Transdermal patch for parkinson disease

She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in , and has written about science and health for SelfHacked and the Genetics Society of America. Tags Neupro patches , review , rotigotine , UCB.

View Forums. Recommended reading. A few open-label extension studies have also documented motor benefits lasting up to 6 years [ 42 , 43 , 44 , 45 ].

Although levodopa remains the gold standard of PD treatment, plenty of high-quality contemporary research appears to corroborate the use of rotigotine to alleviate motor symptoms in PD. Dyskinesias are a key challenge in treating patients with PD, although recent data suggest the problem may be subsiding [ 47 ], possibly as a result of personalized therapeutic approaches such as surgery or a wider use of CDD systems [ 48 ], including rotigotine.

A post hoc analysis of two open-label extension studies of patients with early PD on rotigotine for up to 6 years indicated that the incidence of dyskinesia was lower in the absence of levodopa treatment 4 vs. The authors of both studies independently concluded that the majority of dyskinesias developed after the addition of levodopa to rotigotine treatment [ 42 , 43 ].

Although various dyskinesia variants have been proposed, diphasic dyskinesias are considered the most problematic [ 50 ], and the role of the rotigotine patch remains unclear. Data to support the specific use of the rotigotine patch as an anti-dyskinetic agent in its own right remain scarce. NMS are an integral aspect of PD from prodromal through to palliative stages and are classified as dopaminergic or non-dopaminergic, with dopaminergic NMS including those that may fluctuate with motor symptoms and representing part of the described non-motor fluctuations [ 51 , 52 , 53 ].

The different results may be due to differences in the populations studied. Several double-blind RCTs explored the effects of rotigotine on non-motor functions in early and advanced PD [ 36 , 54 , 55 , 56 , 57 ] and are summarised in Table 4. There is also a view that motor improvement caused by dopaminergic drugs, in this case rotigotine, may exert a concurrent positive effect on NMS, thus introducing bias in our observations.

However, evidence from large cohort-based linear regression analysis indicated that the effect of NMS burden on QoL in PD may be differential and does not go hand in hand with motor progression [ 58 ]. Nocturnal sleep disturbances, such as insomnia, nocturnal akinesia, restless legs syndrome RLS , and others, represent common, disabling, and occasionally overlapping complaints within the multifaceted spectrum of NMS in PD [ 59 ]. The benefits of transdermal rotigotine on sleep disturbances appeared to be sustained for up to 1 year in an open-label study that included 84 completers of the RECOVER study [ 45 ].

There have also been indications that rotigotine might be effective on early-morning off EMO symptoms Sect. One of the above-mentioned RCTs also documented a significant improvement in polysomnography parameters increased sleep efficiency and REM sleep; reduced sleep onset latency and wakefulness [ 61 ]. Researchers from an open-label pilot study suggested that improvements in perceived sleep quality after rotigotine treatment was at least partly mediated by a reduction in motor activity during sleep, as confirmed by actigraphic recordings [ 68 ].

The beneficial effect of rotigotine on sleep impairment was further corroborated in an open-label study in which patients with PD were assessed using both objective video-polysomnography and subjective Epworth Sleepiness Scale, PDSS-2 approaches [ 69 ].

Therefore, some justification does exist of the notion that rotigotine can improve aspects of sleep in PD, not just by improving nocturnal motor intrusions but also through modification of intrinsic properties related to sleep structure and thus sleep fragmentation, a major source of subjective nocturnal complaints in PD during the course of the disease, right from the early stages.

High-quality evidence from original studies underlines the beneficial effect of rotigotine on various aspects of sleep impairment in PD, spanning from motor to non-motor benefits, including a possible effect on sleep architecture [ 70 ].

Pain has partly a dopaminergic basis, and management of fluctuation-related pain can be assisted by optimization of dopaminergic therapy [ 73 , 74 ]. These results were further confirmed in a post hoc analysis of the RECOVER study [ 71 ]; significant effects of rotigotine on nocturnal pain were also corroborated in a large open-label study based on the use of PDSS-2 and a pain visual analogue scale [ 75 ]. The MDS-EBM committee agreed that evidence is currently insufficient to define the efficacy of rotigotine on pain in PD [ 9 ], although rotigotine and oxycodone—naloxone remain the only two drugs for which a high level of evidence for PD and pain management is available.

From a pragmatic point of view, there exists reasonable evidence to support the use of rotigotine in the management of fluctuation off -related pain and nocturnal pain [ 55 , 70 , 71 ]. In general, fatigue is a challenging, troublesome, and common NMS of PD that is typified by excessive tiredness and a feeling of debilitation or exhaustion independent of physical activity [ 76 , 77 ]. However, until a study using a validated fatigue-specific scale shows a positive effect of rotigotine, its effects on fatigue cannot be certain.

In patients with PD with fatigue, the transdermal rotigotine patch could be considered as a therapeutic option with a multimodal action and a potential benefit on comorbidities of fatigue, such as mood impairment, pain, and aspects of sleep dysfunction [ 78 ]. These findings were replicated by the first RCT to use changes in NMSS total score as a primary outcome, although the latter did not reach statistical significance [ 36 ]. On the other hand, a South Korean RCT of patients showed no change in the item Hamilton Depression Rating Scale outcome, whereas significant improvements in motor scores were observed with rotigotine versus placebo [ 57 ].

In patients with PD, the rotigotine transdermal patch should not be considered as a first choice to manage depression. However, rotigotine could be considered as a treatment option with a multimodal action in managing both motor dysfunction and depression in relation to personalising treatment and avoiding the use of additional antidepressants in selected cases.

Apathy is widely recognised as an individual symptom of PD and can be distinguished from other PD-related psychiatric symptoms and personality traits [ 81 , 82 ]. Apathy is described as a decline in goal-oriented behaviour and cognition and in emotional expression, with a reported pooled prevalence of However, it has not been assessed as a primary outcome in clinical studies [ 78 ]. The authors concluded that treatment with the rotigotine transdermal patch was effective at improving neuropsychiatric symptoms and QoL in patients with PD.

However, some studies did indicate a benefit of the transdermal rotigotine patch on apathy [ 1 , 36 , 80 ]. If patients with PD are experiencing apathy, the rotigotine transdermal patch is a treatment option that may be considered. Urinary symptoms, as part of the NMS spectrum, represent a significant factor in reducing QoL and increasing morbidity in patients with PD [ 84 ].

Among them, nocturia is a common complaint, with a reported prevalence ranging from A Spanish observational, retrospective, multisite study reported a positive effect from rotigotine on urinary function and urgency in patients with PD [ 66 ], whereas a few open-label either observational or routine clinical practice studies found that nocturia in particular improved with rotigotine [ 64 , 65 , 68 , 86 ].

However, specific and detailed studies are still needed so these findings can be translated into clinical practice. For the time being, rotigotine cannot be recommended for urinary dysfunction or nocturia treatment in PD.

However, if there are any indications that the patient experiences off or EMO-related nocturia, then treatment with rotigotine may be recommended as it is one of only a few drugs to have shown an effect on nocturia. An observational study suggested that switching from conventional oral therapy to the rotigotine transdermal patch offers a significant advantage by reducing existing GIT symptoms, such as heartburn, bloating, nausea, abdominal pain, vomiting, or diarrhoea [ 87 ].

Using a simple non-oral transdermal therapy has inherent advantages in circumstances when the effects of oral therapies may become erratic because of limitations in oral absorption [ 11 ]. However, the specific effects of rotigotine on a range of GIT symptoms need to be further investigated in controlled clinical trials.

Use of rotigotine for the management of specific GIT symptoms cannot be recommended at present. Dysphagia is partly dopaminergic [ 96 ], and a small retrospective open-label study of six subjects showed a significant improvement of dysphagia, as assessed by video-fluoroscopy both oral and pharyngeal phase with rotigotine [ 97 ].

An open-label pilot study in seven subjects indicated a beneficial effect from rotigotine on drooling [ ]. We encourage the investigative use of the rotigotine transdermal patch as a possible therapeutic option for patients with PD with dysphagia with or without drooling. In many UK hospitals, rotigotine is already recommended as the treatment of choice for patients with PD with severe dysphagia or those who are to receive nil by mouth because of surgical procedures or acute illness.

This strategy is clinically useful [ 88 ] and to be recommended. Large-scale studies of the acceptability and efficacy of rotigotine use in dysphagic PD are advisable.

Typically, off-related phenomena develop over time in patients with PD receiving chronic levodopa therapy and have initially been perceived as motor symptoms only [ , ]; however, recent research has highlighted the key importance of non-motor off phenomena and non-motor fluctuations [ 52 ]. EMO periods have been identified as a significant cause of disability in patients with PD [ ], especially in those with advanced motor symptoms [ ]. The study sub-cohort treated only with the rotigotine transdermal patch exhibited a significantly lower rate of EMO and had the highest rate of EMO-free patients, even compared with other prolonged-release DAs [ ].

RECOVER was the first RCT to explore early-morning motor function as a co-primary outcome in patients with PD; results indicated that rotigotine treatment may significantly reduce early-morning motor off periods [ 54 ]. The rotigotine transdermal patch should be considered the first option for management of troublesome early-morning dystonia and off symptoms.

Periodic limb movement disorder PLMD is a sleep disorder characterised by excessive involuntary and periodic movements of the limbs during sleep, leading to arousals, sleep fragmentation, and subsequent excessive daytime sleepiness [ ]. One open-label study confirmed the efficacy of the rotigotine transdermal patch in reducing periodic limb movements as measured by video PSG recordings [ 69 ] in patients with PD.

This study reported a high acceptance of the patch among patients, most of whom would select this treatment again for future surgery. Data suggest that switching from oral DAs to rotigotine can be done safely, even overnight [ ], and published data imply that the delivery of rotigotine is not affected by surgery and that the applied doses and plasma levels remain within the desired range [ , ].

A proposed algorithm to guide the selection and dosage of rotigotine during perioperative treatment could be based on the adjusted levodopa equivalent daily dosage LEDD.

A shift in dopaminergic therapy is a major cause of emergencies in patients with PD and can aggravate motor symptoms or cause severe non-motor complications, including psychosis [ ]. Abrupt discontinuation, inappropriate dosing, or dose omission of anti-PD medication can cause serious, potentially fatal complications, including an akinetic crisis [ , ].

One treatment option for PHS is increasing the oral levodopa dose. If this proves ineffective, the rotigotine patch may be considered to further escalate dopaminergic treatment [ ]. The rotigotine transdermal patch is a major part of many nil-by-mouth strategies, may optimise treatment management during hospitalization, and could be beneficial in emergency situations or intensive care environments in addition to levodopa. Its non-invasive, once-daily, transdermal application ensures a CDD under demanding circumstances.

In this context, rotigotine played an important role in strategies applied to manage patients with PD with coronavirus disease COVID infections who were acutely ill and needed dopaminergic therapies to avoid DA withdrawal syndrome DAWS.

This becomes particularly interesting as overnight control of PD symptoms can be difficult [ ]. The use of the rotigotine transdermal patch overnight in combination with advanced therapies represents a valid therapeutic strategy to provide h treatment but with strict specialist monitoring.

The combination of daily apomorphine subcutaneous infusion and rotigotine transdermal patch overnight was safe and useful in the management of PD symptoms, particularly sleep and mood impairment, at a 2-year follow-up [ ]. Similarly, the overnight use of a rotigotine transdermal patch can be effective in controlling night-time symptoms in patients with PD on intrajejunal levodopa carbidopa gel LCIG infusion, particularly in countries where the use of a single LCIG cassette per day is recommended so that associated costs can be contained [ ].

Older participants are frequently under-represented in PD research [ ]. However, the safety profile of the transdermal rotigotine patch appeared relatively unaffected by increasing age in a double-blind RCT, suggesting that rotigotine should be considered as an adjunct therapy in elderly patients upper limit of 75 years with PD [ 31 ].

Two observational prospective studies, one with [ ] and one without a control group [ ], demonstrated that rotigotine was relatively well-tolerated in older patients with PD upper limit of 70 and 75 years, respectively , without any alerting safety issues. Although the former study reported more adverse effects AEs in the older group, improvement between age groups was similar for the secondary effectiveness variable of PDSS-2 [ ], and the beneficial effect of rotigotine in the latter study was mostly related to the reduction of nocturnal symptoms [ ].

Finally, a recent study in a real-life setting in which Instead, the best way to dispose of your medication is through a medicine take-back program. If someone applies extra rotigotine patches, remove the patches. Then call your local poison control center at If the victim has collapsed or is not breathing, call local emergency services at Do not let anyone else use your medication.

Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital.

It is also important information to carry with you in case of emergencies. Rotigotine Transdermal Patch pronounced as roe tig' oh teen. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?

What side effects can this medication cause? What should I know about storage and disposal of this medication? Brand names. Do not cut or damage a rotigotine patch. To apply the patch, follow these steps: Hold the two sides of the pouch and pull apart.

Remove patch from the pouch. Apply the patch right away after removing it from the protective pouch. Hold the patch with both hands, with the protective liner on top. Bend the edges of the patch away from you so that the S-shaped cut in the liner opens.

Peel off one half of the protective liner. Do not touch the sticky surface because the medicine could come off on your fingers. Apply the sticky half of the patch to a clean area of skin and remove the remaining liner. China, Find articles by Peng Lei. China, Find articles by Guo-Guang Peng. Hideyuki Sawada, Editor.

Author information Article notes Copyright and License information Disclaimer. Competing Interests: The authors have declared that no competing interests exist. Received Oct 28; Accepted Jun This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.

This article has been cited by other articles in PMC. Results Six randomized controlled trials patients were included in this meta-analysis. Conclusions Our meta-analysis showed that the use of rotigotine can reduce the symptoms of PD. Statistical Analysis We combined the results of each trial by using standard meta-analytic methods to estimate the overall efficacy, tolerability, and safety. Results Search Results and Study Characteristics The literature searches identified potential articles, of which 12 were randomized controlled clinical trials.

Open in a separate window. Figure 1. Flow diagram of literature search and selection process. Table 1 The main characteristics of the included randomized controlled trails. Figure 2. Table 2 Efficacy and tolerability results of overall and subgroup analyses. Withdrawals In all six trials [19] — [24] that reported the overall number of patient withdrawals, we found no difference between rotigotine and placebo RR 0.

Figure 3. Effect of rotigotine versus placebo on withdrawals. Panel A: Overall withdrawals. Panel B: Withdrawals due to adverse events.

Figure 4. The pooled incidence of adverse events in PD patients treated with rotigotine. Table 3 Safety results of overall and subgroup analyses.

Figure 5. Effect of rotigotine versus placebo on the incidence of adverse events. Discussion This is the first meta-analysis of randomized controlled trials to assess the efficacy, tolerability, and safety of rotigotine in PD patients. DOC Click here for additional data file. Acknowledgments We are indebted to the authors of the primary studies.

Funding Statement The authors have no support or funding to report. References 1. J Neural Transm : — Lancet : — Mov Disord 19 : — Mov Disord 20 : — Arch Neurol 61 : — N Engl J Med : — Neurology 57 : — A community-based study.

Brain : — In: Jankovic J, Tolosa E, editors. Neurology 65 : S3—5.