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Experimental Drug Effective in Treating Anxiety

Side effects can include nausea, headache and sexual dysfunction

MONDAY, March 25, 2002 (HealthDayNews) -- If you suffer from an anxiety disorder, there soon may be another drug to help you.

The experimental drug escitalopram, brand name Lexapro, is effective in treating three different kinds of anxiety disorders: generalized anxiety disorder, panic disorder and social anxiety disorder, according to three new studies.

The results were presented at the annual meeting of the Anxiety Disorders Association of America, which concluded yesterday in Austin, Texas. The studies were funded by Forest Laboratories Inc., the maker of escitalopram.

One of the clinical trials showed that escitalopram significantly reduced symptoms in patients with generalized anxiety disorder (GAD) when compared to a placebo. The eight-week study, done by researchers at Duke University, included 240 patients from 18 to 80 years old.

"We found that folks with generalized anxiety disorder who entered the trial did better if they were on escitalopram, or Lexapro, than they did on placebo," says the study's lead author, Dr. Jonathan Davidson, the director of Duke University Medical Center's anxiety and traumatic stress program.

Davidson says escitalopram reduced such GAD symptoms as worry, dread, tiredness and irritability. It took about four weeks of use for the drug's benefits to be seen.

Those improvements were measured in different ways. The primary method of evaluation was the Hamilton Anxiety Scale (HAMA), which scores people based on interviews with a doctor.

To be eligible for the study, people had to have a minimum HAMA score of 18, which represents a moderate level of GAD, Davidson says.

People in the escitalopram group showed an average decline of about 10 points in their HAMA score compared to the placebo group, which averaged a decline of about seven points, Davidson says.

Side effects included nausea, insomnia, headache and sexual dysfunction.

A second study involved 247 people with panic disorder, while the third comprised 358 people with social anxiety disorder. Both studies found those who took escitalopram showed more improvement than those given a placebo.

One expert says escitalopram seems to be a promising treatment for anxiety disorders.

"What's interesting about this medication is that these studies show it's superior to placebo in treating anxiety," says Dr. Youssef Hassoun, chief resident in the department of psychiatry at the University of Connecticut Health Center.

That difference is an important indication of whether a new drug may prove effective, Hassoun says.

Escitalopram is in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). They are among the first line of therapy for anxiety and are safe, well-tolerated by patients and have no risk for addiction, Hassoun says.

SSRIs act in the brain on a chemical messenger called serotonin. Other drugs in this class include Prozac, Zoloft and Celexa.

Forest Laboratories applied in March 2001 to the U.S. Food and Drug Administration (FDA) to market escitalopram as a treatment for depression. The FDA in January issued an approvable letter for the drug. An approvable letter is the final stage before the FDA gives a company the OK to market a drug in the United States.

Forest Laboratories says it expects final approval to market escitalopram for depression by the middle of this year.

The company says the data collected from the clinical trials on anxiety disorders may be used to seek approvals from the FDA to market escitalopram as a treatment for such disorders.

Generalized anxiety disorder (GAD) affects 3 percent to 4 percent of Americans each year. It is characterized by six months or more of chronic, exaggerated and unfounded worry and tension.

Panic disorder affects about 2.4 million Americans between the ages of ages 18 and 54. It involves brief episodes of intense fear, accompanied by multiple physical symptoms, including a racing heartbeat, difficulty breathing, dizziness or nausea. These attacks occur repeatedly and unexpectedly without any type of external threat.

Social anxiety disorder, or phobia, affects 5.3 million Americans between the ages of 18 and 54. These people experience persistent, intense fear of being watched and judged by others and of being embarrassed or humiliated by their own actions.

What to Do: You can learn more about anxiety disorders at the National Institute of Mental Health, or the Anxiety Disorders Association of America.

SOURCES: Jonathan Davidson, M.D., professor, department of psychiatry and behavioral sciences, and director, anxiety and traumatic stress program, Duke University Medical Center, Durham, N.C.; Youssef Hassoun, M.D., chief resident, department of psychiatry, University of Connecticut Health Center, Farmington; presentation to Anxiety Disorders Association of America, Austin, Texas
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