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August 31, 2004
Safety and Effectiveness of Long-acting Risperdal
Safety and Efficacy of Long-Acting Risperidone in Schizophrenia: A 12-Week, Multicenter, Open-Label Study in Stable Patients Switched From Typical and Atypical Oral Antipsychotics.
Lindenmayer JP, Eerdekens E, Berry SA, Eerdekens M.
Pharmaceutical companies have recently been touting long-acting injectable medications as the answer to maintaining reliable, consistent levels of medication and helping with preventing relapse through medication compliance in those with schizophrenia. Risperidone has been the first such atypical medication available in such a long-acting injectable form. This study aimed to look at the safety and effectiveness of this type of medication in a clinically stable group of people with schizophrenia. The study involved a 12 week open label, multicenter, exploratory clinical trial, where they collected data from a from clinics, hospitals, and physicians' offices.
Participants with schizophrenia entered a 4 week period where they continued to receive the same dose of their current oral medication (which was Haldol, Seroquel or Zyprexa). They received 25mg of long acting injectable risperodone at baseline and then every 2 weeks, with allowance for the doctor to change the dose upto a certain point. Safety measurements were based on the patientís self-report, clinical observation, lab reports and physical exams. They measured the effectiveness of the medication based on symptom checklists (PANSS & CGI).
The authors report that long-acting risperidone was well tolerated. Of the 141 patients who completed the study, the most frequently reported adverse events were insomnia (16%), headache (15%), psychosis (11%), and agitation (11%). There was a slight increase in body weight (0.4 kg). 5 patients experienced adverse effects that resulted in the discontinuation of the study and a few experienced serious side effects that that included psychosis and agitation. The authors do not report any significant lab abnormalities or ECG results. They also report that the severities of certain side effects (extrapyramidal symptoms) were reduced during treatment and there were improvements in symptoms of schizophrenia that started during the 4th week and continued through the 12-week period.
Limitations of this study are the open label and lack of a control group. This means that the raters were not blind to the medication the patients were on, and this could have biased their ratings of symptoms. Also, since this study allowed other medications to be used at the same time, it is difficult to parse out the unique contributions of the injectable risperidone while the flexible dose approach used could have also biased the results.
The authors have disclosed financial support from Lilly, Pfizer, Janssen, AstraZeneca, Bristol Myers-Squibb, Repligan & Johnson & Johnson (see article for detailsPosted by Farzin at August 31, 2004 06:57 PM | TrackBack