What Is A Rotigotine Skin Patch And How Does It Work
Rotigotine is a type of dopamine agonist medication. Rotigotine comes in the form of a skin patch which you put onto your skin to release your medication. Neupro is the brand name for rotigotine.
A rotigotine skin patch releases your dopamine agonist medication slowly over a 24-hour period.
How do dopamine agonist medications work?
Dopamine is a chemical messenger made in the brain. The symptoms of Parkinsons appear when dopamine levels become too low.
This is because many of the cells in your brain that produce dopamine have died or are dying. Taking dopamine as a drug doesnt work because it cannot cross the blood brain barrier. To get around this, doctors use other medication that can act in a similar way. One approach is to use dopamine agonist drugs, which act like dopamine to stimulate your nerve cells.
Rotigotine can be used at any stage of Parkinsons. It is used on its own, with levodopa medication or with other Parkinsons medication. If it is used with levodopa, this will usually happen later on in the condition when levodopa can be less effective and more doses are needed.
The patient information leaflet that comes with your medication will give you full details about how to use each patch correctly. We have included some key information here.
You need to apply a new patch every day. This should be done at the same time each day. A good time to put on a new patch is in the morning after your bath or shower.
- shoulder area
- upper arms
What Is Known About This Drug
Rotigotine efficacy as adjunctive therapy in advanced disease is non-inferior to that of cabergoline. In terms of reducing off-time as adjunctive therapy rotigotine is non-inferior to pramipexole.
Compared with treatment with levodopa DCI alone, rotigotine adjunctive therapy significantly reduced off-time, by 1.8 hours and 1.2 hours in the PREFER study and by 1.6 hours in the CLEOPATRA-PD study, from the baseline mean daily off-time of 67 hours.
Reduction in off-time with rotigotine adjunctive therapy is similar to that with pramipexole.
More people treated with levodopaDCI plus rotigotine reported 30% reductions in mean daily off-time than people treated with levodopa alone. However, non-inferiority of rotigotine compared with pramipexole was not shown for this outcome.
Rotigotine increased the incidence of adverse events, including dyskinesia, hallucinations and application/instillation-site reactions compared with levodopaDCI alone.
To Apply The Patch Follow These Steps:
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Rotigotine In Apomorphine Or Other Advanced Therapies Treated Advanced Parkinsons Patients
The effects of RTG on sleep disturbances in PD are most frequently assessed in groups of patients with a fairly early disease course, however the described potential beneficial effects of RTG might be observed in advanced PD patients as well. An open-label single-arm study in a small sample of 6 PD patients investigated the effects of RTG patch on sleep disorders in advanced PD treated with day-time apomorphine infusion .76 Compared to baseline, the PDSS total score decreased on average 44.8% at 4-month follow up. Improvements in 12 out of the 15 items of the scale were recorded, with quality of sleep and difficulty in staying asleep showing statistically significant differences . Furthermore, the VAS score used to quantify sleep problems improved by 65% . This small-open label study supports the use of low-dosage RTG in advanced PD patients with sleep disturbances, indicating a good tolerance with no incidence of relevant side effect such as hallucinations. Further studies addressing the effect and tolerability of RTG on sleep disturbances in advanced PD patients are needed to confirm these preliminary observations.
Exenatide As A Treatment For Patients With Parkinsons Disease
Objective/Rationale: Laboratory data from several teams have indicated potential beneficial effects of the drug Exenatide on the survival of dopamine cells. In a small group of patients with Parkinsons disease who injected Exenatide twice daily for a year, the drug was tolerated well and improvements were seen in physical and cognitive functions compared to patients not given the drug. Further exploration is needed to identify whether Exenatide can indeed slow the progression of PD.
Project Description: This randomized, double-blind, placebo-controlled, proof-of-concept trial aims to confirm whether the preliminary findings of beneficial effects seen in both motor and non-motor PD symptoms can be replicated. Sixty patients with PD will be randomly assigned to self-administer a slow-release version of Exenatide or matched placebo once weekly for 12 months. Levels of the drug will be measured in blood and spinal fluid, and biological effects on Parkinsons will be assessed using clinical scales, diaries and scans of dopamine transporter availability . The study will include a washout period at the end to help distinguish whether any changes seen are purely related to symptom relief or are related to effects on the neurodegenerative process.
Additional Support:The Michael J. Fox Foundation would like to acknowledge the generous contribution of the Demoucelle Parkinson Charity as a lead supporter providing funding for this project.
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Potential For Compulsive Behaviours
People treated with dopamine agonists, including rotigotine, have reported compulsive behaviours such as increased libido, hypersexuality, repetitive meaningless actions , binge eating and pathological gambling.18-22 These symptoms are generally reversible on rotigotine dose reduction or discontinuation.1
In a safety analysis of rotigotine, pathological gambling was the most frequently reported compulsive behaviour.23 It has been described in case reports, along with punding and hypersexuality, in patients treated with adjunctive rotigotine.24 The incidence of increased libido, hypersexuality, punding and pathological gambling in studies of patients treated with rotigotine was 0.1% to 1% the incidence of binge eating was 0.01% to 0.1%.
Inform patients and carers about the risk of compulsive behaviour and ask about the development of new or increased urges while being treated with rotigotine.
Rotigotine Adjunctive Therapy May Increase Incidence Of Dyskinesia And Hallucinations
As described for other dopamine agonists, rotigotine may potentiate the dopaminergic adverse reactions of levodopa and may cause and/or exacerbate pre-existing dyskinesia and hallucinations.1
In adjunctive therapy trials, dyskinesia and hallucinations were more common in patients receiving rotigotine and levodopa than in those receiving levodopa alone.8,9
In the PREFER study 14% and 17% of trial participants in the rotigotine 8 mg/24 hour and 12 mg/24 hour arms, respectively, reported experiencing dyskinesia, compared with 7% in the placebo arm.8
In the CLEOPATRA-PD study dyskinesia was reported by 12% of trial participants in the rotigotine arm compared with 3% in the placebo arm. Dyskinesia was reported in 15% of people taking pramipexole.9
Incidence of hallucinations was higher in people taking rotigotine than placebo in both key trials.8,9 In the PREFER study reports of hallucinations were also increased in trial participants in the 12 mg/24 hour arm compared with those in the 8 mg/24 hours arm .8
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Reason For Pbs Listing
The PBAC recommended listing of rotigotine transdermal patches on the PBS on the basis of non-inferiority to cabergoline in levodopa-treated patients with motor complications.4 The PBAC considered that there were probably fewer serious safety issues associated with the use of rotigotine compared with cabergoline, but they highlighted that the absolute magnitude of the benefit was unclear.33
The appropriate equi-effective daily doses were considered to be 8.8 mg rotigotine to 3.42 mg cabergoline.33
The PBAC was concerned that information relating to the relative incidence of important adverse events including sleep attacks, ophthalmological adverse reactions and fibrosis was incomplete.33
Characteristics Of Included Reviews
The characteristics of the 11 SRs/MAs included in our final analysis are summarized in Table 2. They were published between 2010 and 2019, and 9 of them were published since 2015 . The number of primary studies included in each review ranged from 8 to 42, and the sample sizes ranged from 474 to 2,625. The interventions in the therapy groups were mainly acupuncture or acupuncture plus medication, and the interventions in the control groups were mainly medication and sham placebo acupuncture. The conclusions from these reviews differed: 10 reviews reached the conclusion that acupuncture was effective in relieving PD symptoms, while the remaining 1 reached the opposite conclusion.
Table 2. Characteristics of the included reviews.
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Perform Regular Cardiac Review As Part Of Physical Examination
Cabergoline and pergolide increase the risk of valvular heart disease, but it is not known if this is true of rotigotine.25,26
The incidence of cardiac valve abnormalities was similar between rotigotine and placebo treatment groups in controlled trials, but this finding should be interpreted with caution because of the small sample size and short duration of studies. Cardiac valve abnormalities have been observed in open-label trials of rotigotine.1
Perform regular cardiovascular review as part of a physical examination of people taking rotigotine, including echocardiogram to test for potential presence of valvular disease, with clinical diagnostic monitoring for the development of cardiac valvular disease or fibrosis, as appropriate.27
After the initial echocardiogram before starting treatment, the next echocardiogram should occur within the first 36 months of treatment. Subsequent echocardiograms should occur every 612 months.27
How Does It Compare
The efficacy and safety of rotigotine as an adjunct to levodopaDCI were compared with those of levodopaDCI alone in two placebo-controlled, double-blind, randomised controlled trials in people with advanced Parkinson’s disease.8,9
In a randomised controlled trial rotigotine has only been directly compared with pramipexole .9 Therefore it is not known how it compares with other Parkinson’s disease treatments in terms of efficacy and safety.
In the PREFER study the efficacy and safety of the addition of up to 8 mg/24 hours or up to 12 mg/24 hours rotigotine b was compared with placebo in a 24-week study.8
In the CLEOPATRA-PD study the efficacy and safety of rotigotine was compared with that of pramipexole up to 4.5 mg/day orally, n = 201)b and placebo .9
Has Anyone Tried The Tao Patchwhich Is Advertised For Pd
To those with pain or other conditions looking at TaoPatch, please dont be blinded by desperation! As much as you want a cure or solution, you need to stay skeptical if you dont want to be fooled by products just like this.— Some of the articles that look behind the curtain….—–Taopatch Offers Everything Except ScienceTaopatch promises all kinds of vague benefits, but the mechanism of action is implausible and what they call scientific proof is no such thing.— From
Lets look at the info on the Taopatch website, and then look at the evidence that Taopatch provides. — From
If you are a Multiple-Sclerosis patient looking at Taopatch for MS treatment, please tread carefully. Dont be persuaded by testimonials or the offer of a money-back guarantee as sufficient evidence, regardless of how desperate you are, talk to your doctor, and make sure you look for concrete evidence that this is not a placebo product. The product is NOT FDA approved.
Rotigotine May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:
- rash, redness, swelling or itching of the skin that was covered by the patch
- difficulty falling asleep or staying asleep
- abnormal dreams
- dizziness or feeling that you or the room is moving
- swelling of the hands, feet, ankles, or lower legs
- increased sweating
- having strange thoughts or beliefs that have no basis in reality
- frenzied or abnormally excited mood
Rotigotine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .
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Has Anyone Tried Any Of These
Has ANYONE tried PS128 Probiotic? Or Tao Patch? Or Mannitol? Have you had any success with any of these? Has anyone on this site ever done one of the Clinical Trials for Parkinsons that are out there????
See my post on Mannitol.
Could not identify any positives with either PS128 or Mannitol. I tried each for three months. A waste of inflated US dollars.
See my post re mannitol.
My wife had PS128 probiotic for 2 months. It increased her mental concentration.
Despite all the hype about mannitol –especially after it appeared to have promise in preclinical fruit fly and rodent models of PD — a recent randomized controlled clinical trial showed no hint of a clinical benefit in people with PD. frontiersin.org/articles/10…
Have tried Mannitol Balance for about 4 months….saw no positive change and acquired a host of digestive issues. Have just begun Solace…purchased a 3 month supply and have been taking for about a week. Seems to be have some effect on constipation. Will see how it goes.
Yes, Solace has ended my husbands constipation problem. Research looks good, will continue for another 3 months.
I did experience improvement with mannitol, and more particularly significant slowing of disease progression. I can see in retrospect, that during the 3 years before I took mannitol, I was deteriorating much faster than since then
Rem Sleep Behavior Disorder
While the pathophysiological origin of RBD is unclear and likely to be non-dopaminergic, one study from China performed an open label study in 11 PD patients using a RBD Questionnaire-Hong Kong and blinded VPSG assessments.70 The authors reported a subjective improvement of the motor aspects of RBD after RTG along with improvement in PLMS index and total sleep time, although RBD related sleep parameters were unaffected. The role of RTG in the management of RBD therefore, needs to be explored.
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Possible Adverse Sleep Related Events
Most studies do not mention any specific sleep related side effects of RTG use and it seems well tolerated.66, 69, 7173, 75, 76 In the RECOVER study, two RTG treated subjects reported a sleep attack and one participant had suggestive findings of compulsive sexual behavior.7
An open-label study investigated the Clinical Global Impression item 4 assessing safety as a primary outcome of RTG as an add-on to oral dopamine agonist therapy.77 In a sample of 79 PD patients with EMO or nocturnal sleep disturbance, the RTG maintenance dose was 5.71±2.28mg/24h for 58.7±14.9 days, while the concomitant oral dopamine agonist as RTG converted dose at baseline was 4.02±1.66mg/24h. The authors noted an adverse event profile similar to previous studies of RTG in patients with advanced PD. Hallucinations were observed in two subjects, and somnolence, insomnia and impulse compulsive behavior in three subjects. Furthermore, no obvious relationship with total dopamine agonist dose was found. Improvements in the PDSS-2 total score, PSQI global score, and PDSS-2 individual items relating to sleep maintenance, while worsening of item 7 were also observed. Most importantly, 93% of the subjects showed a CGI-4 score < 3 indicating that the add-on therapy did not interfere with functioning. Besides the above mentioned nocturnal hallucinations in two subjects and insomnia in one patient, no other sleep related events were reported.
Scientific Proof No Way
Samuel Pinches, in Australia, has reviewed the literature offered by Taopatch. He found low quality, small preliminary studies, authors who apparently dont exist, plagiarism, a poster, insufficient details, and red flag use of language like quantum dots and upconverting nanocrystals without explanation. One study didnt even mention Taopatch. He points out that low-level laser is low-level, not zero, and compares biophoton therapy to homeopathy because both claim that incredibly weak signals offer immense healing power. He concluded that Taopatch does not understand scientific rigor. Perhaps the understatement of the year.
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What Does Nps Medicinewise Say
Rotigotine is an adjunctive therapy option for people with Parkinson’s disease who experience off-time inadequately controlled by levodopa alone.
There is no evidence that rotigotine is more effective than oral dopamine agonists in levodopa-treated patients. It is an alternative to oral treatment for patients who have difficulty swallowing or impaired gastric emptying or who prefer a once-daily patch to oral dosing.
More than one rotigotine patch may be required to achieve the optimal therapeutic dose.
As adjunctive therapy in a patient being treated with a levodopaDCI combination.
Note that the PBS listing is more restrictive than the TGA indication, which is for use as monotherapy or in combination with levodopa for the treatment of idiopathic Parkinson’s disease from early stage to advanced disease.