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Exelon (Rivastigmine) Shows Long-term Efficacy in Alzheimer's disease: Presented at ATT

BASEL, SWITZERLAND -- April 5, 2002 -- ExelonÒ (rivastigmine) provides sustained benefits for people with Alzheimer's disease for at least two years, according to a large multicenter data analysis presented today at the Seventh International Geneva/Springfield Symposium on Advances in Alzheimer's Therapy (ATT)(1).

The report included data from the longest studies conducted to date on Exelon, and showed the drug slowed cognitive decline compared to placebo or no treatment for up to two years. Exelon is currently approved for treatment of mild to moderate Alzheimer's disease.

"These are important results because they are the first to confirm the benefits of Exelon over such a long period of time and in a large number of patients," said George Grossberg, MD, lead author of the report and Director of Geriatric Psychiatry at Saint Louis University School of Medicine in St. Louis, Missouri, USA. "The finding of a sustained benefit is good news for individuals with Alzheimer's disease and for the physicians and family members who care for them," he said.

Although its exact causes are not understood, Alzheimer's disease (AD) is associated with decreased transmission of signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine. Exelon is unique because it treats AD by inhibiting the two key enzymes involved in breaking down acetylcholine -- acetylcholinesterase and butyrylcholinesterase -- thus preventing the breakdown of the neurotransmitter and prolonging its action.

Other drugs commonly used to treat AD, such as donepezil and galantamine, inhibit acetylcholinesterase but not butyrylcholinesterase. Recent research suggests that butyrylcholinesterase may play an increasingly important role in regulating acetylcholine levels as AD progresses, and that the dual inhibitory action of Exelon may provide greater and more sustained efficacy in treating patients with the disorder (2).

For the analysis, the cognitive performance of 2010 Exelon-treated patients from 113 centers in the U.S. and other countries was compared both to their projected performance if they were untreated and to published data of patients treated with a placebo. Data on Exelon patients were from open-label extension studies of four six-month, randomised, placebo-controlled trials. During the extension studies, patients received from 1 to 6 mg Exelon twice daily, within the recommended range. Standardised tests were used to measure patients' cognitive performance and the clinician's overall assessment of the patients' condition (3).

Exelon treatment resulted in less cognitive deterioration than projected for untreated or placebo-treated patients. For example, after two years, scores of cognitive function (ADAS-Cog scale, zero to 70 point range) for Exelon patients deteriorated an average of five points less than projected for untreated patients (8.6 versus 13.6 points, respectively). The lower rate of cognitive decline was determined to be clinically relevant, as shown by smaller-than-expected declines in clinicians' assessments of the patients' global functioning.

References:

(1) Grossberg G, Spiegel R, Satlin A, Mesenbrink P. Rivastigmine in Alzheimer's disease: efficacy over two years. Abstract 33A. Presented at: The Seventh International Geneva/Springfield Symposium on Advances in Alzheimer's Therapy, Geneva Switzerland, April 4, 2002.

(2) Ballard CG. Advances in the treatment of Alzheimer's disease: benefits of dual cholinesterase inhibition. Eur Neurol 2002; 47(1):64-70.

(3) Cognitive performance was assessed by the Alzheimer Disease Assessment Scale - Cognitive subscale and the Mini-Mental State Examination; clinical relevance of the changes observed were assessed by the Clinician Interview-Based Impression of Change (CIBC-Plus), the Global Deterioration Scale (GDS), and the Progressive Deterioration Scale (PDS).

SOURCE: Novartis

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