Dee Anna Glaser1, Adelaide A Hebert2, Alexander Nast3, William P Werschler4, Lawrence Green5, Richard Mamelok6, Janice Drew7, John Quiring8, David M Pariser9. 1. Saint Louis University, St. Louis, Missouri. Electronic address: glasermd@slu.edu. 2. UTHealth McGovern Medical School, Houston, Texas. 3. Charité-Universitätsmedizin Berlin, Berlin, Germany. 4. Premier Clinical Research, Spokane, Washington. 5. George Washington University School of Medicine, Washington, DC. 6. Mamelok Consulting, Palo Alto, California. 7. Dermira, Inc, Menlo Park, California. 8. QST Consultations, Allendale, Michigan. 9. Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia.
Abstract
BACKGROUND:Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis. OBJECTIVE: Assess the efficacy and safety of GT for primary axillary hyperhidrosis. METHODS: 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. RESULTS: 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. LIMITATIONS: Short trial duration and inherent challenges in gravimetrically assessing sweat production. CONCLUSIONS: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.
RCT Entities:
BACKGROUND:Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis. OBJECTIVE: Assess the efficacy and safety of GT for primary axillary hyperhidrosis. METHODS: 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. RESULTS: 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. LIMITATIONS: Short trial duration and inherent challenges in gravimetrically assessing sweat production. CONCLUSIONS: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.
Authors: Aaron R Kaufman; Shawn Gulati; John H Pula; Timothy M Janetos; Neena R Cherayil; Eric Chiu; Emily Anne Shepherd; Karl C Golnik; Enrique Garcia-Valenzuela; Peter W MacIntosh; Brooke T Johnson; Kimberlee M Curnyn Journal: J Neuroophthalmol Date: 2022-03-24 Impact factor: 4.415
Authors: L M Nelson; D DiBenedetti; D M Pariser; D A Glaser; A A Hebert; H Hofland; J Drew; D Ingolia; K K Gillard; S Fehnel Journal: J Patient Rep Outcomes Date: 2019-09-05
Authors: Adelaide A Hebert; Dee Anna Glaser; Lawrence Green; Cheryl Hull; Jennifer Cather; Janice Drew; Ramanan Gopalan; David M Pariser Journal: Pediatr Dermatol Date: 2020-03-08 Impact factor: 1.588
Authors: Adelaide A Hebert; Dee Anna Glaser; Lawrence Green; William P Werschler; Douglass W Forsha; Janice Drew; Ramanan Gopalan; David M Pariser Journal: Pediatr Dermatol Date: 2018-11-19 Impact factor: 1.588