Glycopyrronium tosylate (GT) is a topical anticholinergic that has been licensed in the United States for the treatment of primary axillary hyperhidrosis in individuals over the age of nine. GT has studied in duplicate, randomized, double-blind, vehicle-controlled phase III studies for primary axillary hyperhidrosis. GT was well accepted and decreased perspiration severity and output compared to the vehicle. For a study, researchers wanted to assess patient-reported outcomes (PROs). Patients aged greater than or equal to 9 with primary axillary hyperhidrosis for more than or equal to 6 months, gravimetrically measured sweat production for equal or more than 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD) Item 2 severity score greater than or equal to 4, and Hyperhidrosis Disease Severity Scale (HDSS) score more than or equal to 3 were randomly assigned 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. The four-item ASDD, six Weekly Impact (WI) items, the Patient Global Impression of Change (PGIC), the HDSS, and the Dermatology Life Quality Index (DLQI) were used.
In the pooled population, 463 patients were randomly assigned to GT and 234 to the vehicle; 426 (92.0%) and 225 (96.2%) completed the trials, respectively. At the outset, the majority of patients rated their axillary sweating as moderate in degree, effect, and bothersomeness (ASDD items 2, 3, and 4, respectively). Every research week, GT improved significantly more than the vehicle, and at week 4, ASDD ratings improved from baseline by 62.6 compared to 34.0% (severity), 65.5 versus 40.3% (impact), and 65.4 versus 39.0% (impact) (bothersomeness). WI items, PGIC, HDSS, and DLQI all improved in favor of GT over vehicles.
The PRO findings showed that GT decreased the illness burden of primary axillary hyperhidrosis.
Reference:link.springer.com/article/10.1007/s40257-018-0395-0
