2022 Volume 39 Issue 1 Pages 55-63
A long-term study was performed to assess the safety and efficacy of glycopyrronium tosylate hydrate (GT) wipes in Japanese patients with primary axillary hyperhidrosis. Patients applied 3.75% or 2.5% of GT wipe to the left and right axillae once daily for up to 52 weeks. A total of 377 patients (GT 3.75% group, n=194; GT 2.5% group, n=183) received at least one application and outcomes were analyzed. The incidence rates of adverse events were 69.1% and 73.8% in the GT 3.75% group and GT 2.5% group, respectively. Many adverse events were mild in severity and recovered or improved. One death (due to cardiac failure congestive) was reported in the GT 3.75% group and 1 and 6 serious adverse events were reported in the GT 3.75% and GT 2.5% groups, respectively. Of these, only 1 case, mydriasis, in the GT 3.75% group had a causal relationship with the study drug. Adverse events leading to discontinuation or interruption of the treatment and adverse events on the application sites were limited. The rates of adverse events related to anticholinergic activity mydriasis/vision blurred were 13.4% and 10.9% in the GT 3.75% group and GT 2.5% group, respectively, and symptoms associated with urination was reported in 6.7% and 5.5% in these groups, respectively. The rates of these adverse events did not increase with long-term application. GT efficacy, which was measured based on the Hyperhidrosis disease severity scale, gravimetrically-measured sweat production and Dermatology life quality index was maintained throughout the study. The long-term efficacies of GT 3.75% and 2.5% were comparable. The long-term application of a GT wipe in patients with primary axillary hyperhidrosis was well tolerated, and high efficacy was maintained. This finding suggests that a GT wipe can provide benefit as a first-line treatment for primary axillary hyperhidrosis in Japan.
