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CME

Rivastigmine May Be Helpful for the Dementia of Parkinson's Disease

  • Authors: News Author: Laurie Barclay, MD
    CME Author: Charles Vega, MD, FAAFP
  • CME Released: 12/8/2004
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 12/8/2005
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Target Audience and Goal Statement

This article is intended for primary care physicians, neurologists, and other specialists who care for patients with dementia related to Parkinson's disease.

The goal of this activity is to provide the latest medical news to physicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Identify criteria used to differentiate dementia related to Parkinson's disease from Lewy-body dementia.
  • Describe the efficacy and tolerability of rivastigmine in the treatment of dementia related to Parkinson's disease.


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Medscape encourages Authors to identify investigational products or off-label uses of products regulated by the U.S. Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Laurie Barclay, MD

    Laurie Barclay is a freelance reviewer and writer for Medscape.

    Disclosures

    Disclosure: Dr. Barclay has reported no significant financial interests.

Reviewer(s)

  • Gary Vogin, MD

    Senior Medical Editor, Medscape

    Disclosures

    Disclosure: Dr. Vogin has reported no significant financial interests.

CME Author(s)

  • Charles P Vega, MD

    Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

    Disclosures

    Disclosure: Dr. Vega has disclosed that he has received grants for educational activities from Pfizer.


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CME

Rivastigmine May Be Helpful for the Dementia of Parkinson's Disease

Authors: News Author: Laurie Barclay, MD CME Author: Charles Vega, MD, FAAFPFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME Released: 12/8/2004

Valid for credit through: 12/8/2005

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Dec. 8, 2004 — The cholinesterase inhibitor rivastigmine is somewhat helpful for the dementia of Parkinson's disease, according to the results of a randomized, double-blind, multicenter study published in the Dec. 9 issue of the New England Journal of Medicine.

"Cholinergic deficits are prominent in patients who have dementia associated with Parkinson's disease," write Murat Emre, MD, from Istanbul University in Turkey, and colleagues. "Preliminary studies suggested that cholinesterase inhibitors were beneficial in patients who had dementia associated with Parkinson's disease."

In this study, patients in whom mild-to-moderate dementia developed two years or more after they were diagnosed as having Parkinson's disease were randomized to receive placebo or 3 to 12 mg of rivastigmine per day for 24 weeks. Primary efficacy outcomes were the cognitive subscale score on the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC). Secondary outcomes were the scores for the Alzheimer's Disease Cooperative Study-Activities of Daily Living, the 10-item Neuropsychiatric Inventory, the Mini-Mental State Examination, Cognitive Drug Research power of attention tests, the Verbal Fluency test, and the Ten-Point Clock-Drawing test.

Of 541 patients enrolled, 410 (75.8%) completed the study. Although the outcomes were better in the rivastigmine group than in the placebo group, the differences were moderate and similar to those reported in trials of rivastigmine for Alzheimer's disease. Change in the 70-point ADAS-cog was a mean improvement of 2.1 points from a baseline score of 23.8 in the rivastigmine group compared with a 0.70-point worsening in the placebo group from a baseline score of 24.3 (P < .001).

There were clinically meaningful improvements in ADCS-CGIC scores in 19.8% of patients in the rivastigmine group and in 14.5% of patients in the placebo group. Clinically meaningful worsening occurred in 13.0% and 23.1%, respectively (mean score at 24 weeks, 3.8 and 4.3, respectively; P = .007). For all secondary efficacy variables, outcomes were significantly better with rivastigmine than with placebo.

The most frequent adverse events were nausea, which occurred in 29.0% of the rivastigmine group and in 11.2% of the placebo group (P < .001), vomiting (16.6% vs 1.7%; P < .001), and tremor (10.2% vs 3.9%; P = .01). If at least subjective worsening of parkinsonian symptoms, especially tremor, may occur in a subgroup of patients, the authors suggest that these symptoms must be specifically looked for during treatment.

Study limitations include differences in the results from a clinical trial compared with the natural rate of deterioration in untreated patients and lack of long-term data.

"In this placebo-controlled study, rivastigmine was associated with moderate improvements in dementia associated with Parkinson's disease but also with higher rates of nausea, vomiting, and tremor," the authors write. "Taking into account the expected effect sizes and potential issues of tolerability, physicians should evaluate each patient individually before deciding to initiate treatment with rivastigmine."

Some of the authors report various financial relationships with Novartis, maker of rivastigmine, Pfizer, AstraZeneca, Eli Lilly, Eisai, Janssen, Allergan, Medtronic, Teva, Orion, Johnson & Johnson, Bristol-Myers Squibb, AstraZeneca, Johnson & Johnson, Lundbeck, Sanofi, Neurochem, Aventis, and/or the Portuguese Drug Agency (INFARMED).

Novartis funded this study and employs three of the authors, who report owning share options in this company.

In an accompanying editorial, Daniel Z. Press, MD, from the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, Massachusetts, notes that patients with Parkinson's disease dementia have a greater cholinergic deficit than those with Alzheimer's disease, and the extent of the deficit correlates with the severity of cognitive symptoms.

However, the results with rivastigmine were "not as impressive as one would have hoped." The difference between groups of 2.8 points in the ADAS-cog represents an average relative improvement of about six months' time. Dr. Press also notes various methodologic limitations that might tend to inflate the observed benefit.

"We must increase our efforts to understand the cognitive aspects of these disorders, since many of the newest treatments for the motor symptoms of Parkinson's disease, such as subthalamic stimulation, can worsen cognition and behavior," Dr. Press writes. "Although cholinesterase inhibitors such as rivastigmine offer a moderate improvement in only a portion of patients with Parkinson's disease dementia, such agents offer the potential for clinically significant benefits in cognition. Such agents can now be added to the list of medications that may benefit these patients."

N Engl J Med. 2004;351:2509-2518, 2547-2549