Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation

Abstract Background and Aim Stimulant laxatives may cause electrolyte abnormalities, dehydration, and abdominal pain; their long‐term use can lead to tolerance and subsequent refractory constipation. We investigated the effectiveness, safety, and quality of life after switching from stimulant laxati...

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Main Authors: Masaki Maruyama, Suguru Miida, Toshihiro Sato, Takazumi Kimura, Azuma Watanabe, Hideo Watanabe, Masafumi Nishizawa, Kyohei Horikawa, Takahiro Kajiwara, Yusuke Karasawa, Yuko Hasebe, Kazutaka Nozawa, Shuji Terai
Format: Article
Language:English
Published: Wiley 2023-09-01
Series:JGH Open
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Online Access:https://doi.org/10.1002/jgh3.12956
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author Masaki Maruyama
Suguru Miida
Toshihiro Sato
Takazumi Kimura
Azuma Watanabe
Hideo Watanabe
Masafumi Nishizawa
Kyohei Horikawa
Takahiro Kajiwara
Yusuke Karasawa
Yuko Hasebe
Kazutaka Nozawa
Shuji Terai
author_facet Masaki Maruyama
Suguru Miida
Toshihiro Sato
Takazumi Kimura
Azuma Watanabe
Hideo Watanabe
Masafumi Nishizawa
Kyohei Horikawa
Takahiro Kajiwara
Yusuke Karasawa
Yuko Hasebe
Kazutaka Nozawa
Shuji Terai
author_sort Masaki Maruyama
collection DOAJ
description Abstract Background and Aim Stimulant laxatives may cause electrolyte abnormalities, dehydration, and abdominal pain; their long‐term use can lead to tolerance and subsequent refractory constipation. We investigated the effectiveness, safety, and quality of life after switching from stimulant laxatives to lubiprostone in elderly patients with chronic constipation (CC). Methods This multicenter, interventional, open‐label, single‐arm, before‐and‐after comparison study enrolled 99 Japanese patients aged 65–90 years with CC who took stimulant laxatives for ≥2 weeks prior to switching to lubiprostone monotherapy. Results The mean ± SD spontaneous defecations at Week 1 of 7.8 ± 6.2 times/week was not significantly different from that at baseline (8.3 ± 4.7). Spontaneous defecations were significantly reduced at Weeks 2 (−1.5 ± 4.0, P < 0.001) and 4 (−1.5 ± 3.7, P < 0.001). The Bristol Stool Form Scale score did not change from baseline (4.7 ± 0.9) at Weeks 1 (4.5 ± 1.3) or 4 (4.3 ± 1.3), but it did at Week 2 (4.3 ± 1.5, P < 0.05). The Patient Assessment of Constipation Quality of Life questionnaire score increased (0.36 ± 0.07, P < 0.001) after 28 days. Nausea was the only symptom that worsened from baseline and was the most frequently reported adverse drug reaction (15.2%). Conclusion Switching to lubiprostone monotherapy for CC was not associated with significant concerns in short‐term spontaneous defecation frequency and safety, but it might affect the efficacy and patient quality of life over 2 weeks. Careful treatment strategies facilitating gradual switching to lubiprostone monotherapy may be needed in patients using stimulant laxatives.
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spelling doaj.art-a859dfd9f6cc48efa567bebe5ac1dc2a2023-09-23T10:54:38ZengWileyJGH Open2397-90702023-09-017961061710.1002/jgh3.12956Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipationMasaki Maruyama0Suguru Miida1Toshihiro Sato2Takazumi Kimura3Azuma Watanabe4Hideo Watanabe5Masafumi Nishizawa6Kyohei Horikawa7Takahiro Kajiwara8Yusuke Karasawa9Yuko Hasebe10Kazutaka Nozawa11Shuji Terai12Department of Internal Medicine Kashiwazaki General Hospital and Medical Center Kashiwazaki Niigata JapanDepartment of Internal Medicine Kashiwazaki General Hospital and Medical Center Kashiwazaki Niigata JapanSato Clinic Kashiwazaki Niigata JapanKimura Internal Medicine Clinic Yokohama Kanagawa JapanDepartment of Gastroenterology Kameda Daiichi Hospital Niigata JapanDepartment of Surgery Watanabe Hospital Matsuyama Ehime JapanDepartment of Internal Medicine Minamisanriku Hospital Motoyoshi‐gun Miyagi JapanWakamatsuen Health Care Facility for the Elderly Okinawa JapanLotus Care Center, Health Care Facility for the Elderly Chiba JapanMedical Affairs, Viatris Pharmaceuticals Japan Inc. Tokyo JapanMedical Affairs, Viatris Pharmaceuticals Japan Inc. Tokyo JapanMedical Affairs, Viatris Pharmaceuticals Japan Inc. Tokyo JapanDivision of Gastroenterology & Hepatology, Graduate School of Medical and Dental Sciences Niigata University Niigata JapanAbstract Background and Aim Stimulant laxatives may cause electrolyte abnormalities, dehydration, and abdominal pain; their long‐term use can lead to tolerance and subsequent refractory constipation. We investigated the effectiveness, safety, and quality of life after switching from stimulant laxatives to lubiprostone in elderly patients with chronic constipation (CC). Methods This multicenter, interventional, open‐label, single‐arm, before‐and‐after comparison study enrolled 99 Japanese patients aged 65–90 years with CC who took stimulant laxatives for ≥2 weeks prior to switching to lubiprostone monotherapy. Results The mean ± SD spontaneous defecations at Week 1 of 7.8 ± 6.2 times/week was not significantly different from that at baseline (8.3 ± 4.7). Spontaneous defecations were significantly reduced at Weeks 2 (−1.5 ± 4.0, P < 0.001) and 4 (−1.5 ± 3.7, P < 0.001). The Bristol Stool Form Scale score did not change from baseline (4.7 ± 0.9) at Weeks 1 (4.5 ± 1.3) or 4 (4.3 ± 1.3), but it did at Week 2 (4.3 ± 1.5, P < 0.05). The Patient Assessment of Constipation Quality of Life questionnaire score increased (0.36 ± 0.07, P < 0.001) after 28 days. Nausea was the only symptom that worsened from baseline and was the most frequently reported adverse drug reaction (15.2%). Conclusion Switching to lubiprostone monotherapy for CC was not associated with significant concerns in short‐term spontaneous defecation frequency and safety, but it might affect the efficacy and patient quality of life over 2 weeks. Careful treatment strategies facilitating gradual switching to lubiprostone monotherapy may be needed in patients using stimulant laxatives.https://doi.org/10.1002/jgh3.12956constipationdrug therapyelderlylaxativeslubiprostone
spellingShingle Masaki Maruyama
Suguru Miida
Toshihiro Sato
Takazumi Kimura
Azuma Watanabe
Hideo Watanabe
Masafumi Nishizawa
Kyohei Horikawa
Takahiro Kajiwara
Yusuke Karasawa
Yuko Hasebe
Kazutaka Nozawa
Shuji Terai
Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
JGH Open
constipation
drug therapy
elderly
laxatives
lubiprostone
title Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
title_full Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
title_fullStr Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
title_full_unstemmed Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
title_short Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
title_sort effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation
topic constipation
drug therapy
elderly
laxatives
lubiprostone
url https://doi.org/10.1002/jgh3.12956
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