Pooled Data from Five Comparator Studies Presented at American Psychiatric
Association Annual Meeting
PHILADELPHIA, May 21 /PRNewswire-FirstCall/ -- A subgroup of patients with
severe major depression demonstrated higher response rates after 12 weeks of
treatment with sertraline hydrochloride (HCl) compared to treatment with
fluoxetine, according to a new mega-analysis of data pooled from five
double-blind head-to-head, 12-week studies presented today at the American
Psychiatric Association (APA) annual meeting.
The analysis pooled available studies of the same design and duration to
examine the effect of two selective serotonin reuptake inhibitors (SSRIs) --
sertraline HCl and fluoxetine -- in patients with major depression. A
sub-analysis of the pooled data examined the 212 patients with a Hamilton
Depression Rating Scale (HDRS or HAM-D) score of greater than or equal to
26 representative of a patient population with severe depression. Among the
patients who completed the trials, a comparison of outcomes based on the
Clinical Global Impression-Improvement Scale (CGI-I) score showed that
significantly more patients treated with sertraline HCl responded to therapy
than did patients treated with fluoxetine (88 percent vs. 71 percent, p=0.03).
Response was defined as a CGI-I score of one, "very much improved," or two,
"much improved." A comparison of responses based on the HAM-D total score
trended towards statistical significance (82 percent for patients treated with
sertraline HCl vs. 69 percent for those treated with fluoxetine, p=0.054).
Response was defined as a greater than or equal to 50 percent reduction in
HAM-D total score by week 12. The total sample of patients from the five
comparator studies showed similar response rates between sertraline HCl and
fluoxetine.
"The pooled results from these comparator studies show that sertraline HCl
may be more effective than fluoxetine in treating patients with severe
depression," said Alan D. Feiger, MD, Director of the Feiger Health Research
Center.
Major depression is characterized by depressed mood and/or the loss of
interest or pleasure in most activities for a period of at least two weeks, in
combination with other symptoms that may include weight gain or loss or
changes in appetite, sleep disturbances, fatigue or loss of energy, feelings
or worthlessness or guilt, diminished ability to think or concentrate and
recurrent thoughts of death or suicide.
Depression affects approximately 20 million Americans and can be mild,
moderate or severe. Patients with severe depression experience symptoms that
typically interfere more seriously with the patient's ability to function at
home, at work and in other areas of their lives.
Sertraline HCl is indicated for depression, posttraumatic stress disorder
(PTSD), panic disorder (with or without agoraphobia), and obsessive-compulsive
disorder (OCD). It has been shown to be safe for long-term use in the
treatment of pediatric OCD when used as prescribed. Sertraline HCl is the
first and only FDA-approved therapy for the long-term treatment of PTSD.
Sertraline HCl is the most prescribed brand of its kind in the United
States and is available in 96 countries around the world. Since its approval
more than a decade ago, millions of people have been treated with sertraline
HCl.
Sertraline HCl is contraindicated until at least 14 days have passed since
discontinuing a monoamine oxidase inhibitor (MAOI) medicine. Patients should
never take sertraline HCl at the same time as an MAOI. Patients must wait at
least two weeks before switching from sertraline HCl to an MAOI or from an
MAOI to sertraline HCl.
Sertraline HCl is contraindicated in patients with a hypersensitivity to
sertraline HCl or any of the inactive ingredients in sertraline HCl.
Some people taking sertraline HCl may have side effects. The most common side
effects of sertraline HCl include upset stomach, having trouble sleeping,
diarrhea, dry mouth, sexual side effects, feeling unusually sleepy or tired,
tremor, indigestion, increase of sweating, feeling agitated and decreased
appetite. In clinical studies with sertraline HCl, few patients were bothered
enough by side effects to stop taking their medicine.
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines, for humans and animals, and many of the world's
best-known consumer products.
Full prescribing information is available upon request, or at
http://www.pfizer.com.
SOURCE Pfizer Inc
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