Differences between objective efficacy and perceived efficacy in patients with palmar hyperhidrosis treated with either botulinum toxin or endoscopic thoracic sympathectomy

Álvarez, M.A.; Ruano, Juan; Gómez, F; Casas, Estefania; Baamonde, C.; Salvatierra, A.; Moreno, J.C.

doi:10.1111/j.1468-3083.2012.04630.x

Cited by 10 publications

(7 citation statements)

References 16 publications

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“…6,10 Only 51% of patients discussed their excess sweating with a health care professional, possibly due to patients' inability to recognize symptoms as a medical condition and/or dissatisfaction with available therapies. 1,11 Though not pediatric-specific, these findings highlight the need for increased awareness and new treatments. 6 Glycopyrronium tosylate (GT; formerly DRM04) is a topical anticholinergic approved by the US Food and Drug Administration (June 2018) for primary axillary hyperhidrosis in patients 9 years and older (QBREXZA ™ [glycopyrronium] cloth, 2.4%, for topical use).…”

Section: Introductionmentioning

confidence: 96%

“…Hyperhidrosis largely remains underrecognized as a treatable medical condition, particularly for pediatric patients . Only 51% of patients discussed their excess sweating with a health care professional, possibly due to patients' inability to recognize symptoms as a medical condition and/or dissatisfaction with available therapies . Though not pediatric‐specific, these findings highlight the need for increased awareness and new treatments .…”

Section: Introductionmentioning

confidence: 99%

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Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Hebert

Glaser

Green

et al. 2018

Pediatric Dermatology

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Objectives Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle‐controlled, 4‐week trials (ATMOS‐1 [NCT02530281] and ATMOS‐2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients. Methods Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD‐Children [ASDD‐C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4‐point improvement on ASDD/ASDD‐C Item 2 (a validated patient‐reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups. Results Six hundred and ninety‐seven patients were randomized in ATMOS‐1/ATMOS‐2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT‐treated pediatric vs older patients had comparable improvements in ASDD/ASDD‐C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2‐grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment‐emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation. Conclusions Topical, once‐daily GT improved disease severity (ASDD/ASDD‐C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment‐emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.

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Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Hebert

Glaser

Green

et al. 2018

Pediatric Dermatology

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“…The side effects described by our cohort are consistent with those when the sympathectomy is done for other reasons, 2,[8][9][10]16 and may be more severe because of the ablation of the second thoracic ganglion, which is associated with more pronounced compensatory hyperhidrosis. 10,17 However, most other indications, such as hyperhidrosis, involve bilateral sympathectomy, so the harlequin effect does not occur. Furthermore, patients with LQTS and CPVT tend to have underlying anxiety 18 and sometimes depression 19 related indirectly to their condition and also to the sacrifices and lifestyle changes they must make.…”

Section: Discussionmentioning

confidence: 99%

Physical and Psychological Consequences of Left Cardiac Sympathetic Denervation in Long-QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia

Waddell-Smith

Ertresvaag

et al. 2015

Circ: Arrhythmia and Electrophysiology

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Background— Left cardiac sympathetic denervation reduces risk in long-QT syndrome (LQTS) and catecholaminergic polymorphic ventricular tachycardia. Side effects and patient satisfaction have not been systematically analyzed in patients who underwent left cardiac sympathetic denervation. Aims of this study included documenting physical and psychological consequences and patient satisfaction after left cardiac sympathetic denervation in LQTS or catecholaminergic polymorphic ventricular tachycardia. Methods and Results— Patients with LQTS (N=40) and catecholaminergic polymorphic ventricular tachycardia (N=7) underwent video-assisted thoracoscopic left cardiac sympathetic denervation, with a median follow-up of 29 months (range, 1–67 months). Clinical records were reviewed; 44 patients completed a telephone survey. Of 47 patients (53%), 25 were preoperatively symptomatic (15 syncope, 7 near-drowning, and 3 resuscitated sudden death). Indications for left cardiac sympathetic denervation included β-blocker intolerance (15; 32%) or nonadherence (10; 21%) and disease factors (18; 38%; catecholaminergic polymorphic ventricular tachycardia [6], near-drowning [2], exertional syncope [1], symptoms on therapy [2], LQT3 [1], QTc>520 ms [6]). Other indications were competitive sports participation (2), family history of sudden death (1), and other (1). Median QTc did not change among patients with LQTS (461±60 to 476±54 ms; P =0.49). Side effects were reported by 42 of 44 (95%). Twenty-nine patients (66%) reported dryness on left side, 26 (59%) a Harlequin-type (unilateral) facial flush, 24 (55%) contralateral hyperhidrosis, 17 (39%) differential hand temperatures, 5 (11%) permanent and 4 (9%) transient ptosis, 5 (11%) thermoregulation difficulties, 4 (9%) a sensation of left arm paresthesia, and 3 (7%) sympathetic flight/fright response loss. Majority of the patients were satisfied postoperatively: 38 (86%) were happy with the procedure, 33 (75%) felt safer, 40 (91%) recommended the procedure to others, and 40 (91%) felt happy with their scar appearance. Conclusions— Despite significant morbidity resulting from left cardiac sympathetic denervation, patients with LQTS and CPVT have high levels of postoperative satisfaction.

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“…Although treatment regimens may vary according to patient characteristics and symptom severity, 2 patients generally remain unsatisfied with the currently available treatment options. 5,10,11 Patients with hyperhidrosis often delay or avoid seeking treatment, likely owing to a lack of recognition of hyperhidrosis as a medical condition, the social stigma of excessive sweating, and/ or low levels of satisfaction with or awareness of available treatments. 5,10,11 Glycopyrronium tosylate (GT [formerly DRM04]) is a topical anticholinergic approved by the US Food and Drug Administration (June 29, 2018) for primary axillary hyperhidrosis in patients 9 years and older (glycopyrronium cloth, 2.4%, for topical use).…”

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confidence: 99%

Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials

Glaser

Hebert

Nast

et al. 2019

Journal of the American Academy of Dermatology

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Differences between objective efficacy and perceived efficacy in patients with palmar hyperhidrosis treated with either botulinum toxin or endoscopic thoracic sympathectomy

Abstract: In studies of expectations regarding the outcome of palmar hyperhidrosis treatment, doctors should consider the factors that determine patient satisfaction in relation to the treatment options.

Cited by 10 publications

References 16 publications

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Physical and Psychological Consequences of Left Cardiac Sympathetic Denervation in Long-QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia

Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials

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