Abstract

Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation

Barish CF1,2, Crozier RA3, Griffin PH3. Curr Med Res Opin. 2018 Oct 9:1-5. doi: 10.1080/03007995.2018.1527303. [Epub ahead of print]
 
     

Author information

1 a Wake Gastroenterology/Wake Research Associates , Raleigh , NC , USA.

2 b Department of Gastroenterology , UNC School of Medicine , Chapel Hill , NC , USA.

3 c Synergy Pharmaceuticals Inc. , New York , NY , USA.

Abstract

OBJECTIVE: This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

METHODS: Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies. Safety was assessed by treatment-emergent adverse events (AEs). Patient-reported questionnaires assessed overall IBS symptoms, treatment satisfaction, and desire for treatment continuation. No dose adjustments or treatment interruptions were permitted during the study.

RESULTS: Of the 2272 patients enrolled, 1842 (81.1%) completed the study. AEs were experienced by 27.3%, and 4.3% discontinued due to an AE. Most AEs were mild or moderate (90.3%). The incidence of diarrhea, the most commonly reported AE, was low (6.7%), and declined in frequency over time. Diarrhea was the most common cause of AE-related withdrawals (2.7% of patients). At week 53 or end of treatment, 88.2% of patients reported "significant" or "moderate" relief, 72.4% were "very" or "quite" satisfied with treatment, and 76.6% were "very" or "quite" likely to continue treatment.

CONCLUSIONS: Plecanatide 6 mg was safe and well tolerated in patients with IBS-C treated for up to 53 weeks, with an overall safety profile similar to the 12-week IBS-C studies. Patients reported high rates of relief and satisfaction with treatment, and interest in continuing therapy.

© Copyright 2013-2019 GI Health Foundation. All rights reserved.
This site is maintained as an educational resource for US healthcare providers only. Use of this website is governed by the GIHF terms of use and privacy statement.