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New Data Published In Medical Journal Suggest Certain Atypical Antipsychotics Increase Diabetes Risk; RISPERDAL® (Risperidone) Found To Be An Exception
Oct 24, 2002
New Data Published In Medical Journal Suggest Certain Atypical Antipsychotics Increase Diabetes Risk; RISPERDAL® (Risperidone) Found To Be An Exception

TITUSVILLE, N.J., Oct. 24 /PRNewswire/ -- Data published this week in the Journal of Clinical Psychiatry suggest that while the atypical antipsychotic risperidone (RISPERDAL®) does not increase patients' chances of developing Type II (adult-onset) diabetes, risk is increased with olanzapine (Zyprexa*), clozapine (Clozaril*) and some older, conventional medications.

In the study, the association with newly diagnosed diabetes was numerically lower in persons taking risperidone than in untreated patients, although not significantly different. However, the other antipsychotics showed an opposite trend: The odds of being diagnosed with diabetes were seven times greater for patients taking clozapine than among those receiving no treatment (odds ratio of 7.44), more than three times greater for persons taking olanzapine (3.10) or low-potency conventionals such as chlorpromazine (3.46), and slightly more than double (2.13) for those receiving high-potency conventionals such as haloperidol.

Diabetes is a serious, life-threatening illness that can lead to heart failure, stroke, renal failure and blindness, said Henry Nasrallah, MD, a professor of psychiatry, neurology and internal medicine at the University of Mississippi Medical Center and one of the study authors. Treating schizophrenia is complicated enough without adding diabetes to the equation.

The study published in the Journal of Clinical Psychiatry looked at medical and prescription claims data from two health-insurance plans covering 2.5 million individuals. Records for 4,308 patients diagnosed with psychosis who received at least 60 days of antipsychotic treatment between April 1, 1996, and Dec. 31, 1997, were compared to 3,625 patients who received no such therapy. Patients with pre-existing Type 2 diabetes were excluded from the analysis.

This study is based on claims data, and thus is subject to the usual limitations of retrospective research. That includes not being able to control for some variables that may have affected the outcomes, such as race and changes in weight, said Frank Gianfranceso, PhD, principal study author and president of HECON Associates, Inc. a pharmaceutical outcomes-research firm. Diabetes is an important issue for patients with mental illness, and further research is certainly needed to better define the risks related to particular treatments. However, the findings of this study are very similar to several other publications and add to the growing body of information practitioners should consider as they choose among the various treatments available to their patients.

The claims analysis was supported by Janssen Pharmaceutica Products, LP, maker of Risperdal. Available in 0.25, 0.5, 1, 2, 3 and 4 mg tablets as well as 1mg/mL oral solution, Risperdal is indicated for the treatment of schizophrenia. In clinical trials, Risperdal was generally well tolerated. However, as with all other psychotropic medications, Risperdal was associated with adverse events. In two controlled trials involving individuals with schizophrenia and schizoaffective disorder, adverse events with an incidence of > 5 percent in at least one of the Risperdal groups and at least twice that of placebo were anxiety, drowsiness, extrapyramidal symptoms (uncontrolled tremors and muscle stiffness), dizziness, constipation, nausea, dyspepsia (upset stomach), rhinitis (runny nose), rash and tachycardia (rapid heart beat).

Individuals with schizophrenia are known to be up to four times more likely to develop diabetes than the population at large. In schizophrenia patients participating in pre-marketing clinical trials for Risperdal, diabetes mellitus was observed infrequently. In the years since Risperdal was introduced to the market in 1994, hyperglycemia (high blood sugar) and aggravated diabetes mellitus, including diabetic ketoacidosis (a life-threatening complication in which there is too little insulin and too much sugar in the blood) have been reported as temporally (but not necessarily causally) related to Risperdal therapy.

* Zyprexa is a registered trademark of Eli Lilly and Company. Clozaril

is a registered trademark of Novartis AG.

** For more information on Risperdal, please see full U.S. prescribing

information http://www.risperdal.com/risperd.pdf or visit the Web

site, http://www.risperdal.com

Janssen Pharmaceutica Products, L.P., is a wholly owned subsidiary of Johnson & Johnson (NYSE: JNJ) with a long track record in developing and marketing treatments for central nervous system disorders. Based in Titusville, NJ, its other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at http://www.us.janssen.com

Contact: Melissa Saunders Katz

Janssen Pharmaceutica


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