Drug updated on 11/1/2024
| Dosage Form | Capsule (oral; 72 mcg, 145 mcg, 290 mcg) |
| Drug Class | Guanylate cyclase-C agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults
- Indicated for the treatment of chronic idiopathic constipation (CIC) in adults
- Indicated for the treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Chronic Constipation (CC) Treatment - Bowel Movement Frequency: Linaclotide demonstrated comparable efficacy to sodium picosulfate, velusetrag, elobixibat, lubiprostone, and prucalopride in increasing spontaneous bowel movements (SBMs: 2.5 to 4 per week; complete spontaneous bowel movements (CSBMs): 1 to 2.1 per week).
- IBS-C (irritable bowel syndrome with constipation) - Primary Outcome: Linaclotide showed the highest improvement in abdominal bloating among IBS-C patients, with a relative risk (RR) of failure to achieve improvement of 0.78 (95% CI (confidence interval) 0.74-0.83; NNT (number needed to treat) = 7; P-score 0.97). Lubiprostone, tenapanor, and tegaserod were effective but less so than linaclotide.
- Chronic Idiopathic Constipation (Overall Response): Linaclotide’s efficacy in failure to achieve one or more CSBM per week was similar to prucalopride, reflected by P-scores of 0.76 for linaclotide and 0.71 for prucalopride.
- Primary Safety Outcomes: Linaclotide was associated with the highest risk of diarrhea, lubiprostone with the highest risk of nausea, and elobixibat with the highest risk of abdominal pain.
- Chronic Idiopathic Constipation Adverse Events: Linaclotide had a safety profile comparable to other drugs, excluding bisacodyl, which had the highest total adverse events and greater incidence of abdominal pain.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Linzess (linaclotide) Prescribing Information. | 2023 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm | 2024 | BMC Gastroenterology |
| Systematic review and network meta-analysis: efficacy of licensed drugs for abdominal bloating in irritable bowel syndrome with constipation | 2021 | Alimentary Pharmacology & Therapeutics |
| Comparative Efficacy of Drugs for the Treatment of Chronic Constipation: Quantitative Information for Medication Guidelines | 2020 | Journal of Clinical Gastroenterology |
| Irritable bowel syndrome and functional constipation management with integrative medicine: A systematic review | 2019 | World Journal of Clinical Cases |
| Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis | 2019 | The Lancet. Gastroenterology & Hepatology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation | 2023 | Gastroenterology |
| 2022 Seoul consensus on clinical practice guidelines for functional constipation. | 2023 | Journal of Neurogastroenterology and Motility |
| AGA clinical practice guideline on the pharmacological management of irritable bowel syndrome with constipation. | 2022 | Gastroenterology |
| ACG Clinical Guideline: Management of Irritable Bowel Syndrome | 2021 | The American Journal of Gastroenterology |
| European society of neurogastroenterology and motility guidelines on functional constipation in adults. | 2020 | Neurogastroenterology and Motility |