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WCBP: Escitalopram and Citalopram Appear Safe, Effective for Depression BERLIN, GERMANY -- July 5, 2001 -- Researchers will report today on the results of a pooled analysis of escitalopram and citalopram incorporating results from 1,715 patients with major depressive disorder. The pooled analysis will report on the safety results of the escitalopram registration database including all placebo-controlled studies conducted thus far for escitalopram, three of which included a citalopram arm. Each study was eight weeks in duration and similar in design. The efficacy results from the pooled database of phase III placebo-controlled studies of escitalopram and citalopram were presented at this year's American Psychiatric Association (APA) annual convention in May by Dr. Jack Gorman, Lieber Professor and Vice Chair for Research at the College of Physicians and Surgeons at Columbia University. In this analysis, escitalopram (10-20mg/day) improved depressive symptoms and produced greater effects relative to placebo than did citalopram at all time points. These results were further supported by the results of a fixed dose, Phase III study that was also presented at APA in May by Dr. William Burke, Professor of Psychiatry at the University of Nebraska Medical School. In this study escitalopram 10mg/day and citalopram 40 mg/day demonstrated similar improvements in depression symptoms at study endpoint. Escitalopram 10mg/day however, significantly separated from placebo at earlier time points than did citalopram 40mg/day. In the pooled safety analysis to be presented in Berlin, incidence rates for adverse events occurring at rates of greater than 5 percent and higher than placebo were presented. Both escitalopram (10-20mg/day) and citalopram (20-40mg/day) were very well tolerated with very few adverse events occurring at incidence rates above 10 percent (escitalopram - nausea at 15 percent; citalopram - nausea at 17 percent, diarrhea at 11 percent). A separate analysis examined the incidence of adverse events from two trials that included a fixed dose of 10mg/day of escitalopram, a dose that had shown similar efficacy at endpoint to citalopram 40mg/day and earlier separation from placebo in a Phase III clinical trial. Only four adverse events were reported with an incidence rate greater than 5 percent (all were below 14 percent) and with a higher incidence than placebo (nausea, insomnia, diarrhea and influenza-like symptoms). Noticeably absent from the list were the common selective seretonin reuptake inhibitor (SSRI) adverse events of somnolence and ejaculation disorder as well as several central nervous system (CNS) stimulant side effects such as nervousness, anxiety and agitation. The incidence rate of discontinuation due to adverse events for escitalopram was low in the pooled analysis of escitalopram studies at 6 percent versus a placebo rate of 2 percent. All fixed dose trials of escitalopram 10 mg/day have demonstrated discontinuation rates due to adverse events that were not statistically different than placebo. This finding has also been repeated in flexible-dose trials (10 to 20 mg/day escitalopram) in which patients were initiated on 10 mg/day and titrated to 20 mg/day based upon clinical need. The consistency of this finding across several studies provides further evidence as to the excellent tolerability of escitalopram. "We are pleased with the safety results presented at the World Congress of Biological Psychiatry meeting in Berlin. These results are especially impressive when they are considered in the context of the previously presented pooled efficacy results demonstrating greater improvement relative to placebo for escitalopram than for citalopram at substantially lower doses," said Lawrence Olanoff, MD, PhD, Executive Vice President for Scientific Affairs at Forest. Citalopram is a racemic mixture with two mirror image halves called the S- and R-isomers. The S-isomer of citalopram is the active isomer in terms of its contribution to citalopram's antidepressant effects, while the R-isomer does not contribute to its antidepressant activity. With escitalopram, the R-isomer has been removed, leaving only the therapeutically active S-isomer. Based on the clinical trial data, Forest Laboratories submitted a new drug application (NDA) on March 23, 2001 to the U.S. Food and Drug Administration seeking an indication for escitalopram for the treatment of depression. SOURCE: Forest Laboratories, Inc. Related Link: Forest Laboratories, Inc. E-mail this page to a friend or colleague! To print, use this version