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Title: APA: Antidepressant Fluoxetine May Reduce Frequency, Severity of Panic Attacks
URL: http://www.pslgroup.com/dg/1D1FFA.htm
Doctor's Guide
May 17, 2000


INDIANAPOLIS, IN -- May 17, 2000 -- New research suggests that the therapeutic 20 mg daily dose of fluoxetine hydrochloride prescribed for depression may be effective in reducing the severity and frequency of panic attacks as well as other symptoms of panic disorder. The research was presented today at the 153rd Annual Meeting of the American Psychiatric Association in Chicago, Ill.

"This study suggests that fluoxetine can reduce the severity and frequency of panic attacks at a dose of 20 mg per day, which is the recommended dose for the treatment of depression and is a dose familiar to most health care professionals," said David Michelson, M.D., medical director at Eli Lilly and Company and lead author of the study.

Key study findings include:
* After six weeks and at endpoint (12 weeks), fluoxetine was associated with a statistically significant reduction in severity of global panic disorder symptoms (p=.035, p=.009) as rated on the Panic Disorder Severity Scale.
* A statistically significantly greater number of patients were panic free at six weeks and endpoint compared with placebo (p=.024, p=.02).
* Fluoxetine was associated with a greater percentage of patients who reported a 50 percent or greater reduction in frequency of full panic attacks at six weeks and endpoint compared with placebo (p=.036, p=.001).
* Fluoxetine demonstrated greater mean reduction in anxiety and functional impairment compared with placebo from baseline to endpoint as ranked by the Hamilton Anxiety rating scale (p=.043), the State-Trait Anxiety Inventory (p=.005), and Sheehan Work and Social scales (p=.004, p=.002).

Patients involved in the study met diagnostic criteria for panic disorder as assessed by the Structured Clinical Interview for DSM-IV. Data were gathered from a double-blind, randomized, parallel, placebo-controlled nine- site trial conducted with 180 patients in Europe. Patients were randomized to either fluoxetine at 20 mg/day (initiated at 10 mg/day for one week) or placebo for 12 weeks. Baseline characteristics for the groups were similar as rated on the Panic Disorder Severity Scale (p=.27), CGI-severity scale (p=.95), and Hamilton Anxiety rating scale (p=.42).

Panic disorder is a potentially debilitating illness that affects up to three million adults each year in the United States. Panic disorder includes recurrent and unexpected panic attacks and can include a significant change in behavior related to the attacks and excessive worry regarding the implication of those attacks. Additionally, the National Mental Health Association estimates that approximately 50 percent of people with panic disorder develop the condition prior to age 24. Women are twice as likely as men to suffer from the disorder.

A person experiencing a panic attack often suffers from physical symptoms -- such as rapid heart rate or choking sensation -- as well as psychological symptoms, including intense fear and anxiety. Consequently, many people who suffer panic attacks can become housebound from the fear of experiencing a public attack.

Fluoxetine currently is indicated by the U.S. Food and Drug Administration for the treatment of depression, obsessive-compulsive disorder and bulimia nervosa. The most commonly observed events associated with fluoxetine vs. placebo in U.S. controlled clinical trials for depression, obsessive- compulsive disorder and bulimia combined were nausea (23 vs. 10 percent), headache (21 vs. 20 percent), insomnia (20 vs. 11 percent), anxiety (13 vs. 8 percent), nervousness (13 vs. 9 percent) and somnolence (13 vs. 6 percent). Fluoxetine is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at least five weeks after discontinuation with fluoxetine. Fluoxetine should be discontinued immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be identified. Safety and effectiveness in pediatric patients have not been established.

The study was funded by a grant from Lilly Research Laboratories, a division of Eli Lilly and Company. Other researchers involved in the study were Christer Allgulander, MD; Neena Sarkar, Ph.D.; and S. Craig Pemberton, B.S.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

Related Link: Eli Lilly and Company.

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