Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials
| Autor: | Alexander Nast, Dee Anna Glaser, William Philip Werschler, Adelaide A. Hebert, David M. Pariser, Janice Drew, John Quiring, Richard Mamelok, Lawrence Green |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Administration Topical Dermatology Cholinergic Antagonists law.invention SWEAT 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law medicine Humans Hyperhidrosis Adverse effect Intention-to-treat analysis business.industry Dermatology Life Quality Index Glycopyrrolate Axilla medicine.anatomical_structure 030220 oncology & carcinogenesis Anesthesia Female Patient-reported outcome medicine.symptom business |
| Zdroj: | Journal of the American Academy of Dermatology. 80:128-138.e2 |
| ISSN: | 0190-9622 |
| Popis: | Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis.Assess the efficacy and safety of GT for primary axillary hyperhidrosis.ATMOS-1 and ATMOS-2 were replicate randomized, double-blind, vehicle-controlled, 4-week phase 3 trials. Patients were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. Coprimary endpoints were responder rate (≥4-point improvement from baseline) on item 2 (severity of sweating) of the Axillary Sweating Daily Diary (ASDD), which is a newly developed patient-reported outcome measure, and absolute change from baseline in axillary gravimetric sweat production at week 4. Safety evaluation included treatment-emergent adverse events.Pooled data, which are consistent with the individual trial results, show that significantly more GT-treated patients achieved an ASDD-Item 2 response than did those treated with vehicle (59.5% vs 27.6%), and they had reduced sweat production from baseline (-107.6 mg/5 min vs -92.1 mg/5 min) at week 4 (P .001 for both coprimary end points). Most treatment-emergent adverse events were mild or moderate and infrequently led to discontinuation.Short trial duration and inherent challenges in gravimetrically assessing sweat production.GT applied topically on a daily basis over 4 weeks reduced the severity of sweating as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in patients with primary axillary hyperhidrosis. |
| Databáze: | OpenAIRE |
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