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.

中文翻译：

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局部使用甲苯磺酸格隆铵治疗原发性腋窝多汗症：ATMOS-1和ATMOS-2 3期随机对照试验的结果

背景

甲苯磺酸格隆铵（GT）是一种局部抗胆碱能药，每天一次用于治疗原发性腋窝多汗症。

客观的

评估GT治疗原发性腋窝多汗症的疗效和安全性。

方法

ATMOS-1和ATMOS-2是重复随机，双盲，载体对照，为期4周的3期临床试验。患者按2：1的比例随机分配至3.75％的GT或媒介物，每天一次，每次腋窝一次，持续4周。首要研究终点是腋窝出汗每日日记（ASDD）的第2项（出汗严重程度）的缓解率（比基线提高4分以上），这是一项新近开发的患者报告的结局指标，而腋窝自基线起的绝对变化在第4周时发生重量汗水产生。安全性评估包括治疗紧急不良事件。

结果

汇总的数据与单独的试验结果一致，结果表明，接受GT治疗的患者实现ASDD-Item 2应答的人数明显多于接受载体治疗的患者（59.5％比27.6％），并且他们的出汗量比基线减少（在第4周时为–107.6 mg / 5分钟，而–92.1 mg / 5分钟（ 两个主要主要终点的P <.001）。大多数出现治疗的不良事件是轻度或中度的，很少导致停药。

局限性

用重量分析法评估汗液产生的试验时间短且存在固有的挑战。

结论

按ASDD-Item 2的规定，每天局部使用GT可以降低出汗的严重程度（按ASDD-Item 2的测定），可以减少出汗的量（按重量分析），并且在原发性腋窝多汗症患者中一般耐受性良好。