Two Drugs May Help Crohn's Disease, IBS Patients
Lubiprostone and teduglutide studied in patients with bowel symptoms
TUESDAY, May 23 (HealthDay News) -- Lubiprostone (Amitiza), a drug approved in January 2006 for chronic constipation, may be helpful for patients with irritable bowel syndrome, and teduglutide, a naturally occurring hormone under study that regulates the growth and maintenance of cells lining the gastrointestinal tract, seems to help Crohn's disease patients, according to two studies reported Monday at the annual Digestive Disease Week meeting in Los Angeles.
John F. Johanson, M.D., of Rockford Gastroenterology Associates in Illinois, randomized about 50 patients each to one of four groups in a phase II study: placebo or 16, 32 or 48 micrograms of lubiprostone daily. After one month, the decline in abdominal discomfort from baseline on a five-point scale was 0.19 for placebo and 0.45, 0.40 and 0.46 for the drug-treated groups, respectively. By the third month, the decreases were 0.34, 0.56, 0.59 and 0.53, respectively.
Improvements were found in all those who took the drug and the highest dose produced the most relief. "The 48 microgram dose showed the most effectiveness, but also the most side effects," Johanson said. "Sixteen micrograms gave the best balance."
In the second study, Alan Buchman, M.D., of Northwestern University in Chicago, conducted a study of 100 patients and found a remission rate of 56 percent in patients on the highest dose (0.20 milligrams per kilograms per day) of teduglutide after eight weeks. Patients injected themselves daily with that dose or lower doses: 0.10 and 0.05 mg/kg, or placebo. Crohn's disease remission rates are usually less than 40 percent in most clinical trials.
"These data note that use of teduglutide was safe and effective to induce remission of moderate to severe Crohn's disease as early as two weeks into therapy," Buchman said.