Ariela:

Beware of drug company promotions and salesmanship.  It may still rain on
the Rasagiline parade!

It is not clear that the so-called "amphetamine like properties" in
selegiline are a disadvantage.  Indeed, selegiline has antidepressant and
"energizing" qualities, probably in part due to those same qualities which
the drug company for the other side has focused on.

In addition, selegiline has antidepressant qualities (which rasagiline
undoubtedly shares) due to its abiity to delay the metabolism of
catecholamines, the same reason that it may be useful in Parkinson's
Disease, by delaying the metabolism of dopamine - extending the duration of
action of a single dose of levodopa to some extent.

The problem with selegiline is that it did not meet the expectations of the
DATATOP study in delaying the progression of PD.  After much hoopla, and
enormous profits to Somerset and Sandoz, it fell flat on its face when the
longer term follow-up studies became available, showing no delay in
progression of PD.

Thus, the only remaining use for selegiline was to try to extend the
duration of the effect of each dose of levodopa, which was, in fact, the
indication for which the FDA approved it in the first place.  I am not aware
that Rasagiline claims any EXTRA effect from selegiline - and the only
selling point to date is this "lack of amphetamine like qualities," which is
nothing more than an empty claim to emphasize a difference which is not
known to be important.

> improvements were greater for rasagiline than for placebo at all
> time points and for all doses, but were ***INSIGNIFICANT*** due to a
"confounding
> strong placebo effect,"

That means that the study was UNABLE to show that the drug was better than
the  placebo control.

It is interesting that they are claiming that the rasagiline group was
better at 18 weeks after washout, althought the difference was not
significant.  It seems they are positioning themselves to make a claim for
delay in the progression of the disease.  However, remember that selegiline
made that claim on the basis of 6 months' data, and the five year data
proved them wrong.

It would be like selling you a minivan with three doors instead of four, and
claiming that one door less makes it safer, when most manufacturers are
promoting the four door models as more convenient.

We all want newer and better drugs for PD.  Drug companies will do
everything they can to sell you their drugs.  Buyer beware!!!

Jorge Romero, MD

----- Original Message -----
From: "ariela" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Saturday, November 03, 2001 6:18 PM
Subject: Re: Fw: new clinical trials / Rasagiline


> in february 2001, "wemove.org" published an updated report on a rasagiline
> study group that originally appeared in Clinical Neuropharmacology some
> months earlier.
>
> below are the URL and a copy of that short, rather plain-english article:
>
> it seems that while both selegiline and rasagiline are 'selective,
irreversible
> MAO-B inhibitors,' apparently the important distinction between the two
> is that rasagiline does NOT have selegiline's amphetamine-like properties.
>  i guess what's needed now is a study comparing the drugs to each other,
> rather then their individual efficacy.
>
> ariela
>
> ************************************************
> http://www.wemove.org/emove/article.asp?ID=299
>
> Subject: Rasagiline as Levodopa Adjunct in Fluctuating PD
>
> Date: 2/19/01
>
> Rasagiline mesylate, a new MAO-B inhibitor for the treatment of
Parkinson's
> disease: A double-blind study as adjunctive therapy to levodopa
>
> JM Rabey, I Sagi, M Huberman, E Melamed, A Korczyn, N Giladi, R Inzelberg,
> R Djaldetti, C Klein, G Berecz, for the Rasagiline Study Group
>
> Clinical Neuropharmacol 2000;23:324-330
>
> Rasagiline may be a modestly effective adjunct to levodopa for patients
> with motor fluctuations in Parkinson's disease, according to this
double-blind,
> placebo-controlled study. Rasagiline is a selective, irreversible MAO-B
> inhibitor without selegiline's amphetamine-like properties.
>
> Seventy patients were randomized to receive either placebo or rasagiline
> at 0.5 mg, 1.0 mg. or 2.0 mg per day for 12 weeks. Approximately half
> of the patients in each group had motor fluctuations, defined as
persistent
> morning akinesia, end-of-dose akinesia, or unpredicted off episodes for
> 1-25% of waking hours. Six patients dropped out of the study, including
> two due to falling and syncope while taking 1 mg rasagiline. UPDRS scores
> were determined at baseline, 12 weeks, and 18 weeks (after 6-week
washout).
>
> UPDRS improvements were greater for rasagiline than for placebo at all
> time points and for all doses, but were insignificant due to a
"confounding
> strong placebo effect," according to the authors. The strongest difference
> between treatment and placebo was seen for fluctuating patients at week
> 18. Placebo patients showed a 5.7% worsening in total UPDRS, while treated
> patients showed improvements of 13.4%, 8.3%, and 11.3% for the three
> doses (p=0.082 for the combined effects vs. placebo). Improvements were
> primarily seen in motor and ADL scores.
>
> Financial support for this study was provided by Teva Pharmaceuticals.
>
> *************************************************
>
> ----    Charlotte M <[log in to unmask]> wrote:
> > I was in the trial in 1998-1999 for six months, but not for "off."
> >  This drug is
> > much like selegiline, Eldepryl.
> >
> > Charlotte Mancuso
> >
> > Linda J Herman wrote:
> >
> > > I received the following message from CenterWatch about clinical
> > trials in many locations for rasagiline. SEE summary of the study below
> and the forwarded message. Is anyone already participating in a  trial
> of this drug?
>
> > > Linda
> > >
> > > "Trial Information
> > >
> > > Summary: PRESTO (Parkinson's Rasagiline: Efficacy & Safety in the
> > > Treatment of "OFF")
> > > The Parkinson Study Group (PSG), in collaboration with Teva
> > > Neurosciences, Inc., is conducting a study for patients with moderate
> > to
> > > advanced Parkinson's Disease. This 26-week study will examine the
> > safety,
> > > effectiveness and tolerability of an investigational drug in patients
> > who
> > > do not experience full benefit from their L-dopa dosage.
> > >
> > > The study plans to recruit 450 subjects at 59 sites across the United
> > > States and Canada. Enrollment began in September 2000. For more
details,
> > > contact one of the participating sites near you."
> > > <http://www.centerwatch.com/patient/studies/stu30215.html>
> > >
> > > --------- Forwarded message ----------
> > > From: CenterWatch Patient Notification Service
<[log in to unmask]>
> > > Date: Sat Nov  3 06:42:19 2001
> > >
> > > New clinical trials recently posted on the CenterWatch web site at
> > > http://www.centerwatch.com.
>
>
>
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