[Bill Morrow]

HI everybody,
I was diagnosed 10 years ago and have been opn Sinemet , Mirapex and Comtan for years. Two months ago my neurologist suggested switching from Comtan to Azilect. Initially it seemed like an improvement but lately I have been getting freezing spells more frequently and walking is very poor ( staggering along) Has anyone had experience with Azilect? I wonder if I should change back to Comtan --or maybe it's just the disease progressing??

Thanks,

Bill

[paula_w]

Here is an upcoming abstract from the group below, some of whom you will recognize....and, therefore, look closely and follow it if you get the chance.
Does it convince you?
Is this ok to copy here? i received it email and don't know where the session is /was.

Early Rasagiline Treatment Slows UPDRS Decline in the ADAGIO Delayed Start Study

C Warren Olanow, MD, and Olivier Rascol Mount Sinai School of Medicine; University Hospital, Toulouse, France

Background: Slowing disease progression remains an unmet need in the management of Parkinson s disease (PD). Previous
laboratory studies and clinical trials suggest rasagiline might have disease modifying effects in PD. We here describe results of the
first prospective double-blind trial using the delayed-start design to assess the effect of rasagiline on PD progression.
Methods: 1176 untreated early PD patients were randomized to receive rasagiline 1 or 2 mg/day for 72 weeks (early start) or
placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for 36 weeks (delayed start). The primary analysis included three
hierarchal endpoints based on Total-UPDRS scores: superiority of slopes between weeks 12-36; superiority in change from
baseline to week 72, and non-inferiority of slopes (0.15 margin) during weeks 48-72.
Results: Early treatment with rasagiline 1 mg/day met all 3 endpoints compared to delayed start: superiority of slope in weeks 12-
36 (-0.05; p=0.013, 95%CI -0.08,-0.01), change from baseline to week 72 (-1.7 units; p=0.025, 95%CI: -3.15,-0.21), and noninferiority
of slope in weeks 48-72 (0.0; 90% CI -0.04,0.04). The 2 mg/day dose did not meet the second primary endpoint.
Conclusions: Early treatment with rasagiline 1 mg/day provided benefits that were not obtained with later initiation of the drug.
These results are consistent with a disease-modifying effect.

Disclosure:

The authors agree with the abstract authors acknowledgment, concurrence, and disclosure statement . This study
has been supported by Teva Pharmaceutical Industries Ltd. (Israel) and Teva Neuroscience Inc. (USA). The authors do have a
financial relationship. The authors have both served as consultants to Teva.
WIP-11 has been selected for oral presentation during the Derek Denny-Brown New Member Symposium on Tuesday, September
23, 2008, 11:45 am 12:00 pm.
Tuesday, September 23, 2008 1:00 PM

Works in Progress Abstracts (7:30 AM-4:00 PM)

__._,_.___

[paula_w]

sorry i didn't answer your question Bill. i took eldepryl (early 90s) - it was selegiline and was supposed to 'slow the progression of pd" - but it wasn't proven. Patients didn't hear the last part of that statement.

here we are 2008, with a new med that they "think slows the progression of pd" - delivered by authors in gobbledegook and admitting "i was paid by the owner of this drug."

Why don't they add, "bet we didn't even need to rename it."

But on top of all my ranting, it also sounds like it doesn't work for you Bill. no experience with it.

paula

[pegleg]

this was just posted by PDF after their scientific people reviewed the article:

The statement is available here: http://www.pdf.org/news/news.cfm?typ...lectedItem=450

The Parkinson’s Disease Foundation Counsels Caution in Interpreting Recent News Announcements about the Potential of Azilect® to Slow the Progression of Parkinson’s Disease

(08/29/08) (New York, NY)

PDF Urges that Conclusions About the Drug’s Effectiveness in Slowing PD Be Deferred Until Peer-Reviewed Results Have Been Published

The Parkinson’s Disease Foundation (PDF) is advising that the Parkinson’s community withhold judgment as to the potential neuroprotective effect of Azilect®, an anti-PD medication already approved and on the market for symptomatic relief in Parkinson’s, until the complete data from a large-scale recent study have been properly studied, peer reviewed and published in a reputable journal.

This PDF statement was prompted by an announcement earlier this week from Teva Pharmaceuticals, the Israel-based manufacturer of Azilect, that it had for the first time presented the data from ADAGIO, a Phase III trial studying the drug’s ability to protect dopamine neurons and thereby to delay disease progression, to a scientific conference. The announcement was made in Madrid, Spain, at the 12th Congress of European Federation of Neurological Societies (EFNS).

At this time, the Parkinson’s Disease Foundation (PDF) has the following statement to share with the community. The statement has been approved by Dr. Christopher Goetz, Chief of Movement Disorders at Rush University in Chicago: “This week’s report that results from ADAGIO have been presented at a scientific meeting is noteworthy in that it confirms completion of a very large and well-designed study of the potential modifying effects of clinical outcome in PD patients taking an anti-Parkinson’s medication. It is also interesting to note that the investigators reported that the group of patients receiving daily doses of 1 mg of Azilect from the onset of the study were less impaired at the end of the study than those who started the drug later during the study. The investigators presenting the data reported that the group receiving the chronic 1 mg dose of rasagiline (Azilect) met all three of the “primary end points” that were determined at the outset of the study to be the key outcomes of interest.

“It is also important to note that the data – though promising and provocative -- have not yet been made available widely in the scientific community, and even more importantly, they have not yet been exposed to the process of scientific peer review that is crucial to validating the results of scientific research. Until such time as the findings are published in a refereed scientific journal – which we hope will be no more than a few months from now – we are unable to say whether or not early treatment with Azilect has long term benefits in modifying the course of Parkinson’s disease-related disabilities. After critical review of the data and scholarly interpretation of the results, clinicians will be in a better position to determine if prescribing patterns and advice to patients will change. In the meantime, people with Parkinson’s who are interested in this matter, or who are concerned about their own treatment regimen, should consult individually with their physicians.”

Teva’s new announcement, along with an earlier one in June, have attracted considerable attention around the Parkinson’s community because to date, no medication has been proven to slow the course of Parkinson’s disease. All of the treatments currently available, including Azilect itself, have been approved for their capacity to ease symptoms, not to alter the underlying course of the disease. The PDF will continue to keep its community, and the general public, apprised of relevant developments as they occur.

Robin Anthony Elliott, Executive Director

[lou_lou]

Originally Posted by Bill Morrow

HI everybody,
I was diagnosed 10 years ago and have been opn Sinemet , Mirapex and Comtan for years. Two months ago my neurologist suggested switching from Comtan to Azilect. Initially it seemed like an improvement but lately I have been getting freezing spells more frequently and walking is very poor ( staggering along) Has anyone had experience with Azilect? I wonder if I should change back to Comtan --or maybe it's just the disease progressing??

Thanks,

Bill

________________



hello Bill, -
I do not use azilect - yet here are some of the adverse reactions -

http://www.druglib.com/adverse-react...fects/azilect/
please go to the link to read on -

All cases (22)
Blood Pressure Increased (4), Blood Urine Present (3), Urinary Tract Infection (3), more >>

Cases resulting in a serious event (21)
Blood Pressure Increased (4), Blood Urine Present (3), Urinary Tract Infection (3), more >>

Cases resulting in death (3)
Myocardial Infarction (2), Cerebral Infarction (1), Completed Suicide (1), more >>

Cases resulting in life threatening events (2)
Blood Pressure Increased (2), Flushing (2), Dyspnoea (2), more >>

[PDengineer]

Originally Posted by Bill Morrow

HI everybody,
I was diagnosed 10 years ago and have been opn Sinemet , Mirapex and Comtan for years. Two months ago my neurologist suggested switching from Comtan to Azilect. Initially it seemed like an improvement but lately I have been getting freezing spells more frequently and walking is very poor ( staggering along) Has anyone had experience with Azilect? I wonder if I should change back to Comtan --or maybe it's just the disease progressing??

Thanks,

Bill

Seems strange that you would be taken off of comtan.
comtan is a COMT inhibitor where as Azilect is a MAO-B inhibitor. Two different modes of action. Both of which make more dopamine available.

http://www.webmd.com/drugs/drug-1776...me=Comtan+Oral

http://www.webmd.com/drugs/drug-1444...e=AZILECT+Oral

[paula_w]

Bill,

Was the difference between the two meds explained to you; did you go away understanding they were not identical in function?

thanks!
paula

[pegleg]

Bill

I have taken Sinemet, Comtan, and Requip for many years (at least 10). The Mirapex and Requip are agonists and both operate similarly - by "stimulating" your neuron receptors. It's a game of balance; if you have more dopamine but not enough receptors, then your brain doesn't "get the message" (that's putting it in simple terminology). And the Comtan (as PDEngineer said) works entirely different from the agonists in that it is an enzymatic action (catechol O-methyltransferase or COMT) that makes the dopamine last longer by breaking down the levadopa-carbidopa before it gets to the brain. It is NOT to be taken without levadopa/carbidopa (l-dopa or brand name Sinemet).(Tasmar is almost the same drug and was the first approved COMT inhibitor. It had some associated deaths and was puled from the market temporarily, then was reformulated into Comtan. But some people got better benefit from Tasmar so it is now back on the market). And just for the record, Stalevo is Sinemet and Comtan combined into one pill (Comtan & Sinemet are approved generic and Stalevo is not).

Azilect - in very simple terms - is a monamine oxidase inhibitor (very similar to Eldepryl/Selegeline, but stronger). Azilect works by works by blocking the breakdown of dopamine in the brain. I have taken Eldepryl for as long as I can remember. When I wanted to try Azilect, my doctor told me I should stop Eldepryl but not Comtan or Requip. I did not do well on Azilect - I guess it was too strong. Azilect also has interactions when you eat foods high i n tyramine (see azilect.com for the list)

They have had conflicting studies saying Eldepryl/Selegeline is neuroprotective, which is why I continue to take it (only 5 mg per day). What concerns me about the recent claims that Azilect is neuroprotective is:
1) it was only done using patients never on L-dopa
2) it wasn't a long enough study to tell if iit neuroprotectiive for years (I've had PD for 14 y ears)

I know this is probably more than you wanted to know, but it helps me remembr why I take wwhat I take. And remember, everyone reacts differently to medications. I have a friend (actually 2-3 friends) on Azilect and no l-dopa and they are doing well. I hope this helps.
Peggy

[GregD]

Something to watch for with Azilect. I have a 74 year old woman in my support group taking Azilect for about a year now. Her husband came up to me wanting to know more about the side effects of Azilect because she was having bad diarrhea. Not knowing much about this drug and his explaniation
of how bad the diarrhea was, I told him to stop the Azilect and call the doctor right away. I even handed him my cell phone to use right then and there. As it turned out, this action may very well have saved her life. She was becoming malnourished, her intestines were basically raw. She had just been to see her doctor two days before. I can't believe her doctor allowed this to go on. Then again, he is not an MDS.

GregD