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Thought this would be of interest to the group: Keith Chancey 46/15 months Memphis, TN New Hope For the Treatment of Alzheimer's and Parkinson's Diseases SEROQUEL(R) (quetiapine fumarate) Tablets Shown to be an Effective Treatment for Elderly Population Date: Thursday, December 17, 1998 Source: PR Newswire LAS CROABAS, Puerto Rico, Dec. 16 /PRNewswire/ via NewsEdge Corporation -- At a time when an increasing number of Americans are concerned about health problems associated with aging, data presented today at a U.S. psychiatry conference offer new hope for treating two of the most debilitating elderly illnesses. (1)(2) SEROQUEL(R) (quetiapine fumarate) Tablets were associated with improvements in patients with Parkinson's and Alzheimer's diseases, according to the posters presented. Results came from two sub-analyses of a trial conducted by Zeneca Pharmaceuticals to evaluate the short- and long-term safety and tolerability of SEROQUEL in the treatment of elderly subjects with selected idiopathic and organic psychoses. 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.(3) 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.(4) "The use of SEROQUEL to treat these two very important patient populations represents a critical advance in treating the elderly," said Lisa Arvanitis, M.D., Senior Medical Director, Medical Research and Communications Group, Zeneca Pharmaceuticals and an author of the study. "Our analyses indicate SEROQUEL will become an important therapeutic option for both Parkinson's disease and Alzheimer's disease -- adding to its already strong product profile." SEROQUEL Therapy May Reduce Hostility in Patients with Alzheimer's Disease 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, cognitive dysfunction, or dysphoria. The results presented here suggest that SEROQUEL treatment is associated with improvement in hostility in patients with psychoses related to Alzheimer's. Seventy-eight patients with Alzheimer's disease, 45 of whom had hostility, showed significant improvement in this one-year, open-label trial using SEROQUEL.(2) SEROQUEL Therapy Improves Psychotic Symptoms Associated with Parkinson's Disease Another devastating condition associated with aging, Parkinson's disease affects approximately 340,000 people, or one percent of the population over 65 years old, in the United States.(5) An exploratory analysis showed that SEROQUEL is effective and well tolerated in patients with Parkinson's disease and psychosis. The analysis also showed short-term improvement in patients' motor performance which remains unexplained. "Our analysis shows that SEROQUEL is an effective treatment for the psychotic symptoms associated with Parkinson's disease," said Paul Yeung, M.D., M.P.H., Associate Medical Director, Clinical Medicine Group, Medical Research and Communications Group, Zeneca Pharmaceuticals, and an author of the study. "We are also encouraged by the initial improvement shown in motor performance and will continue to explore the efficacy of SEROQUEL in this incapacitating condition." In the trial, from which both of these subanalyses came, the most common adverse events reported in 184 patients were somnolence (31%), accidental injury (21%) (most involved falls that investigators reported as not related or probably not related to drug), and dizziness (17%). However, these side effects were not necessarily related to the drug. Americans Fear Aging This data about SEROQUEL comes at a time when increasing numbers of Americans are concerned about health problems associated with aging. A recent survey conducted by Wirthlin Worldwide found that more Americans are very or somewhat more concerned about Alzheimer's disease (81%) and decline in mental skills (81%) than depression (67%). This research can offer new hope for treating psychotic symptoms of these two common diseases associated with aging. Background on SEROQUEL Tablets 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 300-400 mg can be given in two divided doses daily. The drug is manufactured in the United States by Zeneca Pharmaceuticals 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 346,000 prescriptions written for SEROQUEL for more than 112,000 patients.(6)(7) 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 safety. 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. 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 rated as mild or moderate. The safety and effectiveness of SEROQUEL in pediatric patients (less than 18 years of age) have not been established. In the US, Zeneca Inc. is a $3.4 billion bioscience business with approximately 7,500 employees. Zeneca Inc. is a wholly-owned subsidiary of the UK-based Zeneca Group PLC (NYSE: ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacture, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services. NOTE: For full prescribing information for SEROQUEL Tablets, please visit the US SEROQUEL web site at www.usa.zeneca.com/pharm/pibs/pib_seroquel.htm (1) Juncos J, Yeung P, Sweitzer D, Arvanitis L, Nemeroff C. "Quetiapine Improves Psychotic Symptoms Associated with Parkinson's Disease": Poster presented at the 37th American College of Neuropsychopharmacology Annual Meeting in Las Croabas, Puerto Rico, December 1998. (2) Schneider L, Yeung P, Sweitzer D, Arvanitis L. "Quetiapine May Reduce Hostility in Patients With Psychoses Related to Alzheimer's Disease": Poster presented at the 37th American College of Neuropsychopharmacology Annual Meeting in Las Croabas, Puerto Rico, December 1998. (3) "Public's Concerns about Aging" survey conducted by Wirthlin Worldwide, October 1998. (4) Arvanitis L, Rak I, et al. "Efficacy, Safety and Tolerability of SEROQUEL(R) (quetiapine fumarate) in Elderly Subjects with Psychotic Disorders," Schizophrenia Research 1997; 24(1,2):196 (5) Berkow, R., ed. The Merck Manual, 16th Edition. New Jersey: Merck Research Laboratories, 1992, 1495-1497. (6) Source(TM) Prescription Audit (SPA) 13-Month Period Ending October 1998 and Month October 1998, Scott Levin, a division of PMSI Scott-Levin, Inc. (7) NDC Health Information Services, SEROQUEL Patient Tracking Analysis, October, 1998. SOURCE Zeneca Pharmaceuticals /CONTACT: Jim Minnick of Zeneca Pharmaceuticals, 302-886-5135, [log in to unmask] (ZEN)