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Safety and tolerability of donepezil 23 mg with or without intermediate dose titration in patients with Alzheimers disease taking donepezil 10 mg: a multicenter, randomized, open-label, parallel-design, three-arm, prospective trial

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dc.contributor.authorHong, Yun Jeong-
dc.contributor.authorHan, Hyun Jeong-
dc.contributor.authorYoun, Young Chul-
dc.contributor.authorPark, Kyung Won-
dc.contributor.authorYang, Dong Won-
dc.contributor.authorKim, SangYun-
dc.contributor.authorKim, Hwa Jung-
dc.contributor.authorKim, Ji Eun-
dc.contributor.authorLee, Jae-Hong-
dc.date.accessioned2019-06-12T08:08:51Z-
dc.date.available2019-06-12T17:10:20Z-
dc.date.issued2019-05-01-
dc.identifier.citationAlzheimer's Research & Therapy. 11(1):37ko_KR
dc.identifier.issn1758-9193-
dc.identifier.urihttps://hdl.handle.net/10371/153909-
dc.description.abstractBackground
High-dose donepezil is currently prescribed for patients with Alzheimers disease (AD) who showed poor or waning response to a lower dose at the risk of increasing cholinergic side effects. However, the adverse events (AEs) depending on the method of dose escalation have not been clarified yet. This study aimed to find out whether dose titration before escalating to donepezil 23 mg is preferred. We investigated safety and tolerability of donepezil 23 mg during the first 12 weeks of dose escalation in patients with moderate to severe AD.

Methods
This study was a 12-week, multicenter, randomized, open-label prospective trial. We included patients with moderate to severe AD who were treated with a stable dose of donepezil 10 mg/day. Patients were randomized into 3 groups according to the dose escalation method: 15 mg of donepezil for 4 weeks before escalating to 23 mg (group 1), 10 mg and 23 mg on alternate days for 4 weeks prior to escalation (group 2), and direct escalation to 23 mg (group 3). Safety analyses included incidence, severity, timing of AEs, relationship to the study drug, and premature study discontinuation due to AEs between the groups.

Results
Among 175 enrolled, 110 patients completed the study. Baseline characteristics were similar among the groups. Using safety population (N = 160), cholinergic gastrointestinal symptoms including anorexia and nausea were the most common AEs and titration groups showed significantly fewer cases of nausea as compared with those in no-titration group.

Conclusions
In this study, dose titration before escalating to donepezil 23 mg/day showed better safety in terms of cholinergic AEs. We suggest that dose titration during the first 4 weeks can be recommended for patients with moderate to severe AD.

Trial registration

Clinicaltrials.gov, NCT02550665. Retrospectively registered on 15 Sep 2015.
ko_KR
dc.description.sponsorshipThis research was supported by a grant (# 2014-0576) from the Asan Institute for Life Sciences, Asan Medical Center and a grant from the Eisai Korea Inc., Seoul, Korea.ko_KR
dc.language.isokoko_KR
dc.publisherBioMed Centralko_KR
dc.subjectAlzheimer’s diseaseko_KR
dc.subjectSafetyko_KR
dc.subjectTolerabilityko_KR
dc.subjectDose-titrationko_KR
dc.subjectHigh-dose donepezilko_KR
dc.titleSafety and tolerability of donepezil 23 mg with or without intermediate dose titration in patients with Alzheimers disease taking donepezil 10 mg: a multicenter, randomized, open-label, parallel-design, three-arm, prospective trialko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor홍윤정-
dc.contributor.AlternativeAuthor한현종-
dc.contributor.AlternativeAuthor윤용철-
dc.contributor.AlternativeAuthor박경원-
dc.contributor.AlternativeAuthor양동원-
dc.contributor.AlternativeAuthor김상윤-
dc.contributor.AlternativeAuthor김화정-
dc.contributor.AlternativeAuthor김지은-
dc.contributor.AlternativeAuthor이재홍-
dc.identifier.doi10.1186/s13195-019-0492-1-
dc.language.rfc3066en-
dc.rights.holderThe Author(s).-
dc.date.updated2019-05-05T03:36:32Z-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Dept. of Neurology (신경과학교실)Journal Papers (저널논문_신경과학교실)
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