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| |  Ziprasidone Plus Lithium or Divalproex Is More Effective Than Monotherapy in Bipolar Disorder: Presented at ECNP By Jenny Powers ISTANBUL, Turkey -- September 17, 2009 -- Ziprasidone as adjunctive treatment of bipolar disorder yields better efficacy than monotherapy and does not have the side effect of weight gain, according to researchers here at the 22nd European College of Neuropsychopharmacology (ECNP) Congress. Eduard Vieta, MD, Bipolar Disorders Program, Clinical Institute of Neuroscience, Barcelona, Spain, and colleagues investigated the efficacy of combining ziprasidone with standard mood stabilisers. Because few bipolar patients experience adequate symptom control with long-term lithium or divalproex therapy, the use of adjunctive treatment with atypical antipsychotics is being investigated. This double-blind study enrolled 239 patients with bipolar I disorder to evaluate the efficacy and safety of ziprasidone combined with a mood stabiliser as maintenance treatment. Results were presented on September 14. Patients who were stabilised for 8 weeks with ziprasidone 80 to 160 mg/day plus either lithium or divalproex were randomised to receive the same mood stabiliser plus either ziprasidone 80 to 160 mg/day or placebo for a 6-month, double-blind maintenance period. In the placebo group, ziprasidone was tapered off during the first week. The primary endpoint was time from randomisation to intervention for a mood episode, and the secondary endpoint was time to discontinuation for any reason. Kaplan-Meier product-limit estimator (log-rank test) was used for inferential analyses. Body weight, body mass index, waist circumference, safety assessments of treatment-emergent events, clinical laboratory results, physical examination findings, blood pressure, pulse rate, and electrocardiography were assessed. Of the 127 subjects treated with mood stabiliser plus ziprasidone and 112 subjects given placebo, 19.7% and 32.4%, respectively, needed intervention for a mood episode. A significant difference was seen for the median time to intervention between the ziprasidone and placebo groups (43.0 vs 26.5 days, respectively; P = .0104). Discontinuations for any reason occurred in 33.9% and 51.4% of the ziprasidone and placebo groups, respectively. Ziprasidone treatment resulted in a significantly longer time to discontinuation for any reason (P = .0047). Treatment with adjunctive ziprasidone was generally well tolerated, with sedation and somnolence being the most common treatment-emergent adverse events. Adjunctive ziprasidone treatment did not cause clinically significant weight gain vs placebo, and changes in laboratory results were similar between groups and generally insignificant. Symptoms were better controlled with ziprasidone plus a mood stabiliser than with placebo plus a mood stabiliser, as demonstrated by a longer time to intervention and lower discontinuation rate. The researchers concluded that use of ziprasidone with a mood stabiliser is an effective and well-tolerated treatment for long-term maintenance of bipolar I disorder. Funding for this study was provided by Pfizer Inc. [Presentation title: A 6-Month, Double-Blind Trial of Ziprasidone Plus a Mood Stabilizer in Subjects With Bipolar I Disorder. Abstract P.3.a.030]
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