Summary

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• Linzess (linaclotide) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, the treatment of chronic idiopathic constipation (CIC) in adults, and the treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.
• This summary is based on the review of eight systematic reviews/meta-analyses. ^[1-8]
• Chronic Constipation (CC) and Chronic Idiopathic Constipation (CIC): Linaclotide was effective in treating CC and CIC, with a relative risk (RR) of 3.26 for CC and 2.26 for IBS-C in achieving the FDA-approved composite endpoint response (p < 0.00001). In Japanese patients, it increased spontaneous bowel movements (SBMs) within 1 week with a mean difference of 1.95 (95% CI: 1.51-2.39).
• Irritable Bowel Syndrome with Constipation (IBS-C): Linaclotide was superior to placebo in reducing abdominal bloating in IBS-C patients, with a RR of failure to achieve improvement in abdominal bloating of 0.78 (95% CI: 0.74-0.83).
• Comparative Effectiveness: Linaclotide showed similar efficacy to lubiprostone and elobixibat in treating CC and had a lower efficacy ranking than bisacodyl and prucalopride for increasing complete spontaneous bowel movements (CSBMs).
• The primary adverse reactions associated with linaclotide were gastrointestinal, with a significant incidence of diarrhea (RR = 3.56 for CC and RR = 8.23 for IBS-C, both p < 0.00001).
• Compared to other drugs, linaclotide had a higher risk of diarrhea, while lubiprostone was more associated with nausea, and elobixibat with abdominal pain.
• The reviewed evidence highlights that linaclotide is effective in both adults with Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C), including specific efficacy in Japanese populations. Although linaclotide is also indicated for functional constipation in pediatric patients aged 6 to 17 years, the reviewed studies did not specifically address this subgroup.