Efficacy and Safety of Topical Anticholinergics in the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-analysis.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2026-06-01 Epub Date: 2026-04-16 DOI:10.1007/s40261-026-01550-2

Jiah Kim, Nayoung Han, Hyunji Koo, Younghwa Kim, Eun Jung Hwang, Min-Soo Kim, Christine E Staatz, In-Hwan Baek

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引用次数: 0

Abstract

Background: Topical anticholinergic agents are non-invasive treatment options for primary axillary hyperhidrosis (PAH). Sofpironium bromide was recently approved by the US Food and Drug Administration (FDA). A comprehensive evaluation of the efficacy and safety of available topical anticholinergics may inform clinical practice.

Objectives: To assess the efficacy and safety of topical anticholinergic therapies for PAH through systematic review and meta-analysis of randomized controlled trials (RCTs).

Methods: Five databases were searched on September 9, 2024. Primary outcomes included a ≥2-point improvement in the Hyperhidrosis Disease Severity Scale (HDSS) and ≥50% reduction in gravimetric sweat production (GSP). Secondary outcomes included subjective symptom improvement and objective sweat reduction. Safety outcomes included treatment-emergent adverse events (TEAEs), anticholinergic-related adverse events, and local application site reactions. The review protocol was registered in PROSPERO (CRD42024583376).

Results: Eight RCTs (n = 1921) that evaluated glycopyrronium, sofpironium bromide, and umeclidinium were included. Topical agents significantly outperformed placebos for HDSS ≥2-point improvement (risk ratio [RR]: 2.40; 95% confidence interval [CI]: 2.01-2.86) and GSP ≥50% reduction (RR: 1.43; 95% CI: 1.21-1.70). Sofpironium was the most effective HDSS treatment, whereas glycopyrronium showed highest efficacy against GSP. Topical agents were associated with increased risk of TEAEs (RR: 1.43; 95% CI: 1.14-1.79), with sofpironium associated with highest risk of dry mouth and glycopyrronium with highest risks for mydriasis and constipation.

Conclusions: Topical anticholinergic agents are effective for PAH treatment, with distinct efficacy and safety profiles. Although the available evidence is limited by the small number of trials, short follow-up durations, and heterogeneity in outcome reporting, these findings support the role of topical anticholinergic therapy as an effective non-invasive option for PAH.

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局部抗胆碱能药物治疗原发性腋下多汗症的疗效和安全性：系统回顾和荟萃分析。

背景：局部抗胆碱能药物是原发性腋下多汗症（PAH）的非侵入性治疗选择。索非溴铵最近获得美国食品和药物管理局（FDA）的批准。对可用的局部抗胆碱能药物的疗效和安全性进行综合评价，可为临床实践提供参考。目的：通过随机对照试验（RCTs）的系统评价和荟萃分析，评价局部抗胆碱能治疗PAH的疗效和安全性。方法：于2024年9月9日检索5个数据库。主要结局包括多汗症严重程度量表（HDSS）改善≥2点，重力产汗量（GSP）减少≥50%。次要结局包括主观症状改善和客观出汗减少。安全性指标包括治疗出现的不良事件（teae）、抗胆碱能相关不良事件和局部应用部位反应。该审查方案已在PROSPERO注册（CRD42024583376）。结果：纳入了8项随机对照试验（n = 1921），评估了甘普罗铵、溴化索匹溴铵和乌莫利维铵。局部用药在HDSS改善≥2点（风险比[RR]: 2.40； 95%可信区间[CI]: 2.01-2.86）和GSP降低≥50% （RR: 1.43; 95% CI: 1.21-1.70）方面显著优于安慰剂。索匹溴铵是治疗HDSS最有效的药物，而glycopyronium对GSP的疗效最高。外用药物与teae风险增加相关（RR: 1.43; 95% CI: 1.14-1.79），索匹溴铵与口干风险最高相关，glycopyronium与流鼻涕和便秘风险最高相关。结论：局部抗胆碱能药物治疗多环芳烃是有效的，具有明显的疗效和安全性。虽然现有的证据受到试验数量少、随访时间短和结果报告异质性的限制，但这些发现支持局部抗胆碱能治疗作为PAH有效的非侵入性选择的作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.