Real Help for Irritable Bowel Syndrome
Editor's Note: In March 2007 the FDA asked Novartis -- the maker of Zelnorm -- to pull the drug from the market because of evidence that it raises the risk of heart attacks and stroke. But in July 2007 the FDA ruled that Zelnorm may be used by some patients in critical need of the drug who do not have heart problems.
May 23, 2001 (Atlanta) -- It seems it's been all bad news lately for people with irritable bowel syndrome. Lotronex, the drug with so much hope, was voluntarily removed from the market this past November after some patients experienced life-threatening side effects, and before that Propulsid -- which was linked to serious heart problems -- became unavailable this past July. But now, things are looking up.
This week, researchers at the Digestive Disease Week conference here presented new findings that could mean relief for the one in five Americans suffering from the pain, bloating, diarrhea, and constipation of IBS.
According to Martin Lefkowitz, MD, "there is no proven effective therapy for the group of IBS patients with abdominal pain, bloating, and constipation." But within a week of being on a new drug called Zelnorm, "these patients had significantly less discomfort and improved quality of life," he says.
After a four-week observational period, Lefkowitz' team randomly assigned more than 1,500 female volunteers with IBS to a 12-week course of twice-daily Zelnorm or placebo. The women all had moderate to severe abdominal pain and three or more bowel movements per week, usually with straining.
Zelnorm "stimulates motility or movement of the digestive tract, stimulates intestinal secretions, and inhibits visceral sensitivity or the perception of pain," says Lefkowitz. He is director of clinical research at Zelnorm manufacturer Novartis Pharmaceuticals Corporation, in East Hanover, N.J.
The new drug works by mimicking the effects of the naturally occurring chemical called serotonin, says Lefkowitz. Lotronex, in contrast, did essentially the opposite. It inhibited the action of serotonin and was recommended for IBS patients whose primary complaint is diarrhea.
Considerably more patients in the Zelnorm group than in the placebo group reported complete or considerable relief from IBS symptoms, and a significant increase in their overall sense of well-being. "Zelnorm twice a day results in rapid improvement of multiple IBS symptoms," and the effect lasted as long as they continued the medication, he tells WebMD.