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Rivastigmine in Alzheimer Disease

Efficacy Over Two Years

Received June 11, 2002; revised March 3, May 13, 2003; accepted May 14, 2003. From Novartis Pharmaceuticals Corporation, East Hanover, NJ (PI,AS,PM), Novartis Pharma AG, Basel, Switzerland (RS), and St. Louis University Medical Center, St. Louis, MO (GG). Send correspondence to René Spiegel, Novartis Pharma AG, Lichtstrasse 36, CH-4002, Basel, Switzerland. e-mail: Rene.Spiegel{at}pharma.novartis.com
© 2004 American Association for Geriatric Psychiatry

Objective: Beyond 6 to 9 months of treatment with cholinesterase inhibitors (ChE-Is), there is a notable increase in the rate of cognitive decline in Alzheimer disease (AD) patients, and there are few longer-term studies to evaluate this finding. The authors examined whether the ChE-I rivastigmine continued to be therapeutically effective after up to 2 years of treatment in 2,010 patients with probable AD. Methods: The clinical course of AD patients treated with rivastigmine was compared with a prediction of their course derived by a baseline-dependent historical model of disease progression developed from data in untreated AD patients. Rivastigmine efficacy data came from four 6-month, placebo-controlled, randomized, controlled trials (RCTs) and two open-label extension studies. Cognitive performance was assessed by various clinician- and caregiver-rated measures. Results: After 2 years on rivastigmine, there was less cognitive deterioration than in historical-control subjects. These effects of rivastigmine on cognitive performance were considered clinically meaningful relative to expected global decline. Treatment-emergent adverse events were the commonly-seen side effects of ChEIs and were similar in frequency to those seen in patients assigned to shorter-term rivastigmine therapy. Conclusion: Rivastigmine had a beneficial effect on cognitive performance for up to 2 years in patients with AD, versus no treatment or placebo treatment in historical-control subjects. Caregiver and clinician assessments indicated that the cognitive performance findings were of a magnitude relevant to global patient functioning. Rivastigmine remained safe over this 2-year treatment period.

Key Words: Alzheimer Disease • Rivastigmine

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