Story Filed: Wednesday, April 12, 2000 11:39 AM EST

NEW YORK, Apr 11, 2000 /PRNewswire via COMTEX/ -- Patients diagnosed with posttraumatic stress disorder (PTSD) who were treated with Zoloft (sertraline HCl) showed significant reduction in the symptoms of PTSD compared to placebo, according to a study published this week in the Journal of the American Medical Association (JAMA).

Patients in the double-blind, placebo-controlled trial also experienced significant improvement in their quality of life and social and occupational functioning. Zoloft, a selective serotonin reuptake inhibitor discovered and developed by Pfizer Inc, is the first medicine to receive FDA approval for the treatment of PTSD.

"Despite the high prevalence of PTSD and its physical and emotional impact on patients, few placebo-controlled studies have evaluated the efficacy of treatment for the disorder in the general population," said Dr. Kathleen Brady, lead author of the study, and Professor of Psychiatry at the Medical University of South Carolina. "This study is the largest done with any treatment to date, and it showed that Zoloft had significant effect not only on the symptoms of PTSD, but on quality of life as well."

Approximately 50 percent of the general population are exposed to a traumatic event during the course of a lifetime, with 10 to 20 percent developing PTSD. The prevalence of PTSD is twice as high in women as in men.

In some people, posttraumatic stress disorder may develop following an extreme traumatic event in which there was threatened death or serious injury, and the individual's response involved intense fear, helplessness or horror. Such events include physical and sexual assault, natural disasters, serious accidents or the sudden, unexpected death of a loved one.

Symptoms can include persistent intrusive thoughts of the event, flashbacks, overall emotional numbness, or being easily startled. These symptoms affect daily life, including the ability to work or interact with family and friends.

Total direct and indirect costs to society of anxiety disorders, including PTSD, are estimated to be $42.3 billion annually in the United States (1990 dollars). Posttraumatic stress disorder is associated with a high incidence of comorbid depression and other anxiety disorders.

The Zoloft study included 187 patients who had suffered from PTSD for an average of 12 years and had experienced a trauma such as a serious accident or injury or a natural disaster. Seventy-three percent of the patients were women, and of those, 61.5 percent had experienced physical or sexual assault.

Zoloft is approved to treat PTSD in both men and women. More women than men experience PTSD. There were three times more women than men in the Zoloft PTSD clinical studies and in these studies, women responded better to Zoloft than men. What this means to the treatment of a patient is unknown. Only a doctor can determine if Zoloft is right for a patient.

Zoloft is indicated for depression, obsessive-compulsive disorder (OCD), panic disorder and posttraumatic stress disorder (PTSD). Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) medicine.

MAOI medicines are used to treat depression and other conditions. A patient should never take Zoloft at the same time as a MAOI. A patient must wait at least two weeks before switching from Zoloft to a MAOI or from a MAOI to Zoloft. Some people taking Zoloft may get side effects. The most common side effects of Zoloft include upset stomach, having trouble sleeping, diarrhea, dry mouth, sexual side effects in men and women, feeling unusually sleepy or tired, tremor, indigestion, sweating, decreased appetite and feeling agitated.

Pfizer Inc (NYSE: PFE) is a research-based global pharmaceutical company that discovers, develops, manufactures and markets innovative medicines for humans and animals. The company reported revenues of more than $16 billion in 1999 and expects to spend about $3.2 billion on research and development this year.

Full prescribing information is provided upon request.

SOURCE Pfizer Inc

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