Linzess Helps Those with Irritable Bowel Syndrom in Trials
Two studies show that Linzess® helps reduce abdominal pain and constipation
According to the American Journal of Gastroenterology, the results of studies that were published online on September 18, 2012 aided in facilitating the approval of Linzess by the U.S. Food and Drug Administration (FDA) in August, 2012. The two trials were funded by two pharmaceutical companies that produce the drug, namely Ironwood Pharmaceuticals, Inc. and Forest Research Institute.
Only 2 other drugs are available to treat this disorder
Before Linzess was approved, doctors had only two drugs to choose from to treat Irritable Bowel Syndrome (IBS) in their patients. The studies had over 800 adults who were mostly women. Test subjects received a dose of Linzess or a placebo one time each day for six months. Patients said that their abdominal pain was improved by 30% or more. They also reported having an increase of at least one bowel movement weekly for up to three months.
FDA-specified results were met by test subjects/h3>
The FDA required that test subjects needed to have at least a 30% improvement in symptoms of IBS, such as reduced abdominal pain and increased bowel movements to approve the drug. Around 33% of the people in the first study who were taking Linzess reported improvements in their condition, but only 14% of those who were taking placebos had improvements.
Other results of the first study
Test subjects said that they had 43% less abdominal pain when the treatment was over. Cramps and bloating were also reduced. It was noted that improvements began very soon after starting Linzess treatment.
Second trial also showed that Linzess helped IBS
The second trial involving Linzess involved 800 patients who were given either Linzess or a placebo for 3 months. Again around 33% of them said that their pain and constipation improved. The placebo group reported an improvement of 21%. When patients were switched from Linzess to a placebo at a later time, symptoms returned.
Side effects of Linzess
Diarrhea was found to be the main side effect of the drug used in the trials. It is thought to stimulate chloride and water in the intestine to soften stool and lead to bowel movements. Dr. Timothy Pfanner, gastroenterologist and assistant professor of internal medicine at Texas A & M Health Science Center College of Medicine noted that Linzess works in a different way than other drugs available for IBS. He commented that the drug works on nerve receptors and stimulates them to stop pain, reduce bloating, and increase motility.