PMID- 35993999 OWN - NLM STAT- MEDLINE DCOM- 20220907 LR - 20220907 IS - 1747-4132 (Electronic) IS - 1747-4124 (Linking) VI - 16 IP - 8 DP - 2022 Aug TI - Analysis of the impact on efficacy of lubiprostone dose reduction to manage adverse events in the treatment of chronic constipation in Japan. PG - 809-817 LID - 10.1080/17474124.2022.2114455 [doi] AB - OBJECTIVE: To compare outcomes between two doses of lubiprostone in patients with chronic constipation (CC), to assess whether dose reduction affects efficacy. METHODS: This open-label exploratory study involved 146 patients with CC treated initially with lubiprostone 24 mcg twice daily for a planned duration of 4 weeks. Patients who experienced adverse events (AEs) had their dose reduced to 12 mcg twice daily (for 4 weeks). RESULTS: Lubiprostone dose was unchanged in 104 patients and reduced due to AEs in 42 patients. Significant differences in the mean number of bowel movements per week favored the dose-reduced group at Week 1 and end of follow-up. No between-group differences were observed over time for mean number of days per week with bowel movements or mean Bristol Stool Form Scale scores. Symptoms of abdominal bloating, strained defecation, and sensation of incomplete evacuation improved in both groups. Before dose reduction, nausea was reported by 64.3% and diarrhea by 45.2% of patients in the dose-reduced group; after dose reduction, no patients reported nausea and one patient reported diarrhea. CONCLUSION: Dose reduction of lubiprostone reduced the incidence of AEs, with no compromise to efficacy, and may be a suitable approach for patients who develop AEs during treatment. FAU - Ohbayashi, Hiroyuki AU - Ohbayashi H AD - Department of Allergy and Respiratory Medicine, Tohno-Chuo Clinic, Mizunami, 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 - Nagazumi, Atsushi AU - Nagazumi A AD - Department of Internal Medicine, Kanauchi Medical Clinic, Shinjuku- ku, Tokyo, Japan. FAU - Kanzo, Takumi AU - Kanzo T AD - Medical Affairs, Mylan EPD G.K, Tokyo, Japan. FAU - Kimura, Takazumi AU - Kimura T AD - Department of Gastroenterology, Kimuranaika-ichonaika, Yokohama, Kanagawa, Japan. LA - eng PT - Journal Article DEP - 20220829 PL - England TA - Expert Rev Gastroenterol Hepatol JT - Expert review of gastroenterology & hepatology JID - 101278199 RN - 7662KG2R6K (Lubiprostone) RN - F5TD010360 (Alprostadil) SB - IM MH - *Alprostadil/adverse effects MH - Constipation/diagnosis/drug therapy MH - Diarrhea/drug therapy MH - Double-Blind Method MH - *Drug Tapering MH - Humans MH - Japan MH - Lubiprostone/adverse effects MH - Nausea/chemically induced MH - Treatment Outcome OTO - NOTNLM OT - Lubiprostone OT - adverse events OT - chronic constipation OT - dose reduction OT - efficacy EDAT- 2022/08/23 06:00 MHDA- 2022/09/08 06:00 CRDT- 2022/08/22 10:42 PHST- 2022/08/23 06:00 [pubmed] PHST- 2022/09/08 06:00 [medline] PHST- 2022/08/22 10:42 [entrez] AID - 10.1080/17474124.2022.2114455 [doi] PST - ppublish SO - Expert Rev Gastroenterol Hepatol. 2022 Aug;16(8):809-817. doi: 10.1080/17474124.2022.2114455. Epub 2022 Aug 29.