Treatment for Parkinson's Patients with Psychosis

Released: 12/1/1998 12:00 AM EST
Source Newsroom: AstraZeneca
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Contact: Jim Minnick
Zeneca Pharmaceuticals
(302) 886-5135
jim.minnick@phwilm.zeneca.com

NEUROLOGISTS OFFER SEROQUEL(R) (quetiapine fumarate) TABLETS AS FIRST-LINE TREATMENT FOR PARKINSON'S PATIENTS WITH PSYCHOSIS

Two presentations at the International Congress of Parkinson's Disease and Movement Disorders Highlight Effectiveness of SEROQUEL

December 1, 1998--NEW YORK--SEROQUEL has become the treatment of choice for Parkinson's patients with psychosis,(1) according to leading neurologists who gathered at the recent International Congress of Parkinson's Disease and Movement Disorders Annual Meeting. 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.(2)

"For years doctors have struggled to control the psychotic symptoms often caused by anti-Parkinson Disease drugs, but with little luck," said Hubert H. Fernandez, M.D., an author of the study. "However, with the advent of atypical antipsychotic medications, including SEROQUEL, it seems as though we have finally found an effective, safe, and powerful solution."

In a study(3) entitled, "Quetiapine for the Treatment of Drug-Induced Psychosis in Parkinson's Disease," 35 patients with Parkinson's Disease 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 (p=0.024) in the ten patients who participated in a 4-week follow-up survey, as measured by the Brief Psychiatric Rating Scale (the mean post treatment MMSE score of 24 was not significant). After eight weeks of treatment, 20 patients who took part in an open-ended telephone interview reported that they had remained on SEROQUEL (R) (quetiapine fumarate) without complaints of increased psychosis or decline in motor function.

Joseph H. Friedman, M.D., agrees that SEROQUEL offers an important, new option for a group of patients who otherwise are quite difficult to treat. In a presentation entitled "Atypical Neuroleptics in the Treatment of Drug-Induced Psychosis in Parkinson's Disease," Dr. Friedman advises that when treating this type of patient, SEROQUEL is the first atypical antipscyhotic medication that he uses.(1)

"Parkinson's Disease is probably the most stringent test of a drug's freedom from parkinsonian-like side effects," said Dr. Friedman. "Since SEROQUEL has such an excellent side-effect profile in this regard and is so easy to administer, I recommend it be used as a first-line therapy for this type of patient."

SEROQUEL was well tolerated by 83 percent of the neuroleptic naÔve Parkinson's patients in the study, who experienced minimal and transient side effects that included lightheadedness, sedation, and nausea.(3) The remaining 11 patients in the study were switched from previous antipsychotic therapy to SEROQUEL. Of these patients, five stayed on SEROQUEL, and the remaining six were switched back, most likely due to rapid titration.(3)

"Since the completion of this study, we have tested this titration theory on four additional patients, whom we slowly titrated from previous therapy to SEROQUEL," said Dr. Fernandez. "We found that when titrated in a slower fashion, four out of four patients were switched successfully--making SEROQUEL an option for patients who need a change in therapy."

Background on SEROQUEL Tablets

SEROQUEL is the most recent atypical antipsychotic medication indicated for the management of the manifestations of psychotic disorders, including schizophrenia. 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.

An effective agent in the elderly population, SEROQUEL(R) (quetiapine fumarate) has been tested in an open-label trial involving patients at least 65 years of age with idiopathic (i.e., schizophrenia, bipolar disorder) and organic (ie, Alzheimer's disease and dementia) psychoses.(2) The low incidence of EPS, including rigidity, shaking, and difficulty starting and stopping movement when using SEROQUEL is especially attractive to physicians who are treating elderly patients, who are more sensitive to this type of side effect. For older patients, depending on the clinical response and tolerance of the individual, the rate of titration may need to be slower and the daily therapeutic dose lower than that used in younger patients.

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.

(1) Friedman, J.H., Factor, S.A. Atypical Neuroleptics in the Treatment of Drug-Induced Psychosis in Parkinson's Disease. Breakfast Seminar Presentation at International Congress on Parkinson's Disease and Movement Disorders, New York, October, 1998. (2) Arvantis, L.,Ihor, R., et al. Efficacy, Safety and Tolerability of SEROQUEL (quetiapine fumarate) in Elderly Subjects with Psychotic Disorders," Schizophrenia Research 1997; Vol. 24 (1,2): 196 (3) Fernandez, H., Friedman, J., Jacques, C., Rosenfeld, M. Quetiapine for the Treatment of Drug-Induced Psychosis in Parkinson's Disease. Poster presentation at International Congress on Parkinson's Disease and Movement Disorders, New York, October, 1998.

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NOTE: For full prescribing information for SEROQUEL, please visit the US Zeneca web site at www.usa.zeneca.com/pharm/pibs/pib_seroquel.htm


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