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Paxil CR (Paroxetine) Reduces Menopausal Hot Flashes

PHILADELPHIA, PA -- June 4, 2003 -- Paxil CR™ (paroxetine HCl Controlled-Release tablets) reduces hot flash symptoms and is well tolerated in women suffering from menopausal hot flashes, according to a study published in the June 4 issue of the Journal of the American Medical Association (JAMA).

Findings from this trial showed that women taking Paxil CR experienced more than a 60 percent reduction in hot flashes, compared to 38 percent for the placebo group. This is the first large-scale, placebo- controlled study to look at the efficacy of an antidepressant, like Paxil CR, as a treatment for hot flashes in a general cross-section of menopausal women.

Although hormone replacement therapy (HRT) was considered the gold standard treatment for hot flashes, recent clinical findings have called the safety of the long-term use of HRT into question. Experts are currently seeking alternatives to treat menopausal symptoms over an extended period of time. Researchers of the government-funded Women's Health Initiative (WHI) discontinued the HRT arm of the study last summer when they reached the groundbreaking conclusions that the risks of HRT, when used long-term, outweighed its benefits. Currently, HRT is the only approved treatment for hot flashes.

"Approximately 25 million women experience hot flashes with menopause, and the news that HRT may not be safe, when taken over an extended period of time, left many concerned about how to treat this often debilitating symptom," said Marsha Lynn Speller, M.D., Clinical Investigator, Director, Women's Healthsource. "These data are encouraging and clearly showed a reduction in hot flashes with Paxil CR."

First Large-Scale, Placebo-Controlled Study in Menopausal Women of an Antidepressant for Hot Flashes

In a randomized, double-blind, placebo-controlled multi-center study, 165 menopausal women meeting a clinical definition for menopause who experienced at least two to three hot flashes daily, or at least 14 bothersome hot flashes per week, were randomized to receive Paxil CR(TM) (paroxetine HCl Controlled-Release tablets) 12.5mg/day, Paxil CR 25mg/day or placebo for six weeks. The participants were screened for and excluded if an active psychiatric disorder or substance abuse disorder was detected.

The primary endpoint of this study was the mean change from baseline in the daily hot flash composite score (as calculated by frequency multiplied by severity). Daily hot flash diaries were used to document the frequency and severity of hot flashes. Secondary endpoints included weekly changes in the hot flash composite score and a measure of menopausal symptoms (e.g., hot flashes, night sweats and an assessment of medication). These findings were corroborated by a significant improvement in vasomotor symptoms, as assessed by a validated questionnaire used to measure core menopausal symptoms.

Data Highlight Paxil CR Efficacy and Tolerability in Managing Menopausal Hot Flashes

By week six, women treated with Paxil CR 12.5mg/day and 25 mg/day experienced more than three fewer hot flashes per day, a statistically significant finding compared to placebo (3.3, 3.2 and 1.8 flashes/day respectively). The data also showed a significant reduction in the composite score -- a measure of both frequency and severity -- of 62 percent and 65 percent for the Paxil CR groups respectively, compared to a 38 percent reduction for placebo. Significant improvement in the hot flash composite score was noted in the Paxil CR 25 mg/day arm within the first week of treatment. These findings were corroborated by significant improvement in vasomotor symptoms, as assessed by an analysis of the secondary measure of core menopausal symptoms.

Paxil CR was generally well tolerated in this trial. A total of 54 percent of patients receiving placebo reported an adverse event during the study, compared to 58 percent treated with Paxil CR. Events experienced by patients receiving Paxil CR were in line with its known tolerability profile. In both groups, the majority of adverse events reported were mild to moderate in severity, and of those women who experienced adverse events, only 12 (4 Paxil CR 12.5mg/day (8%) and 8 Paxil CR 25.5mg/day (14%)) did not complete the study.

"The most common complaint in menopausal women is hot flashes, but some women are apprehensive about the safety of treatment," stated Dr. Speller. "These data clearly demonstrate that Paxil CR reduced vasomotor symptoms of menopause in women without a depressive or anxiety disorder."

About Hot Flashes
Hot flashes are the most common complaint among women entering menopause. Today, more than 25 million women in the United States suffer from hot flashes, 4 million of whom reported severe symptoms. Hot flashes are a subjective and transient sensation of heat that can last for up to ten minutes, and are accompanied by differing degrees of flushing, palpitations, anxiety, irritability and rarely, panic. Many women experience hot flashes for up to five years, and approximately one-fifth of all women suffer from hot flashes for up to 15 years.

About Paxil CR
Paxil CR™ (paroxetine HCl Controlled-Release tablets) is approved by the U.S. Food and Drug Administration for the treatment of major depressive disorder and panic disorder. Most common adverse events (incidence of 5% or greater and incidence for Paxil CR and at least twice that for placebo) in studies for major depressive disorder and panic disorder include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawning, sweating, abnormal vision, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from antidepressant medication, including Paxil CR. Concomitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated.


SOURCE: GlaxoSmithKline

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