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Stopping Excessive Sweating: First Long-Term Study of Botox Shows It's Effective, Improves Quality of Life

Embarrassing Disease Can Be More Debilitating Than Rheumatoid Arthritis, Depression

(press release from Saint Louis University Health Sciences Center)

ST. LOUIS, July 29 -- A new study from Saint Louis University School of Medicine offers good news for patients with a surprisingly common disease that causes them to sweat too much, even during the dead of winter.

Interim data from the first long-term study of repeated treatment with Botox(r) (botulinum toxin type A) for the treatment of severe primary axillary hyperhidrosis (severe underarm sweating) inadequately managed with topical agents demonstrated that Botox is safe and effective and consistently results in clinically meaningful, long-lasting improvements in patients' symptoms, daily functioning and quality of life.

These findings are from one of several new studies assessing Botox safety, efficacy and cost-effectiveness -- as well as the impact of this serious medical condition on patients' daily lives -- being presented this week by researchers at the summer meeting of the American Academy of Dermatology in Chicago.

"These long-term data demonstrate that Botox for severe primary axillary hyperhidrosis over a two-year period is a safe and effective therapeutic option for patients who otherwise struggle with substantial impairment," said Dee Anna Glaser, M.D., professor of dermatology and vice chairman of dermatology at Saint Louis University School of Medicine, and lead investigator of the study. "The fact that this condition causes more debilitation than such serious ailments as osteoarthritis, rheumatoid arthritis and depression indicates the importance for patients to get the right diagnosis and treatment as soon as possible."

Hyperhidrosis is a treatable medical disorder that results in sweating that exceeds the normal amount required to maintain consistent body temperature. A past research survey by Dr. Glaser concluded that up to 8 million people or 2.8 percent of the U.S. population has this condition. Patients with hyperhidrosis produce up to four times the average volumes of sweat that may often cause social embarrassment or interfere with daily activities.

It is believed that hyperhidrosis is the result of a malfunction in the sympathetic nervous system, which regulates body temperature. People with hyperhidrosis are thought to produce too much of a specific neurotransmitter in the sympathetic nervous system, or to have sweat glands that overreact to normal levels of the neurotransmitter. In either case, excessive perspiration is the result.

The three-year open-label extension study was designed to assess the safety and efficacy of repeated Botox treatment for severe primary axillary hyperhidrosis and its effect on measures of health-related quality of life (HRQOL) and daily functioning. The study enrolled 193 patients who had participated in a previous, one-year randomized, placebo-controlled clinical trial. Repeat Botox injections were administered when the clinical effect of a previous injection diminished and patients reported a score of 3 or 4 on the Hyperhidrosis Severity Scale (HDSS), indicating their underarm sweating was barely tolerable or intolerable and frequently or always interfered with their daily activities, and when a gravimetric measurement was recorded of at least 50 mg of spontaneous sweat in each axilla over five minutes at rest.

Interim results from this study showed that Botox continued to be effective with repeated treatment. After treatment sessions 2 and 3, 81 percent (83/104) and 78 percent (40/51) of patients, respectively, reported at least a 2-grade improvement in HDSS score. Repeated treatment with Botox also produced a consistent reduction ( greater than or equal to 75 percent) in sweat production. Patient-reported measures of treatment efficacy reflected this clinical improvement, e.g.:

-- Patients reported significantly less occupational dissatisfaction and limitation. Before treatment, 66 to 72 percent of patients were somewhat or very dissatisfied with their ability to perform their current work activities, compared to just 9 to 20 percent of patients after treatment (p<0.001).
-- The number of patients who reported feeling "emotionally damaged or injured" because of their hyperhidrosis was reduced by approximately half (76 to 83 percent of patients before vs. 32 to 42 percent after treatment, p<0.001).
-- Patients reported significantly less limitation in interpersonal and social situations. Before treatment only 17 to 33 percent of patients reported being somewhat or very satisfied with their ability to perform non-work activities, a proportion that increased to 78 to 88 percent of patients after treatment.

No serious treatment-related adverse events were reported. The most frequently reported adverse events were infection (respiratory system: 14 percent), infection (body as a whole: 12 percent) and injection-site pain (11 percent). The majority of adverse effects were mild in severity.

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.

Contact:
Joe Muehlenkamp
Phone: 314.977.8015
muehlenk@slu.edu


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