References
- Spiegel BM, Bolus R, Agarwal N et al. Measuring symptoms in the irritable bowel syndrome: development of a framework for clinical trials. Aliment. Pharmacol. Ther. 32(10), 1275–1291 (2010).
- Spiegel B, Strickland A, Naliboff BD, Mayer EA, Chang L. Predictors of patient-assessed illness severity in irritable bowel syndrome. Am. J. Gastroenterol. 103(10), 2536–2543 (2008).
- Busby RW, Bryant AP, Bartolini WP et al. Linaclotide, through activation of guanylate cyclase C, acts locally in the gastrointestinal tract to elicit enhanced intestinal secretion and transit. Eur. J. Pharmacol. 649, 328–335 (2010).
- Eutamene H, Bradesi S, Larauche M et al. Guanylate cyclase C-mediated antinociceptive effects of linaclotide in rodent models of visceral pain. Neurogastroenterol. Motil. 22(3), 312–e84 (2010).
- Bryant AP, Busby RW, Bartolini WP et al. Linaclotide is a potent and selective guanylate cyclase C agonist that elicits pharmacological effects locally in the gastrointestinal tract. Life Sci. 86(19–20), 760–765 (2010).
- Castro J, Martin C, Hughes PA et al. A novel role of cyclic GMP in colonic sensory neurotransmission in healthy and TNBS-treated mice. Gastroenterology 140(Suppl. 5), S538 (2011).
- Lee N, Wald A. The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide. Expert Opin. Drug Metab. Toxicol. 7(5), 651–659 (2011).
- Kurtz CB, Fitch DA, Busby RW, Fretzen A, Geis S, Currie MG. Effects of multidose administration of MD-1100 on safety, tolerability, exposure, and pharmacodynamics in healthy subjects. Gastroenterology 130(Suppl.), Abstract 132 (2006).
- Andresen V, Camilleri M, Busciglio IA et al. Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome. Gastroenterology 133(3), 761–768 (2007).
- Johnston JM, Kurtz CB, Macdougall JE et al. Linaclotide improves abdominal pain and bowel habits in a Phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology 139(6), 1877–1886 (2010).
- Rao S, Lembo AJ, Shiff SJ et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am. J. Gastroenterol. 107, 1714–1724 (2012).
- Chey WD, Lembo AJ, Lavins BJ et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am. J. Gastroenterol. 107, 1702–1712 (2012).
- Quigley EMM, Tack J, Choi HS et al. Randomised clinical trials: linaclotide Phase 3 studies in IBS-C – a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment. Pharmacol. Ther. 37(1), 49–61 (2013).
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 94(2), 149–158 (2001).
- Schoenfeld PS, Chey WD, Lavins BJ et al. Linaclotide significantly improved abdominal pain compared with placebo in patients with irritable bowel syndrome regardless of baseline pain severity in two Phase 3 trials. Presented at: Digestive Disease Week (DDW). San Diego, CA, USA, 19–22 May 2012.
- Macdougall JE, MacKinnon DP, Lavins BJ et al. Mediation analysis supports a direct effect of linaclotide on relief of abdominal pain independent of constipation improvement. Presented at: Digestive Disease Week (DDW). San Diego, CA, USA, 19–22 May 2012.
- Chey WD, Quigley EMM, Lavins BJ et al. Effects of 26 weeks of linaclotide treatment on adequate relief and IBS. Presented at: Digestive Disease Week (DDW). San Diego, CA, USA, 19–22 May 2012.
- Hungin APS, Whorwell PJ, Tack J, Mearin F. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40,000 subjects. Aliment. Pharmacol. Ther. 17(5), 643–650 (2003).
- Akehurst RL, Brazier JE, Mathers N et al. Health-related quality of life and cost impact of irritable bowel syndrome in a UK primary care setting. Pharmacoeconomics 20(7), 455–462 (2002).
- Dibonaventura M, Sun SX, Bolge SC, Wagner JS, Mody R. Health-related quality of life, work productivity and health care resource use associated with constipation predominant irritable bowel syndrome. Curr. Med. Res. Opin. 27(11), 2213–2222 (2011).
- Hillila MT, Farkkila NJ, Farkkila MA. Societal costs for irritable bowel syndrome – a population based study. Scand. J. Gastroenterol. 45(5), 582–591 (2010).
- Longstreth GF, Wilson A, Knight K et al. Irritable bowel syndrome, health care use, and costs: a US managed care perspective. Am. J. Gastroenterol. 98(3), 600–607 (2003).
- Lembo A, Carson R, Shiff SJ et al. Factors contributing to treatment satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) treated with linaclotide vs placebo. Presented at: Digestive Disease Week (DDW). San Diego, CA, USA, 19–22 May 2012.
- Chey WD, Spiegel BM, Lavins BJ et al. The effect of comorbid psychological distress on baseline irritable bowel syndrome with constipation symptoms and response to linaclotide treatment. Presented at: Digestive Disease Week (DDW). San Diego, CA, USA, 19–22 May 2012.
Websites
- EMA, CHMP Assessment Report. EMA/CHMP/60979/2012, 1–133 (2012). www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002490/WC500135624.pdf
- US FDA. FDA approves Linzess™ to treat certain cases of irritable bowel syndrome and constipation. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317505.htm
- Almirall. Constella summary of product characteristics. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002490/WC500135622.pdf