Posted by Zo on July 7, 2001, at 0:37:07
from Psychiatry Medscape:
Adverse Event Rate Lower With Escitalopram Than Citalopram for Depression
NEW YORK (Reuters Health) Jul 05 - Researchers for Forest Laboratories on Thursday presented results of a pooled analysis of phase III trials that indicate that escitalopram, the company's new treatment for depression, yields fewer side effects than citalopram.
Forest sells citalopram as an antidepressant in 70 countries under several trade names, including Celexa, Cipramil and Seropram. The company submitted a new drug application to the US Food and Drug Administration in March seeking an indication for escitalopram in the treatment of depression.
In May, researchers reported that a 10 mg/day dose of escitalopram had shown similar efficacy to citalopram at 40 mg/day, as well as earlier, significant separation from the placebo arm in a phase III clinical trial. Escitalopram demonstrated statistically significant separation from placebo at week one while citalopram demonstrated significant separation at week four.
Pooled safety data, presented on Thursday at the annual World Congress of Biological Psychiatry meeting in Berlin, showed that both escitalopram (10 to 20 mg/day) and citalopram (20 to 40 mg/day) were well tolerated in 1,715 patients with a major depressive disorder.
Only three adverse events occurred at a rate higher than 10%: nausea with escitalopram, 15%; and nausea and diarrhea with citalopram, 17% and 11%, respectively.
Separately, the researchers examined the occurrence of adverse events from two trials that included a fixed dose of 10 mg/day of escitalopram. Only four adverse events--nausea, insomnia, diarrhea and influenza-like symptoms--were reported with a higher incidence than in the placebo arm, greater than 5% but less than 14%.
Noticeably absent from the list, according to Forest, were the adverse events commonly associated with selective serotonin reuptake inhibitors, including somnolence and ejaculation disorder. In addition, the data revealed fewer CNS stimulant side effects such as nervousness, anxiety and agitation.
Only 6% of the patients discontinued participation in the trials due to adverse events, compared to 2% for placebo recipients. Both fixed-dose trials of escitalopram 10 mg/day demonstrated discontinuation rates due to adverse events that were not statistically different from the placebo groups, according to Forest.
"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,'' Dr. Lawrence Olanoff, Forest executive vice president for scientific affairs, said in a statement.
poster:Zo
thread:69243
URL: http://www.dr-bob.org/babble/20010701/msgs/69243.html