In two 12-week, phase III trials, this synthetic peptide significantly improved bowel and abdominal symptoms and reduced constipation severity.
Linaclotide is a synthetic peptide that activates the guanylate cyclase C receptor on the surface of intestinal epithelial cells, resulting in secretion of chloride and bicarbonate into the intestinal lumen, thereby accelerating transit. In two similar manufacturer-supported, multicenter, double-blind, phase III trials conducted in the U.S. and Canada, researchers evaluated the safety and efficacy of this agent in adults with chronic constipation.
In all, 1276 patients were randomized to receive linaclotide (145 µg or 290 µg) or placebo, once daily, at least 30 minutes before breakfast. The primary efficacy endpoint was defined as both a weekly frequency of ≥3 complete spontaneous bowel movements (CSBMs) and an increase of ≥1 CSBMs from base…
Reviewing Author
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)