Schoenfeld P et al. – This study evaluating the efficacy and safety of low–dose linaclotide (72 μg) in patients with chronic idiopathic constipation (CIC) concluded that it significantly improved CIC symptoms in both male and female patients and discontinuation rate due to diarrhea was low over 12 weeks of treatment.

Methods

• The double–blind, placebo–controlled study randomized 1223 patients with CIC to receive either once–daily linaclotide 72 or 145μg, or placebo over a period of 12 weeks.
• The primary efficacy endpoint was the 12–week complete spontaneous bowel movement (CSBM) overall responder (a patient who had ≥3 CSBMs and an increase of ≥1 CSBM per week from baseline in the same week for ≥9 of the 12 weeks of the treatment period).

Results

• Significantly more patients met the primary endpoint with linaclotide 72 and 145 μg patients compared with placebo (13.4% and 12.4% vs 4.7%, respectively).
• Significantly more patients achieved sustained response with linaclotide 72 and 145μg compared with placebo (12.4% and 11.4% vs 4.2%, respectively).
• Diarrhea, which was the most common adverse event, was mild in nature in most cases and resulted in discontinuation of 0, 2.4%, and 3.2% of patients in placebo, 72 and 145 μg linaclotide groups, respectively.