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      Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials

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          Abstract

          Background

          Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years. GT was evaluated for primary axillary hyperhidrosis in replicate, randomized, double-blind, vehicle-controlled, phase III trials. GT reduced sweating severity and production versus vehicle and was generally well tolerated.

          Objective

          Our objective was to evaluate patient-reported outcomes (PROs) from these trials.

          Methods

          Patients aged ≥ 9 years with primary axillary hyperhidrosis ≥ 6 months, gravimetrically measured sweat production ≥ 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD) Item 2 severity score ≥ 4, and Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 3 were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. The 4-item ASDD, 6 Weekly Impact (WI) items, Patient Global Impression of Change (PGIC), HDSS, and Dermatology Life Quality Index (DLQI) were utilized.

          Results

          In the pooled population, 463 patients were randomized to GT and 234 to vehicle; 426 (92.0%) and 225 (96.2%) completed the trials. At baseline, most patients considered their axillary sweating to be at least moderate in severity, impact, and bothersomeness (ASDD items 2, 3, and 4, respectively). Improvement was substantially greater for GT than for vehicle at every study week, and, at week 4, ASDD scores improved from baseline by 62.6 versus 34.0% (severity), 65.5 versus 40.3% (impact), and 65.4 versus 39.0% (bothersomeness). Improvements favoring GT versus vehicle also occurred for WI items, PGIC, HDSS, and DLQI.

          Conclusions

          PRO results demonstrated that GT reduced the disease burden of primary axillary hyperhidrosis.

          Trial registration

          Clinicaltrials.gov; ATMOS-1 (NCT02530281), ATMOS-2 (NCT02530294).

          Electronic supplementary material

          The online version of this article (10.1007/s40257-018-0395-0) contains supplementary material, which is available to authorized users.

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          Most cited references19

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          Translating the science of quality of life into practice: What do dermatology life quality index scores mean?

          This study's aim was to determine the relationship between Dermatology Life Quality Index (DLQI) scores and a Global Question (GQ) concerning patients' views of the overall impairment of their skin-related quality of life (QoL), and to express this relationship by identifying bands of DLQI scores equivalent to each GQ descriptor. A DLQI questionnaire and the GQ were mailed to 3834 adult general dermatology outpatients. There were 1993 (52%) responses: male 841; female 1152. Mean DLQI score = 4.86 (range 0-30, standard deviation (SD) = 5.83). Mean GQ score = 1.22 (range 0-4, SD = 1.20). The mean, mode, and median of the GQ scores for each DLQI score were used to devise several sets of bands of DLQI scores, and kappa coefficients of agreement calculated. The set proposed for adoption is: DLQI scores 0-1 = no effect on patient's life (GQ = 0, n = 754); DLQI scores 2-5 = small effect on patient's life (GQ = 1, n = 611); DLQI scores 6-10 = moderate effect on patient's life (GQ = 2, n = 327); DLQI scores 11-20 = very large effect on patient's life (GQ = 3, n = 242); DLQI scores 21-30 = extremely large effect on patient's life (GQ = 4, n = 59); kappa coefficient 0.489. Banding of the DLQI will aid the clinical interpretation of an individual's DLQI score and allow DLQI scores to inform clinical decisions.
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            Determining the Minimal Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index (DLQI): Further Data

            Aims: To determine the minimal clinically important difference (MCID) of the Dermatology Life Quality Index (DLQI) and its responsiveness to change in inflammatory skin diseases. Methods: A longitudinal study: at stage 1, patients completed the DLQI and a disease severity global question; at stage 2, a global rating of change in quality of life (QoL; Global Rating of Change Questionnaire, GRCQ) was added and used as an anchor to measure the MCID of the DLQI. Results: 192 patients completed stage 1 and 107 completed stage 2. The mean DLQI score at stage 1 was 9.8 and 7.4 at stage 2 with a mean change of 2.4 (p < 0.0001). 31 patients experienced a ‘small change' in their QoL (±3 and ±2) on the GRCQ. The mean corresponding change in DLQI scores was 3.3, which is regarded as the approximate MCID. Conclusions: Previous estimates of the MCID of the DLQI have varied from 3 to 5. Although this study demonstrated a MCID of 3.3, we recommend that the MCID in inflammatory skin diseases should be 4.
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              US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey.

              The current epidemiologic data on hyperhidrosis are scarce and insufficient to provide precise prevalence or impact estimates. We sought to estimate the prevalence of hyperhidrosis in the US population and assess the impact of sweating on those affected by axillary hyperhidrosis. A nationally representative sample of 150,000 households was screened by mailed survey for hyperhidrosis and projected to the US population based on US census data. Ascertainment of hyperhidrosis was based on a question that asked whether participants experienced excessive or abnormal/unusual sweating. The prevalence of hyperhidrosis in the survey sample was 2.9% (6800 individuals). The projected prevalence of hyperhidrosis in the United States is 2.8% (7.8 million individuals), and 50.8% of this population (4.0 million individuals) reported that they have axillary hyperhidrosis (1.4% of the US population). Only 38% had discussed their sweating with a health care professional. Approximately one third of individuals with axillary hyperhidrosis (0.5% of the US population or 1.3 million individuals) reported that their sweating is barely tolerable and frequently interferes, or is intolerable and always interferes, with daily activities. Hyperhidrosis affects a much larger proportion of the US population than previously reported. More than half of these individuals have axillary hyperhidrosis, in which sweating can result in occupational, emotional, psychological, social, and physical impairment.
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                Author and article information

                Contributors
                757-622-6315 , dpariser@pariserderm.com
                Journal
                Am J Clin Dermatol
                Am J Clin Dermatol
                American Journal of Clinical Dermatology
                Springer International Publishing (Cham )
                1175-0561
                1179-1888
                30 October 2018
                30 October 2018
                2019
                : 20
                : 1
                : 135-145
                Affiliations
                [1 ]GRID grid.478129.1, Eastern Virginia Medical School and Virginia Clinical Research, Inc., ; 6160 Kempsville Circle, Suite 200A, Norfolk, VA 23502 USA
                [2 ]UTHealth McGovern Medical School, Houston, TX USA
                [3 ]GRID grid.476220.5, Dermira, Inc., ; Menlo Park, CA USA
                [4 ]QST Consultations, Allendale, MI USA
                [5 ]ISNI 0000 0004 1936 9342, GRID grid.262962.b, Saint Louis University, ; St. Louis, MO USA
                Article
                395
                10.1007/s40257-018-0395-0
                6516143
                30378087
                3741ac7e-962e-4b75-9a30-04a08cd35da7
                © The Author(s) 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Funding
                Funded by: Dermira, Inc.
                Categories
                Original Research Article
                Custom metadata
                © Springer Nature Switzerland AG 2019

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