APA MEETING: Seroquel Improves Psychotic Symptoms Of Alzheimer's, Parkinson's Diseases
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APA MEETING: Seroquel Improves Psychotic Symptoms Of Alzheimer's, Parkinson's Diseases

WASHINGTON, DC -- May 21, 1999 -- Findings from several studies presented at the American Psychiatric Association's annual meeting show that Seroquel(R) (quetiapine fumarate) Tablets shows promise for the relief of psychotic symptoms for the estimated 4.3 million American sufferers of Alzheimer's or Parkinson's Diseases and their families.

In some elderly patients, Alzheimer's and Parkinson's Diseases can be complicated by psychotic symptoms. Unfortunately, physiologic changes can make these patients more vulnerable to the side effects of standard antipsychotic medications. This is especially true for movement disorder side effects called extrapyramidal symptoms (EPS). Researchers say Seroquel, an atypical antipsychotic, may be a very attractive therapeutic option in the elderly who are EPS-sensitive because it has not demonstrated treatment-emergent or dose-related EPS or elevations of plasma prolactin.

Seroquel is indicated for the management of the manifestations of psychotic disorders, including schizophrenia, and has been shown to be safe and effective in treating elderly patients with psychotic symptoms. For older patients, depending on the clinical response and tolerance of the individual, the rate of titration may need to be slower and the total daily therapeutic dose lower than that used in younger

The results of one study presented at the meeting suggest that Seroquel may be a potential alternative to standard antipsychotic agents for long-term use in the elderly. This 52-week, multicentre, open-label trial in men and women at least 65 years of age (for patients with Parkinson's Disease 50 years or older) with psychotic disorders was initiated to explore the therapeutic utility and tolerability of Seroquel in the EPS-sensitive elderly population.

Significant improvement from baseline in the Brief Psychiatric Rating Scale (BPRS) Total and Clinical Global Impression Severity of Illness scores was noted at all time points measured (from week two onward). BPRS positive and negative symptom cluster scores also showed improvement at all time points.

Clinically significant improvement, defined as a decrease of at least 20 percent from baseline scores on the BPRS, was achieved by 49 percent of the patients. No clinically important effects on mean hematology or clinical chemistry values, ECGs, or vital signs were observed. The most common adverse events reported in the 184 patients were somnolence and dizziness (side effects that also can be seen in younger adult patients treated with Seroquel) and accidental injury (events that are common in the elderly and are not necessarily related to drug).

Researchers also performed two subanalyses of this 52-week study to explore the effect of Seroquel in Alzheimer's Disease and Parkinson's Disease, respectively. The results of these subanalyses point to improvements in psychotic symptoms such as hostility and motor disability associated with these two diseases. An additional study, presented by Joseph Friedman, MD, further shows the ability of Seroquel to treat psychotic symptoms in patients with Parkinson's Disease and drug-induced psychosis.

Experts say uncontrolled hostility and psychosis are major reasons for institutionalising people with Alzheimer's Disease. Though standard antipsychotics can reduce this hostility, they also may produce side effects such as EPS, cognitive dysfunction or a mood of general dissatisfaction, restlessness, depression or anxiety.

Seroquel has treatment-emergent EPS no different than placebo across the entire clinical dose range and could represent an important advance for the approximately four million Americans afflicted with the disease and their families.

An exploratory subanalysis from the one-year, open-label trial of Seroquel in elderly patients presented at the meeting suggests that Seroquel may be associated with improvement in hostility in patients with psychoses related to Alzheimer's Disease. Results were presented from patients diagnosed with Alzheimer's Disease and the subset of patients with Alzheimer's Disease who were at least mildly hostile at baseline.

Significant improvement over baseline score in Total BPRS and three hostility measures (Factor V, BPRS Hostility Item and Hostility Cluster Score) were noted at all time points analysed for patients with Alzheimer's Disease with hostility and at most time points for the remaining patients with Alzheimer's Disease. More research is needed to confirm these results.

Researchers also performed an exploratory analysis of 40 patients with advanced Parkinson's Disease participating in the one-year, open-label trial of Seroquel in elderly patients discussed above. Like Alzheimer's Disease, Parkinson's Disease is another devastating condition associated with the aged. It affects approximately 340,000 people, or one percent of the population over 65 years old, in the United
States and, like Alzheimer's Disease, the condition can be associated with psychotic symptoms.

Treatment with conventional antipsychotics, however, can lead to intolerable motor disability. The exploratory analysis presented at the meeting shows that Seroquel may be effective and well tolerated in patients with Parkinson's Disease and psychosis. The analysis also showed short-term improvement in patients' motor performance. This improvement remains unexplained. More work will need to be done to further research these findings.

Related Links: Zeneca Pharmaceuticals.

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