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Exelon (Rivastigmine Tartrate) Reduces Behavioral Disturbances Associated With Alzheimer's Disease

EAST HANOVER, NJ -- August 22, 2003 -- Data show that the cholinesterase inhibitor Exelon ® (rivastigmine tartrate) may reduce certain behavioral symptoms associated with Alzheimer's disease (AD), such as delusions and hallucinations. These data were presented in a poster at the 11th Annual Congress of the International Psychogeriatric Association in Chicago, IL. A second poster was also presented that showed a reduction in the time to first antipsychotic use in Exelon-treated patients.

"Behavioral symptoms such as agitation, aggression and paranoia present enormous burdens on caregivers and often lead to a decision to institutionalize a patient," explained Jeffrey Cummings, M.D., Professor of Medicine at the UCLA Alzheimer's Disease Center in Los Angeles. "My data suggest that treatments such as Exelon may reduce specific disruptive behaviors, which is important because of the significant impact these symptoms have on patients and caregivers alike. This is in addition to demonstrated benefits in cognitive performance, global functioning, and activities of daily living."

The first analysis, led by Dr. Cummings, evaluated the effects of Exelon on neuropsychiatric and behavioral disturbances of 173 nursing home residents with Alzheimer's disease. This was a retrospective analysis of a 26-week, prospective open-label study, involving 13 primary centers in the U.S. and 29 nursing homes.

Seventy-seven percent of patients had at least one behavioral symptom at baseline, as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) scale (n=173). At the end of the 26-week study period, more than half (59%) of Exelon-treated patients with at least one behavioral symptom at baseline showed improvement on the NPI-NH scale for psychiatric and behavioral disturbances. These patients demonstrated a mean improvement of 64% (n=92).

Moreover, forty-nine percent (49%) of those patients demonstrated a >/=30% reduction in collective psychiatric and behavioral symptoms with a mean improvement of 72% (n=92).

Of the 12 neuropsychiatric disturbances evaluated by the NPI-NH scale present at baseline, Exelon treatment demonstrated a statistically significant improvement from baseline (p<0.050) in the following eight disturbances in patients with that specific symptom: delusions, hallucinations, agitation, apathy/indifference, irritability, aberrant motor behavior, night-time behavior, and appetite/eating change.

In the second poster, researchers presented a retrospective analysis of drug claims data to assess the effect of Exelon on the time to first antipsychotic drug prescription. The analysis compared patients identified with Alzheimer's disease who received Exelon with those who did not receive cholinesterase inhibitor (ChEI) treatment during the 18-month period that preceded the analysis. Both groups excluded patients who had filled prescriptions for any antipsychotic medications during the 18 months prior to the study date. The researchers included 978 patients identified from longitudinal data provided by approximately 100 U.S. insurance companies and assigned the patients to two study groups: an Exelon group (n=370) and a non- ChEI group (n=608).

Using statistical analyses, the researchers demonstrated a significantly decreased risk of first antipsychotic use among patients taking Exelon compared to those not treated with a ChEI. Researchers concluded that Exelon users were 60% less likely to take antipsychotic medications compared to patients who were not receiving ChEI treatment. [Relative risk (RR)=0.40; 95% CI=0.28-0.58 with adjustments for age, sex and use of other CNS agents. RR=0.37; 95% CI=0.26-0.53 without these adjustments.] By the end of the observation period (median time=395 days), 10% (38 patients) of the Exelon group had been prescribed an antipsychotic medication compared to 25% (150 patients) of the non-ChEI group (p<0.0001).

Additional Information About Alzheimer's Disease Alzheimer's disease is a neurodegenerative disease involving deterioration of the brain. It is the fourth leading cause of death behind cardiovascular disease, cancer, and stroke and affects up to four million adults in the United States and more than 10 million worldwide. It has an annual U.S. price tag of approximately $100 billion in direct (healthcare and related) and indirect (income) costs.

Additional Information About Exelon

Exelon is approved for mild-to-moderate Alzheimer's disease. Exelon use is associated with significant stomach-related side effects, including nausea, vomiting, loss of appetite, and weight loss. If therapy is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose in order to avoid the possibility of severe vomiting and its potentially serious consequences.

In clinical studies, stomach-related side effects occurred more frequently as doses were increased. The weight loss associated with Exelon occurred more commonly among women receiving high doses in clinical studies. Because these side effects can be serious, caregivers should be encouraged to monitor for these adverse events and inform the physician if they occur. People at risk for certain heart conditions or stomach ulcers should notify their doctor before starting Exelon therapy. In clinical studies, some patients also experienced fainting, weakness, and upset stomach. For more information, please see complete prescribing information at http://www.AlzheimersDisease.com.


SOURCE: Novartis Pharmaceuticals Corporation

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