Activator, for the Treatment of Constipation. Abstract R.0662]
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