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From: "WE MOVE" < [log in to unmask]>
Dte: Sat, 15 May 2004 08:04:56 -0400

Saturday, May 15, 2004  Issue 3    VOLUME 1 ISSUE 3

 The Use of Pergolide May Be Linked to Changes in Heart Valves

 Previously published reports have identified a limited number of cases
of abnormalities in the heart valves of patients who have taken
pergolide. In a study that was published in the journal Lancet in April
2004, researchers examined all patients with Parkinson's disease in their
clinic and found that the connection between the use of pergolide and
damage to heart valves was more common than previously thought to be.
[FULL STORY]

The Use of Pergolide May Be Linked to Changes in Heart Valves

Researchers in Belgium recently published their findings on a possible
association between the use of pergolide (Permax®) and problems with the
valves of the heart. (To see a review of the structure and function of
the heart, please click here). Pergolide (a dopamine-receptor agonist) is
a drug that mimics the effects of a chemical in the body that helps to
regulate movement—dopamine—and  is approved by the US Food and Drug
Administration for the treatment of Parkinson’s disease. It may also be
used to treat restless legs syndrome. This drug is an ergot derivative,
meaning that it has a chemical structure based on ergot, a substance that
is produced from a fungus called Claviceps purpurea.

Several scientific papers have been published that have identified a
possible increased risk of problems with heart valves with the use of
pergolide; however, this is the first time that researchers have examined
a large group of patients who are taking pergolide and determined the
rate at which these problems occurred.

Dr. Van Camp and his associates used sound waves to create a moving
picture of the heart (echocardiography) and examined the structures and
pressures in the hearts of 96 people—78 of whom had taken pergolide for
the treatment of Parkinson’s disease and 18 people who had Parkinson’s
disease but who had never taken an ergot-derived dopamine-receptor
agonist (these people served as the control group). Those who had taken
pergolide were divided into two groups—a high-dose group (defined as
those people taking 5 mg or more per day of pergolide) and a low-dose
group (those taking less than 5 mg per day).

The researchers identified stiffening of the valves of the heart and
regurgitation, or backward flow of blood through these valves,
(restrictive valvular heart disease) in 42% of the patients in the
high-dose group, 29% in the low-dose group, and 0% in the control group.
Twenty patients had stiffening of the mitral valves, seven of the aortic
valve, and six of the tricuspid valve. Those patients who had taken
pergolide, as compared to those in the control group, had higher
pressures in the blood vessels that carry the blood from the heart to the
lungs (pulmonary hypertension).

Six patients stopped taking pergolide after they were found to have
restrictive valvular heart disease; two of these six had less stiffening
of their valves when they were reexamined six months later. However, the
researchers noted that the size of the group that stopped taking
pergolide was too small to be able to draw conclusions about the
reversibility of the valvular disease.

The authors concluded, “Although pergolide remains a good treatment for
the symptoms of Parkinson’s disease, our findings underline the necessity
to inform patients of the possible risk of inducing restrictive valvular
heart disease and pulmonary hypertension. Clinicians must be aware of
this possible side-effect, and close clinical and echocardiographic
follow-up is mandatory.”

Van Camp G, Flamez A, Cosyns B, et al. Treatment of Parkinson's disease
with pergolide and relation to restrictive valvular heart disease.
Lancet. 2004;363(9416):1179-1183.

http://www.imakenews.com/wemovenews/e_article000257909.cfm?x=a2R6THW,a1NT
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Results from a Preliminary Study of the Use of Glial Cell-Line Derived
Neurotrophic Factor in Parkinson's Disease Hold Promise

In a report presented at the American Academy of Neurology meeting in San
Francisco, researchers provided the results of a preliminary study of the
treatment of Parkinson's disease with glial cell-line derived
neurotrophic factor (GNDF). In this two-year study, the five patients
showed improved scores on a subjective rating scale and increased density
in dopamine transporters on imaging studies. GDNF is a protein that the
body requires in order to create, maintain, and grow nerve cells.
[FULL STORY]
 Results from a Preliminary Study of the Use of Glial Cell-Line Derived
Neurotrophic Factor in Parkinson's Disease Hold Promise

At the American Academy of Neurology meeting held in April 2004,
physicians and scientists shared the results of their latest research on
a wide variety of neurologic disorders. In one of these seminars,
researchers from London presented the findings from their two-year study
of five patients with Parkinson’s disease who received an experimental
treatment called glial cell-line derived neurotrophic factor, or GDNF.
(Click here to learn more about GDNF.) The patients, on average, were 54
years old and had had Parkinson’s disease for 19 years. Medication was no
longer effective in controlling their symptoms, and, rather than
undergoing one of the commonly performed operations for the treatment of
PD (pallidotomy or deep brain stimulation), they opted instead to receive
GDNF for two years.

Both a rating scale (the Unified Parkinson Disease Rating Scale) and an
imaging study (fluorodopa PET scanning) showed that the five patients had
positive results. The UPDRS scores improved by 40%, whereas scores
normally would have gotten worse over this two-year period, and the
density of dopamine transporters seen with the PET scanning increased by
60%, which the investigators think means that the dopamine cells had
sprouted new nerve endings, a sign of restored health; however, both of
these findings could have alternative explanations.

The announcement of these results produced cautious optimism among
neurologists who specialize in Parkinson's disease. The results must be
confirmed by randomized, double-blind, placebo-controlled studies. There
is, in fact, such a study currently underway in which more than 350
patients are enrolled. All of these patients have had an operation to
implant the drug-delivery pump, but only half are receiving GDNF.
Therefore, both patients and their physicians are “blinded” to their
treatment status. The results of this study are expected to be announced
in the fall of 2004.

Even if these forthcoming results are positive, GDNF will not be
available for at least several years because of the lengthy approval
process. Both the drug and the delivery device need to be separately
approved by the Food and Drug Administration; the use of GDNF has not
been approved for any condition, and the device has not been approved for
delivery directly into the brain. Before it can be approved, GDNF will
need to be shown to be not only effective, but also safe for long-term
use; to date, the treatment appears to be safe and well tolerated, but
more data in more patients will be needed before all of the remaining
questions can be answered.

http://www.imakenews.com/wemovenews/e_article000258982.cfm?x=a2R6THW,a1NT
jR5g

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