SAN FRANCISCO — Positive results were found in two pivotal safety and efficacy studies that looked at lurasidone HCl treatment in patients with depressive disorders associated with bipolar I disorder.
In the PREVAIL 1 study, 348 patients with bipolar depression were assigned lurasidone HCl (Latuda, Sunovion Pharmaceuticals; 20 mg/day to 120 mg/day) with or without rapid cycling as adjunctive therapy to lithium or valproate for 6 weeks. Metabolic changes in lipids, glucose, weight and insulin were assessed.
Mean weight change from baseline to 6 weeks for lurasidone was 0.51 lb vs. 0.31 lb for placebo, which was not statistically significant, according to the press release issued by Sunovion here at the 2013 American Psychiatric Association Annual Meeting.
There was weight gain from baseline (≥7%) in 3.1% of lurasidone patients vs. 0.7% of patients treated with placebo. Other changes reported were cholesterol (–3 mg/dL vs. –3.8 mg/dL); LDL (–3.2 mg/dL vs. –2 mg/dL); triglycerides (9 mg/dL vs. –6.2 mg/dL); glucose (0.9 mg/dL vs. –0.3 mg/dL); insulin (1.66 mU/L vs. –0.16 mU/L) and homeostatic model assessment of insulin resistance (HOMA-IR; 0.26 vs. –0.07), respectively. None of these changes were statistically significant.
In the PREVAIL 2 study, which, similar to PREVAIL 1, was a randomized, double blind, placebo-controlled study, 505 patients with bipolar depression were assigned lurasidone (20 mg/day to 60 mg/day) as monotherapy or placebo.
Mean weight change from baseline to 6 weeks for lurasidone vs. placebo was 0.64 lb vs. –0.09 lb, respectively, according to the press release.
There was weight gain from baseline (≥7%) in 2.4% vs. 0.7% of patients, respectively. Other changes reported were cholesterol (–1.7 mg/dL vs. –3.2 mg/dL); LDL (–2.7 mg/dL vs. –3.5 mg/dL); triglycerides (3 mg/dL vs. 6 mg/dL); glucose (0.5 mg/dL vs. 1.8 mg/dL); insulin (3.56 mU/L vs. 2.95 mU/L) and HOMA-IR (1.08 vs. 1.19), respectively.
None of the data points in PREVAIL 2 were statistically significant.
Frequently reported adverse events in PREVAIL 1 were nausea, somsolence, tremor, akathisia and insomnia, with discontinuation rates of 6% for lurasidone and 7.9% for placebo due to adverse events. In PREVAIL 2, frequently reported adverse events were nausea, headache, akathisia, somnolence and sedation, with discontinuation rates of 6% for lurasidone and 6% for placebo due to adverse events, according to the press release.
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