Lexapro Significantly Reduces Anxiety
New studies show Lexapro™ significantly reduces anxiety in patients with generalized anxiety disorder (GAD).
Each year during the holidays, a significant number of Americans experience stress, anxiety and depression. Anxiety disorders are the most common mental illness in the U.S. with a significant portion of patients suffering from "generalized anxiety disorder," or GAD.
"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 Laboratories, Inc. (NYSE: FRX) announced the results of a pooled analysis of three positive generalized anxiety disorder (GAD) studies involving Lexapro(TM) (escitalopram oxalate) at an annual meeting of neuropsychopharmacologists. Additionally, one of the studies included in the pooled analysis was presented separately during the meeting. Each of the data sets showed patients receiving Lexapro had significantly greater improvement in anxiety symptoms relative to placebo beginning at the end of week one and continuing through the end of week eight.
GAD Pooled Analysis
More than 800 GAD patients participated in the three double blind, placebo-controlled, multi-center, eight-week studies. All three GAD studies were virtually identical in design, where the dose of Lexapro was fixed at 10 mg per day for the first four weeks and then flexibly dosed from 10-20 mg per day.
The primary efficacy variable was the HAMA total score. The HAMA psychic anxiety subscale, the CGI-I and the CGI-Severity were secondary efficacy variables. Analyses of the primary and secondary efficacy variables revealed significantly greater improvement in the Lexapro group relative to placebo beginning at the end of week one and continuing through the end of the study.
Lexapro was well tolerated by patients in the study with low rates of adverse events. The most common adverse events reported were headache, ejaculation disorder, nausea, diarrhea, and insomnia.
GAD Placebo-Controlled Study
One of the studies included the pooled analysis involved three hundred fifteen patients, aged 18 years and older, with GAD. Patients were randomly assigned to double-blind treatment with Lexapro (10 mg per day for the first four weeks, then flexibly dosed from 10-20 mg per day) or placebo for eight weeks. Patients treated with Lexapro showed a significantly greater improvement at endpoint compared with placebo in all prospectively defined efficacy parameters, including the Hamilton Rating Scale for Anxiety (HAMA), the Clinical Global Impressions (CGI) scores, the Hospital Anxiety and Depression (HAD) scale, the Covi and Raskin scales and the Quality of Life (QOL) scale.
In addition, treatment with Lexapro was well tolerated, with low rates of reported adverse events and an incidence of discontinuation due to adverse events not statistically different from placebo (8.9 percent vs. 5.1 percent).
About Generalized Anxiety Disorder
Anxiety disorders are the most common mental illness in the U.S., affecting 19.1 million adults, and they cost the U.S. more than $42 billion a year. The prevalence of generalized anxiety disorder is estimated to be 4 million or 2.8 percent of the U.S. population, and it affects women twice as often as men. According to DSM-IV-TR, the essential feature of GAD is excessive anxiety and worry (apprehensive expectations) about every day events or activities for a period of six months or more. This constant worry affects daily functioning and can cause physical symptoms. For a diagnosis to be made, worry must be present more days than not for at least six months. GAD frequently co-occurs with mood disorders, including depression. Additionally, up to 80 percent of people suffering from depression also experience symptoms of anxiety.
About Lexapro: An Isomer of Celexa
Lexapro is the product of a relatively new approach that involves the removal of one of two enantiomers from Celexa(TM) (citalopram HBr) to create a single-enantiomer drug. Celexa is a racemic mixture of two mirror-image halves called the S- and R-enantiomers. With Lexapro, the R-enantiomer (that does not contribute to Celexa's antidepressant activity) has been removed, leaving only the therapeutically active S-enantiomer. For more information on Lexapro, visit http://www.lexapro.com
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H. Lundbeck A/S, which developed both citalopram and escitalopram in Europe.