Twice as Many Risperdal Patients Experience Significant Weight Gain

i-Newswire, 2005-01-28 - NEW YORK, January 21, 2005 -- Patients with schizophrenia found Pfizer?s atypical antipsychotic, Geodon? ( ziprasidone ) to be more tolerable than and just as effective as Risperdal? ( risperidone ), according to a head-to-head study published in a recent issue of the Journal of Clinical Psychiatry. Results from the eight-week study showed that Geodon and Risperdal were equally effective in improving psychotic symptoms associated with schizophrenia and schizoaffective disorder. However, Geodon showed a lower movement disorder burden, which can include stiffness, rigidity, tremors and restlessness; reduced effects on weight; and a more favorable impact on prolactin levels, which can be associated with sexual dysfunction and menstrual irregularity. In fact, Risperdal-treated patients had prolactin levels that were three times greater, on average, than those patients treated with Geodon. Poor tolerability is one of the most common barriers to patient compliance. If a medicine?s side effects are distressing enough, patients may stop taking it even if it is working to manage their disorder and for people with schizophrenia, this could lead to significant worsening of psychosis, said Dr. Peter Buckley, professor and chairman of the Department of Psychiatry and Behavioral Health at the Medical College of Georgia. This study shows that Geodon demonstrates efficacy on par with what is considered a well established treatment for efficacy and well-tolerated with reduced risks for certain harmful side effects that commonly affect patients with schizophrenia. In the trial, 296 hospitalized patients diagnosed with acute exacerbation of schizophrenia or schizoaffective disorder were randomized to receive either Risperdal ( 3-5 mg twice a day ) or Geodon ( 40-80 mg twice a day ). Primary efficacy measures included PANSS and CGI-S scores, which showed comparable effects for both agents. Safety assessments included movement disorder evaluations, laboratory tests, electrocardiography, vital signs and body weight. During the course of the trial, twice as many patients treated with Risperdal experienced clinically significant weight gain, at least 7 percent or more of baseline weight, as those treated with Geodon. Patients treated with Geodon were also less likely to demonstrate akathisia ( restlessness ) and experienced a lower movement disorder burden ( MDB ). The MDB score was 0.35 at end point for the Risperdal group compared to 0.20 for the Geodon group with the higher score indicating greater adverse effect burden. Other adverse events were mild or moderate in nature. The percentage of patients experiencing at least one treatment-related adverse event was comparable for both groups. Weight Gain and Schizophrenia Schizophrenia, which affects approximately one in every 100 people, is among the most chronic and disabling of mental illnesses, striking in early adulthood and often persisting throughout adult life, with consequent devastating effects on sufferers, families and society. While the development of atypical antipsychotics marks an advance in the management of schizophrenia, some of these agents are associated with significant weight gain. Research shows that weight gain associated with atypical antipsychotics contributes to 50-90 percent of non-compliance among patients with schizophrenia, which, in turn leads to the probability of relapse and subsequent hospitalization. The amount of weight a patient may gain varies from drug to drug. However, a recent study shows that some of the most widely prescribed atypical antipsychotic medications can cause a weight gain of nearly 25 pounds or more within the first year of treatment. Approved in the United States in February of 2001 for the treatment of schizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in 73 countries, and more than 4.5 million prescriptions have been written worldwide. It is widely accepted on hospital, Medicaid, national VA and managed care formularies. Geodon is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs. Geodon has a greater capacity to prolong the QTc interval than several antipsychotics. With some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia. Hyperglycemia related adverse events, sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with Geodon, and it is not known if Geodon is associated with these events. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia. In four pooled short-term trials, the incidence of EPS was 14 percent for Geodon-treated patients vs. 8 percent for placebo; the incidence of akathisia was 8 percent for Geodon-treated patients vs. 7 percent for placebo; extrapyramidal symptoms were one of the most commonly observed adverse events in Geodon-treated patients. Prolactin elevation has been associated with amenorrhea, galactorrhea, gynecomastia, and impotence. The clinical significance of elevated prolactin levels is unknown for most patients. Discovered and developed by Pfizer, Geodon is a serotonin and dopamine antagonist. In short-term trials, the most commonly observed side effects associated with Geodon at an incidence of ≥ 5 percent and at least twice the rate of placebo were somnolence ( 14 percent vs. 7 percent ), respiratory distress ( 8 percent vs. 3 percent ), of which more than 90 percent were cold symptoms or upper respiratory infections. # # # # If you have questions regarding information in these press release contact the company listed below. Please do not contact us as we are unable to assist you with your inquiry. We disclaim any content contained in this press release. More Information http://www.pfizer.com/ Press Release Date 2005-01-28