New Findings Published In The Lancet Suggest Exelon (R) (rivastigmine tartrate) Improves Behavioral
Disturbances In Patients With Dementia With Lewy Bodies
First Study of its Kind to Demonstrate Efficacy of a Cholinesterase Inhibitor
for Common Form of Dementia
EAST HANOVER, N.J., Dec. 18 /PRNewswire/ -- Study results published in the
December 16th Lancet suggest that Exelon (R) (rivastigmine tartrate), a
cholinesterase inhibitor indicated for the treatment of mild to moderate
Alzheimer's disease, improves behavioral disturbances often seen in patients
with dementia with Lewy bodies (DLB). DLB (previously referred to as the Lewy
Body variant of Alzheimer's disease) accounts for 15 to 25 percent of dementia
cases in the elderly.
In the study, approximately twice as many patients (63 percent) taking
Exelon showed at least a 30 percent improvement in psychiatric symptoms -
which included apathy, anxiety, and delusions - compared to those receiving
placebo. Additionally, hallucinations and psychotic behavior resolved almost
completely in 55 percent of patients treated with Exelon, compared with 23
percent of placebo patients. Symptoms re-emerged rapidly in the three weeks
after treatment was withdrawn.
A total of 120 DLB patients from Italy, Spain and the UK were enrolled in
the study, the first double-blind, placebo controlled study with a
cholinesterase inhibitor for the treatment of DLB. Patients were treated with
up to 12 mg of Exelon or placebo daily for 20 weeks. The patients were
assessed using the Neuropsychiatric Inventory (NPI), the Cognitive Drug
Research (CDR) computerized assessment system, and a battery of
neuropsycholgical tests. At week 20, patients were removed from all
treatments and followed for an additional three weeks.
In the Lancet study, DLB patients treated with Exelon also showed marked
improvement in objective measures of cognitive functioning, particularly in
tests of attention and memory; such improvements were significantly greater
than those observed in patients treated with placebo.
The most common adverse events reported in the trial were cholinergic in
nature (i.e., nausea, vomiting, anorexia) and were seen more frequently with
Exelon than with placebo. The majority of adverse events were considered mild
to moderate in both groups.
About Dementia with Lewy Bodies
Dementia with Lewy bodies (DLB - also known as the Lewy body variant of
Alzheimer's disease) is the second most common form of dementia after
Alzheimer's disease (AD), accounting for 15 to 25 percent of cases. The
clinical symptoms of DLB overlap with those of AD, but DLB is also marked by
the prominence of fluctuations in cognition; the early presence of behavioral
symptoms such as visual hallucinations, delusions, apathy, anxiety; and the
presence of Parkinsonian features. DLB patients are differentiated from AD
patients by the presence of large numbers of Lewy bodies, a relative lack of
neurofibrillary tangles, and a more profound deficit of the neurotransmitter
acetylcholine.
About Exelon
Exelon is a cholinesterase inhibitor that was recently approved by the
U.S. FDA for the treatment of mild to moderate AD. The safety and efficacy of
Exelon were established in the largest Phase III clinical program to date of
any Alzheimer's disease medication. Patients treated with Exelon demonstrated
a significant benefit in global functioning based on evaluation of activities
of daily living (ADLs), behavior and cognition.
Exelon should not be used in patients with known hypersensitivity to
rivastigmine, other carbamate derivatives or other components of the
formulation.
In controlled clinical trials, the most common adverse events were nausea,
vomiting, anorexia, dyspepsia and asthenia. Exelon use is associated with
significant gastrointestinal adverse reactions, including nausea and vomiting,
anorexia and weight loss. In the controlled studies, these side effects
occurred more frequently as doses were increased. The weight loss associated
with Exelon occurred more frequently among women receiving high doses in
clinical trials. Exelon should be used with caution in patients with peptic
ulcers, gastrointestinal bleeding, and "sick sinus syndrome" or other
supraventricular cardiac conduction conditions. In clinical studies, 3
percent of Exelon-treated patients experienced syncope compared to 2 percent
of placebo-treated patients. (Please see important WARNINGS in complete
prescribing information.)
Exelon has been cleared for marketing in more than 70 countries worldwide,
including all 15 member states of the European Union, Switzerland, New
Zealand, Australia, Canada and Mexico.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation
is an affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare with
core businesses in pharmaceuticals, consumer health, generics, eye-care, and
animal health. In 1999, the Group (including Agribusiness) achieved sales of
USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered
in Basel, Switzerland, Novartis employs about 82,400 people and operates in
over 140 countries around the world. The Group recently announced plans to
spin off its Crop Protection and Seeds sectors and to merge them with the
agrochemicals business of AstraZeneca in the second half of 2000.
The foregoing press release contains forward-looking statements that can
be identified by terminology such as "may," "the study results suggest that"
or similar expressions. Such forward looking 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 expectations regarding future research development results could
be affected, by among other things, uncertainties relating to clinical trials
and product development; unexpected regulatory delays or restrictions or
government regulation generally; the company's ability to obtain or maintain
patent and other proprietary intellectual property protection; and competition
in general.
FOR MORE INFORMATION CONTACT:
Rod Smith
Feinstein Kean Healthcare
Tel: (617) 761-6723
Email: rsmith@fkhealth.com
SOURCE Novartis Pharmaceuticals Corporation
CONTACT: Rod Smith of Feinstein Kean Healthcare, 617-761-6723,
rsmith@fkhealth.com |
