A study, published in The American Journal of Gastroenterology, examined the efficacy and safety of linaclotide for patients with chronic idiopathic constipation.
Philip Schoenfeld, MD, of Detroit-based John D. Dingell Veterans Administration Medical Center, and colleagues conducted a double-blind, placebo-controlled randomized trial of 1,223 CIC patients. The patients received either a once-daily 72-μg or 145-μg dose of linaclotide or a placebo for 12 weeks.
Researchers measured complete spontaneous bowel movement overall response rate. Patients were required to have more than or equal to 3 CSBMs or an increase of 1 CSBM for at least 75 percent of the treatment period. Secondary endpoints included change in baseline from bowel and abdominal symptoms.
Here's what they found:
1. Approximately 13.4 percent of linaclotide 72-μg patients met the primary endpoint versus 4.7 percent of placebo patients.
2. A sustained response was achieved by 12.4 percent of linaclotide 72-μg patients and 4.2 percent of placebo patients.
3. Linaclotide 72-μg patients met 90 percent of the study's secondary endpoints.
4. Exactly 12.4 percent of linaclotide 145 μg patients also experienced improved CIC and 11.4 percent sustained that response.
5. The most common adverse event was mild diarrhea.
Researchers concluded, "Once-daily linaclotide 72 μg significantly improved CIC symptoms in both men and women with a low rate of discontinuation due to diarrhea over 12 weeks of treatment."