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| |  AAGP MEETING: Seroquel Effective At Treating Psychosis In Patients With Alzheimer's, Parkinson's NEW ORLEANS, LA -- March 16, 1999 -- New analyses from research indicate that Zeneca Pharmaceuticals’ Seroquel(R) (quetiapine fumarate) may be associated with improvements in patients with Alzheimer's and Parkinson's diseases. Results came from three presentations: two exploratory subanalyses of a trial conducted by Zeneca to evaluate the short- and long-term safety and tolerability of Seroquel in the treatment of elderly subjects with selected idiopathic and organic psychoses; and a study investigating Seroquel for the treatment of drug-induced psychosis in Parkinson's disease. At a time when an increasing number of Americans are concerned about health problems associated with aging, the data presented today at the annual meeting of the American Association for Geriatric Psychiatry (AAGP) offer new hope for treating these two debilitating elderly illnesses. The good news comes to the more than 80 percent of Americans who are concerned about growing old, particularly due to the threat of Alzheimer's disease and the decline in mental skills associated with aging. An atypical antipsychotic, Seroquel is indicated for the management of the manifestations of psychotic disorders, including schizophrenia, and has also been shown to be safe and effective in treating elderly patients with psychotic symptoms. Approximately four million Americans are afflicted with Alzheimer's disease. For the families of sufferers, hostility associated with the disease often forces the painful decision to move a loved one into an institution. Standard antipsychotics can reduce hostility in patients with Alzheimer's disease but also may produce side effects such as extrapyramidal symptoms (EPS) which include rigidity and tremor, cognitive dysfunction, or dysphoria. Therapies that reduce hostility without inducing EPS represent an important advance. The results presented here suggest that Seroquel may be associated with improvement in hostility in patients with psychoses related to Alzheimer's disease. In this subanalysis from a one-year, open-label trial, 78 patients with Alzheimer's disease (mean age 78 years) treated with Seroquel, 45 of whom had hostility, showed significant improvement in hostility based on a number of different rating scales. Significant improvement over baseline score in Total BPRS, Factor V, Hostility and Hostility items scores was noted at all time points analysed for Alzheimer's disease patients with hostility and at most time points for the remaining Alzheimer's disease patients. More research is needed to confirm these results. Another devastating condition associated with aging, Parkinson's disease (PD), affects approximately 340,000 people, or one percent of the population over 65 years old, in the United States. An exploratory analysis of 40 patients with advanced PD showed that Seroquel may be effective and well tolerated in patients with PD and psychosis. The analysis also showed short-term improvement in patients' motor performance which remains unexplained. In the trial from which both of these exploratory analyses came, the most common adverse events reported in the 184 patients were somnolence and dizziness (side effects that can also be seen in other adult patients treated with Seroquel) and accidental injury (events that are common in the elderly). In another study, 35 patients with PD and drug-induced psychosis were treated with Seroquel. Twenty of the 24 patients who had previously never been treated with a neuroleptic, reported marked improvement of psychosis without a decline in motor function, as assessed by the United Parkinson's Disease Rating Scale. In addition, psychotic symptoms decreased significantly in the 10 patients who participated in a four-week follow-up survey, as measured by the Brief Psychiatric Rating Scale (the mean post treatment MMSE score of 22.8 was not significant). Eleven psychiatrically stable patients in the study were switched from previous antipsychotic therapy to Seroquel. Of these patients, six stayed on Seroquel without a loss of effect and the Clinical trials with Seroquel have demonstrated efficacy in treating the positive and negative symptoms of schizophrenia and were no different from placebo across the clinical dose range in the incidence of extrapyramidal symptoms (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 to 400 mg can be given in two divided doses daily. 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 hospitalised 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 labelling 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. 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 percent), somnolence (18 percent) and dizziness (10 percent), and the majority of events rated were 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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