[Stitcher]

Lundbeck Reports Results Of ADAGIO Study With Azilect

Published:24-September-2009
Azilect 1mg/day early-start met all endpoints of the primary analysis
http://www.oursocialmedia.com/uk/tev...iopublication/

Lundbeck's partner Teva has announced that results from the ADAGIO trial, which demonstrated that Parkinson's disease patients receiving Azilect (rasagiline) 1mg/day at the start of the study (early-start group) experienced superior benefit over 18 months compared with those who started the exact same treatment nine months later (delayed-start group). The finding is consistent with a possible disease-modifying effect for Azilect 1mg/day.

The company claims that Azilect is the first Parkinson's disease treatment to succeed in a prospective delayed-start study, a trial design specifically developed to test for the possibility of a disease-modifying effect.

Professor C Warren Olanow, department of neurology at Mount Sinai School of Medicine, NY and co-principal investigator of the ADAGIO study, said: "A therapy that slows or stops disease progression is the greatest unmet need in the treatment of patients with Parkinson's disease. Current therapies do not prevent the development of disability in such patients. The results of the ADAGIO study provide support for the possibility that early treatment with Azilect 1mg/day may slow the development of disability."

[Stitcher]

Drug May Slow Progression of Parkinson's Disease

Study suggests early treatment may be effective in patients with very mild disease

http://www.modernmedicine.com/modern...tegoryId=40133

WEDNESDAY, Sept. 23 (HealthDay News) -- Early treatment with rasagiline may slow the progression of Parkinson's disease in patients with very mild disease, according to a study in the Sept. 24 issue of the New England Journal of Medicine.

C. Warren Olanow, M.D., from Mount Sinai School of Medicine in New York City, and colleagues randomly assigned 1,176 patients with untreated Parkinson's disease to rasagiline (1 or 2 mg daily) for 72 weeks (the early-start group) or to placebo for 36 weeks followed by rasagiline (1 or 2 mg daily) for 36 weeks (the delayed-start group).

As assessed by the Unified Parkinson's Disease Rating Scale, the researchers found that patients in the early-start group receiving 1 mg rasagiline daily had a significantly slower rate of progression compared with placebo between weeks 12 and 36, a significantly slower rate of progression compared with the delayed-start group between baseline and week 72, and a similar rate of progression compared with the delayed-start group between weeks 48 and 72.

[Stitcher]

September 23, 2009

From Teva's ADAGIO Trial: Inconclusive Results, but Possible Disease-modifying Effect, for Azilect (Rasagiline)

http://www.michaeljfox.org/research_...icle.cfm?ID=15

This week, the New England Journal of Medicine published data from the ADAGIO Phase 3 clinical trial of Israeli drugmaker Teva’s Azilect (rasagiline). The trial was designed to test whether Azilect, which is already approved for symptomatic treatment of Parkinson’s, may also have a disease-modifying effect. For early-stage PD patients, a 1-milligram dose of Azilect met all three clinical endpoints for disease modification. However, a 2-milligram dosage met only two of three endpoints. Because of this inconsistency, we cannot definitively conclude that the drug has disease-modifying effects. The Michael J. Fox Foundation spoke with Karl Kieburtz, MD, MPH, about how patients should interpret the news.

NOTE: The medical information contained in this article is for general information purposes only. The Michael J. Fox Foundation has a policy of refraining from advocating, endorsing or promoting any drug therapy, course of treatment, or specific company or institution. It is crucial that care and treatment decisions related to Parkinson’s disease and any other medical condition be made in consultation with a physician or other qualified medical professional.

[jeanb]

Thank you, Stitcher

this is wonderful news!

[Debi Brooks]

Yesterdays news on Azilect reported in the NEJM, provided long-awaited data from the Teva rasagiline study, ADAGIO.

There are two places where you can find additional commentary...one at PDOR. http://www.pdonlineresearch.org/news...difying-effect and additionally via a "News in Context" interview on the home page of the MJFF site. www.michaeljfox.org

Debi

[LindaH]

Some more opinions on rasagiline study -- a controversy seems to be brewing.


From: Medpage Today 9/23/09
"Rasagiline Said to Delay Parkinson Progression, Skeptics Abound"

http://www.medpagetoday.com/Neurolog...sDisease/16106

Excerpts from news article:
"Even one investigator in the trial cast doubt on the study's importance.
William Weiner, MD, chairman of neurology at the University of Maryland, said he disagreed with the NEJM report's emphasis on the possible disease-modifying effect.
"I was never given the opportunity to review the article and I would not have agreed to stressing the neuroprotection angle so strongly," he wrote in an e-mail.
He said the primary outcome ended up as less than two points' difference on the 176-point UPDRS scale. "[It is] maybe statistically significant, but it is surely not clinically meaningful," Weiner said."
or
"Despite the skepticism voiced by others, one prominent neurologist told MedPage Today and ABC News that the ADAGIO results were persuasive and immediately practice-changing.
"I do believe that this constitutes a major advance in Parkinson's," wrote Daniel Kremens, MD, of Thomas Jefferson University in Philadelphia, in an e-mail. "From this study alone and the use of this drug, the paradigm of Parkinson's treatment really should shift."
He said it was no longer appropriate to initiate drug treatment only after symptoms become disabling.
"We should no longer be waiting. We should consider starting [patients] on treatment as soon as diagnosis is made with hope that we can modify the disease course. And that's a major change in how Parkinson's is treated currently," Kremens wrote"

Whom do we believe?

I thinkThe News in Context article on the MJFF website is probably the best analysis of this study, in terms of what patients need to know to be able to discuss the study with their neuros and make their decisions.
http://www.michaeljfox.org/research_...icle.cfm?ID=15


Also interesting/ disturbing/ enlightening (choose your description?) are the financial disclosure statements of the study authors. (from NEJM article) At least we know now

“Dr. Olanow reports receiving consulting and lecture fees from Teva and Lundbeck and consulting fees from Boehringer Ingelheim, Novartis/Orion, Solvay, Ceregene, and Merck Serono and owning equity in Ceregene; Dr. Rascol, receiving consulting fees from Eisai, Eutherapie, GlaxoSmithKline, Osmotica, Novartis, Schering-Plough, Boehringer Ingelheim, Solvay, and Teva, lecture fees from Eutherapie, Novartis, Boehringer Ingelheim, and Lundbeck, and grant support from Eutherapie, Novartis, Boehringer Ingelheim, Pierre Fabre, GlaxoSmithKline, and Lundbeck; Dr. Hauser, receiving consulting and lecture fees from Allergan Neuroscience, Alphamedica, ApotheCom, Axis Healthcare, Bayer Schering, Boehringer Ingelheim, CNS Schering-Plough, Centopharm, Embryon, Eisai, Genzyme, GlaxoSmithKline, Impax, Ipsen, Kyowa, Merck, Novartis, Ortho-McNeil, Pfizer, Prestwick, Quintiles, Santhera, Schwarz Pharma, Schering-Plough, Solvay, Teva Neuroscience, Valeant Pharm, and Vernalis and serving as an investigator for Allergan, Solvay, Schering-Plough, Acadia, Eisai, Bayer, SkyePharma, GlaxoSmithKline, UCB Pharma, Novartis, Kyowa, Boehringer Ingelheim, INC Research, Mentor, Asubio, Valeant Pharm, Quintiles, Vernalis, i3 Research, Teva Neuroscience, and Chelsea Therapeutics; Dr. Feigin, receiving consulting fees from Teva and being an employee of Technion–Israel Institute of Technology, a subsidiary of which receives royalties from sales of Azilect; Dr. Jankovic, receiving consulting fees from Teva and grant support from Boehringer Ingelheim, Advanced Neuromodulation Systems, Ceregene, Medtronic Neurological, Kyowa, Novartis, Schwarz Biosciences (UCB Pharma), SkyePharm (GlaxoSmithKline), Chelsea Therapeutics, Solvay, Neurogen, and Eisai; Dr. Lang, receiving consulting and lecture fees from Teva; Dr. Langston, receiving consulting and lecture fees from Teva and consulting fees from Merck Serono and Newron; Dr. Melamed, receiving lecture fees from Lundbeck; Dr. Poewe, receiving consulting fees from Teva, Boehringer Ingelheim, Genzyme, Solvay, and Novartis, lecture fees from Teva, Boehringer Ingelheim, Novartis, UCB, and Orion, and grant support from Boehringer Ingelheim and AstraZeneca; Dr. Stocchi, receiving consulting and lecture fees from Lundbeck and Teva; and Dr. Tolosa, receiving consulting fees from Teva, UCB, Novartis, and Boehringer Ingelheim and lecture fees from Novartis, Lundbeck, and Boehringer Ingelheim. No other potential conflict of interest relevant to this article was reported. “