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New Study Suggests Patients With Schizophrenia Improved With Treatment Change to Risperdal Consta (Risperidone)

Significant improvements seen in symptom control and treatment tolerability

TITUSVILLE, NJ -- August 4, 2005 -- A study published in International Clinical Psychopharmacology has found that many patients with psychoses improved when their treatment was transitioned to Risperdal(R) Consta(R) (risperidone), a long acting injection. Patients in the study were symptomatically stable but required a change of treatment in their existing antipsychotic regimen.

The study was conducted by Janssen-Cilag, the company that markets Risperdal(R) Consta(R) in most European countries.

According to the study's authors, patients in the study experienced significant improvements in psychotic symptoms and satisfaction with treatment. Statistically significant improvements in symptoms were observed as early as one month after treatment, and continued to improve for the remaining six months of the study. Patient satisfaction with treatment also significantly improved, with the proportion of patients who rated their treatment satisfaction as "very good" increasing from six% on previous treatment to 31% on risperidone long-acting injectable.

"The final results from this study are encouraging, especially as clinical improvements in symptom control with risperidone long-acting injection increased continuously over the six months of treatment, and nearly three quarters of patients successfully stayed on their medication," said Professor Hans-Juergen Moeller, director of the Department of Psychiatry at the Ludwig- Maximilan University, Munich and lead investigator for the Switch to Risperidone Microspheres (StoRMi) study in Germany. "Risperidone long-acting injection provides an important treatment option for people with schizophrenia requiring antipsychotic therapy."

The six-month European StoRMi study was a non-randomized, single arm, multicenter study assessing 1,876 patients in 22 countries. The study was designed to investigate the efficacy and safety of Risperdal(R) Consta(R) in patients with schizophrenia or other psychotic disorders who required a change of treatment. The most frequent reasons for treatment change to risperidone long-acting injectable were non-compliance (38%), insufficient efficacy (33%) and side effects (26%) with their previous antipsychotic therapy.

The primary efficacy endpoint of this study was the mean change from baseline to endpoint as measured by the Positive and Negative Syndrome Scale (PANSS). At the end of the study:

-- More than a third (38%) of patients had a 20% or greater improvement in the PANSS total score compared with baseline.*

-- This finding was supported by the Clinical Global Impression of Severity Scale (CGIS) in which the number of patients considered to be "borderline ill" or "not ill" improved from 11% to 28%by study endpoint.**

-- Overall improvements were identified in health-related quality of life during the 6 months.***

Within the StoRMi trial, 72% of patients reported adverse events. Frequently reported adverse events included insomnia (seven%), anxiety (seven%) and exacerbation of disease (6%).

Movement disorders were reported by 12% of patients, however the percentage of patients reporting the onset of a movement disorder decreased during the 6-month study duration from 4% in the first month to 1% during months four to six.

Severity of extrapyramidal side effects, as measured by the Extrapyramidal Symptom Rating Scale (ESRS), were significantly reduced relative to baseline after one month of treatment, and further improvements were seen until treatment endpoint.

Overall, patients experienced a mean weight gain of 2.3 pounds from baseline to endpoint and five patients had a treatment-emergent glucose-related adverse event, including three cases of new-onset diabetes mellitus. Treatment-emergent endocrine related adverse events were reported by one% of patients.

Risperdal(R) Consta(R) (risperidone) long-acting injection is the first and only long-acting, atypical antipsychotic to be approved by the U.S. Food and Drug Administration and now is approved in more than 57 countries worldwide. The treatment uses advanced technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks.

Risperdal(R) Consta(R) is manufactured and marketed in the United States by Janssen, L.P. The delivery system for Risperdal(R) Consta(R) is manufactured by Alkermes, Inc. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Risperdal(R) Consta(R) (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

In a study of people taking Risperdal(R) Consta(R), the most common side effects were: sleepiness, restlessness, tremors and muscle stiffness, stomach upset, constipation, dry mouth, feeling tired, and weight increase.

Studies suggest an increased risk of elevated blood sugar-related side effects, which are sometimes potentially fatal, in patients treated with this class of medications, including Risperdal(R) Consta(R). Some people may need regular blood sugar testing.

Patients may have heard the term "tardive dyskinesia." These are potentially persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. If patients have these symptoms, they should talk with their health care professional.

A rare but serious side effect that has been reported with this kind of medicine, including Risperdal(R) Consta(R), is known as NMS or neuroleptic malignant syndrome. NMS is characterized by muscle rigidity and fever, and can be serious.

Weight gain is associated with many antipsychotic medicines and can be a concern for you. In a clinical trial, the average weight gain was about one to three pounds.


* At baseline, the PANSS score for the total population was 73.4 +/- 22.3 (range 30-158) and this was reduced at endpoint (63.1 +/- 22.8, range 30-151; P < .001).

** As measured by the Clinical Global Impression of Severity Scale (measuring symptom severity and treatment response). Overall, there was a significant improvement form baseline to endpoint (3.9 +/- 1.1 vs. 3.3 +/- 1.3, P < .001).

*** As measured by the SF-36 Quality of Life questionnaire which was completed at baseline, three and six months. Significant improvements were reported from baseline to endpoint for all factors of the SF-36.


SOURCE: Janssen, L.P.

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