PMID- 33206011
OWN - NLM
STAT- MEDLINE
DCOM- 20211029
LR  - 20211029
IS  - 1747-4132 (Electronic)
IS  - 1747-4124 (Linking)
VI  - 15
IP  - 3
DP  - 2021 Mar
TI  - Open-label study to evaluate the treatment continuation rate after a dose 
      reduction of lubiprostone due to onset of adverse events.
PG  - 333-342
LID - 10.1080/17474124.2021.1833714 [doi]
AB  - OBJECTIVE: To investigate the continuation rate with a reduced lubiprostone dose 
      (12 mcg twice daily, BD) after the onset of adverse events (AEs) in patients with 
      chronic constipation (CC). METHODS: In this exploratory, open-label, multicenter 
      study, patients with CC received lubiprostone 24 mcg BD and the dose was reduced 
      to 12 mcg BD in subjects experiencing AEs. The primary objective was the 
      continuation rate after dose reduction due to nausea/vomiting. Secondary 
      objectives included the continuation rate after dose reduction due to 
      diarrhea/any AE and efficacy, including changes in number of weekly bowel 
      movements and Bristol Stool Form Scale. RESULTS: Of the 146 patients included in 
      the study, 42 (28.8%) received lubiprostone 12 mcg BD (dose-reduced group) due to 
      any AE. Thirty-six (85.7%) subjects in the dose-reduced group continued treatment 
      and completed the study. 22/27 (81.5%) and 17/19 (89.5%) patients in whom the 
      dose was reduced due to nausea/vomiting or diarrhea, respectively, continued 
      treatment. There was no clinically relevant difference in efficacy after dose 
      reduction. CONCLUSION: These results suggest that treatment withdrawal due to AEs 
      associated with lubiprostone 24 mcg BD could be minimized in patients with CC 
      after dose reduction to 12 mcg BD, thus resulting in improved long-term outcomes. 
      CLINICAL TRIAL REGISTRATION: Japan Registry of Clinical Trials 
      (https://jrct.niph.go.jp/latest-detail/jRCTs031180069).
FAU - Ohbayashi, Hiroyuki
AU  - Ohbayashi H
AD  - Department of Allergy and Respiratory Medicine, Tohno-Chuo Clinic , Mizunami, 
      Gifu, Japan.
FAU - Sato, Yasuo
AU  - Sato Y
AD  - Department of Gastroenterology, Sato Clinic , Shibuya- ku, Tokyo, Japan.
FAU - Kiuchi, Mari
AU  - Kiuchi M
AD  - Department of Internal Medicine, Kanauchi Medical Clinic , Shinjuku- ku, Tokyo, 
      Japan.
FAU - Asano, Takamitsu
AU  - Asano T
AD  - Department of Allergy and Respiratory Medicine, Tohno-Chuo Clinic , Mizunami, 
      Gifu, Japan.
FAU - Nagazumi, Atsushi
AU  - Nagazumi A
AD  - Department of Internal Medicine, Kanauchi Medical Clinic , Shinjuku- ku, Tokyo, 
      Japan.
FAU - Kimura, Takazumi
AU  - Kimura T
AD  - Department of Gastroenterology, Kimuranaika-ichonaika , Yokohama, Kanagawa, 
      Japan.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20201118
PL  - England
TA  - Expert Rev Gastroenterol Hepatol
JT  - Expert review of gastroenterology & hepatology
JID - 101278199
RN  - 0 (Chloride Channel Agonists)
RN  - 7662KG2R6K (Lubiprostone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Chloride Channel Agonists/*adverse effects/therapeutic use
MH  - Chronic Disease
MH  - Constipation/*drug therapy
MH  - Diarrhea/chemically induced
MH  - Drug Tapering
MH  - Female
MH  - Humans
MH  - Lubiprostone/*adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Vomiting/chemically induced
MH  - Withholding Treatment
OTO - NOTNLM
OT  - Lubiprostone
OT  - adverse events
OT  - chronic constipation
OT  - nausea
OT  - vomiting
EDAT- 2020/11/19 06:00
MHDA- 2021/10/30 06:00
CRDT- 2020/11/18 12:11
PHST- 2020/11/19 06:00 [pubmed]
PHST- 2021/10/30 06:00 [medline]
PHST- 2020/11/18 12:11 [entrez]
AID - 10.1080/17474124.2021.1833714 [doi]
PST - ppublish
SO  - Expert Rev Gastroenterol Hepatol. 2021 Mar;15(3):333-342. doi: 
      10.1080/17474124.2021.1833714. Epub 2020 Nov 18.