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| |  SBP MEETING: Risperdal Significantly Decreases Schizophrenia Relapse Risk WASHINGTON, DC -- May 14, 1999 -- Individuals with schizophrenia who take Janssen Pharmaceutica, Inc.’s atypical antipsychotic Risperdal(R) (risperidone) suffer a significantly lower incidence of relapse than patients on haloperidol, a conventional antipsychotic long considered to be the standard of care, according to new research presented this week at the annual meeting of the Society of Biological Psychiatry. This is the first head-to-head study that compares an atypical antipsychotic medication to an older, conventional antipsychotic to assess the drugs' ability to prevent relapse. "Even after individuals with schizophrenia achieve initial success with treatment, they face the frightening possibility of relapse and a host of resulting consequences -- including hospitalisation and suicidal thoughts that can drive them to suicide," said John Csernansky, MD, lead investigator and professor of psychiatry at Washington University in St. Louis. "This research is good news. It shows that Risperdal, one of the atypical antipsychotic medications, reduces the risk of relapse to a significant degree over the longer term -- thus allowing patients to remain in an outpatient, community-based setting." In a multicentre, randomised, double-blind study, U.S. investigators monitored stable outpatients with schizophrenia or schizoaffective disorder to compare the rate of and time to relapse in individuals treated for a period of at least one year. Among the definitions of relapse were the need for psychiatric hospitalisation and the recurrence during treatment of significant symptoms such as deliberate self-injury, violent behaviour or suicidal thoughts. Of the 365 patients receiving medication, 177 took Risperdal, at a dose that averaged 4.9 mg per day. The other 188 participants received haloperidol, taking a mean dose of 11.7 mg per day. Assessments were conducted weekly for the first four weeks and at four-week intervals for the remainder of the study. The longest time that any subject received the test medication was 799 days and 794 days for Risperdal and haloperidol, respectively. During the entire trial, 25.4 percent of patients taking Risperdal relapsed, compared to 39.9 percent of haloperidol recipients. In addition, individuals on Risperdal took a significantly longer time to relapse than persons who received haloperidol. The mean time to relapse was 452 days for Risperdal and 391 days for haloperidol. Another measure of efficacy of the two drugs was patient scores on the Positive and Negative Syndrome Scale (PANSS). Positive symptoms include visual and auditory hallucinations. Examples of negative symptoms are apathy and social withdrawal. Participants who took Risperdal experienced a significantly greater improvement in their total PANSS score at endpoint than did those on haloperidol. In addition, patients taking Risperdal experienced fewer serious side effects during the trial. At endpoint, Risperdal patients reported a lower incidence of extrapyramidal symptoms (uncontrolled tremors and muscle stiffness, a common side effect of antipsychotics) than those on haloperidol (8.5 percent versus 15.4 percent respectively). Individuals taking Risperdal also reported a lower incidence of the most common adverse events: insomnia (23.7 percent versus 28.7 percent), psychosis (16.9 percent versus 25.5 percent) and somnolence (drowsiness) [13.6 percent versus 25.0 percent]. Risperdal was introduced in 1994 for the management of psychotic symptoms. In two, six to eight-week placebo-controlled trials, several spontaneously reported adverse events emerged during treatment in at least one of the Risperdal groups at an incidence rate of five percent or more and at a rate that was at least twice that experienced by those taking a placebo. These adverse events included anxiety, drowsiness, extrapyramidal symptoms (uncontrolled tremors and muscle stiffness), dizziness, constipation, nausea, rhinitis (inflammation of the mucous membranes in the nose), rash and tachycardia (rapid heartbeat). The percentage of patients reporting extrapyramidal symptoms (EPS) in the North American clinical trial was 16 percent for Risperdal 6 mg/day, 13 percent for Risperdal 2 mg/day and 13 percent for placebo. EPS with Risperdal, while dose dependent, occur at a rate that is comparable to that seen with placebo at doses less than or equal to 6 mg/day, and differs significantly from placebo at larger doses. Prescribing should be consistent with the need to minimise the risk of tardive dyskinesia (involuntary movements that affect the face, lips, mouth and tongue). If its signs and symptoms appear, discontinuation of Risperdal should be considered. Related Links: Risperdal, Janssen Pharmaceutica, Inc.
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