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Study Finds Long-Acting Risperidone Associated With Low Relapse Rates

TITUSVILLE, N.J. -- September 8, 2006 -- In a recently published one-year study of clinically stable individuals with schizophrenia or schizoaffective disorder who transitioned from oral antipsychotics to Risperdal(R) Consta(R) (risperidone) long-acting injection, 78% and 85% of patients (for the 25 mg and 50 mg dose groups, respectively) remained relapse free during their participation in the study.

The international study was published in a recent issue of Journal of Clinical Psychiatry.

This 52-week, double-blind, randomized, controlled trial of Risperdal(R) Consta(R) in the treatment of schizophrenia and schizoaffective disorder (n=323) enrolled patients who had been taking only oral antipsychotic medications and who were symptomatically stable for four months. Patients were randomized to receive a fixed dose of either 25 mg or 50 mg of Risperdal(R) Consta(R) every two weeks in either physicians' offices or clinics. One hundred sixty-six patients (51%) completed the study.

"Schizophrenia is a significantly debilitating illness, and proper treatment, which includes drug and non-drug therapy, has been demonstrated to be successful in helping many patients regain control of their lives," said lead investigator George M. Simpson, MD, professor of research and director, Outpatient Clinic, Keck School of Medicine of the University of Southern California. "Lack of adherence to treatment, even for a short period of time, especially in this population, can increase the risk of relapse."

In fact, other studies suggest that risk of relapse can be as high as 46% per year even in treated patients with schizophrenia.(1) The consequences of relapse are numerous and impact the patient's life as well as society as a whole. One major benefit of injection therapy is that it allows the treatment team to monitor the patient's condition and adherence to therapy. Dr. Simpson notes that the results of this study suggest that Risperdal(R) Consta(R) is an important first line treatment option that physicians should consider, especially in those patients at risk for non-adherence to their oral antipsychotic therapy.

The study's primary endpoint was time to relapse and difference between the 25 mg and 50 mg doses of Risperdal(R) Consta(R) was not statistically significant.

Relapse was defined as the need for psychiatric hospitalization (noted in 10% and 6% of subjects in the 25 mg and 50 mg groups, respectively), substantial clinical deterioration (6%, 4%), increase in the level of psychiatric care (3%, 1%), violent behavior (1%, <1%) or oral risperidone supplementation required (3%, 3%).

The study also found statistically significant improvement in symptoms from stable baseline in both the 25 mg and 50 mg dose groups following their transition from oral antipsychotics as measured by the Positive and Negative Syndrome Scale (PANSS).(2) Further, patient functioning was significantly improved from baseline for both groups as measured by the Personal and Social Performance (PSP) Scale.(3)

The most common adverse events (AEs) reported (experienced by greater than or equal to 10% in each treatment group) in each of the 25 mg and 50 mg dose groups, respectively, include, insomnia (25%, 30%), non-specified psychotic disorder (23%, 18%), headache (21%, 16%) and anxiety (18%, 15%). The mean body weights of patients in the study remained essentially unchanged from the respective baselines for the 25 mg and 50 mg dose groups (199.74 pounds; 193.35 pounds) to endpoints (200.4 pounds and 195.55 pounds). Overall, 5.9% of patients discontinued treatment due to treatment-emergent AEs (5.5%, 6.2%).

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. It is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking.

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 70 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 by Alkermes, Inc. and marketed in the United States by Janssen, L.P. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia. For more information, visit www.risperdalconsta.com.

Important safety information: Increased Mortality in Elderly Patients with Dementia-Related Psychosis:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Risperdal(R) Consta(R) (risperidone) long-acting injection is not approved for the treatment of patients with Dementia-Related Psychosis.

In a study of people taking Risperdal(R) Consta(R), 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, fever and can be serious.


REFERENCES:
1. APA Guidelines second edition (2004).
2. The PANSS is a validated, multi-item inventory composed of five factors: positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement and anxiety/depression.
3. The Personal and Social Performance scale (PSP) is a validated, clinician-rated scale that measures personal and social functioning.


SOURCE: Janssen, L.P.

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