ACN MEETING: Seroquel Shown To Be Effective For Alzheimer’s, Parkinson’s
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ACN MEETING: Seroquel Shown To Be Effective For Alzheimer’s, Parkinson’s

LAS CROABAS, PUERTO RICO -- Dec. 16, 1998 -- Trial results show that Zeneca Pharmaceuticals’ Seroquel(R) (quetiapine fumarate) Tablets were associated with improvements in patients with Parkinson's and Alzheimer's diseases.

Results came from two sub-analyses 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. They were presented at the 37th American College of Neuropsychopharmacology annual meeting.

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 asextrapyramidal 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.

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. 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.

In the trial, from which both of these subanalyses came, the most common adverse events reported in 184 patients were somnolence (31 percent), accidental injury (21 percent) (most involved falls that investigators reported as not related or probably not related to drug) and dizziness (17 percent). However, these side effects were not necessarily related to the drug.

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 safety. 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 as 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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