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A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.

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A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.

Am J Clin Dermatol. 2019 May 20;:

Authors: Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM

Abstract
BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%).
OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294).
METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children’s Dermatology Life Quality Index.
RESULTS: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children’s Dermatology Life Quality Index.
CONCLUSIONS: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged.
TRIAL REGISTRY: Clinicaltrials.gov NCT02553798.

PMID: 31111409 [PubMed – as supplied by publisher]

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[A retrospective study on the quality of life of patients with primary focal hyperhidrosis that underwent a video-assisted thoracoscopic sympathectomy].

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[A retrospective study on the quality of life of patients with primary focal hyperhidrosis that underwent a video-assisted thoracoscopic sympathectomy].

Rev Port Cir Cardiotorac Vasc. 2019 Jan-Mar;26(1):31-35

Authors: Teixeira J, Moreira R, Vieira M, Miranda JA, Mota JC

Abstract
Backgroud: Primary focal hyperhidrosis affects between 1 to 4% of the general population, with a higher prevalence in teenagers and young adults. The condition is characterized by excessive sweating in 1 or more body part, most often the palms, face, armpits and soles. This condition causes a significant negative impact on patient’s quality of life. The pathophysiology of focal hyperhidrosis is believed to be due to excessive sympathetic stimulation, and videothoracoscopic sympathectomy is a recognized form of treatment. The aim of this study is to evaluate the post-operative quality of life of patients who underwent thoracoscopic sympathectomy.
MATERIALS AND METHODS: This is a retrospective study of fifty-four patients with primary focal hyperhidrosis submitted to bilateral thoracoscopic thoracic sympathectomy at the Center of Cardiothoracic Surgery of Casa de Saúde da Boavista, between January 2011 and December 2014. The Quality of Life questionnaire and the Hyperhidrosis Severity Scale questionnaire were used to evaluate the quality of life in the pre-operative period and 3 months after surgery. Further to this, data was collected regarding medium-term follow-up by telephone. All patients underwent general anesthesia and had bilateral video-assisted thoracoscopic resection of the sympathetic chain.
RESULTS: The majority of patients are females 59.3% (32). The mean age is 30.8 ± 7.70 (between 16 and 49 years). Prior to surgery, 85% of the patients had severe hyperhidrosis. 79.6% of respondents stated that general discomfort was promoted by the condition, with the Funcional-Social domain being the most affected aspect of their life (61.1%). The rates of peri-operative complications and major post-operative complications were null, and minor complications were 5.5%. After 3 months, improvement in patient’s quality of life and satisfaction level were of 100% and 96.3% respectively, however compensatory hyperhidrosis was observed in 53.7% of patients. 57.3% of the patients reported significant improvements in the Funcional-Social domain. Medium-term follow-up (mean=6 years) allowed for the evaluation of 31 patients (57.4% of the population), of whom 77.4% maintained compensatory hyperhidrosis. 93.5% reported to be highly satisfied with the surgical results and claimed to have improved their quality of life by 93.5%. 94% and 94.4% respectively of the patients evaluated in the medium term follow-up and after 3 months and in the medium term follow-up, recommend the surgery.
CONCLUSION: Sympathectomy by video-assisted thoracoscopic surgery (VATS) is an effective and viable therapeutic option for primary focal hyperhidrosis patients. Despite compensatory hyperhidrosis being observed at time, this procedure produces very satisfactory results particularly in regard to the patient’s post-operative quality of life.

PMID: 31104374 [PubMed – in process]

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Topical Treatment of Primary Focal Hyperhidrosis, Part 2.

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Topical Treatment of Primary Focal Hyperhidrosis, Part 2.

Int J Pharm Compd. 2019 Mar-Apr;23(2):94-104

Authors: Zur E

Abstract
This represents part 2 of a 2-part article on the topic of primary focal hyperhidrosis. Part 1, which was published in the International Journal of Pharmaceutical Compounding’s January/February 2019 issue, provided a comprehensive review of the active pharmaceutical ingredients aluminum salts and methenamine in the treatment of primary focal hyperhidrosis. Part 2 provides a comprehensive review of the active pharmaceutical ingredients glycopyrronium salts and oxybutynin chloride in the treatment of primary focal hyperhidrosis.

PMID: 31085774 [PubMed – in process]

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Exploring hyperhidrosis and related thermoregulatory symptoms as a possible clinical identifier for the dysautonomic subtype of Parkinson’s disease.

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Exploring hyperhidrosis and related thermoregulatory symptoms as a possible clinical identifier for the dysautonomic subtype of Parkinson’s disease.

J Neurol. 2019 Apr 17;:

Authors: van Wamelen DJ, Leta V, Podlewska AM, Wan YM, Krbot K, Jaakkola E, Martinez-Martin P, Rizos A, Parry M, Metta V, Ray Chaudhuri K

Abstract
OBJECTIVE: To identify associated (non-)motor profiles of Parkinson’s disease (PD) patients with hyperhidrosis as a dominant problem.
METHODS: This is a cross-sectional, exploratory, analysis of participants enrolled in the Non-motor Longitudinal International Study (NILS; UKCRN No: 10084) at the Parkinson’s Centre at King’s College Hospital (London, UK). Hyperhidrosis scores (yes/no) on question 28 of the Non-Motor Symptom Questionnaire were used to classify patients with normal sweat function (n = 172) and excessive sweating (n = 56) (Analysis 1; n = 228). NMS scale (NMSS) question 30 scores were used to stratify participants based on hyperhidrosis severity (Analysis 2; n = 352) using an arbitrary severity grading: absent score 0 (n = 267), mild 1-4 (n = 49), moderate 5-8 (n = 17), and severe 9-12 (n = 19). NMS burden, as well as PD sleep scale (PDSS) scores were then analysed along with other correlates.
RESULTS: No differences were observed in baseline demographics between groups in either analysis. Patients with hyperhidrosis exhibited significantly higher total NMSS burden compared to those without (p < 0.001). Secondary analyses revealed higher dyskinesia scores, worse quality of life and PDSS scores, and higher anxiety and depression levels in hyperhidrosis patients (p < 0.001). Tertiary analyses revealed higher NMSS item scores for fatigue, sleep initiation, restless legs, urinary urgency, and unexplained pain (p < 0.001).
CONCLUSIONS: Chronic hyperhidrosis appears to be associated with a dysautonomia dominant subtype in PD patients, which is also associated with sleep disorders and a higher rate of dyskinesia (fluctuation-related hyperhidrosis). These data should prompt the concept of hyperhidrosis being used as a simple clinical screening tool to identify PD patients with autonomic symptoms.

PMID: 30997572 [PubMed – as supplied by publisher]

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Hyperhidrosis and Dysautonomia in a Patient with a History of Tetraplegia following Cervical Facet Radiofrequency Ablation: A Case Report.

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Hyperhidrosis and Dysautonomia in a Patient with a History of Tetraplegia following Cervical Facet Radiofrequency Ablation: A Case Report.

PM R. 2019 Apr 15;:

Authors: Reddy R, Zardouz S, Rejai S, Chen J

Abstract
Chronic pain in those with spinal cord injury (SCI) can significantly impact quality of life, with prevalence ranging from 26%-96%1 . Treatment of chronic pain is notoriously challenging and unsatisfactory for providers and patients1,2 . Patients with traumatic SCI and fusion can develop adjacent-level degeneration3 . Facet-mediated pain can be treated with radiofrequency ablation (RFA) of the medial branch nerves that innervate the zygapophyseal joints4 .

PMID: 30985080 [PubMed – as supplied by publisher]

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Glycopyrronium Tosylate (Qbrexza) for Hyperhidrosis

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Glycopyrronium Tosylate (Qbrexza) for Hyperhidrosis

Skin Therapy Lett. 2019 Mar;24(2):1-3

Authors: Nwannunu CE, Limmer AL, Coleman K, Shah R, Patel RR, Mui UN, Tyring SK

Abstract
Hyperhidrosis is a condition characterized by excessive sweat production beyond which is physiologically necessary for thermal regulation. Affecting over 4.8% of the United States population, studies have shown that severe primary hyperhidrosis interferes with daily activities and can be considered intolerable, negatively impacting a patient’s quality of life. Glycopyrronium tosylate is a topical anticholinergic agent that reduces sweat production by blocking the activation of acetylcholine receptors in peripheral sweat glands. In clinical trials, topical glycopyrronium tosylate, a pre-moistened cloth containing 2.4% glycopyrronium solution, was shown to be an effective, safe and non-invasive treatment for patients suffering from primary hyperhidrosis. This review examines the clinical trials of topical glycopyrronium tosylate and its role in primary hyperhidrosis. Glycopyrronium tosylate was recently US FDA-approved (as of June 2018) to manage patients with primary axillary hyperhidrosis.

PMID: 30970203 [PubMed – as supplied by publisher]

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Analysis of Contact Position for Subthalamic Nucleus Deep Brain Stimulation-Induced Hyperhidrosis.

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Analysis of Contact Position for Subthalamic Nucleus Deep Brain Stimulation-Induced Hyperhidrosis.

Parkinsons Dis. 2019;2019:8180123

Authors: Yang C, Qiu Y, Wu X, Wang J, Wu Y, Hu X

Abstract
Objectives: To analyze the hyperhidrosis neural network structure induced by subthalamic nucleus (STN) – deep brain stimulation (DBS).
Materials and Methods: Patients with Parkinson’s disease treated with STN-DBS in Changhai Hospital between July 1, 2015, and December 1, 2016, were analyzed retrospectively. Using records of side effects of the intraoperative macrostimulation test, patients with skin sweats were selected as the sweating group. Based on the number of cases in the sweating group, the same number of patients was randomly selected from other STN-DBS patients without sweating to form the control group. The study standardized electrode position with Lead-DBS software to Montreal Neurological Institute (MNI) standard stereotactic space to compare the differences in three-dimensional coordinates of activated contacts between groups.
Results: Of 355 patients, 11 patients had sweats during intraoperative macrostimulation tests. There was no significant difference in the preoperative baseline information and the postoperative UPDRS-III improvement rate (Med-off, IPG-on) between groups. Contacts inducing sweat were more medial (X-axis) (11.02 ± 0.69 mm vs 11.98 ± 0.84 mm, P=0.00057) and more upward (Z-axis) (-7.15 ± 1.06 mm VS -7.98 ± 1.21 mm, P=0.032) than those of the control group. The straight-line distance between the center of the sweat contact and the nearest voxel of the red nucleus was closer than that of the control group (2.72 ± 0.65 mm VS 3.76 ± 0.85 mm, P=0.00012).
Conclusions: STN-DBS-induced sweat indicated that the contact was at superior medial of STN.

PMID: 30956787 [PubMed]