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Friday December 10, 5:35 pm Eastern Time
Company Press Release
SOURCE: AstraZeneca
AstraZeneca: Medication Side Effects Make Psychosis Hard to Treat In The Elderly
New Data Show SEROQUEL(R) Causes Fewer Side Effects than Other Antipsychotic
ACAPULCO, Mexico, Dec. 13 /PRNewswire/ -- Studies presented this week at a major U.S. psychiatry conference provide further evidence of the favorable side effect profile of the atypical antipsychotic SEROQUEL® (quetiapine fumarate) in elderly patients. Data indicate the medication causes fewer of the side effects that can make psychosis difficult to treat in elderly patients.
''Older people are at risk for developing psychosis from a variety of fronts,'' said Jamie Mullen, M.D., Medical Director, CNS Therapeutic Area, AstraZeneca. ''Treating psychosis associated with Alzheimer's and Parkinson's disease often calls for similar antipsychotic treatments that are used in treating schizophrenia and schizoaffective disorder. The data presented at the conference further support that SEROQUEL is an alternative to standard antipsychotic agents for use in the elderly.''
SEROQUEL Less Likely to Cause EPS, Tardive Dyskinesia
Elderly patients can be difficult to treat with standard antipsychotic medications because physical changes associated with aging often make them more vulnerable to side effects. Extrapyramidal symptoms (EPS) are particularly a problem in elderly patients(1) and can cause them to feel zombie-like, or become restless and unable to sit still. Many also develop tremors and muscle spasms.(2)
The newer medications, called atypical antipsychotics, are associated with lower rates of EPS in the elderly, but to-date there have been no studies comparing the use of atypical antipsychotics in the treatment of the elderly. A subanalysis, presented at the conference, of a large trial comparing the tolerability and safety of the atypical antipsychotics SEROQUEL and risperidone in a broad patient population, however, provides preliminary data regarding EPS in geriatric patients. The subanalysis of 92 patients between 60 and 80 years of age indicates that SEROQUEL is less likely than risperidone to produce EPS in elderly patients with psychosis and is as effective in treating the positive and negative symptoms of psychosis in elderly outpatients.(3)
Another serious side effect associated with antipsychotic treatment is tardive dyskinesia (TD), a disorder that causes potentially irreversible involuntary muscle movements.(4) Patients over age 45 are five times more likely to develop TD than younger patients, and one study found that 60 percent of older patients taking traditional antipsychotics developed the condition by the end of three years. An analysis of data from a long-term, multicenter study involving 184 elderly patients showed a several-fold lower incidence of TD in patients taking SEROQUEL than has been reported with conventional antipsychotics in older populations.(5)
''SEROQUEL is well tolerated in geriatric patients, who are more susceptible to extrapyramidal symptoms,'' said Paul Yeung, M.D., M.P.H., an author of the study and Clinical Research Physician, CNS Therapeutic Area, AstraZeneca. ''The data presented here demonstrating the low incidence of EPS and TD in elderly patients are good news for elderly patients experiencing psychosis, as well as their doctors and their loved ones.''
SEROQUEL Effective in Patients with Psychosis Associated with Parkinson's
Psychosis in patients with Parkinson's disease can also be particularly difficult to treat because of the movement problems associated with the disease. Conventional antipsychotics may cause intolerable motor disability such as shaking and difficulty starting and stopping motion. Previously available antipsychotics, however, may be associated with EPS and anticholinergic or hematologic side effects. SEROQUEL has been shown to be effective and well tolerated in patients with Parkinson's disease experiencing psychosis. A single-center, long-term, open-label trial was conducted to evaluate the safety, tolerability and efficacy of the medication for the treatment of psychosis in 29 patients with parkinsonism who failed treatment with other atypical antipsychotic medications.(6)
The mean scores on two common rating scales, the Brief Psychiatric Rating Scale and Neuropsychiatric Inventory, improved more than 30 percent and 50 percent respectively. The mean scores on the Unified Parkinson's Disease Rating Scale and motor subscale scores did not worsen, indicating that the motor symptoms did not deteriorate. The results show that SEROQUEL is effective and well tolerated in patients with Parkinson's disease.(6)
Results of another trial in patients with Parkinson's disease were also presented here demonstrating SEROQUEL's efficacy for the treatment of psychosis caused by medications prescribed to treat Parkinson's. After following 69 patients with drug-induced psychosis, researchers found that SEROQUEL is useful and well-tolerated as a first-line drug to treat this condition in most patients with Parkinson's.(7)
SEROQUEL Tablets and AstraZeneca
Clinical trials with SEROQUEL have demonstrated efficacy in treating the positive and negative symptoms of schizophrenia. There were no differences from placebo across the clinical dose range in the incidence of EPS, including rigidity and difficulty starting and stopping movement, or elevation of plasma prolactin levels. In addition, studies have shown that SEROQUEL exhibits a low incidence of hormonal, reproductive (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation).
In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given in two divided doses daily. The drug is manufactured in the United States by AstraZeneca and is available by prescription in strengths of 25-mg, 100-mg, and 200-mg tablets. Since its approval in September of 1997, in the United States there have been more than 1.2 million prescriptions written for SEROQUEL for more than 370,000 patients.(8,9)
The efficacy of SEROQUEL, as well as the atypical profile which distinguishes the compound from standard antipsychotic agents, is supported by several placebo- and comparator-controlled Phase II and III clinical trials in patients hospitalized for acute exacerbation of chronic or subchronic schizophrenia. SEROQUEL was well tolerated in more than 4,000 male and female patients 18 years and older. SEROQUEL is comparable to placebo with regard to EPS. No blood monitoring is required.
As with other agents in its class, the labeling for SEROQUEL Tablets includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Precautions include orthostatic hypotension and the risk of cataract development. As with other antipsychotics, SEROQUEL therapy should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events exhibited across placebo-controlled trials included headache (19%), somnolence (18%), and dizziness (10%), and the majority of events were rated mild or moderate. The safety and effectiveness of SEROQUEL in pediatric patients (less than 18 years of age) have not been established.
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