Metabolic Effects Significantly Lower With INVEGA(R) Compared To Olanzapine

Main Category: Schizophrenia
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 19 Nov 2009 - 14:00 PST

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New data from a 6-month open label randomised controlled trial show INVEGA® (paliperidone ER) is associated with significantly less metabolic effects compared to oral olanzapine in people with schizophrenia, while demonstrating comparable efficacy.1 The results were presented at the 15th Biennial Winter Workshop in Psychoses in Barcelona, Spain.

Metabolic side effects, including changes in serum lipid levels, glucose levels and weight gain, are a recognised effect of treatment with atypical antipsychotics, and can increase the risk of developing longer-term chronic health conditions such as diabetes and cardiovascular disease.2

The primary endpoint of the study was the change over 6 months in the triglyceride to high density lipoprotein ratio (TG:HDL), a sensitive marker for insulin resistance in non-diabetic patients. Results from the intent-to-treat analysis on a total population of 559 patients showed no statistically significant change in the TG:HDL ratio from baseline to endpoint in patients treated with INVEGA® (-0.08 plus or minus 1.10, p=0.47184). In patients treated with oral olanzapine, the TG:HDL ratio significantly increased from baseline to endpoint (0.42 plus or minus 1.19, p<0.0001).(1) As the difference between INVEGA® and olanzapine at endpoint was statistically significant (p<0.0001), the primary endpoint of the trial was met.

"Metabolic changes as a result of antipsychotic treatment are associated with increased health risks such as weight gain and diabetes which in turn can impact on a patient's self-confidence and compliance with medication -significant concerns in what is an already vulnerable patient population," said Dr D.J.H Niehaus, Flexivest Fourteen Research Centre, Oakdale, Bellville, Cape Town, South Africa. "Minimising treatment-related metabolic effects is an important clinical goal for effective management of schizophrenia, and this study demonstrates that INVEGA® can help meet this need."

The study showed comparable efficacy between INVEGA® and olanzapine in reducing symptoms of schizophrenia, as assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression Scale (CGI-S). In both treatment groups, PANSS total scores decreased significantly at endpoint (p<0.0001 versus baseline). After intergroup testing, it was concluded that INVEGA® and olanzapine were non-inferior in efficacy as measured by change in PANSS total score. In both treatment groups, a statis-tically significant improvement in symptoms at 6 weeks, 3 and 6 months and endpoint (p<0.0001) was also reported using the CGI-S.

During the study, adverse events were reported by 54.4% of INVEGA® patients and 51.8% of olanzapine patients. The three most frequently reported treatment-emergent adverse events (greater than or equal to 5% in any treatment group) were weight gain (OLA 18.2%, INV 9.6%), insomnia (OLA 1.4%, INV 9.6%), and somnolence (OLA 9.5%, INV 3.3%). In patients treated with INVEGA®, the increase in weight over the 6-month period was significantly lower compared to patients treated with olanzapine (p<0.0001). At endpoint, the mean weight increase was 1.2 plus or minus 4.6kg for INVEGA® and 3.8 plus or minus 5.9kg for olanzapine.(1)

About Schizophrenia

An estimated one percent of the world's population suffers from schizophrenia - a serious and usually chronic brain disorder that impairs a person's ability to think clearly, relate to others and distinguish between reality and imagination. It typically develops in adolescence or the early 20s, although symptoms may not become immediately obvious and requires long-term or life-long treatment with antipsychotic drugs.

More information can be found about schizophrenia at http://www.psychiatry24x7.com

About INVEGA®

INVEGA® (paliperidone ER), an atypical antipsychotic medication, was first approved in Europe in June 2007 for the treatment of schizophrenia. INVEGA® is a novel molecule (paliperidone) delivered via an osmotic drug delivery system (OROS®) which provides a steady, smooth release of medication over 24 hours. This eliminates the peaks and troughs in drug plasma levels and leads to a low potential for increased side effects as well as ensuring consistent efficacy. INVEGA® is the first antipsychotic medication to have significantly improved personal & social performance recognised in its Summary of Product Characteristics (SPC).

About Janssen-Cilag

The Janssen-Cilag companies are part of the Johnson & Johnson family of companies. They have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at http://www.janssen-cilag.com.

References

1 Schreiner A, Korcsog P, Neihaus D et al. A prospective randomized controlled trial of paliperidone ER versus oral olanzapine in patients with schizophrenia. Poster presented at: 15th Biennial Winter Workshop in Psychosis, 15-18 November 2009, Barcelona, Spain.

2 Wetterling T, Müssigbrodt HE. Weight gain: side effect of atypical neuroleptics? J Clin Psychopharmacology 1999;19:316-21.

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Johnson&Johnson