[8]. This suggests that comfort/familiarity with DA therapy in RLS leads to less caution with DA dose increases. High values demonstrate a skewed utilization pattern and is characteristic of drugs of abuse, such as high-potency opioids or short-acting benzodiazepines. The authors have no funding and conflicts of interest to disclose. 4B). Correspondence: Min Chen, No.15 Lequn Road, Xiufeng District, Guilin City 541001, China (e-mail: [emailprotected]). This effect in rats is thought to be due to the prolactin-lowering effect of ropinirole. Dopamine agonists are often used as adjuncts to LD in an attempt to reduce these complications. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. When DAs were prescribed in combination, doses were summed across the individual agents using algorithms to calculate equivalent doses: equivalence of 4:1 was used for ropinirole and/or rotigotine when prescribed in combination with pramipexole, and equivalence of 1:1 when ropinirole and rotigotine were prescribed in combination. Medicine. Patients (%) prescribed DA therapy by dose level and (A) age group (B) prescribing specialty. Drug treatment can improve the symptoms of PD and improve the quality of life of patients. being unable to get an erection at any time. Three RCTs[19,20,25] reported the changes of UPDRS II scores before and after treatment with ropinirole or control in PD patients. [7] Understanding the effectiveness and safety of ropinirole in the treatment of PD has important guiding significance for clinical medication. This suggests that prescribers use different DA agents when they exhaust DA increases for a single agent, and that they are unaware of cumulative augmentation and AE risk when prescribing DAs in combination. Robust efficacy and tolerability data exist for the three DAs currently approved by the US Food and Drug Administration (FDA) for RLS: immediate-release oral ropinirole [1116] and pramipexole [1722] and transdermal patch rotigotine [2325]. Uses This medication is used alone or with other medications to treat Parkinson's disease. Descriptive statistics were used to evaluate the proportion of patients prescribed RLS treatment (overall and by dose level). may email you for journal alerts and information, but is committed [29] A number of clinical studies[3032] have discussed its therapeutic effect and safety, but the results are not consistent. Grayson M. Parkinson's disease. Ropinirole had no dose-related effect on electrocardiogram wave form and rhythm in young, healthy, male volunteers in the range of 0.01 to 2.5 mg. Ropinirole had no dose- or exposure-related effect on mean QT intervals in healthy male and female volunteers titrated to doses up to 4 mg/day. Ropinirole, a non-ergoline dopamine agonist. The Lorenz analysis demonstrated a very skewed distribution of pramipexole dosing, with the highest 1% of pramipexole users constituting 10.4% of all combined dosing of that medication. It is also used to treat Restless Legs Syndrome. The OR (95% CI) of HIGH/VERY HIGH DA dose prescribing by neurologists was double that of other specialties (2.1 [1.2 to 2.0]; Supplementary Table e-1). The dopamine receptors (D2) are g-protein-coupled inhibitory neurons predominantly in the striatonigral, mesolimbic, and tuberoinfundibular systems. The maximum dose is 24 mg per day. 342 Similar to dopamine, its selectivity toward dopamine receptors is in the order of D3 > D2 > D4. Of all patients prescribed HIGH/VERY HIGH DA doses, 58.7% of prescriptions were by primary care physicians, 16.9% by NP/PAs, 13.8% by neurologists, and 10.8% by sleep specialists (Figure 2B). Applies to the following strengths: 12 mg; 6 mg; 2 mg; 4 mg; 8 mg; 0.25 mg; 0.5 mg; 1 mg; 5 mg; 3 mg; 0.25 mg-0.5 mg-1 mg Usual Adult Dose for: Parkinson's Disease Restless Legs Syndrome Additional dosage information: Renal Dose Adjustments At present, the non-ergot receptor agonists pramipexole and piribedil hydrochloride are widely used at home and abroad. Logistic regression (odds ratio [OR], 95% CI) was performed on raw patient counts to evaluate factors associated with HIGH/VERY HIGH DA dosing. The results of this meta-analysis show that ropinirole has a significant effect in improving PD motor function and ability of daily living, but its risk of dizziness, nausea, vomiting, and lethargy is also significantly higher. Nanotechnology-based drug delivery of, [45]. Jalles A, Vieira C, Pereira-Sousa J, Vilasboas-Campos D, Mota AF, Vasconcelos S, Ferreira-Lomba B, Costa MD, Da Silva JD, Maciel P, Teixeira-Castro A. Biomedicines. To better understand DA dosing in RLS, we examined data from a longitudinal prescription database to determine how frequently DA prescriptions exceed the FDA-approved and guideline limits, and factors associated with high and very high dosing. Disclaimer. [40]. Barcia E, Boeva L, Garcia-Garcia L, et al. Am J Med 2019;132:8027. [5] At present, new long-acting non-ergot DA preparations such as ropinirole have been developed, and their effectiveness and safety have been extensively studied to guide the clinical drug use and treatment of PD. The daily LD dose was decreased from 734.1 +/- 254.8 mg to 502.8 +/- 228.4 mg. After 12 months 25 patients were still on high doses of ropinirole whereas 11 patients had, after either the emergence of side effects or a worsening . It works by mimicking dopamine in. At the same time, we manually searched related documents and references. For Parkinson's disease, it is taken once a day , with or without food. Ropinirole is a prescription medication used for the treatment of movement disorders. [34]. Korczyn AD, Brooks DJ, Brunt ER, Poewe WH, Rascol O, Stocchi F. [14]. [19]. If there was a prior prescription for the same DA and the run-out date (fill date + 1.5 days supply) overlapped with the index prescription, the patient was assigned to the continued treatment category. Parkinson disease (PD) is a common neurodegenerative disease in middle-aged and elderly people. Restless legs syndrome (RLS) affects approximately 2.5% of the general population (approximately twofold greater incidence in women than men) [13], and is characterized by dysesthesias and irresistible urge to move the legs. Federal government websites often end in .gov or .mil. Ropinirole versus bromocriptine for levodopa-induced complications in Parkinson's disease. The highest 10% of users of pramipexole constituted 45.0% of all prescribed supply. Female Follow-Up Studies Humans Indoles / administration & dosage* Indoles / adverse effects Levodopa / administration & dosage Male Middle Aged Motor Skills / drug effects Motor Skills / physiology Parkinson Disease / drug therapy* Parkinson Disease / physiopathology Cochrane Database Syst Rev. Dosage Print Save Ropinirole Dosage Medically reviewed by Drugs.com. Alternatives to DAs, calcium channel 2 ligands (gabapentin enacarbil, pregabalin, and gabapentin) are also often prescribed for RLS based on demonstrated efficacy in clinical trials, although only gabapentin enacarbil is currently approved by the FDA [31]. official website and that any information you provide is encrypted The prescribing patterns for DA therapy with or without concomitant non-DA therapy vs non-DA therapy alone varied by specialty. [3]. As presented in Table 2, the incidence of dizziness (OR = 1.85, 95%CI 1.502.28), nausea (OR = 2.17, 95%CI 1.812.59), vomiting (OR = 2.73, 95%CI 1.475.09), and lethargy (OR = 2.19, 95%CI 1.393.44) in the ropinirole group was significantly higher than that in the control group (all P < .05), and there were no significant differences in the incidence of headache (OR = 1.14, 95%CI 0.791.65) and insomnia (OR = 1.06, 95%CI 0.721.55) were found between 2 groups (all P > .05). The daily dose of ropinirole was increased from 18.4 +/- 3.5 mg to 34.7 +/- 5.5 mg, generally in four separate doses. Lastly, it is not known how many patients were taking levodopa/carbidopa because these data were not collected; however, it should be noted that a PD diagnosis was a criterion for exclusion from this study. LRx is a longitudinal prescription database subset of the National Prescription Audit database and captures approximately 150 million unique deidentified patients from >1 million prescribers. We used computers to search the Dutch medical literature database (Embase), the U.S. National Library of Medicine Medical Literature Retrieval System (Pubmed), the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Knowledge Service Platform for informal non-inferiority design studies on the effect and safety of ropinirole in the treatment of PD. How to cite this article: Zhu J, Chen M. The effect and safety of ropinirole in the treatment of Parkinson disease: a systematic review and meta-analysis. M C designed research; J Z, M C conducted research; J Z, M C analyzed data; M C wrote the first draft of manuscript; M C had primary responsibility for final content. 2005 Sep;11(6):393-8. doi: 10.1016/j.parkreldis.2005.03.005. Ropinirole has shown effective symptom relief in the treatment of patients with PD and is usually well tolerated. Pahwa R, Stacy MA, Factor SA, et al. Stocchi F, Torti M, Fossati C. Advances in dopamine receptor agonists for the, [43]. Adler CH, Sethi KD, Hauser RA, et al. Nervenarzt. [2]. In animal models, D2 receptors have a dual role. Fox SH, Katzenschlager R, Lim SY, et al. 2001;(1):CD001517. A thorough QT study conducted in male and female healthy volunteers who received doses of 0.5, 1, 2 and 4 mg of ropinirole film-coated (immediate release) tablets once daily showed a maximum increase of the QT interval duration at the 1 mg dose of 3.46 milliseconds (point estimate) as compared to placebo. We searched Dutch medical literature database, Pubmed, Cochrane Library, China National Knowledge Infrastructure, Wanfang Knowledge Service Platform up to December 15, 2020. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study, Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome, Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial, Requip (Ropinirole). Previous meta-analysis[33] has included 12 RCT studies prior to 2010 involving ropinirole, demonstrating a higher incidence of adverse event of ropinirole such as somnolence, dyskinesia in addition to dizziness, nausea, vomiting observed in this study, which may be associated to the fact that the adverse effects of ropinirole are reduced with the development of biopharmaceutical technology, this study mainly focused on the adverse effects of ropinirole, we have both focused on the therapeutic effects and safety of ropinirole in the treatment of PD. In rat studies using a low oral dose (5 mg/kg) during the prolactin-dependent phase of early pregnancy (gestation days 0 to 8), ropinirole did not affect female fertility at oral doses up to 100 mg/kg/day (40 times the MRHD on a mg/m 2 basis). As a non-ergot dopamine D2/D3 receptor agonist, ropinirole has been proven to be a monotherapy and adjuvant treatment of L-dopa to reduce the symptoms of PD. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. However, as higher DA doses are associated with greater risk and severity of augmentation, RLS symptoms often increase thereafter, leading to a cycle of progressively worsening augmentation and, ultimately, prescription of DAs at doses far higher than are approved for RLS. Interestingly, for all DA agents, ORs for HIGH/VERY HIGH prescribing were slightly higher in patients receiving DAs combined with non-DA therapy, suggesting that prescribers add on non-DA therapy when they have exhausted dose-level increases. Prescriptions for any RLS product (DAs: pramipexole, ropinirole, rotigotine; non-DAs: gabapentin enacarbil and off-label treatments [amantadine, cabergoline, carbamazepine, clonazepam, codeine sulfate, gabapentin, pregabalin, tramadol]) were tracked and reported along with fill date, product strength, days supply, and quantity dispensed. UPDRS score II & III were not used in all included studies. drug is taken with a high-fat meal. The Cochrane risk bias assessment tool was used to evaluate the quality of the included literature, and the RevMan5.3 software was used for meta-analysis. Epub 2020 Jul 15. Ropinirole has a high relative in vitro specificity and full intrinsic activity at the D 2 and D 3 dopamine receptor subtypes, binding with higher affinity to D 3 than to D 2 or D 4 receptor subtypes; relevance of D 3 receptor binding in Parkinson disease is unknown. Continuous variables use mean difference (MD), and binary variables use odd risk (OR) as the statistic used for efficacy analysis, with 95% confidence interval (CI) represented each effect size. Shepherd TA, Edelstyn NMJ, Longshaw L, Sim J, Watts K, Mayes AR, Murray M, Ellis SJ. your express consent. Please enable it to take advantage of the complete set of features! Dizziness is a common neurological adverse reaction in the ropinirole group in this study. Motor symptoms include bradykinesia, muscular rigidity, resting tremor, and postural and gait impairment. Restless legs syndrome: The typical starting dose is 0.25 mg by mouth once daily, one to three hours before bedtime. FOIA http://creativecommons.org/licenses/by/4.0. The search deadline was December 15, 2020. Although rotigotine was prescribed much less commonly, when prescribed, patients were also 6 times more likely to receive doses higher than the FDA-approved/guideline recommendations when compared with those prescribed ropinirole. Patients may end up with severe RLS symptoms much of the day, in both upper and lower extremities, unable to sleep for more than a few hours per day. The results of this safety analysis have showed that the incidence of adverse events in the ropinirole group was higher than that in the control group. modify the keyword list to augment your search. DA, dopamine agonist. Giladi N, Boroojerdi B, Korczyn AD, et al. Unauthorized use of these marks is strictly prohibited. DA dose level progression of patients between first and last treatment episode. Kang SY, Ryu HS, Sunwoo MK, et al. Disclaimer. doi: 10.1002/14651858.CD001517. Twice as many neurologists (31.1%) prescribed HIGH/VERY HIGH doses vs other specialties (OR [95% CI], 2.1 [1.2 to 2.0]). The inclusion criteria of this meta-analysis were as follows: All participants were not limited in gender, age, and nationality, and the diagnosis of PD met the relevant PD diagnostic criteria. [10]. We searched Dutch medical literature database, Pubmed, Cochrane Library, China National Knowledge Infrastructure, Wanfang Knowledge Service Platform up to December 15, 2020. Int J Med Chem. None of the 12 RCTs reported selective results and other sources of bias. Get new journal Tables of Contents sent right to your email inbox, November 19, 2021 - Volume 100 - Issue 46, http://creativecommons.org/licenses/by/4.0, The effect and safety of ropinirole in the treatment of Parkinson disease: A systematic review and meta-analysis, Articles in Google Scholar by Jiali Zhu, MD, Other articles in this journal by Jiali Zhu, MD, Efficacy and safety of combination therapy with pramipexole and levodopa vs levodopa monotherapy in patients with Parkinson disease: A systematic review and meta-analysis, Efficacy of therapies in the treatment of Guillain-Barre syndrome: A network meta-analysis, Privacy Policy (Updated December 15, 2022). What is this medication? Zesiewicz TA, Chriscoe S, Jimenez T, Upward J, Davy M, VanMeter S. A randomized, fixed-dose, dose-response study of, [25]. A subset of these data was previously presented at a virtual congress poster presentation at the annual SLEEP meeting of the Associated Professional Sleep Societies in August, 2020. The https:// ensures that you are connecting to the [35] In PD patients with exercise fluctuations, ropinirole, as an adjunct to L-DA, has been proven in early trials to improve the symptoms of PD. Some error has occurred while processing your request. The heterogeneity test indicated that the synthesized results of the various studies have no heterogeneity (P = .58, I2 = 0%). [13]. A total of 12 RCTs with 3341 patients were included. The .gov means its official. Meta-analysis results showed that the changes of UPDRS III score in the ropinirole group was significantly lower than that in the control group (MD = 4.93, 95%CI 5.25 to 4.61) (see Fig. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. For any DA therapy, with or without concomitant non-DA therapy, 19.0% of patients (75,058/394,482) were prescribed HIGH/VERY HIGH DA doses and 10.5% (41,311/394,482) were prescribed VERY HIGH DA doses (Table 3). Specialties that prescribed DAs over non-DA therapy were also the specialties that prescribed a higher percentage of HIGH/VERY dose DA therapy proportionally, namely primary care, NP/PAs, neurology, and sleep medicine. We used RevMan5.3 statistical software for meta-analysis. Madrid J, Benninger DH. You may be trying to access this site from a secured browser on the server. It is necessary to conduct a meta-analysis of the clinical randomized controlled trials (RCTs) on ropinirole in the treatment of Parkinson disease (PD), to explore the effects and safety of ropinirole, and to provide a theoretical basis for clinically safe and rational drug use. Clin Neuropharmacol. Medicine100(46):e27653, November 19, 2021. The flow chart of study selections was presented in Figure 1. All included studies were RCTs. Curr Opin Neurol 2012;25:43347. Zagmutt FJ, Tarrants ML. For oral dosage form (tablets): For Parkinson's disease: AdultsAt first, 0.25 milligram (mg) 3 times a day. Please enable scripts and reload this page. [41]. Patients with a history of brain stereotactic surgery in the patient's medical history, or patients with serious underlying diseases and mental disorders. Consent for publication is not applicable. [26] At present, compound levodopa, dopamine receptor agonists, monoamine oxidase B inhibitors, catecholamine-O-methyltransferase inhibitors, etc are common drugs for the treatment of PD. MeSH There was a significant reduction in the Dyskinesia Rating Scale scores during both ON and OFF periods, indicating a reduction in dyskinesias during ON periods and a reduction in dystonias during OFF periods (p < 0.001). Do not drive or operate machinery until you know how ropinirole affects you. 2001 Nov-Dec;24(6):346-51. doi: 10.1097/00002826-200111000-00006. Switching from bromocriptine to ropinirole in patients with advanced Parkinson's disease: open label pilot responses to three different dose-ratios. In the past, dopamine receptor agonists were mostly partial agonists of the receptor. Full Prescribing Information, Increased Risk for new-onset psychiatric adverse events in patients with newly diagnosed primary restless legs syndrome who initiate treatment with dopamine agonists: a large-scale retrospective claims matched-cohort analysis, Dopaminergic augmentation in restless legs syndrome/Willis-Ekbom disease: identification and management, Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS), Restless legs syndrome (RLS) augmentation associated with dopamine agonist and levodopa usage in a community sample, Comparison of pregabalin with pramipexole for restless legs syndrome, Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: a combined task force of the IRLSSG, EURLSSG, and the RLS-foundation, Exploration of claims-based utilization measures for detecting potential nonmedical use of prescription drugs, Management of treatment failure in restless legs syndrome (Willis-Ekbom disease), Prolonged release oxycodone-naloxone for treatment of severe restless legs syndrome after failure of previous treatment: a double-blind, randomised, placebo-controlled trial with an open-label extension, International Restless Legs Syndrome Study Group (IRLSSG), Evidence-based and consensus clinical practice guidelines for the iron treatment of restless legs syndrome/Willis-Ekbom disease in adults and children: an IRLSSG task force report, Augmentation of restless leg syndrome (Willis-Ekbom disease) during long-term dopaminergic treatment, Gabapentin and pregabalin use and association with adverse outcomes among hemodialysis Patients, Prevalence of gabapentin abuse: comparison with agents with known abuse potential in a commercially insured US Population, Baseline and 1-year longitudinal data from the National Restless Legs Syndrome Opioid Registry, Medical Advisory Board of the Willis-Ekbom Disease Foundation, Willis-Ekbom Disease Foundation revised consensus statement on the management of restless legs syndrome. Barone P, Lamb J, Ellis A, Clarke Z. Sumanirole versus placebo or, [16]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The percentage of patients who were prescribed VERY HIGH DA doses by neurologists (19%, 6355/33,370) was almost double that of all other specialties (Figure 2B). Ropinirole and its . Financial Disclosures: John W. Winkelman has received research funding from American Regent, Inc.; Merck & Co., Inc.; and the RLS Foundation. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with, [12]. The heterogeneity test indicated that the synthesized results of the various studies have moderate heterogeneity (P = .06, I2 = 64%). Low bias means that there is no risk of bias, which is indicated by a green area on the Cochrane evaluation scale; unclear means that the evaluator cannot judge whether there is a bias, and it is indicated by a yellow area on the Cochrane evaluation scale; highly biased indicates that there is a risk of bias, which is indicated by a red area on the Cochrane evaluation scale. Parkinson's disease. Symptoms develop during inactivity, particularly at night, and interfere with sleep [1, 4]. At present, there is no reports on the mechanism of dizziness after ropinirole treatment. However, although such doses are approved for Parkinsons disease, they were never tested in patients with RLS. The Cochrane risk bias assessment tool was used to evaluate the quality of the included literature, and the RevMan5.3 . With reference to the inclusion and exclusion criteria, 96 articles were excluded by reading the title and abstract. Two authors independently conducted literature search and screening. However, it should be noted that this database captured information for patients who were at varying stages of their disease course. Of all patients prescribed DA therapy for RLS, 70.7% (279,071/394,482) were prescribed DA therapy without concomitant non-DA therapy. The mean daily ropinirole dose at endpoint was 26.2 mg (SD, 4.43 mg, range 20-36 mg). 4A). We extracted the number of cases, gender ratio, average age, Hoehn-Yahr scale, treatment dose, and course of treatment in each RCT. Int J Geriatr Psychiatry 2021;36:1530. Kim DY, Park JS, Leem YH, Park JE, Kim HS. Federal government websites often end in .gov or .mil. CNS Drug Rev. 2010 Nov;24(11):941-68. doi: 10.2165/11537810-000000000-00000. Hattori N, Mochizuki H, Hasegawa K, et al. Corresponding author. It may also decrease the number of episodes of not being able to move ("on-off. [Medication treatment for Parkinson's disease]. Patients in the United States treated with marketed products for RLS between October 2017 and September 2018 were identified from LRx. Careers. Dopamine receptor agonists for the treatment of early or advanced Parkinson's disease. It combines the subjective and objective perspectives of patients for a more detailed assessment from various aspects such as different motor symptoms, non-motor symptoms, and motor complications. Dose escalation was often rapid, with 12.3% of all patients receiving DAs for RLS progressing from LOW/MID dosing to HIGH, 8.3% from LOW/MID to VERY HIGH, and 5.4% from HIGH to VERY HIGH during the 12-month reporting period (Figure 3). [21]. Dopamine receptors and Parkinson's disease. You may search for similar articles that contain these same keywords or you may Sy, et al October 2017 and September 2018 were identified from LRx switching from bromocriptine ropinirole... 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