乌鸦传媒

SAN DIEGO -- About 80% of pediatric patients with primary axillary hyperhidrosis had at least a 50% decrease in sweat production when using anticholinergic-containing towelettes, a subgroup analysis of two randomized trials showed.

Axillary sweat production decreased by 64 mg/5 min (from a baseline mean of 146 mg/5 min) in children assigned to a 4-week trial of towelettes containing glycopyrronium tosylate (GT). Sweat production declined by 54 mg/5 min (from a baseline mean of 152 mg/5 min) in children assigned to wipes containing an inert vehicle substance.

Children and adults had similar improvement in quality of life (QOL) when using the GT towelettes, Adelaide Hebert, MD, of the University of Texas Health Science Center in Houston, reported here at the American Academy of Dermatology annual meeting.

"Hyperhidrosis is generally undertreated and underdiagnosed, especially among pediatric patients," said Hebert. "In this post-hoc analysis of two large phase III trials, topically applied glycopyrronium tosylate improved disease severity, sweat production, and quality of life [QOL] relative to vehicle, with similar findings in pediatric and older patients. Glycopyrronium tosylate was generally well tolerated in these studies, and treatment-emergent adverse events in pediatric patients were similar to those in older patients and consistent with those seen with anticholineregic agents.

"Topical [GT] treatment may provide a much-needed treatment option for patients with primary axillary hyperhidrosis, including pediatric patients."

Hyperhidrosis affects about 5% of the U.S. population, adversely affecting QOL to a degree similar to that seen with psoriasis, Hebert noted in the introduction to the findings. Responses to an online survey showed that 17.1% of U.S. teenagers reported excessive sweating.

In the randomized, vehicle-controlled and trials, topical anticholinergic GT significantly decreased disease severity and sweat production and improved QOL. Limited data exist regarding the efficacy of treatments for hyperhidrosis in pediatric patients, Hebert continued. The ATMOS trials included patients as young as 9, affording an opportunity to evaluate the efficacy of GT in pediatric patients.

The two trials involved a combined total of 697 patients. The subgroup analysis focused on 44 patients ages 9 to 16, with 25 randomized to use the GT wipes. The remaining 19 patients were assigned to wipes containing an inert vehicle substance.

The ATMOS trials had co-primary endpoints assessed at 4 weeks: a four-point improvement (responder) on the Axillary Sweating Daily Diary (ASDD) and the absolute change in axillary sweat production. Secondary endpoints included the proportion of patients achieving at least a two-point improvement in the Hyperhidrosis Disease Severity Scale (HDSS) and at least a 50% decrease in sweat production (response). At the end of randomized treatment, all patients had the option to enter a 44-week open-label extension evaluation of the GT wipes.

In the pediatric subset, all 19 patients randomized to the control group completed the study, as did 24 of 25 patients randomized to the GT wipes. Hebert said the patient who discontinued did so because of cholinergic adverse effects. Completion rates in the younger patients were similar to the rates in the patients older than 16.

The results showed that 59.9% of patients in the pediatric subset met ASDD responder criteria, compared with 13.0% of pediatric patients assigned to the control group. That compared with response rates of 60.2% and 28.8% in the over-16 patients allocated to the GT and control groups.

The 64 mg/5 min absolute decrease in axillary sweat production among pediatric patients assigned to the GT wipes compared with an absolute reduction of 81 mg/5 min in adults (from a baseline mean of 174 mg/5 min). The 54 mg/5 min decrease among children in the control group compared with 62 mg/5 min in adults (from a baseline mean of 178 mg/5 min).

Hebert reported that 79.9% of children assigned to the GT wipes had at least a 50% reduction in axillary sweat production, compared with 54.8% assigned to the control groups. Corresponding rates in the older patients were 74.3% and 53.0%.

Improvement in the Dermatology Quality of Life Index was similar in pediatric (8.1 points) and older patients (8.4 points) who used the GT wipes. Children randomized to the control groups had a mean improvement of 1.9 points, whereas the older patients had a mean improvement of 4.7 points.

Treatment-emergent adverse events occurred more often with the GT wipes than with control wipes in the pediatric population (44.0% versus 10.5%) and older patients (56.7% versus 34.3%). The most frequently reported GT-associated adverse events in the pediatric subgroup were nausea, application-site pain, oropharyngeal pain, and epistasis (two cases each). The investigators documented a total of four GT-associated severe adverse events, consisting of three patients in the older group and the one pediatric patient who discontinued treatment.

Anticholinergic treatment-emergent adverse events (TEAEs) in the pediatric group treated with the GT towelettes included six cases of dry mouth, four of mydriasis, and three of blurred vision. Among older patients randomized to the GT wipes, the most common anticholinergic TEAE was dry mouth (105 patients, 24.2%).

Comment