By Karla Gale
NEW YORK (Reuters Health) – Treatment of schizophrenic patients with risperidone is associated with greater reductions in the severity of psychotic symptoms and side effects, and a lower risk of relapse, compared with treatment with haloperidol.
As described in the January 3rd issue of The New England Journal of Medicine, 365 clinically stable patients with schizophrenia or schizoaffective disorder were randomly assigned treatment with one of the two drugs. Mean modal daily doses were 4.9 mg of risperidone and 11.7 mg of haloperidol. Median duration of treatment was 364 days in the risperidone group and 238 days in the haloperidol group.
By the end of the study, Dr. John G. Csernansky, of the Washington University School of Medicine in St. Louis, and associates found that 39.9% of haloperidol-treated patients and 25.4% of risperidone-treated patients had relapsed, for a risk ratio of 1.93 (p < 0.001).
Risperidone patients also scored significantly better at study's end on the Positive and Negative Syndrome Scale, whereas symptoms did not improve over baseline among haloperidol patients. Extrapyramidal symptoms increased in severity among those using haloperidol, but decreased in the risperidone group.
"One didn't notice large differences between patients" in the two groups between visits, Dr. Csernansky told Reuters Health. However, "in the risperidone group overall, we saw fewer symptoms, as well as fewer side effects, in many categories."
"Relapse is without a doubt the worst event that can occur," he added, noting that the patient starts back at "square one," is often hospitalized, becomes a danger to himself or others, and is unable to work or attend school for weeks or months afterwards. "So any kind of societal strategy for better handling the relapse rate in schizophrenia has to be put at the forefront of our concern."
In an editorial in the same issue, Dr. John Geddes, of the University of Oxford in the UK, describes this report as "one of the first adequately designed and analyzed trials to demonstrate the efficacy of an atypical drug in the maintenance treatment of schizophrenia."
Dr. Geddes also urges government agencies and independent private groups to support such psychiatric drug trials in the future to reduce the nearly 100% reliance on industry funding.
N Engl J Med 2002;346:16-22, 56-58.