PMID- 30277094
OWN - NLM
STAT- MEDLINE
DCOM- 20200427
LR  - 20200427
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 35
IP  - 1
DP  - 2019 Jan
TI  - Long-term treatment with plecanatide was safe and tolerable in patients with 
      irritable bowel syndrome with constipation.
PG  - 81-85
LID - 10.1080/03007995.2018.1527303 [doi]
AB  - 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-naive 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.Trial registration: ClinicalTrials.gov 
      identifier: NCT02706483.
FAU - Barish, Charles F
AU  - Barish CF
AD  - Wake Gastroenterology/Wake Research Associates, Raleigh, NC, USA.
AD  - Department of Gastroenterology, UNC School of Medicine, Chapel Hill, NC, USA.
FAU - Crozier, Robert A
AU  - Crozier RA
AD  - Synergy Pharmaceuticals Inc., New York, NY, USA.
FAU - Griffin, Patrick H
AU  - Griffin PH
AD  - Synergy Pharmaceuticals Inc., New York, NY, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02706483
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20181009
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Natriuretic Peptides)
RN  - 7IK8Z952OK (plecanatide)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Constipation/*drug therapy
MH  - Diarrhea/chemically induced
MH  - Female
MH  - Humans
MH  - Irritable Bowel Syndrome/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Natriuretic Peptides/*administration & dosage
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Irritable bowel syndrome with constipation
OT  - Long-term
OT  - Plecanatide
OT  - Safety
OT  - Tolerability
EDAT- 2018/10/03 06:00
MHDA- 2020/04/28 06:00
CRDT- 2018/10/03 06:00
PHST- 2018/10/03 06:00 [pubmed]
PHST- 2020/04/28 06:00 [medline]
PHST- 2018/10/03 06:00 [entrez]
AID - 10.1080/03007995.2018.1527303 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2019 Jan;35(1):81-85. doi: 10.1080/03007995.2018.1527303. Epub 
      2018 Oct 9.