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| |  Olanzapine Long-Acting Injection Proves Safe and Effective for Schizophrenia and Schizoaffective Disorder: Presented at CINP By Bryan DeBusk, PhD MUNICH, Germany -- July 16, 2008 -- A long-acting injection of olanzapine prevents relapses among patients with schizophrenia and has a safety profile comparable to other available medications, according to research presented here at the 26th Collegium Internationale Neuro-Psychopharmacologicum (CINP) Congress. Holland Detke, PhD, Global Neuroscience, Eli Lilly and Co., Indianapolis, Indiana, presented the results in a poster session on July 14. "There are currently only 3 depot antipsychotics available in the United States -- 2 first-generation and 1 second-generation antipsychotic -- and olanzapine long-acting injection would provide another second-generation option," Dr. Detke explained. In a 24-week study examining the maintenance treatment of patients with schizophrenia, Dr. Detke and colleagues evaluated the safety and efficacy of an injection of long-acting olanzapine with oral olanzapine in 1,065 adults who maintained stability on 10, 15, or 20 mg of oral olanzapine per day over 4 to 8 weeks. Patients were randomised to 1 of 4 injection groups: 150 mg/2 weeks, n = 140; 405 mg/4 weeks, n = 318; 300 mg/2 weeks, n = 141; 45 mg/4 weeks, n = 144) or oral olanzapine at the stable maintenance dose previously achieved (n = 322). After 24 weeks of follow-up, 93% of patients receiving oral olanzapine remained relapse free as estimated using Kaplan-Meier methodology compared with 95% of patients receiving olanzapine long-acting injection 300 mg every 2 weeks. The other injection doses also provided freedom from relapse: 405 mg/4 weeks, 90%; 150 mg/2 weeks, 84%; 45 mg/4 weeks, 69%. The 4-week injection demonstrated noninferiority to oral olanzapine, as did pooled data from the 2-week injection doses, and all 3 regimens were superior to the 45-mg/4-week reference dose when comparing time with relapse (P < .01). Weight gain of 7% or more from baseline was observed more frequently with oral olanzapine (21.4% of patients) and the 3 highest injection doses (300 mg/2 weeks, 20.7%; 405 mg/4 weeks, 15.2%; 150 mg/2 weeks, 16.4%) compared with the reference injection dose (8.3%, P <= .05). However, no differences in other safety and adverse effects measures were noted among the groups. Injection-site reactions occurred in 2.8% of participants receiving the long-acting injections, but the frequency of reaction was not associated with the dose. Two cases of sedation and delirium related to accidental intravascular injection of the drug were observed, but symptoms resolved between 1.5 and 72 hours, and the patients continued in the study without adverse effects from future injections. In another poster session on July 14, Dr. Detke presented results of an open-label study that examined the long-term safety and tolerability of olanzapine long-acting-injections. The investigators followed 931 patients aged 18 to 75 years who had schizophrenia or schizoaffective disorder for a period of up to 160 weeks. Patients were enrolled in the study following participation in previous placebo-controlled trials of olanzapine long-acting injections. Participants received flexible-dose injections of the drug every 2 to 4 weeks. Patient retention rate at 160 weeks was 60.4%, and 20.1% of patients discontinued the study due to withdrawal of consent, 6.3% due to an adverse event, and 5.6% due to loss at follow-up. Mean score on the Clinical Global Impression Severity of Illness Scale at 160 weeks increased to 0.16 from 2.92 at baseline. Adverse effects reported in at least 5% of patients were increased weight, insomnia, somnolence, anxiety, headache, and nasopharyngitis. Weight gain of at least 7% of body weight was reported in 28.1% of patients with an average gain of 1.4 kg among all participants. A fraction of patients experienced an increase from normal to high fasting glucose (4.7%), total cholesterol (5.2%), or triglycerides (11.9%) during the study. Dr. Detke said the findings are promising for patients who have difficulty with oral medications. "Olanzapine long-acting injection was both safe and effective for the treatment of schizophrenia, with a safety profile similar to oral olanzapine, except for injection-related adverse events," Dr. Detke concluded. Olanzapine long-acting injection is currently under review by the US Food and Drug Administration, the European Medicines Agency, and other regulatory agencies, Dr. Detke said, "but once approved, it will represent an important new option in the treatment of patients with schizophrenia who struggle with adherence to their oral antipsychotic medications." Funding for these studies was provided by Eli Lilly and Co.
[Presentation titles: 160-week Interim Results From an Open-Label Extension Trial of Olanzapine Long-Acting Injection. Abstract P-02-77. Olanzapine Long-Acting Injection for the Maintenance Treatment of Schizophrenia: A 24-Week, Randomized, Double-Blind Trial. Abstract P-02-78]
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