Editor's note: In March 2007, the FDA asked Novartis - the creator of Zelnorm - to pull the drug from the market because of evidence that increases the risk of heart attacks and spills. But in July 2007, the FDA decided that zelnorm can be used by some patients in critical drug need that has no cardiac problems.
(Atlanta) it seems that it has been all bad news lately for people with irritable bowel syndrome. LotRonex, the drug with so much hope, was voluntarily removed from the market in the last November after some patients experienced life-threatening side effects, and before the propulsid - that was connected to serious heart problems - it was unavailable in this past. But now, things are looking up. This week, researchers from the disease Digestive Week Conference here presented new discoveries that may mean relief to that in five Americans who suffer from pain, swelling, diarrhea and constipation of IBS. according to Martin Lefkowitz, MD, "There is no proven effective therapy for the group of patients with IBS with abdominal pain, swelling and constipation." But within a week of being in a new drug called Zelnorm: "These patients had significantly less discomfort and improved quality of life," he says.
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After a four-week observation period, the Lefkowitz team 'randomly assigned more than 1,500 volunteers with IBS to a 12-week zelnorm course or placebo twice daily. All women had moderate to severe abdominal pain and three or more intestinal movements per week, usually with effort. zelnorm "stimulates the motility or movement of the digestive tract, stimulates intestinal secretions, and inhibits visceral sensitivity or pain perception," says Lefkowitz. He is director of clinical research in Zelnorm manufacturer of Novartis Pharmaceuticals Corporation in East Hanover, N.j. The new drug works by imitating the effects of the natural chemical called serotonin, says Lefkowitz. LotRonex, in contrast, did essentially the opposite. Inhibited serotonin action and was recommended for IBS patients whose primary claim is diarrhea. considerably more patients in the zelnorm group than in the placebo group reported complete or considerable relief of IBS symptoms and a significant increase in its general sense of well-being. "Zelnorm twice a day results in rapid improvement of multiple IBS symptoms," and the effect lasted while they continued the medication, he tells WebMD. So far, an extensive research did not reveal worse side effects with the drug. The most common problems have been headache and nausea. "There was an increase of twice in diarrhea at about 6% of those who took zelnorm, but solved by themselves, did not cause dehydration, and most patients were able to continue in the study," says Lefkowitz. Even so, it warns that anyone whose IBS symptoms include diarrhea should not take the drug. Zelnorm is currently under the FDA review with the expected approval for summer, says Lefkowitz. help is also on the way to those who suffer mainly with diarrhea. A new drug, Cilansetron, is now in the final stages of the clinical trial, and the approval is just around the corner, says researcher IBS Michael Camilleri, MD, Professor of Medicine and Physiology at Mayo Clinic in Rochester, Minn. This drug falls in the same serotonin inhibitory class as the now extinct drugs, he says. and in other medicines, researchers are trying to modulate pain messaging, and a compound known only as a particular substance. "P means pain," says Camilleri, "and the theory is that in IBS, something went wrong with the transmission of intestine pain signs for the brain." These new compounds will try short circuit for defective signs, it explains it.
Even with these new promising drugs on the horizon, there will probably be "some patients with IBS who do not respond to any treatment available," says researcher Francis Creed, MD, of Manchester University in England. "About 50% of them have depression or anxiety, as well as their symptoms of IBS." Creed team has specifically looked in this most difficult group to treat, randomly assigning eight weeks of standard medical treatment of a gastroenterologist, eight weeks of Prozac, or eight weeks of session individual psychotherapy. They followed patients for a whole year after treatment. General, psychotherapy was more effective than Prozac, and ProZac was more effective than standard medical treatment to improve overall quality of life. Curiously, although one-on-one counseling was more expensive in the short term, it was less expensive in the long run due to less medical visits, drug prescriptions and loss of working time, says Creed. "Psychotherapy really worked on about two-thirds of these patients," he says. This was true, regardless of the specific symptoms of the patient's IBS, and especially for those patients with a history of childhood abuse. More importantly, says Creed, "patients in the psychotherapy group reported significant improvement in their quality of life, even if the symptoms of IBS did not change. They still had pain," he says. "But they were better able to handle it." He advises all patients with IBS who are experiencing depression or anxiety, as well as their physical symptoms to seek advice.
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