My Published Articles for ViewsHound: What's Hot ( Not New) in Parkinson Disease Therapy

Wednesday, January 11, 2017

What's Hot ( Not New) in Parkinson Disease Therapy

Just recently, I learned that there is a new controlled released formulation of Carbo-Levodopa manufactured by Impax Pharmaceuticals called Rytary. Since my wife has PD I was very curious if switching from the immediate release formulation she is currently taking to this controlled release medication will benefit her. The following is an article published by the National Parkinson Foundation that I found very informative.

"The What’s Hot in Parkinson’s disease blog written in April 2013 featured a new extended release dopamine drug called IPX066. This new dopamine formulation achieved full FDA approval in January 2015. The drug is now sold under the name Rytary. At National Parkinson Foundation we frequently hear from Parkinson’s disease patients that current Carbidopa/levodopa medication preparations fail to adequately address disease-related symptoms. In this month’s What’s Hot column we will update you on important information on Rytary, and also offer a few tips for switching.

It is important to understand the reasons that an individual Parkinson’s disease patient may consider an extended release dopamine medication. The frequently cited medication related problems include:

1. Medication dosages taking too long to “kick in” and start working

2. Medication wearing off before the next scheduled medication dose

3. Severe on-off medication fluctuation periods (e.g. rapid cycling during the day ranging from feeling completely on medication to completely off medication)

4. Dyskinesia (too much movement, usually resulting from too high of a blood level of dopamine)

5. Too many pills:

6. Too many medication dosage intervals (e.g. taking medications every 1-2 hours throughout the waking day).

Patients may also have other disease related issues that levodopa preparations will not address, including walking, balance, talking, and thinking issues, but these will likely require a totally different approach than simple levodopa replacement or Rytary. Dr. Robert Hauser at the National Parkinson Foundation Center of Excellence at the University of South Florida, along with colleagues from 68 North American and European study sites, recently published a paper on a new extended release formulation of carbidopa/levodopa (IPX066 now called Rytary).

The new formulation of carbidopa/levodopa extended release (IPX066/Rytary), is different than its predecessors. It contains special beads designed to dissolve at different rates within the stomach and the intestines. The medication capsule was designed to provide longer lasting benefit for patients with Parkinson’s disease. The randomized study included 393 Parkinson’s disease patients who reported at least of 2.5 hours of “off time,” defined as periods when they felt the medication was not working. The authors aimed to improve the number of hours of “off time” each day for patients randomized to the new extended release formulation (IPX066/Rytary) as compared to the older and standard regular release carbidopa/levodopa. The results revealed that the group on extended release formulations took less overall medication dosages (3.6 vs. 5 doses per day); however they also took more total pills. The daily “off-time” improved by over an hour each day in the extended release formulation. Both medications in this trial were safe and well tolerated.

If we return to the six areas (listed above in bullet points) where Parkinson’s disease patients have been seeking improved medication formulations, Rytary was observed to improve issues in two categories: wearing off between dosages, and improvement by increasing the time interval between dosages. The results of the current study cannot be widely applied to patients with severe dyskinesia, severe on-off fluctuations, and later stage disease. The new extended release formulation also increased the total blood-stream levodopa exposure by 30-40% as compared to conventional immediate release levodopa. Increasing levodopa in the bloodstream is thought to decrease the threshold for dyskinesia, and this has been observed with other Parkinson’s drugs such as Entacapone and Stalevo. Although dosed less frequently, the extended release formulation can require more total pills per day (see FDA conversion table below). The authors of the Rytary study felt that a newer formulation of the same drug, which they anticipate will be used in future clinical practice, would allow for a decrease in pill number.

In a recent interview with the lead author, Dr. Hauser, we addressed some of the important tips for switching to Rytary.
Though it is unknown who the “best” patients in clinical practice will be, it is suspected that patients with bothersome motor fluctuations, and patients taking a minimum of four 25/100 Sinemet regular or extended release (or the equivalent Madopar dosing) may be reasonable candidates.

Patients with motor fluctuations on three doses of Sinemet or Madopar could benefit, but a satisfactory benefit could possibly be obtained by adding a dose of Sinemet or Madopar rather than switching to Rytary. There may be select patients who can take a Rytary dose that is approximately three times the usual individual Sinemet or Madopar doses, and be able to maintain three times a day dosing at least for a period of time (i.e. before disease progression).

Dosages of Rytary are not interchangeable with other levodopa (Sinemet or Madopar) products. The capsules can be opened and the contents sprinkled onto foods such as apple sauce, if swallowing problems are present. The most important information for patients and families is to avoid magical thinking when switching to the Rytary formulation of levodopa. Further dose adjustments will be likely after the initial medication switch. It will be important for the patient, family, and doctor to discuss the symptoms and optimize and tweak dosages and intervals on the Rytary formulation.

Patients and families should be excited by the news of this new formulation of carbidopa/levodopa. However, patients and clinicians should be aware that there are limitations in the use of Rytary, and that caution should be exercised, especially because in select cases dyskinesia may manifest after switching. Dosages and dosage intervals of any formulation of carbidopa/levodopa, including Rytary, should be carefully adjusted at each clinic visit to address changes in Parkinson’s symptoms.

Patients may also be slightly disappointed that 3-4 capsules of Rytary may need to be taken at each dosage interval. The success or failure of dopamine replacement therapy will always be more dependent on the expert adjusting the therapy than the formulation itself. The “timing is critical principle” from Parkinson’s Treatment: 10 Secrets to a Happier Life should be considered during dose adjustments for any Parkinson’s disease patient. It is really positive news that drug manufacturers are now listening to Parkinson’s disease patients, and are trying to address the major concerns, though there is a lot of room for improvement and more formulations in the marketplace.

Source: http://www.parkinson.org/find-help/blogs/whats-hot/february-2015

Personal Conclusion: As of today, My wife will not benefit switching from her current immediate release medication since she is taking less than 4 pills a day. Moreover, this new drug is much more expensive than my wife's current immediate released formulation medication.

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Guest Article from Susan Creamer Joy

In The Silence, by Susan Creamer Joy.

Today's guest article is from Susan Creamer Joy. Susan is one of my favorite authors in the ViewsHound community. Susan writes, draws, paints and cobbles together art from found objects making a variety of creations from jewelry to religious shrines. She frequently sports burns on her fingers from her soldering iron, paint on her palms and ink under her fingernails, but her hair is usually combed. When she is not losing time in the creative vortex of her studio, she is likely to be putting her knowledge of metaphysics and esoteric principles including Tarot, numerology, astrology and graphology to good use in consultations. Her children are grown, her husband still works and her four dogs believe she needs serious help. The title of her article is "A Matter Of Love And Death". Thank you Susan.

By the time they reached my bedroom door, I was already sitting up – my stomach ratcheted in the tense grip of an unnamed anxiety; my pillow, unburdened of my drowsy head.

To this day I cannot explain how I heard them coming up those stairs in their bare feet or how I knew that my father struggled to hold his composure as my mother unnaturally clutched at the folds of her dressing gown and followed him through the dark just a little too closely.

As the wooden groan of those old stairs tore into my bones that morning like a hacksaw, all I could see between the predawn shadows was the letter I’d written just hours earlier to my boyfriend, Chris, propped against the lamp on my desk across the room awaiting an envelope.

I had not slept well. It was late November and there had been so many changes since the middle of August when he left for the Air Force in Texas to begin basic training and I began my third new school in as many years.

The conspiracy between fate and the last surge of the Vietnam draft had broken apart the every-waking-minutes of our two-year union with unceremonious indifference. All that night my sleep had been infested by difficult dreams and by the illogical fear that truth and reality were merging into a darkness only a martyr could grasp; and at sixteen, martyrdom seemed reasonable only for the nuns among the poor in Bangladesh

I tried to remind myself that he would be home on leave for Thanksgiving in another few days. It was the only tether to calm I could find, but reviewing the facts offered little relief from my baseless fears.

Chris had been girding his pacifist sensibilities preparing to fight in an unpopular war that had not yet slaughtered its last innocent. I was hovering just over the line of inclusion at an exclusive girl’s school – missing him – and finding myself at odds with these young women and their attachment to propriety and with the prep-school veneer that blinded them to the fact that they were no better than anyone else.

Neither one of us was coping well with the worlds into which we were respectively summoned, and although we both knew that the best hope for any future together depended upon our individual successes apart, it was far from comforting most days.

But in spite of our discomfort, we each did our best; and, of course, there were the letters: Thin, plain-paper sheets with row after row after row of inky blue words penned with the intensity and awkward locutions of a love learned too soon. It had come down to just that little, but without them, I would have had nothing.

Chris was learning to fly. I was learning to drive, and both of us were aching to transport our souls to an earlier time through the hallowed intercourse of memories and dreams. Of course, as with all progress, there was the positive element: We were both clean and drug-free for the first time in years.

Now, without pretense, both healthy cognition and sincere motivation surfaced regularly in my psychology and prompted me to care about myself and to arbitrate against all temptation for a better standing in the world, in school and in my own eyes. I even did my homework.

No longer was I escaping today but, instead, living for my day of escape. Lying still in the dark of my room, I listened to the slow, padded footfall of my parents approaching and looked to the floor and to my history book half hidden beneath the nightstand where I’d tossed it the night before. Even in this early morning dark I could make out the swirls and stars in colored marker and the bubble-formed letters that spelled C H R I S in soft, juvenile curves on the torn book cover I’d fashioned out of a brown paper grocery bag.

I vaguely remembered throwing it there somewhat hastily. I had been doing my homework when a sense of urgency struck and I realized I had not written him as I promised I would and glancing at the clock, I noted it was nine-twenty-three. Why that mattered I had no way of knowing in that strange moment, but within hours, it would be one I would never forget; and although I was becoming drowsy and still needed to finish my work, I felt beyond reason that my letter to him could not wait.

So, I wrote. I would always write. I would always be there. He would always be there.“Suzi."It was my name spoken in the smooth and familiar voice of my mother, although weighted and slow, her head bowed to her chest almost as though she were speaking only to herself.

"Suzi.” She said it again, this time with sharp gravity, like a chisel against stone.

As if on cue, I leaned forward, flanked now by my parents who were sitting on either side of my bed.

I had been waiting for them. I don’t know how. I didn’t know why. The lights in my room remained off, but it seemed that the darkness clung more to them than to me, as though they were holding it there – away from me to give me enough light to see through the next moment. They were crying. My father was crying. My father. “Suzi. We have something very, very bad to tell you." Chris has been in a car accident." And he was killed."

If the world moved forward from that moment, I could not know it. f there were air around me worth breathing, I could not take it in. And if there were another sound beyond the leaden bellow of my own raw grief, I could not hear it.

"Who am I going to talk to? Who am I going to love?” I wailed. Who will love me? In that sodden moment violated by the intrusion of a predawn light that had no business rising, everything I ever believed about happiness, hoped for in life, trusted in or held as my own was annihilated.

After that – there was no after that. After that came months of hollow redundancies that would inform my way of being in the world for years to come. A serial commitment to waking up each morning, remembering he was gone and dedicating the remaining hours to forgetting. To that end I would try anything, drink anything, ingest anything, inject anything. It was a slow and arbitrary suicide by indifference.

Many years later, at 25 years-old and in the midst of a pharmaceutical free-fall leaning dangerously close to terminal, I discovered that I was expecting a child, and after a decade of forgetting, I remembered. I named him Griffin after the legendary winged lion, a symbol of the divine because what he inspired and the miracle that he was, were nothing less. I remembered and I loved again, and I went on to marry and to the gift of two beautiful daughters.

Today my son is struggling not to drown in the same well of drug abuse and apathy that almost swallowed me – his great, divine wings clipped by his own hand; and while it is up to him to restore his place in the sky, I will do my best to help provide an open runway.

In the meantime, I will continue soaring for both of us; bequeathed as I have been, with a determination to fly from a boy whose ragged fate precluded that dream.

Death took one young man from me once upon a dark time. If it has any intention of coming for this one, it will have to go through me. And trust me, it will be in for one hell of a fight.

Note: If you enjoy this article, please let me know.

Wednesday, January 11, 2017

What's Hot ( Not New) in Parkinson Disease Therapy

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