You can find out more about NPF's National Medical Director, Dr. Michael S. Okun, by also visiting the NPF Center of Excellence, University of Florida Health Center for Movement Disorders and Neurorestoration. Dr. Okun is also the author of the Amazon #1 Parkinson's Best Seller 10 Secrets to a Happier Life.
One of the common dreams shared by Parkinson’s disease patients around the globe is the possibility of living a pill free existence, and one year ago we shared the news of a therapy coming to the United States with the possibility to make this a reality for a select group of patients. This month we will update the previous blog post from 2014, and bring to you all of the information you need to know about the therapy. The therapy has received a full FDA approval and will be sold under the name Duopa (AbbVie, USA).
One cannot blame the Parkinson’s disease patient or caregiver for dreaming big. A single day living in Parkinson’s disease shoes is not uncommonly accompanied by the need for dozens of pills. In many cases, pills are taken as frequently as every hour or two. If you ask a Parkinson’s disease patient to place an entire pill regimen for the day into the palms of their hands, there is a very good chance that he or she will not be able to hold all of tablets and capsules. Previously, there was a hope that deep brain stimulation (DBS) may have offered the highly sought after “pill free existence,” however over two decades into its history, it is clear that in the majority of cases medications will still be required.
Entering the market in the coming weeks is a new dopamine pump. The pump strategy offers the possibility for constant stimulation of the brain’s dopamine receptors through the use of a continuous dopamine infusion pump technology. Last year we wrote about a Lancet Neurology article that detailed the first randomized controlled trial of a continuous pump infusion technology for Parkinson’s disease. The trial utilized an intrajejunal (i.e. a tube inserted in the small intestine) levodopa-carbidopa intestinal gel pump infusion strategy, and it was designed to collect safety and effectiveness data. The study was carefully conducted and was double blind (neither the patients nor the raters knew what was administered) and randomized. It was conducted in 26 centers including Germany, New Zealand, and the US. Participants were randomized (1:1) to “immediate-release oral levodopa-carbidopa pills plus a placebo intestinal gel infusion or to levodopa-carbidopa intestinal gel infusion plus oral placebo pills.” It is important to remember that everyone in the study received a pump, but half of the patients did not receive active therapy (through the continuous pump infusion). The authors were most interested in improving the amount of time spent in the “off state” following 4 months of therapy. Off-time improved by 4 hours in the pump group versus 2.1 hours in the pill group. The amount of “on” time without troublesome dyskinesia was better in the pump group when compared to the pill group (4.1 vs. 2.2 hours).
The pump is approved and available in 43 countries. The United States has lagged behind the world in adopting this new approach. Prior to the publication of the Lancet Neurology pump trial, all previous results were based on uncontrolled evidence. The benefits of the pump have been now been clearly demonstrated. In this population of fluctuating patients, the data suggest that the pump out-performs standard medical therapy. The study did not enroll patients with severe dyskinesia, and it is unclear how the continuous infusion pump will perform in more severe and more disabled Parkinson’s disease patients. The study also did not compare the pump to other medications or to deep brain stimulation.
One of the major drawbacks to the pump approach is the need for a percutaneous gatrojejunostomy (a small feeding tube). These types of tubes can serve as the starting locations for infections and other complications, and in the current study, device complications were present in 89% of subjects. The complications were addressable in most cases, and were reported as lower than in previous pump trials.
Below is picture from a recent review that appeared in Nature.com showing the electronic pump (a) and all of the parts necessary to deliver the dopamine gel to the intestine (e).
Richards L. Parkinson disease: Intrajejunal duodopa improves nonmotor symptoms. Nature Reviews Neurology 5, 354 (July 2009); Google Images.
These are the points about the pump every patient interested in the therapy should be familiar with:
- The current version of the pump requires wearing an external device.
- The pump requires changing a dopamine cassette once or twice a day.
- The dopamine cassettes are a little smaller than a cellular phone, and usually last about 14-16 hours.
- Even with the pump, some patients will require two cassettes, and some will need additional medications during the bedtime hours.
- The pumps require continuous maintenance and also require programming by a qualified professional.
- The tube connected to the stomach requires constant monitoring for infection and/or inflammation.
- Many patients and family members in the clinical trials for the dopamine pump commented that the pump required a lot of care and that an active caregiver may be critical for the success of the therapy.
- There is a need to compare pump effectiveness against deep brain stimulation therapy (DBS). Understanding which patients are appropriate for each technique will be important.
- Experts in the field will need to turn their focus to patient selection for pumps as compared to DBS therapy. This is currently not clearly delineated and will require a detailed discussion with the neurologist or expert clinician.
- It remains unknown if patients with dementia are viable candidates for the pump.
- Pumps are powerful symptomatic therapies, but not cures.
- The continuous infusion pump will not address the dopamine resistant symptoms of walking, talking, and thinking.
- Pumps have not been shown to delay disease progression and they are not a cure.
- The good news for the Parkinson’s disease community is that for a subset of patients a “pill free existence” may be on the horizon.
The FDA lebeling for Duopa (AbbVie) is provided at this link: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203952s000lbl.pdf
The National Parkinson Foundation has a free Helpline with nurses available to answer questions at: 1-800-4PD-INFO (473-4636).
Posted: 3/2/2015 2:10:35 PM by
Browse current and archived What's Hot in PD? articles, the National Parkinson Foundation's monthly blog for people with Parkinson's written by our National Medical Director, Dr. Michael S. Okun.
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