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| |  Seroquel (Quetiapine Fumarate) Safe, Tolerable In Long-Term Treatment Of Psychosis In Elderly WILMINGTON, DE -- November 29, 2000 -- Study results recently published in the Journal of Clinical Therapeutics suggest that Seroquel® (quetiapine fumarate) Tablets are safe and tolerable in the long-term treatment of elderly patients who suffer from psychotic disorders.(1) The study results offer good news to clinicians who are increasingly faced with treating a burgeoning elderly population and support the need for further studies in this group. Seroquel is indicated for the management of the manifestations of psychotic disorders as demonstrated by clinical trials in patients with schizophrenia. Historically, the use of antipsychotics in elderly patients was based on clinical data that was tested and examined on younger populations because these were the only data available.(1) This study is important in that it directly assessed the use of an atypical antipsychotic, Seroquel, on elderly patients, instead of conventional, or older antipsychotic medications.(2),(3) The US elderly population is projected to reach more than 70 million by 2030, when the majority of Baby Boomers reach the age of 65.(4) Aging is a risk factor for the development of conditions associated with psychosis, which is characterized by difficulty in thinking clearly, separating fantasy from reality, and relating to others.(5) However, antipsychotic therapy can unfortunately cause significant side effects-particularly in the elderly population.(1) Further, the elderly are more susceptible to tardive dyskinesia (TD), a specific troubling side effect of many antipsychotic medications characterized by involuntary and abnormal movements that are potentially irreversible.(6) Patients over 45 years of age are five to six times more likely to develop TD than patients younger than 45.(1) The elderly are also vulnerable to extrapyramidal symptoms, (EPS),(7) troubling side effects that can cause patients to experience restlessness, an inability to sit still, muscle rigidity, or cause them to feel "slowed down."(9) In patients with schizophrenia, Seroquel (quetiapine fumarate) Tablets have an excellent EPS tolerability profile across the entire dose range.(8) The most common adverse events exhibited across placebo-controlled trials in patients with schizophrenia included headache (19 percent), somnolence (18 percent), and dizziness (10 percent), the majority of events were rated mild or moderate. "These study results are valuable -- particularly given the growing elderly population," said Pierre N. Tariot, MD, lead author of the study, University of Rochester Medical Center in Rochester, New York. "As physicians, we need to understand the benefits of drugs such as Seroquel in order to be fully prepared for the upcoming influx in the number of elderly patients who suffer from psychosis." This was a multicenter, open-label, uncontrolled trial. Patients received Seroquel for up to 52 weeks. An initial dose of 25 mg once or twice daily, as tolerated, was escalated in 25- to 50-mg increments, up to 600 mg/day, according to the patient's tolerance and clinical response.(1) The study focused on the effect of long-term administration of Seroquel Tablets in older patients with psychosis.(1) One hundred eighty-four patients with psychotic disorders (86 men and 98 women) with a mean age of 76 years entered the trial. The patients were 65 years and older with diagnosed psychotic disorders.(1) Assessments were made using the 18-item Brief Psychiatric Rating Scale (BPRS), which measures major psychotic and nonpsychotic symptoms in patients with major psychiatric illness;(9) the Clinical Global Impressions Scale (CGI), a three item scale that assesses treatment response in psychiatric patients;(11) the Simpson-Angus Scale (SAS), an EPS rating scale used to measure drug-induced parkinsonism;(11) and the Abnormal Involuntary Movement Scale (AIMS), used to assess abnormal involuntary movements associated with antipsychotic drugs.(1),(11) The most common primary diagnoses in the study were Alzheimer's dementia (43 percent), Parkinson's disease (22 percent), and schizophrenia (17 percent). The median total daily dose was 137.5 mg. This study expands the evidence of the safety of Seroquel and tolerability in an elderly population.(1) EPS-related adverse events occurred in only 13 percent of patients and in no more than 3 percent for any single EPS.(1) Events included: tremor (3 percent), abnormal gait (2 percent), akathisia (3 percent), and choreoathetosis, movement disorder, neck rigidity and extrapyramidal syndrome in only 1 percent each. No patients had dystonia.(1) Examination of adverse events suggested that they were mild and moderate, and that they rarely resulted in withdrawal.(1) The three most common adverse events were somnolence (31 percent), accidental injury (24 percent), and dizziness (17 percent).(1) Although the trial was designed primarily as a safety and tolerability assessment, changes in psychiatric function were also measured using the Brief Psychiatric Rating Scale and the Clinical Global Impressions scale. Study results showed decreases in BPRS total score from baseline (n=170).(1) BPRS measures symptoms of psychosis on a seven-point scale, (a patient score of "zero" equates to an absence of symptoms, and a score of "six" equates to the existence of extremely severe symptoms, including anxiety, gradiosity, depressive mood, and emotional withdrawal).(11) The results also showed decreases in CGI Severity of Illness item score (n=177). This test focuses on the improvement of the patient's overall functioning, therefore a decreased score corresponds to improved patient function.(10) Seroquel is indicated for the management of the manifestations of psychotic disorders. In studies supporting the approval of Seroquel, 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 in elevation of plasma prolactin levels. In addition, studies have shown that Seroquel exhibits a low incidence of hormonal, reproductive system (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation). The efficacy and atypical profile of Seroquel 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 by more than 4,000 male and female patients 18 years and older in these trials. No blood monitoring is required. 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, there have been more than 2.4 million prescriptions written for Seroquel(quetiapine fumarate) for more than 623,000 patients in the United States.(11),(12) 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). Labeling precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with Seroquel should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The safety and effectiveness of Seroquel in pediatric patients (less than 18 years of age) have not been established.
References: Related Link: Seroquel (quetiapine fumarate).
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