Long‐term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44‐week open‐label extension study

Hebert, Adelaide A.; Glaser, Dee Anna; Green, Lawrence; Hull, Cheryl; Cather, Jennifer; Drew, Janice; Gopalan, Ramanan; Pariser, David M.

doi:10.1111/pde.14135

Cited by 14 publications

(17 citation statements)

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“…Features of the Pop PK analysis that may limit the generalizability of the results include the lack of pediatric patients in the study population, the moderate size of the study population, and the fact that these data are derived from assumptions used in modeling. In addition, the model also does not provide information on exposure–response relationships with long-term use of GT, though in a long-term extension trial of GT, most patients experiencing TEAEs had mild or moderate events, including pediatric patients [ 11 , 21 ].…”

Section: Discussionmentioning

confidence: 99%

Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis

et al. 2021

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Background Glycopyrronium tosylate (GT; Qbrexza ® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years. Objective The objective of this study was to compare the pharmacokinetics and safety of GT to oral glycopyrrolate (phase I study) and assess the relationship between glycopyrronium pharmacokinetics and anticholinergic-related adverse events or efficacy with population pharmacokinetics using data from two phase II studies. Methods In the phase I study, study staff applied GT to axillae of patients with primary axillary hyperhidrosis (aged 9–65 years) once daily (5 days); oral glycopyrrolate was administered to healthy adults (aged 18–65 years) every 8 hours (15 days). In the phase II studies (NCT02016885 [20 December, 2013], NCT02129660 [2 May, 2014]), adults with primary axillary hyperhidrosis applied topical glycopyrronium (0.8–3.2%) or vehicle to axillae once daily (4 weeks). Pharmacokinetic and adverse event data were collected in all studies. Results Glycopyrronium pharmacokinetic parameters were similar between adult and pediatric patients treated with GT; there was no evidence of accumulation. Systemic absorption of glycopyrronium was lower with GT vs oral glycopyrrolate. No anticholinergic-related adverse events occurred with GT in the phase I study, while dry mouth and nasal dryness occurred with oral glycopyrrolate; anticholinergic adverse events occurred in the phase II studies. In the population pharmacokinetic analysis, frequency/severity of anticholinergic-related adverse events increased with higher glycopyrronium concentration; no relationship was observed between efficacy and pharmacokinetic measures. Conclusions These studies indicate limited absorption of GT compared to oral glycopyrrolate and a low risk of anticholinergic adverse events with proper GT administration when following instructions for use (wipe each underarm once with same cloth, wash hands, avoid ocular contact). Supplementary Information The online version contains supplementary material available at 10.1007/s40262-020-00975-y.

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Section: Discussionmentioning

confidence: 99%

Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis

et al. 2021

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“…27 gic side effects may be seen. 27 Oxybutynin used as a 3% gel has a relatively long half-life of up to 84 h and hence has a longer duration of action than aluminum compounds. It is known to exert its action on remote sites such as exerting its effects for overactive bladder when used in the axilla.…”

Section: Topical Anticholinergicsmentioning

confidence: 99%

“…25,26 Glycopyrronium tosylate (GT) 2.4% cloth is a US FDA-approved treatment for primary AH for patients 9 years and above of age. 27 gic side effects may be seen. 27 Oxybutynin used as a 3% gel has a relatively long half-life of up to 84 h and hence has a longer duration of action than aluminum compounds.…”

Section: Topical Anticholinergicsmentioning

confidence: 99%

“…Glycopyrronium tosylate (GT) 2.4% cloth is a US FDA‐approved treatment for primary AH for patients 9 years and above of age 27 . A study by Hebert AA et al (4‐week double‐blind plus 44‐week open label) concluded that a once daily GT application for up to 48 weeks was an effective and well‐tolerated treatment option for AH in pediatric patients between ten to 15 years of age.…”

Section: Topical Treatmentsmentioning

confidence: 99%

“…A study by Hebert AA et al (4‐week double‐blind plus 44‐week open label) concluded that a once daily GT application for up to 48 weeks was an effective and well‐tolerated treatment option for AH in pediatric patients between ten to 15 years of age. Mild anticholinergic side effects may be seen 27 …”

Section: Topical Treatmentsmentioning

confidence: 99%

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Treatment of Axillary hyperhidrosis

Arora¹,

Kassir

Patil

et al. 2021

J of Cosmetic Dermatology

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Background Axillary hyperhidrosis characterized by excessive sweating in the axillary regions is a frustrating chronic autonomic disorder leading to social embarrassment, impaired quality of life and usually associated with palmoplantar hyperhidrosis. Identifying the condition and its cause is central to the management. Aim The aim of this article is to discuss treatment options for axillary hyperhidrosis. Methods Comprehensive literature search using PubMed and Google Scholar was performed to review relevant published articles related to diagnosis and treatment of axillary hyperhidrosis. Results Treatment modalities for axillary hyperhydrosis vary from topical and systemic agents to injectables, newer devices and surgical measures. None except for physical measures using devices or surgery, which destroys the sweat glands to remove them, is possibly permanent and most are associated with attendant side effects. Conclusion Several treatments including medical and surgical option are available for the treatment of axillary hyperhydrosis. Patient education is important component of its management. Individualized approach of management is necessary for optimal outcome of treatment.

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Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents

et al. 2023

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Introduction Selective serotonin reuptake inhibitors (SSRIs) and, to a lesser extent, serotonin‐norepinephrine reuptake inhibitors (SNRIs) are the cornerstone of pharmacotherapy for children and adolescents with anxiety and depressive disorders. These medications alleviate symptoms and restore function for many youths; however, they are associated with a distinct adverse effect profile, and their tolerability may complicate treatment or lead to discontinuation. Yet, SSRI/SNRI tolerability has received limited attention in the pediatric literature. Methods This review examines the early‐ (e.g., activation, gastrointestinal symptoms, sedation) and late‐emerging (e.g., weight gain) adverse effects of SSRIs and some SNRIs in pediatric patients. Results We provide a framework for discussing SSRI/SNRI tolerability with patients and their families and describe the pharmacologic basis, course, and predictors of adverse events in youth. Strategies to address specific tolerability concerns are presented. For selected adverse events, using posterior simulation of mean differences over time, we describe their course based on Physical Symptom Checklist measures in a prospective, randomized trial of anxious youth aged 7–17 years who were treated with sertraline (n = 139) or placebo (n = 76) for 12 weeks in the Child/Adolescent Anxiety Multimodal Study (CAMS). Main Results In CAMS, the relative severity/burden of total physical symptoms (p < 0.001), insomnia (p = 0.001), restlessness (p < 0.001), nausea (p = 0.002), abdominal pain (p < 0.001), and dry mouth (p = 0.024) decreased from baseline over 12 weeks of sertraline treatment, raising the possibility that these symptoms are transient. No significant changes were observed for sweating (p = 0.103), constipation (p = 0.241), or diarrhea (p = 0.489). Finally, we review the antidepressant withdrawal syndrome in children and adolescents and provide guidance for SSRI discontinuation, using pediatric pharmacokinetic models of escitalopram and sertraline—two of the most used SSRIs in youth. Conclusion SSRI/SNRIs are associated with both early‐emerging (often transient) and late‐emerging adverse effects in youth. Pharmacokinetically‐informed appraoches may address some adverse effects and inform SSRI/SNRI discontinuation strategies.

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Long‐term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44‐week open‐label extension study

Cited by 14 publications

References 14 publications

Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis

Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis

Treatment of Axillary hyperhidrosis

Adverse Effects of Antidepressant Medications and their Management in Children and Adolescents

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