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Post of the Week: New Extended Release Carbidopa-Levodopa


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#1 Dr. Okun

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Posted 15 March 2013 - 06:29 AM

Dear forum members,

There is a new extended release carbidopa-levodopa that is working its way toward being available in the United States under the name Rytary. It was not clearly beneficial for dyskinesia, but did improve Off time. There was a hope that it may help the "delayed on" but this is not clear. We will keep you updated on this drug.


Lancet Neurol. 2013 Feb 25. pii: S1474-4422(13)70025-5. doi: 10.1016/S1474-4422(13)70025-5. [Epub ahead of print]


Extended-release carbidopa-levodopa (IPX066) compared with immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations: a phase 3 randomised, double-blind trial.

Hauser RA, Hsu A, Kell S, Espay AJ, Sethi K, Stacy M, Ondo W, O'Connell M, Gupta S; for the IPX066 ADVANCE-PD investigators.



Source

University of South Florida, Tampa, FL, USA. Electronic address: rhauser@health.usf.edu.



Abstract


BACKGROUND:

IPX066 is an oral, extended-release, capsule formulation of carbidopa-levodopa. We aimed to assess this extended-release formulation versus immediate-release carbidopa-levodopa in patients with Parkinson's disease and motor fluctuations.
METHODS:

We did a phase 3, randomised, double-blind, double-dummy study at 68 academic and clinical centres in North America and Europe. Patients with Parkinson's disease who had at least 2·5 h per day of off-time underwent 3 weeks of open-label immediate-release carbidopa-levodopa dose adjustment followed by 6 weeks of open-label extended-release carbidopa-levodopa dose conversion. These patients were then randomly allocated (1:1), by use of an interactive web-response system, to 13 weeks of double-blind treatment with extended-release or immediate-release carbidopa-levodopa plus matched placebos. The primary efficacy measure was off-time as a percentage of waking hours in all patients randomly allocated to treatment groups, adjusted for baseline value. This study is registered with ClinicalTrials.gov, number NCT00974974.
FINDINGS:

Between Sept 29, 2009, and Aug 16, 2010, we enrolled 471 participants, of whom 393 (83%) were randomly allocated in the double-blind maintenance period and were included in the main efficacy analyses. As a percentage of waking hours, 201 patients treated double-blind with extended-release carbidopa-levodopa (mean 3·6 doses per day [SD 0·7]) had greater reductions in off-time than did 192 patients treated double-blind with immediate-release carbidopa-levodopa (mean 5·0 doses per day [1·2]). Covariate-adjusted end-of-study means were 23·82% (SD 14·91) for extended-release carbidopa-levodopa and 29·79% (15·81) for immediate-release carbidopa-levodopa (mean difference -5·97, 95% CI -9·05 to -2·89; p<0·0001). Extended-release carbidopa-levodopa reduced daily off-time by, on average, an extra -1·17 h (95% CI -1·69 to -0·66; p<0·0001) compared with immediate-release carbidopa-levodopa. During dose conversion with extended-release carbidopa-levodopa, 23 (5%) of 450 patients withdrew because of adverse events and 13 (3%) withdrew because of a lack of efficacy. In the maintenance period, the most common adverse events were insomnia (seven [3%] of 201 patients allocated extended-release carbidopa-levodopa vs two [1%] of 192 patients allocated immediate-release carbidopa-levodopa), nausea (six [3%] vs three [2%]), and falls (six [3%] vs four [2%]).
INTERPRETATION:

Extended-release carbidopa-levodopa might be a useful treatment for patients with Parkinson's disease who have motor fluctuations, with potential benefits including decreased off-time and reduced levodopa dosing frequency.
FUNDING:

Impax Laboratories.
Copyright © 2013 Elsevier Ltd. All rights reserved.


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#2 michelleee

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Posted 24 January 2014 - 11:11 AM

Dear Dr. Okum, 

 

Any further news on Rytary? 

 

Also, my husband has been experiencing labored, heavy breathing (all of a sudden it seems) He is not at all overweight and exercises daily, although

not enough to get his heart racing too much, he rides for 30 mins. his stationary bike. He smokes one cigar per day- no inhale of smoke. 

 

Just thought I'd ask -- not sure it's a possible Parkinson's symptom.

 

Thank you so much!

Michelle



#3 Dr. Okun

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Posted 24 January 2014 - 07:22 PM

No news on the Rytary.  I can't advise on shortness of breath as you describe and whenever I see it I immediately consider the possibility it is heart related and I advise a general doctor.  Also, sometimes it is wearing off of sinemet dosages and simply moving them closer is helpful.  I would get seen!


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#4 michelleee

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Posted 25 January 2014 - 12:33 PM

Better get him to the doctor!!

 

Thanks again!

Michelle



#5 xaxa

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Posted 26 January 2014 - 01:23 AM

Dr. Okun,
What causes this shortness of breath upon wearing off of meds?
Thank you,
Mary

#6 Dr. Okun

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Posted 26 January 2014 - 04:53 PM

This is not known and may not be the same in all PD patients (could be anxiety, could be muscular, etc.).


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#7 LewisMaxie

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Posted 26 January 2015 - 11:24 AM

I see on another sight two new drugs were approved Is that right and what do you think of them? One was Rytary.



#8 Dr. Okun

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Posted 28 January 2015 - 04:58 PM

Rytary is an extended release dopamine drug and is very good; there is also a dopamine pump approved that is good too.


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#9 michelleee

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Posted 28 January 2015 - 05:14 PM

Woo Hoo!! Such good news!!

Thanks for the update!!



#10 The Ducks

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Posted 28 January 2015 - 09:21 PM

Dear Dr Okun,

My husband 's sleep disruption improved when Sinemet was added in half hour before bedtime.

Now he is on Sinemet 25/100, 1.5 tabs at 8am-12n-4pm-8pm and 12am for bedtime around 1am,

How do you convert this  Sinemet 25/100, 1.5 tabs half hour before bedtime to Rytary?

Thank you in advance for your expert's advice



#11 LewisMaxie

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Posted 29 January 2015 - 06:46 AM

Would it be a good replacement to discuss with my neurologists as opposed to now taking 2 tablets every 4 hours of Carb/Levo.



#12 Dr. Okun

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Posted 31 January 2015 - 02:34 AM

It is not a simple conversion of Sinemet to Rytary and that will be the subject of my February What's Hot column at www.parkinson.org.


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#13 Double L

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Posted 03 March 2015 - 08:50 PM

My husband currently takes 2 10/100 carb/lev and 1 25/100 ER at 6 AM and 1 10/100 and 2 25/100 ER at 10:30 AM and at 3:30 PM and if active in the evening, 1 25/100 ER. He asked his neurologist her thoughts on the new Rytary ER carb/lev and her response was it was the same product he is currently taking and was really nothing more than a "repackaging" by the pharmaceutical industry to sell a new drug. This is not exactly what we were taking from the info we were reading about Rytary. So question one is, is she correct? Question two is, the dosages listed above are not working very well. Neurologist said to "play around with the immediate release and ER combos and see what works." Wondering if you have a different suggestion for what strength and amount of carb/dop might be better. Husband has had PD for 8 years and is 65. No other health issues. Thanks.

#14 Dr. Okun

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Posted 04 March 2015 - 03:39 PM

Rytary is a new formulation of levodopa and in some but not all patients it may be helpful.  We have a nice blog explaining all of the in's and outs of the drug Rytary and how to switch if you and your doc are interested.  It clearly won't help everyone.  The blog is at: http://www.parkinson...n-The-Blog.aspx


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#15 Double L

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Posted 04 March 2015 - 08:22 PM

We read the blog posting before talking with the neurologist. At this time, the neurologist is not interested in trying the switch to Rytaryn so I guess we will just try to play with current dosing and see if we can see any improvement. Biggest issues are meds not lasting as long and taking longer to kick in. Also, extreme fatigue.

#16 Dr. Okun

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Posted 06 March 2015 - 02:32 PM

You may asl he/she to move doses closer together.


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips

#17 miracleseeker

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Posted 06 March 2015 - 03:48 PM

Dr O.  -  I have tried adding an extra dose of Stalevo and or  Sinemet for my mom but she gets dyskinesia as a result and closes her eyes and move around in place like she's high until it wears off.  Is Rytary suppose to last longer in the body than Stalevo which she takes 3 times a day?



#18 FlyBaby

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Posted 07 March 2015 - 03:51 AM

 

Dr. Okun

Posted 04 March 2015 - 12:39 PM

Rytary is a new formulation of levodopa and in some but not all patients it may be helpful.  We have a nice blog explaining all of the in's and outs of the drug Rytary and how to switch if you and your doc are interested.  It clearly won't help everyone.  The blog is at: http://www.parkinson...n-The-Blog.aspx

Dr. Okun, In your above post, both of the links provided, only linked to a single page describing the Duopa pump. With zero information about Rytary. Could you please provide the correct links to the Rytary information?

Thanks.


Michael

Current age= 55

First symptoms: 1975

Prior mis-diagnosis: Dyspraxia, Essential Tremors, Ataxia, "Nerves".....

Final Dx. of Parkinson's: 2013

 

DBS surgery 12/2014............ Bilateral lead placement with a single battery/stimulator on RH side. Turned on 12/21/14 

 

"I will do what i can, while I can, and when i can't, I'll do something else"

 


#19 LewisMaxie

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Posted 07 March 2015 - 07:05 AM

My doctor had not heard of Rytery are the drug companies doing a good job of spreading the word. Putting me on the capsules
instead of the pills.

#20 LewisMaxie

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Posted 21 March 2015 - 12:45 PM

My doctor from 8 pills a day 150 mg's 4x times a day to a slower release pills 200 mg's 600 a day. I have difficulty walking it hasn't seemed to improve only got a little worse.
Should I be patient or tell her I want to switch back.




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