Research Performed at Progressive Gastroenterology Leads to FDA Approval of Linzess (Linaclotide) for the Treatment of Irritable Bowel Syndrome and Chronic Constipation
Linzess (Linaclotide) has been shown to be safe and effective for the treatment of Constipation Predominant Irritable Bowel Syndrome (IBS-C) and Chronic Constipation (CC) in adults. The FDA has approved its use as the first cyclic GMP agonist. This new type of medication works locally in the intestine without any absorption into the bloodstream. By elevating C-GMP, Linzess increases intestinal transit, increases intestinal secretions, and decreases activity of pain sensors in the intestine. Because its effects are all local in the intestine, the medication does not create systemic side effects.
Dr. Gutman was a Principal Investigator in four multicenter trials of Linaclotide. The New York Heart Research Foundation with Clinical Research Director Patricia Hodnett, R.N., M.S.N., C.C.R.C. and Principal Investigator David M. Gutman, M.D., F.A.C.G. has been involved in numerous clinical trials in the field of Irritable Bowel Syndrome, leading to opportunities for patients to have significant symptom improvement, enhancement of quality of life, wellness, and achieve clinical breakthroughs. We are currently studying two agents for the treatment of Irritable Bowel Syndrome. Call (516) 739-4982 for more information on how you can participate and benefit from these research studies.
The data from the multicenter trials of Linaclotide in Chronic Constipation were published in the New England Journal of Medicine in August 2011. These studies showed a substantial improvement in spontaneous bowel movements, complete spontaneous bowel movements, straining, stool consistency, bloating and distension. Effects occurred within 24 hours and were sustained over time. The most common side effect was diarrhea. 4% of patients stopped the drug due to diarrhea.
The studies of Constipation predominant Irritable Bowel Syndrome will be published in the New England Journal of Medicine in October 2012. These studies showed patients with IBS-C had improvement in both complete spontaneous bowel movements and abdominal pain.
Long term safety was established by following over 3000 patients for up to 18 months. Linzess does not cure Irritable Bowel Syndrome. Patients returned to baseline status after withdrawal of the drug at the end of the trial.