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| |  Sertindole Shows Promise in Schizophrenia NEW YORK, May 9, 1996 -- Today at the annual meeting of the American Psychiatric Association (APA) data were presented describing the use of Serlect(TM) (sertindole) in the treatment of psychosis. The study results suggest that sertindole may provide a new alternative in the management of schizophrenia and other forms of psychosis. "Schizophrenia affects as many as one out of 100 people in the U.S. It is a devastating illness and many patients often do not respond to treatments currently available, or only partially improve and remain functionally impaired. These study results suggest sertindole may offer hope to people affected by this disabling illness," says Dan Zimbroff, M.D., of Loma Linda University, who presented the study results at APA. The Study Results The multi-center, double-blind, eight-week clinical trial compared three doses of sertindole (12, 20 and 24 mg/day) to three doses of haloperidol (4, 8 and 16 mg/day) and placebo. In the study, all sertindole doses and haloperidol doses showed significant improvement in the positive symptoms of schizophrenia compared with placebo and in reducing the total scores on the Positive and Negative Symptoms Scale (PANSS). Only sertindole at a dose of 20 mg/day reduced negative symptoms, as measured by PANSS Negative Symptom Subscale and total Scale for the Assessment of Negative Symptoms (SANS). On a comprehensive, global scale of improvement (the Clinical Global Impression scale or CGI), all doses of sertindole and haloperidol were associated with significant improvement compared to placebo. Patients using haloperidol experienced motor side effects called extrapyramidal symptoms, or EPS, at rates significantly higher than placebo. EPS-profiles for sertindole were clinically and statistically indistinguishable from placebo. In addition, patients treated with any of the three doses of sertindole exhibited significantly less EPS than patients using any of the three doses of haloperidol. Researchers measured EPS-rates by the number of EPS-related adverse events, use of anti-EPS medication and three standardized movement rating scales. This EPS profile is important because EPS can cause extreme discomfort, be confused with psychotic symptoms and reduce treatment compliance. Statistically, the adverse events that occurred more often with sertindole than placebo included nasal congestion and decreased ejaculatory volume. The adverse events that occurred more often with haloperidol than placebo were EPS-related. The Impact Schizophrenia is a devastating, chronic mental disorder that affects an estimated one out of 100 people. It is characterized by a disintegration in the process of thinking, of contact with reality, and of emotional responsiveness. The condition, which generally manifests early in adulthood, costs America approximately $16-$33 billion annually and accounts for 25 percent of all hospital beds in use. Patients with schizophrenia often do not respond to currently available treatments or only partially improve. In nearly 25 percent of patients who do not respond or remain functionally impaired, the condition is so poorly managed with traditional treatments that they require custodial care. The Compound In September 1995, Abbott submitted a New Drug Application to the U.S. Food and Drug Administration for the use of sertindole in the treatment of psychotic disorders. Sertindole is licensed for marketing in the United States, Canada and Latin America by Abbott Laboratories from H. Lundbeck A/S of Denmark. As demonstrated in pre-clinical studies, sertindole is a potent antagonist at D2, 5HT2 and alpha1 receptors without activity at histaminic, muscarinic or alpha2 receptors. This selectivity suggests that sertindole should not produce sedative effects or anticholinergic effects (such as constipation and dry mouth) related to those receptors. Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12. EDITORS NOTE: In the second-to-last graph in this press release, the "2" following "D", "5HT", and "alpha", respectively, as well as the "1" following "alpha" should appear in subscript.
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