Linzess New Drug For Irritable Bowel Syndrome And Chronic Constipation Treatment Approved By FDA

Linzess New Drug For Irritable Bowel Syndrome And Chronic Constipation Treatment Approved By FDA

FDA approved Linaclotide (Linzess),  a peptide agonist of guanylate cyclase 2C as one-daily treatment for adults with chronic idiopathic constipation and irritable bowel syndrome.

Researchers assessed linaclotide for both the treatment of irritable bowel syndrome and chronic idiopathic constipation  treatment. In order to establish the safety and effectiveness of Linzess, researchers conducted 2 double-blind studies (in which both the participants and researchers are unaware of whether the participant is receiving the drug or a placebo) for management of irritable bowel syndrome and chronic idiopathic constipation. In the first clinical trial were included 1604 patients, randomized to receive either linaclotide or placebo for a period of 12 weeks. Study results showed that patients who received linaclotide had fewer abdominal pain. In the second clinical trial were included 1272 patients that were randomly assigned to take Linzess at doses of 145 mcg or 290 mcg or a placebo for a period of 12 weeks. The results of this study showed that linaclotide in doses of 145 mcg was more effective than doses of 290 mcg or placebo for the treatment of chronic idiopathic constipation.

Dyspepsia (or functional gastrointestinal disease) refers to upper abdominal pain, heartburn, nausea, vomiting or discomfort that lasts for more than 3 months. Rome Consensus classified this disease into several categories: functional esophageal disorders, peptic functional disorders, functional bowel syndrome, functional anorectal disorders and abdominal pain due to functional cause.

Irritable Bowel Syndrome

Functional gastrointestinal disease is manifested by pain or other gastrointestinal symptoms with no apparent cause (paraclinical explorations can not reveal the presence of organic lesions). Therefore, the diagnosis of functional disease is one of exclusion that is established after the patient was investigated for other gastrointestinal disorders. Pathogenesis of these diseases remains unclear although several theories have been proposed. There seems to be a genetic predisposition that causes functional diseases such as irritable bowel syndrome. It is believed that environmental factors, emotions and stress are involved in the pathogenesis of this diseases. There seems to be a change in the threshold of pain perception in patients with irritable bowel and abdominal pain due to functional cause. Motility disorders, disorders of vagal nerves regulation are other mechanisms proposed to explain functional bowel diseases. Functional gastrointestinal diseases, such as irritable bowel syndrome are difficult to treat because there is no known cause that underpin these symptoms.

Irritable bowel syndrome is characterized by chronic abdominal pain, discomfort, bloating and disturbed defecation. In irritable bowel syndrome may predominate constipation or diarrhea. Although there is no cure for this disease, many treatments have been proposed. The treatment of irritable bowel syndrome is generally difficult and the results are often not the expected. Being a functional pathology, the mental component is important, so the role of psychological balancing is also important. Diet may helpful in cases were constipation is the predominant symptom and should include foods that are tolerated by patient and with an increased fiber content.

Drugs such as antacids and gastric secretion inhibitors may be helpful in the treatment of irritable bowel syndrome. Histamine receptor antagonists (ranitidine, famotidine) or proton pump inhibitors (omeprazole) reduce gastric acidity and can relieve heartburn.

Prokinetics (metoclopramide, domperidone) are useful in digestive motility disorders. Prokinetics stimulate gastrointestinal motility which eases pain from chronic constipation. Laxatives and antidiarrheal can be used in cases of irritable bowel syndrome were constipation or diarrhea are the predominate symptom.