Lexapro®/Cipralex® demonstrated significance on prospectively defined efficacy parameter and was better tolerated than Cymbalta® in treatment of depression
06-12-2006 - H. Lundbeck A/S´s partner in the US Forest Laboratories, Inc. today announced the results of a new head to head study of Lexapro®/Cipralex® (escitalopram oxalate) versus Cymbalta® (duloxetine). The study demonstrated Lexapro®/Cipralex® to provide a greater reduction in MADRS scores, p=0.040, utilizing an LOCF approach and was better tolerated than Cymbalta® (duloxetine), based on the percentage of patients discontinuing treatment due to adverse events, in the treatment of patients with moderate to severe major depressive disorder (MDD).
Dr. Arif Kahn, Medical Director of Northwest Clinical Research Center and investigator in this study said, “These findings add to a number of studies that demonstrate the clinical value of Lexapro® in the treatment of depression.”
Patients (aged 18-80 years) with DSM-IV diagnosed MDD as determined by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 26 or greater were randomized to eight weeks of double-blind treatment with Lexapro®/Cipralex® 10-20 mg/day (dose fixed at 10 mg/day for the first four weeks with optional up-titration to 20 mg/day thereafter) or Cymbalta® 60 mg/day. Dosing of the two antidepressants was consistent with information in the FDA-approved package insert of both drugs. The primary, prospectively-defined, efficacy endpoint was the change from baseline at week eight in the MADRS total score, using the last observation carried forward (LOCF) approach. At the start of the study, 137 patients were enrolled in the Lexapro®/Cipralex® arm of the study and 133 in the Cymbalta® arm.
At the end of the eight-week study, Lexapro®/Cipralex® patients demonstrated significantly greater improvement than Cymbalta® patients in the total MADRS score (LSMD, least squared mean difference, -2.42 [95% CI: -4.73, -0.11]; p=0.040) - predefined primary endpoint. The proportion of patients responding to Lexapro®/Cipralex® treatment, as determined by a 50 percent improvement in MADRS total score, also was significantly greater when compared to patients in the Cymbalta® group (68 percent vs. 52 percent, p=0.011; LOCF). Remission rates were 44 percent in the Lexapro®/Cipralex® group and 38 percent in the Cymbalta® group, as determined by a total MADRS score of 10 or less, this difference was not significant. The rate of improvement on the MADRS was similar between the groups when an observed case analysis was conducted. In addition, there was no difference seen between the group on a number of measures of relief of somatic and pain-related symptoms.
More patients in the Lexapro®/Cipralex® group completed eight weeks of treatment than patients in the Cymbalta® group (87 percent vs. 69 percent, p=0.001) and significantly fewer patients receiving Lexapro®/Cipralex® discontinued treatment due to adverse events compared to patients receiving Cymbalta® (2 percent vs. 13 percent, p=0.001).
Forest Laboratories licenses Lexapro® from H. Lundbeck A/S.
The content of this release will have no influence on the Lundbeck Group’s financial result for 2006.
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2005, the company’s revenue was DKK 9.1 billion (approximately EUR 1.2 billion or USD 1.5 billion). The number of employees is approximately 5,000 globally. For further information, please visit www.lundbeck.com
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