Cited 5 times in
Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study
DC Field | Value | Language |
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dc.contributor.author | 김장환 | - |
dc.contributor.author | 손희서 | - |
dc.contributor.author | 손희서 | - |
dc.date.accessioned | 2022-12-22T02:23:48Z | - |
dc.date.available | 2022-12-22T02:23:48Z | - |
dc.date.issued | 2022-06 | - |
dc.identifier.issn | 2093-4777 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/191563 | - |
dc.description.abstract | Purpose: DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients. Methods: This phase 2, randomized, double-blind, parallel-group, active reference- and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged ≥19 years with OAB symptoms for ≥3 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (=∆) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall/urgency urinary incontinence, average/ maximum voided volume, nocturia, and patients' subjective responses were analyzed. Results: In the full analysis set, the mean (standard deviation) [median] values for ∆ 24-hour frequency at 12 weeks were -1.01 (2.44) [-1.33] for placebo, -1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and -1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P=0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P=0.0391 at 4 weeks, P=0.0335 at 8 weeks) and DA-8010 5 mg (P=0.0001 at 4 weeks, P=0.0210 at 8 weeks) showed significant decrease in ∆ 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in ∆ number of urgency episodes, compared with placebo at 4 (P=0.0278) and 8 (P=0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient. Conclusion: Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | Korean | - |
dc.publisher | 대한배뇨장애 및 요실금학회 | - |
dc.relation.isPartOf | INTERNATIONAL NEUROUROLOGY JOURNAL(대한배뇨장애요실금학회지) | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Urology (비뇨의학교실) | - |
dc.contributor.googleauthor | Hee Seo Son | - |
dc.contributor.googleauthor | Cheol Young Oh | - |
dc.contributor.googleauthor | Myung-Soo Choo | - |
dc.contributor.googleauthor | Hyeong Gon Kim | - |
dc.contributor.googleauthor | Joon Chul Kim | - |
dc.contributor.googleauthor | Kyu-Sung Lee | - |
dc.contributor.googleauthor | Dong Gil Shin | - |
dc.contributor.googleauthor | Sung Yong Cho | - |
dc.contributor.googleauthor | Seong Jin Jeong | - |
dc.contributor.googleauthor | Ju Tae Seo | - |
dc.contributor.googleauthor | Hana Yoon | - |
dc.contributor.googleauthor | Hong Sang Moon | - |
dc.contributor.googleauthor | Jang Hwan Kim | - |
dc.identifier.doi | 10.5213/inj.2142382.191 | - |
dc.contributor.localId | A00855 | - |
dc.relation.journalcode | J01817 | - |
dc.identifier.pmid | 35793990 | - |
dc.subject.keyword | DA-8010 | - |
dc.subject.keyword | Muscarinic antagonists | - |
dc.subject.keyword | Overactive | - |
dc.subject.keyword | Receptor, Muscarinic M3 | - |
dc.subject.keyword | Urinary bladder | - |
dc.contributor.alternativeName | Kim, Jang Hwan | - |
dc.contributor.affiliatedAuthor | 김장환 | - |
dc.citation.volume | 26 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 119 | - |
dc.citation.endPage | 128 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL NEUROUROLOGY JOURNAL(대한배뇨장애요실금학회지), Vol.26(2) : 119-128, 2022-06 | - |
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