21st Jan 2005 15:34
First Head-To-Head Study Shows Pfizer's Geodon is Equally Effective as, and Better Tolerated Than, Risperdal For the Treatment of Schizophrenia Twice as Many Risperdal Patients Experience Significant Weight Gain NEW YORK, Jan. 21 -- Patients with schizophrenia found Pfizer's atypicalantipsychotic, Geodon(R) (ziprasidone) to be more tolerable than -- and just aseffective as -- Risperdal(R) (risperidone), according to a head-to-head studypublished in a recent issue of the Journal of Clinical Psychiatry.Results from the eight-week study showed that Geodon and Risperdal were equallyeffective in improving psychotic symptoms associated with schizophrenia andschizoaffective disorder. However, Geodon showed a lower movement disorderburden, 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. Infact, Risperdal-treated patients had prolactin levels that were three timesgreater, on average, than those patients treated with Geodon."Poor tolerability is one of the most common barriers to patient compliance. Ifa medicine's side effects are distressing enough, patients may stop taking iteven if it is working to manage their disorder and for people withschizophrenia, this could lead to significant worsening of psychosis," said Dr.Peter Buckley, professor and chairman of the Department of Psychiatry andBehavioral Health at the Medical College of Georgia. "This study shows thatGeodon demonstrates efficacy on par with what is considered a well establishedtreatment for efficacy and well-tolerated with reduced risks for certainharmful side effects that commonly affect patients with schizophrenia."In the trial, 296 hospitalized patients diagnosed with acute exacerbation ofschizophrenia or schizoaffective disorder were randomized to receive eitherRisperdal (3-5 mg twice a day) or Geodon (40-80 mg twice a day). Primaryefficacy measures included PANSS and CGI-S scores, which showed comparableeffects for both agents. Safety assessments included movement disorderevaluations, laboratory tests, electrocardiography, vital signs and bodyweight.During the course of the trial, twice as many patients treated with Risperdalexperienced clinically significant weight gain, at least 7 percent or more ofbaseline 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 MDBscore was 0.35 at end point for the Risperdal group compared to 0.20 for theGeodon group with the higher score indicating greater adverse effect burden.Other adverse events were mild or moderate in nature. The percentage ofpatients experiencing at least one treatment-related adverse event wascomparable for both groups.Weight Gain and SchizophreniaSchizophrenia, which affects approximately one in every 100 people, is amongthe most chronic and disabling of mental illnesses, striking in early adulthoodand often persisting throughout adult life, with consequent devastating effectson sufferers, families and society. While the development of atypicalantipsychotics marks an advance in the management of schizophrenia, some ofthese agents are associated with significant weight gain. Research shows thatweight gain associated with atypical antipsychotics contributes to 50-90percent of non-compliance among patients with schizophrenia, which, in turnleads to the probability of relapse and subsequent hospitalization.The amount of weight a patient may gain varies from drug to drug. However, arecent study shows that some of the most widely prescribed atypicalantipsychotic medications can cause a weight gain of nearly 25 pounds or morewithin the first year of treatment.Approved in the United States in February of 2001 for the treatment ofschizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in 73countries, and more than 4.5 million prescriptions have been written worldwide.It is widely accepted on hospital, Medicaid, national VA and managed careformularies.Geodon is contraindicated in patients with a known history of QT prolongation,recent acute myocardial infarction, or uncompensated heart failure, and shouldnot be used with other QT-prolonging drugs.Geodon has a greater capacity to prolong the QTc interval than severalantipsychotics. With some drugs, QT prolongation has been associated withtorsade de pointes, a potentially fatal arrhythmia.Hyperglycemia related adverse events, sometimes serious, have been reported inpatients treated with atypical antipsychotics. There have been few reports ofhyperglycemia or diabetes in patients treated with Geodon, and it is not knownif Geodon is associated with these events. Patients treated with an atypicalantipsychotic should be monitored for symptoms of hyperglycemia.In four pooled short-term trials, the incidence of EPS was 14 percent forGeodon-treated patients vs. 8 percent for placebo; the incidence of akathisiawas 8 percent for Geodon-treated patients vs. 7 percent for placebo;extrapyramidal symptoms were one of the most commonly observed adverse eventsin Geodon-treated patients.Prolactin elevation has been associated with amenorrhea, galactorrhea,gynecomastia, and impotence. The clinical significance of elevated prolactinlevels is unknown for most patients.Discovered and developed by Pfizer, Geodon is a serotonin and dopamineantagonist. In short-term trials, the most commonly observed side effectsassociated with Geodon at an incidence of greater than or equal to 5 percentand at least twice the rate of placebo were somnolence (14 percent vs. 7percent), respiratory distress (8 percent vs. 3 percent), of which more than 90percent were cold symptoms or upper respiratory infections.Full Geodon prescribing information is available at http://www.geodon.com.SOURCE Pfizer Inc 01/21/2005/CONTACT: Shreya Prudlo of Pfizer Inc, +1-212-733-4889//Company News On-Call: http://www.prnewswire.com/comp/688250.html //Company News On-Call: Pfizer's press releases are available through PRNewswire's Company News On-Call service on PRN's Web Site. Visit http://www.prnewswire.com/comp/688250.html//Photo: A free corporate logo to accompany this story is available immediatelyvia Wieck Photo Database to any media with telephoto receiver or electronicdarkroom, PC or Macintosh, that can accept overhead transmissions. To retrievea logo, please call 972-392-0888.//Web site: http://www.pfizer.comhttp://www.geodon.com /(PFE) -4- ENDRelated Shares:
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