TY - JOUR
T1 - Safety of elobixibat and lubiprostone in Japanese patients with chronic constipation
T2 - a retrospective cohort study
AU - Ooba, Nobuhiro
AU - Takahashi, Yoshinori
AU - Nagamura, Marina
AU - Takahashi, Masao
AU - Ushida, Makoto
AU - Kawakami, Eiji
AU - Kimura, Masaomi
AU - Sato, Tsugumichi
AU - Tokuyoshi, Junichi
AU - Miyazaki, Choichiro
AU - Shimada, Mitsuaki
N1 - Funding Information:
This work was supported by the Japan Pharmaceutical Association. We express our appreciation to the participating pharmacists for providing reliable data. We also thank the staff of the Japan Pharmaceutical Association for data collection and management.
Publisher Copyright:
© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2021
Y1 - 2021
N2 - Background: We aimed to discuss and compare reported adverse reactions and drug add-ons associated with elobixibat and lubiprostone use in chronic constipation treatment, as the safety of these drugs has not been well examined in post-marketing clinical settings. Research Design and Methods: In this retrospective cohort study, using records of community pharmacies in Japan, we identified new users of elobixibat and lubiprostone. The Japan Pharmaceutical Association sent questionnaires regarding baseline and event data to community pharmacists. The incidence of events and hazard ratio (HR) associated with the study drugs were evaluated. Results: New users of elobixibat (n = 979) and lubiprostone (n = 829) were identified (mean age: 74 and 77 years; females: 59% and 53%, respectively). Although the crude risk ratio of adverse events for elobixibat was 0.79 (95% confidence interval: 0.63–0.99), there was no significant difference in the HR for any of the common events, including drug add-ons (n ≥ 5), compared with those for lubiprostone. Conclusion: No new safety concerns have been raised in relation to elobixibat and lubiprostone use for treating chronic constipation, although the HR of different events varied. Further larger-scale study is needed as the estimates for events of small numbers were unstable.
AB - Background: We aimed to discuss and compare reported adverse reactions and drug add-ons associated with elobixibat and lubiprostone use in chronic constipation treatment, as the safety of these drugs has not been well examined in post-marketing clinical settings. Research Design and Methods: In this retrospective cohort study, using records of community pharmacies in Japan, we identified new users of elobixibat and lubiprostone. The Japan Pharmaceutical Association sent questionnaires regarding baseline and event data to community pharmacists. The incidence of events and hazard ratio (HR) associated with the study drugs were evaluated. Results: New users of elobixibat (n = 979) and lubiprostone (n = 829) were identified (mean age: 74 and 77 years; females: 59% and 53%, respectively). Although the crude risk ratio of adverse events for elobixibat was 0.79 (95% confidence interval: 0.63–0.99), there was no significant difference in the HR for any of the common events, including drug add-ons (n ≥ 5), compared with those for lubiprostone. Conclusion: No new safety concerns have been raised in relation to elobixibat and lubiprostone use for treating chronic constipation, although the HR of different events varied. Further larger-scale study is needed as the estimates for events of small numbers were unstable.
KW - Community pharmacist
KW - new-user design
KW - pharmacy record
KW - primary data collection
KW - retrospective cohort study
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U2 - 10.1080/14740338.2021.1952980
DO - 10.1080/14740338.2021.1952980
M3 - Article
C2 - 34281471
AN - SCOPUS:85111035658
SN - 1474-0338
VL - 20
SP - 1553
EP - 1558
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
IS - 12
ER -