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Response of Patients With Alzheimer Disease to Rivastigmine Treatment Is Predicted by the Rate of Disease Progression
Martin R. Farlow, MD;
Ann Hake, MD;
John Messina, PharmD;
Richard Hartman, PhD;
Jeffrey Veach, MS;
Ravi Anand, MD
Arch Neurol. 2001;58:417-422.
Background Evidence suggests that disease severity predicts the response of patients
with Alzheimer disease (AD) to cholinesterase inhibitor treatment, raising
the question of whether disease progression also predicts response to this
treatment.
Objective To evaluate retrospectively whether rate of disease progression during
placebo treatment affects response to subsequent rivastigmine tartrate therapy
for patients with mild to moderately severe AD.
Design A 26-week, open-label extension study following a 26-week, double-blind,
randomized, placebo-controlled trial.
Setting Outpatient research centers at 22 sites in the United States.
Patients We studied 187 of 235 patients originally randomized to receive placebo
treatment in the double-blind phase of the trial who continued with open-label
(rivastigmine) extension therapy.
Intervention Placebo treatment for 26 weeks followed by rivastigmine treatment, 2
to 12 mg/d, for 26 weeks.
Main Outcome Measures Alzheimer's Disease Assessment Scale–cognitive subscale (ADAS-Cog),
Progressive Deterioration Scale, Mini-Mental State Examination, and Global
Deterioration Scale scores.
Results Rivastigmine administration during open-label extension therapy benefited
patients who had progressed slowly and those who had progressed rapidly during
initial double-blind placebo treatment. Slowly progressive patients responded
with a mean 1.03-point improvement in the week 26 (ie, start of open-label
rivastigmine treatment) ADAS-Cog score at 12 weeks of rivastigmine treatment
(week 38 of treatment; P = .02 vs week 26). However,
more rapidly progressive patients had a significantly larger mean 4.97-point
improvement from the week 26 ADAS-Cog score at 12 weeks (with respect to week
26 of treatment and slowly progressive patient scores, P<.001 for both). Thus, a more rapid disease progression rate while
receiving placebo treatment was predictive of a significantly stronger patient
response to rivastigmine therapy. This relation also was observed with the
other 3 outcome measures and was still apparent when accounting for disease
severity.
Conclusions Rate of disease progression for patients with mild to moderate AD seems
to predict response to rivastigmine treatment. Patients with more rapidly
progressive disease might be particularly likely to benefit from rivastigmine
therapy.
From the Department of Neurology, Indiana University School of Medicine,
Indianapolis (Drs Farlow and Hake); and Novartis Pharmaceuticals Corp, East
Hanover, NJ (Drs Messina, Hartman, and Anand and Mr Veach). Dr Farlow has
acted as a consultant to, or been provided research support by, Novartis Pharmaceuticals
Corp, the sponsor of study B353, from which the data presented herein were
derived.
Corresponding author and reprints: Martin R. Farlow, MD, Department
of Neurology, Indiana University School of Medicine, CL583, 541 Clinical Dr,
Indianapolis, IN 46202-5111 (e-mail: mfarlow{at}iupui.edu).
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