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Risperdal Reduces Dementia And Other Psychoses In Elderly Patients LAS CROABAS, PUERTO RICO – Dec. 15, 1998 -- Two studies presented this week at a major psychiatry meeting suggest that Janssen Pharmaceutica, Inc.’s Risperdal(R) (risperidone) may significantly reduce psychotic symptoms and aggressive behaviour in elderly patients suffering from dementia, schizophrenia and other forms of psychosis. In addition, the drug is associated with a very low risk of tardive dyskinesia (TD), a troubling side effect that has been a common problem with conventional medications. "Psychotic symptoms and aggressive behaviours associated with Alzheimer's disease and other dementias are becoming increasingly prevalent as the population ages," said John Kane, MD, chairman of the department of psychiatry at Hillside Hospital in Glen Oaks, NY. "However, treatment with conventional antipsychotics can cause significant problems of their own. Tardive dyskinesia can be devastating in individuals who are already fragile and difficult to treat." The open-label extension of a 12-week, double-blind study of elderly inpatients with Alzheimer's disease and other forms of dementia, 330 individuals (average age, 82.7) were treated with a mean dose of 0.96 mg/day of Risperdal for a follow-up period of one year. Patients receiving extended treatment with Risperdal showed a continued improvement in both psychosis and aggressive behaviours. In addition, there was only one case of tardive dyskinesia observed and reported as an adverse event. Tardive dyskinesia is a condition characterised by involuntary movements and uncontrolled facial grimacing. Among the 59 patients who started the study with pre-existing TD symptoms, 50 percent showed a persistent improvement at the end of one year of treatment. Of patients without previous symptoms, just 2.6 percent developed signs of TD as measured using an objective scale. In contrast, conventional antipsychotics have been associated with a 20-30 percent incidence of TD after one year of treatment. In the second study -- a 12-month, multinational, open-label trial -- 180 elderly patients with schizophrenia and related psychotic disorders (average age, 72) were treated with a mean dose of 3.7 mg/day of Risperdal. In this study, 54 percent of patients experienced a 20 percent or greater improvement in psychotic symptoms, as measured on the Positive and Negative Syndrome Scale (PANSS). In addition, there was a statistically significant reduction in the severity of pre-existing extrapyramidal symptoms (EPS) -- which include uncontrolled tremors and muscle stiffness -- and no new cases of tardive dyskinesia. Overall, there was a 39 percent decrease in the use of antiparkinsonian medications among patients who completed the study. "Most of the patients taking Risperdal in this study showed quick and marked improvement in both psychotic symptoms and pre-existing tardive dyskinesia," said Michael Davidson, MD, of the Sackler School of Medicine in Tel Aviv, adding that this study and others suggests that Risperdal may offer the same benefits for younger patients with various types of psychosis. "Equally important is the fact that these patients did not develop other signs of TD or EPS after beginning treatment,” he said. “This may have a significant impact on the likelihood that patients will comply with treatment." Risperdal -- the most widely prescribed antipsychotic in the United States -- was introduced in 1994 for the management of psychosis. The approved U.S. prescribing information the most common adverse events reported in premarketing clinical trials, including insomnia, agitation, EPS, headache, anxiety and rhinitis. Less common were somnolence, dizziness, constipation, nausea and tachycardia (rapid heartbeat). Orthostatic hypotension (low blood pressure that occurs while standing) was reported infrequently in clinical trials. Its risk may be minimised by starting with a low dose and titrating up gradually until the lowest effective dose is determined. Prescribing should be consistent with the need to minimise the risk of tardive dyskinesia (uncontrolled facial grimacing); if its signs and symptoms appear, discontinuation of Risperdal should be considered. Related Links: Risperdal E-mail this page to a friend or colleague! To print, use this version