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      Faster Onset, Higher Response Rate With Escitalopram Than Racaemic Counterpart: Presented at ECNP

      By Paula Moyer

      PRAGUE, CZECH REPUBLIC -- October 13, 2003 -- People with moderate depression achieve a faster remission of symptoms when they are treated with the antidepressant escitalopram (Lexapro, Cipralex) than when they are treated with citalopram (Cilexa), according to findings presented here September 22nd at the 16th Congress of the European College of Neuropsychopharmacology.

      "We were able to observe superiority in remission of symptoms that persisted over 24 weeks," said Francois Menard, MD, medical director international clinical research, Lundbeck SA, Paris, France. Lundbeck is the manufacturer of both Lexapro (marketed as Cipralex in Europe) and Cilexa.

      Both escitalopram and citalopram are in the selective serotonin reuptake inhibitor (SSRI) class of antidepressants, and are drawn from the same molecule. Escitalopram, however, is the sinister (S)-enantiomer, or left component within the molecule and is the active antidepressant within the molecule. Citalopram is the racaemic or mixed version. Recent technology has allowed researchers to separate out the S-enantiomer from the racaemic version. The hope has been that escitalopram is at least as effective as citalopram with fewer adverse effects.

      Although previous research had shown escitalopram's efficacy in severely depressed patients, Dr. Menard and a team of investigators wanted to know its usefulness in moderately depressed patients, who comprise the largest number of depressed patients seen in general practice. The researchers compared the effect of treatment with fixed doses of escitalopram versus citalopram in 357 patients in a randomised, double-blinded, comparator-controlled trial.

      Patients received either 10 mg daily of escitalopram or 20 mg daily of citalopram. The investigators measured response to treatment with the Montgomery-Asberg Depression Rating Scale (MADRS) and with the Clinical Global Impression Scale (CGI-S).

      At the end of the 24-week study period, 174 patients treated with citalopram had a mean reduction in MADRS total score of 20.6; the 85 moderately ill patients in that arm had a mean MADRS total score reduction of 17.8. Among the 165 patients treated with escitalopram, the mean MADRS reduction was 21.6. For the 85 patients in the moderately ill group, the mean MADRS reduction was 20.2 (P<0.05). This superiority was seen at all periodic visits during the study period, Dr. Menard said.

      The investigators also observed a faster onset of action with escitalopram. At the eighth week of the study, escitalopram showed a significantly higher response rate, defined as a least a 50% reduction in MADRS total score, with 75% of escitalopram patients responding compared to 58 in the citalopram group (P=0.002).

      The remission rate, defined as a MADRS total score of no more than 12, was 75% in the escitalopram group compared to 53% in the citalopram group (P<0.001). The median time to remission was 5.5 weeks for those treated with escitalopram and 7.3 weeks for those in the citalopram arm.

      The investigators found no safety issues with either drug, and noted that both were well tolerated. They documented that 31% of patients in the citalopram group discontinued, compared with 12% in the escitalopram group (P<0.01).

      The adverse-event profile for both medications was similar, primarily consisting of nausea, rhinitis, headache, and back pain. The higher dropout rate for citalopram became significant by the eighth week, with 19% in the citalopram group discontinuing at that point, compared to 4% in the escitalopram group (P=0.004). The investigators saw no clinically relevant changes over baseline regarding laboratory tests, vital signs, body weight, and electrocardiogram parameters.


      [Study title: Escitalopram Versus Citalopram: More Efficacious And Well Tolerated In Long-Term Treatment Of Moderately Depressed Patients. Abstract P1-097]



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