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Official websites use. Share sensitive information only on official, secure websites. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. The plan for dose adjustment is usually done as per drug information recommendations from the licensing bodies, but there are no clear guidelines with regards to the best practice regarding the tapering off schedule given sudden dose reductions of drugs such as dopamine agonists may have serious adverse consequences. A systematic literature search was, therefore, performed to derive recommendations and the data show that there are no controlled studies or evidence-based recommendations how to taper or discontinue PD medication in a systematic manner. Most of the data were available on the dopamine agonist withdrawal syndrome DAWS and we found only two instructions on how to reduce pramipexole and rotigotine published by the EMA. We suggest that based on the available data, levodopa, dopamine agonists DA , and amantadine should not be discontinued abruptly. Abrupt or sudden reduction of DA or amantadine in particular can lead to severe life-threatening withdrawal symptoms. Based on our clinical experience, we have proposed how to reduce PD medication and this work will form the basis of a future Delphi panel to define the recommendations in a consensus. Parkinson's disease PD is characterised by a wide range of motor and non-motor symptoms some of which remain refractory to conventional management and remains a key unmet need and challenge LeWitt and Chaudhuri A finely balanced risk—benefit ratio is important for optimal management when dealing with dopamine replacement therapy for PD and brings its own challenges in real-life use. In part, this is driven by the heightened awareness of the damaging and medicolegally relevant risk of impulse control disorder ICD and dysregulation behavioral syndromes emerging with the use of DAs. As a result, neurologists or health care professionals may sometimes reduce or discontinue a DA too quickly or abruptly in PD patients leading to dangerous complications such as dopamine agonist withdrawal syndrome DAWS , which can be life-threatening in extreme cases Rabinak and Nirenberg ; Nirenberg ; Ray Chaudhuri et al. The stoppage of oral DA abruptly can also occur in severely ill PD patients where the patient is unable to take drugs orally and have been recently highlighted in a number of patients being admitted with severe COVID infection Antonini et al. The effects can also manifest as deterioration of motor symptoms which lead to complications like immobilization, falls, or dysphagia with aspiration Kofman It is therefore, important to be aware of possible complications and monitor patients carefully if discontinuing or tapering down dopaminergic medications and specifically DAs. However, importantly, little data have been captured on the process of reducing existing dopaminergic medications and strategies to combat withdrawal symptoms. This may be based on the fact that for licensing a DA or dopamine replacement therapy DRT , only the intake times and the changes in dosage are recorded, and as a consequence, dopaminergic drug withdrawal-related issues are only recognized if clinical problems arise such as with DAWS. In this review, we summarize the available data based on a comprehensive literature search on the discontinuation and tapering of PD medication based on the class of dopaminergic drug used and provide a recommendation. A systematic literature search was performed using the PubMed database by the end of March The results are shown in Table 1. We reviewed the matches and found no trials or recommendations how to taper or discontinue PD medication in detail. Based on our experience and the expected outcome if PD medication cannot be continued e. Because levodopa is effective, sometimes in a dramatic fashion to attenuate the akinetic-rigid symptoms of PD and because it has a good well studied time-honoured safety profile compared to other anti-Parkinson drugs PD Med Collaborative Group et al. However, Levodopa reduction or discontinuation can be needed in cases of levodopa over-dosing resulting in severe refractory or diphasic dyskinesias Ray Chaudhuri et al. In the case of a DDS, complete discontinuation of levodopa will generally not be possible, but attempts should still be made to reduce the levodopa medication as much as possible. The complete discontinuation of dopaminergic medication after STN-DBS is usually not possible, because the lack of dopamine in the limbic system and associative circuits can lead to apathy and depression Fasano et al. As levodopa is currently only used through enteral administration either orally or per jejunal in the case of intrajejunal delivery , use of oral levodopa may not be possible after gastro-intestinal surgery or in cases of acute pancreatitis, whereby the medication needs to be given transdermally whenever possible rotigotine , subcutaneous apomorphine , or intravenous amantadine Ray Chaudhuri et al. In the late s and s, a positive and lasting effect on motor behavior after a levodopa pause the so-called drug holidays was repeatedly observed, although drug holidays in PD are strongly discouraged Birkmayer and Riederer , because after the abrupt discontinuation of levodopa PD patients usually in advanced stages of the disease , a state of akinetic mutism may occur. The past studies of the s were performed in hospitals with extensive nursing care because of severe health risk to the patients including increased stiffness, rigidity, tremor, and increased risk for thrombosis Kofman The authors reported that in spite of the abrupt change, no complications were observed Koziorowski and Friedman When attempting to reduce the levodopa dosage, a worsening of motor performance has to be reckoned with due to its short half-life Turjanski et al. Due to a long-duration response to levodopa, further deterioration of motor performance should be expected even after several days 7—15 Cilia et al. Similarly, possible worsening in dysphagia might occur in advanced stages of PD Warnecke et al. Furthermore, there are several case reports of malignant neuroleptic syndrome after discontinuation of levodopa treatment Gibb and Griffith ; Gordon and Frucht ; Keyser and Rodnitzky ; Ong, Chew, and Ong ; Rainer, Scheinost, and Lefeber ; Waqas et al. Likewise, after discontinuation of dopaminergic medication including levodopa subsequent to STN-DBS, changes in personality accentuation have been documented. We have not found any studies so far on the topic of how levodopa should be reduced or rarely, stopped in detail, when necessary. A possible useful strategy would be a stepwise reduction of levodopa for example, decreasing 50— mg levodopa total or 25 mg t. Such reductions have to be clinically monitored very closely and the reduction rate needs to be adjusted to clinical profile of the patient. This is particularly relevant if DDS occurs. Levodopa equivalent dose LED for antiparkinsonian drugs Tomlinson et al. The dopamine agonists DA pramipexole, ropinirole, and rotigotine are used in the treatment of PD as a first line or adjunctive therapy, in particular in younger patients, as stated in some, but not all, clinical guidelines Jost Rotigotine transdermal patch use in older subjects in particular is supported by observational tolerability studies Raeder et al. Apomorphine, applied as a continuous infusion, has proven effective in advanced stages of the syndrome when motor fluctuations develop Trenkwalder et al. When apomorphine infusion pumps are operational, then discontinuation could be due to device-related technical problems, the formation of nodules at the injection sites, somnolence, nausea, and very rarely, autoimmune hemolytic anemia Table 4 Trenkwalder et al. Raising clinician and patient awareness of potential complications to enable proactive management is important to identify and control adverse effects in a timely manner Bhidayasiri, Garcia Ruiz, and Henriksen Reduction and discontinuation of DA may lead to deterioration in motor and non-motor performance, which in turn necessitates the use or increasing levodopa, COMT inhibitors, or MAO-B inhibitors Potenza et al. Ray Chaudhuri and Schapira The risk may also increase after sudden or abrupt discontinuation of DA when intrajejunal levodopa infusion therapy is being initiated Solla et al. The available data on withdrawal symptoms occurring after discontinuing an apomorphine pump are scarce compared to those discontinuing oral or transdermal DA. There are case reports describing acute lethargy after discontinuation of apomorphine pump therapy, which only improved after reintroducing of the therapy and thus could indicate a complication of acute apomorphine withdrawal Cavallieri et al. A detailed literature search failed to reveal any studies documenting clinical and other parameters on evidence-based or expert opinion-guided strategies for discontinuing or reducing DA therapies. Accordingly, the daily dose of pramipexole should be reduced by 0. Our personal recommendations to reduce DA are summarized in Table 5. It should be emphasized that when reducing the dose, 1 a DAWS can occur independent of the rate of the reduction and that 2 a deterioration of motor performance usually has to be compensated with levodopa with or without COMT inhibitors and regular monitoring of patients at home at this period is essential. It has to be mentioned that our proposed time-course can be slowed down significantly according to the patient response. The latter may be aided using wearable sensor based home monitoring systems. If rotigotine causes daytime sleepiness or edemas in patients suffering from RLS, it could be tried to apply the patch only during the night-time. In Table 1 , the conversion factor is given for calculating the levodopa equivalence dosage according to Tomlinson and coworkers Tomlinson et al. This effect could not be observed for ropinirole or rotigotine groups Contin et al. Therefore, reducing pramipexole in older patients should presumably be done more slowly. The reasons for reducing or discontinuation of amantadine could be related to unremitting and troublesome peripheral edema as well as neuropsychiatric side effects, QTc prolongation, sleep disturbances, and livedo reticularis and corneal edema Pahwa et al. In the study by Wolf et al. In the AMANDYSK trial, amantadine was reduced by an amount of mg every second day in 29 patients, and similarly, no significant adverse events were observed except of an aggravation of LID compared with the amantadine group. In a cross-over study with 39 PD patients with LID, of whom 17 received placebo, no adverse events were documented after 27 days of treatment apart from an increase in dyskinesia and an aggravation of off-phenomena Sawada et al. In a similar month double-blind study, elevated body temperatures In these controlled studies, no significant adverse effects were reported at all, but there are several individual case studies describing an amantadine withdrawal syndrome AWS Marxreiter et al. In these case studies, after withdrawal or reduction of amantadine, hyperactive delirium with disorientation, restlessness, hallucinations, and argumentative tendencies occurred as well as a deterioration in motor performance which improved only after treatment with amantadine was reinstated. No alternative explanation for the delirium was evident and other therapies such as clozapine or intravenous hydration failed to achieve any improvement. There are a few similar case studies, reporting that amantadine withdrawal contributed to a malignant neuroleptic syndrome Brantley et al. We recommend reducing amantadine every second or third day by 50 mg. Whereby attention has to be paid to the fact that an AWS can also develop after the discontinuation, and therefore, post-amantadine cessation monitoring is important. The monoamine oxidase inhibitors MAO-B inhibitors rasagiline, selegiline, and safinamide are approved as monotherapy RAS and SEL or as combination therapy with levodopa all three , and could lead to a reduction in off-time as well as an increase in on-time without disturbing dyskinesias Binde et al. In addition, there are some non-motor efficacy such as effect on pain signals with safinamide Cattaneo et al. In a meta-analysis by Binde and coworkers, the risk of terminating treatment with MAO-B inhibitors due to side effects or even the lack of efficacy was not increased compared to placebo Binde et al. To date, we have not found any data on what may be expected after terminating treatment with rasagiline or safinamide. After termination of selegiline, only a worsening of motor performance to pre-treatment levels has been observed, but the number of subjects included in this study was marginal small Negrotti et al. The same effect may be expected in treatments with rasagiline and safinamide. How MAO-B inhibitors should be discontinued has not yet been studied. It is not necessary to ask this question when rasagiline is discontinued as only 1 mg dose is used. However, because it is an MAO inhibitor with long a half-life Finberg , a slow worsening in motor behavior may be anticipated over a period of several days. To discontinue selegiline, we recommend reducing the dose by 2. In case one MAO-B inhibitor cannot be continued e. The Catecholamine-O-Methyltransferase inhibitors COMT inhibitors entacapone, tolcapone, and opicapone are given in addition to levodopa in cases of motor fluctuations. Typical reasons for discontinuation with entacapone are: dyskinesia, diarrhea, discolouration of the urine, nausea, and insufficient effect Parashos et al. Tolcapone is rarely used apart from named patient basis owing to worldwide alert for fatal hepatic failure in the s Lees et al. Our research so far has not found any studies on to how COMT inhibitors should be discontinued or phased out. This effect may also be expected for tolcapone Lees and opicapone. However, as far as we have found in the literature, other adverse effects after terminating of COMT inhibitors in the nature of a withdrawal syndrome have not been observed yet. Considering the likely increase in motor fluctuations after incompatibility of a COMT inhibitor after its discontinuation, we recommend switching to another COMT inhibitor the very next day. In the event that diarrhea as well as urine discolouration may occur with entacapone or tolcapone treatment, switching to opicapone may be considered. As such if opicapone withdrawal is considered, then switching to entacapone where opicapone was used first line or an alternative enzyme inhibitor may be required and deterioration in off-time may occur over several days. In this review, we searched for available evidence to guide PD medication management when tapering or discontinuing becomes necessary, for example because of side effects. To avoid hypodopaminergic states with depression and apathy, motor deterioration with consecutive complications like falls and withdrawals syndromes e. The proposals how to reduce PD medication in this work is based on our experience and they might have to be adjusted in case of adverse events, because reaction to medication change in PD varies from patient to patient and depends on the progression of the disease. The specific suggestion for each medication is shown in the text, and the proposal for a common pathway is shown in Fig. Further research is required to improve medication management when PD medication has to be reduced to maintain a proper life quality of the patients. JK: reports advisory board for Abbvie, honoraria for speaker from Desitin. MT: no conflict of interest. VR: has received funding for educational articles from Britannia pharmaceuticals. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. As a library, NLM provides access to scientific literature. J Neural Transm Vienna. Find articles by J Koschel. Find articles by K Ray Chaudhuri. Find articles by M Thiel. Find articles by V Raeder. Find articles by W H Jost. Received Jun 26; Accepted Jul 21; Issue date Open in a new tab. Levodopa dose per day Over mg to mg Less than mg Velocity of reduction to 50 mg less per day 50 to 25 mg less per day 25 mg les every second or third day. The formation of nodules at the injection sites Nausea Somnolence Device-related technical problems Impulse control disorder Hallucinations Orthostatic dysregulation Very rarely, autoimmune hemolytic anemia. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Pramipexole retard salt 1. Pramipexole salt 1. At mg, reduction can start at 50 mg, after 1 day at 50 mg, every third day thereafter.

Implications of dopaminergic medication withdrawal in Parkinson’s disease

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