EAST HANOVER, N.J., Dec. 9 /PRNewswire-FirstCall/ -- Results from a new study published in the December 9th issue of the New England Journal of Medicine show that the Alzheimer's disease medication Exelon (R) (rivastigmine tartrate) provided important benefits in symptoms of dementia in Parkinson's disease patients. Patients treated with Exelon had better overall functioning, and showed improvements in cognition and behavioral symptoms, compared to patients taking placebo. This is the first large-scale, prospective, placebo- controlled study to demonstrate statistically significant cognitive benefits in Parkinson's disease patients with dementia. Patients also showed improvement in some important aspects of behavior. Exelon is the only medication to demonstrate statistically significant benefits in the treatment of these patients in a large-scale, well-controlled study.
"Results from this study show that Exelon may be able to help Parkinson's disease patients who are experiencing dementia, a problem in many of these patients," commented Jeffrey Cummings, MD, Professor of Neurology at the University of California in Los Angeles. "The outcomes, in both cognitive and certain behavioral aspects, demonstrated in this trial by patients taking Exelon can translate into meaningful gains -- such as taking a more active role in everyday life, interacting with loved ones, and maintaining independence longer -- all of which can make a real difference for both patients and their families."
It is estimated that dementia occurs in approximately 40% of people with Parkinson's disease and that it may affect up to 80% of Parkinson's disease patients as the disease further progresses. Previous studies suggest that patients with Parkinson's disease have up to a six-fold increase in the risk of developing dementia compared to elderly patients without Parkinson's disease. People with Parkinson's disease who have dementia experience cognitive symptoms (such as problems with attention and memory impairments) and behavioral problems (such as agitation and mood swings), and have increasing difficulty performing daily tasks. In the study, patients treated with Exelon exhibited statistically significant benefits in these three symptom domains, compared to patients taking placebo. The primary efficacy outcomes evaluated in the study included effects on patients' cognition and overall functioning.
"Dementia in Parkinson's disease patients takes a significant emotional, economic and social toll on patients and their families," said Abraham Lieberman, MD, Medical Director of the National Parkinson Foundation. "With current Parkinson's disease treatments, we are often able to manage the movement symptoms of the disease, but there has been a significant gap in our ability to treat dementia in these patients."
During the study, 541 patients were randomly assigned to a daily dose of 3-12 mg Exelon or placebo and evaluated at baseline and twice over the 24-week study period. The patients involved had mild to moderate dementia, which they had developed at least two years after they had been diagnosed with Parkinson's disease. Investigators used two primary assessment scales to evaluate efficacy: the Alzheimer's Disease Assessment Scale (ADAS-cog), which assesses cognitive function, including orientation, memory and language; and the Alzheimer's Disease Cooperative Study -- Clinician's Global Impression of Change (ADCS-CGIC), which assesses overall functioning by assigning a global rating to evaluate change from baseline. The primary efficacy analysis included 501 patients.
Patients who were treated with Exelon showed significant improvements in cognition compared with patients taking placebo. At week 24, patients on Exelon showed a mean 2.1-point improvement in ADAS-cog scores, versus a 0.7- point decline in the placebo group (p<0.001). Significantly more Exelon- treated patients also showed benefits in overall functioning. At week 24, 41% of patients treated with Exelon showed improvements on the ADCS-CGIC, versus 30% of patients taking placebo (p=0.02). Mean ratings on the ADCS-CGIC were 3.8 on Exelon versus 4.3 on placebo (p=0.007).
In addition, a greater proportion of patients who were treated with Exelon showed improvements in important aspects of behavior. Significantly more patients treated with Exelon had an improvement of at least 30% on the 10-item Neuropsychiatric Inventory (NPI-10) scores compared to patients taking placebo (45.4% vs. 34.6%, p=0.03). The NPI-10 is a tool used to assess behavioral symptoms commonly observed in patients with dementia. The NPI-10 was one of several secondary efficacy assessment scales used in the study.
Additional specific tests for memory, attention, ability to carry out daily activities, planning and reaction time consistently showed better outcomes for patients treated with Exelon versus placebo.
Exelon was generally well tolerated. The most frequent side effects associated with Exelon were nausea and vomiting, which were mild to moderate in nature. More patients treated with Exelon reported increased tremor than did patients on placebo, but this rarely resulted in withdrawal from the study and the rating scale used to measure motor function did not show a statistically significant difference in increased tremor between Exelon and placebo, or significant deterioration relative to baseline.
Additional Information about Dementia in Parkinson's Disease Patients
Parkinson's disease is a chronic and progressive disease of the nervous system that affects 1.5 million Americans. According to the National Parkinson Foundation, dementia is one of the complications most feared by Parkinson's disease patients. In addition to cognitive impairment, neuro-psychiatric symptoms (e.g., depression, hallucinations, anxiety and apathy) are also common. These symptoms impact the patient's quality of life, course of the disease and caregiver distress.
As with Alzheimer's disease, in Parkinson's disease patients, dementia is associated with a cholinergic deficit, which results in decreased transmission of signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine. This deficit contributes to the cognitive and behavioral problems observed in these patients.
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.exelon.com/.
The foregoing press release contains forward-looking statements relating to the business of Novartis Pharmaceuticals Corporation (the "Company") that can be identified by forward-looking terminology such as "may be able to," "may help," "can translate," "can make a difference," or similar expressions. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectation regarding the commercial success of Exelon could be affected by, among other things, results from future clinical trials, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors referred to in the Company's Form 20F on file with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events, or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The Company's mission is to improve people's lives by pioneering novel healthcare solutions.
Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, attention deficit/hyperactivity disorder, Epilepsy, Schizophrenia and migraine, many of which continue to be regarded as "gold standards" to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world. For further information please consult http://www.pharma.us.novartis.com/.
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