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Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials.
- Source :
-
Pediatric dermatology [Pediatr Dermatol] 2019 Jan; Vol. 36 (1), pp. 89-99. Date of Electronic Publication: 2018 Nov 19. - Publication Year :
- 2019
-
Abstract
- Objectives: Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle-controlled, 4-week trials (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients.<br />Methods: Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD-Children [ASDD-C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4-point improvement on ASDD/ASDD-C Item 2 (a validated patient-reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups.<br />Results: Six hundred and ninety-seven patients were randomized in ATMOS-1/ATMOS-2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT-treated pediatric vs older patients had comparable improvements in ASDD/ASDD-C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2-grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment-emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation.<br />Conclusions: Topical, once-daily GT improved disease severity (ASDD/ASDD-C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment-emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.<br /> (© 2018 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.)
- Subjects :
- Administration, Topical
Adolescent
Adult
Aged
Axilla physiopathology
Child
Female
Germany
Glycopyrrolate adverse effects
Humans
Male
Middle Aged
Muscarinic Antagonists adverse effects
Quality of Life
Randomized Controlled Trials as Topic
Severity of Illness Index
Treatment Outcome
United States
Young Adult
Glycopyrrolate therapeutic use
Hyperhidrosis drug therapy
Muscarinic Antagonists therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1525-1470
- Volume :
- 36
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Pediatric dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 30451318
- Full Text :
- https://doi.org/10.1111/pde.13723