Lexapro
Significantly Reduces Anxiety In Generalized Anxiety Disorder Patients
Awaiting GAD
Approval
(Dec. 11, 2002) Results from three studies
involving
Lexapro (escitalopram oxalate) showed that the drug reduces
anxiety symptoms versus placebo, according to Lexapro manufacturer Forest
Laboratories, Inc.
In a press release Wednesday, the company said
800 patients participated in the eight-week studies and were given 10
milligrams a day for the first four weeks and then were flexibly dosed from 10
to 20 mg a day.
The primary efficacy variable was the Hamilton
Rating Scale for Anxiety, or HAMA, total score. The HAMA psychic anxiety
subscale, the Clinical Global Impressions, or CGI-I, and the CGI-Severity were
secondary efficacy variables.
Lexapro was well-tolerated by patients in the study with
low rates of adverse events including headache, ejaculation disorder, nausea,
diarrhea and insomnia.
One of the studies included the pooled analysis
involved 315 patients, aged 18 years and older, with
generalized anxiety disorder. Patients were randomly
assigned to double-blind treatment with Lexapro or placebo for eight weeks.
Patients treated with Lexapro showed a significantly greater improvement at
endpoint compared with placebo in all efficacy parameters.
Additionally, treatment with Lexapro was
well-tolerated, with low rates of reported adverse events, and discontinuation
from adverse events wasn't statistically different from placebo.
"Currently, more than four million
Americans suffer from generalized anxiety disorder," said Jonathan
Davidson, M.D., Professor of Psychiatry, Director of the Anxiety and Traumatic
Stress Program at Duke University. "For this reason, physicians are
actively seeking new medications for the treatment of anxiety."
Forest Awaiting GAD Indication For Lexapro
In November, the company filed a supplemental
new drug application with the FDA to allow Lexapro to be used for
generalized anxiety
disorder treatment.
Forest Laboratories estimates that anxiety
disorders represent a market worth more than $42 billion a year.
Other Lexapro Stories:
For comprehensive information on depression,
visit the HealthyPlace.com Depression Center. On
HealthyPlace.com Radio, we've done several shows on depression. Listen to them
in our 2002 and
2001 archives.
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