Skip to main content

Advertisement

Log in

A meta-analysis evaluating effects of the rotigotine in Parkinson’s disease, focusing on sleep disturbances and activities of daily living

  • Review Article
  • Published:
Neurological Sciences Aims and scope Submit manuscript

Abstract

Background

Rotigotine transdermal patch (TP) is a useful dopaminergic medication for Parkinson’s disease (PD). This meta-analysis attempted to evaluate the effects of rotigotine TP on motor performance, activities of daily living (ADL) limitations, and sleep disturbances in patients with PD.

Methods

Only randomized controlled clinical trials (RCTs) with placebo design were included in this study. The clinical outcomes, evaluated using the Unified Parkinson’s Disease Rating Scale (UPDRS III), UPDRS-II, UPDRS Part II + III, Parkinson’s Disease Sleep Scale (PDSS)-2, and adverse events (AEs) were evaluated. The Jadad scale was used to evaluate study quality.

Results

A total of 16 RCTs with 4682 patients with PD were enrolled in this study. We found that rotigotine TP significantly reduced the UPDRS-III, UPDRS-II, and UPDRS Part II + III scores, indicating that rotigotine TP led to a significant amelioration of movement symptoms and ADL limitations. Moreover, we found that rotigotine TP significantly reduced PDSS-2 scores, suggesting that rotigotine TP led to a remarkable improvement in sleep quality. Meanwhile, compared with the placebo group, patients taking rotigotine TP did not have added incidence of AEs.

Conclusion

This study verified the efficacy and safety of rotigotine TP in treating PD. The findings of the present study provide compelling evidence concerning and insight into clinical usage of rotigotine TP. Future studies will focus on more non-motor symptoms affected by rotigotine TP.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Asakawa T, Sugiyama K, Nozaki T, Sameshima T, Kobayashi S, Wang L, Hong Z, Chen S, Li C, Namba H (2019) Can the latest computerized technologies revolutionize conventional assessment tools and therapies for a neurological disease? The example of Parkinson’s disease. Neurol Med Chir (Tokyo) 59(3):69–78. https://doi.org/10.2176/nmc.ra.2018-0045

    Article  Google Scholar 

  2. Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P, Investigators B-S (2017) Opicapone as adjunct to levodopa therapy in patients with Parkinson disease and motor fluctuations: a randomized clinical trial. JAMA Neurol 74(2):197–206. https://doi.org/10.1001/jamaneurol.2016.4703

    Article  PubMed  Google Scholar 

  3. Goudreau JL, Pérez A, Aminoff MJ, Boyd JT, Burau KD, Christine CW, Leehey M, Morgan JC, Investigators N-P (2016) Choice of dopaminergic therapy among early, mild Parkinson disease subjects in North America. J Neurol Sci 366:74–81

    Article  Google Scholar 

  4. LeWitt PA, Hauser RA, Grosset DG, Stocchi F, Saint-Hilaire MH, Ellenbogen A, Leinonen M, Hampson NB, DeFeo-Fraulini T, Freed MI, Kieburtz KD (2016) A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson’s disease. Mov Disord. https://doi.org/10.1002/mds.26611

    Article  PubMed  PubMed Central  Google Scholar 

  5. Caraco Y, Oren S, Yacoby-Zeevi O (2013) ND0612, a novel formulation of levodopa/carbidopa for continuous, subcutaneous administration, achieves steady-state levodopa plasma concentration in Parkinson’s disease patients. Mov Disord 79:56

    Google Scholar 

  6. Giladi N, Caraco Y, Gurevitch T, Djaldetti R, Cohen Y, Yacobi-Zeevi O, Oren S (2015) Pharmacokinetics and safety of ND0612L (levodopa/carbidopa for subcutaneous infusion): results from a phase II study in moderate to severe Parkinson’s disease. Age (years) 63(7.4):64–65

  7. Chang FC, Kwan V, van der Poorten D, Mahant N, Wolfe N, Ha AD, Griffith JM, Tsui D, Kim SD, Fung VS (2016) Intraduodenal levodopa-carbidopa intestinal gel infusion improves both motor performance and quality of life in advanced Parkinson’s disease. J Clin Neurosci 25:41–45

    Article  CAS  Google Scholar 

  8. Pellicano C, Benincasa D, Fanciulli A, Latino P, Giovannelli M, Pontieri FE (2013) The impact of extended release dopamine agonists on prescribing patterns for therapy of early Parkinson’s disease: an observational study. Eur J Med Res 18(1):1

    Article  Google Scholar 

  9. Md S, Karim S, Saker SR, Gie OA, Hooi LC, Yee PH, Kang AWC, Zhe CK, Ian N, Aldawsari HM, Hosny KM, Alhakamy NA (2020) Current status and challenges in rotigotine delivery. Curr Pharm Des 26(19):2222–2232. https://doi.org/10.2174/1381612826666200316154300

    Article  PubMed  Google Scholar 

  10. Nomoto M, Iwaki H, Kondo H, Sakurai M (2018) Efficacy and safety of rotigotine in elderly patients with Parkinson’s disease in comparison with the non-elderly: a post hoc analysis of randomized, double-blind, placebo-controlled trials. J Neurol 265(2):253–265. https://doi.org/10.1007/s00415-017-8671-0

    Article  CAS  PubMed  Google Scholar 

  11. Frampton JE (2019) Rotigotine transdermal patch: a review in Parkinson’s disease. CNS Drugs 33(7):707–718. https://doi.org/10.1007/s40263-019-00646-y

    Article  CAS  PubMed  Google Scholar 

  12. Baldwin CM, Keating GM (2007) Rotigotine transdermal patch: a review of its use in the management of Parkinson’s disease. CNS Drugs 21(12):1039–1055. https://doi.org/10.2165/00023210-200721120-00007

    Article  CAS  PubMed  Google Scholar 

  13. Sanford M, Scott LJ (2011) Rotigotine transdermal patch: a review of its use in the treatment of Parkinson’s disease. CNS Drugs 25(8):699–719. https://doi.org/10.2165/11206750-000000000-00000

    Article  CAS  PubMed  Google Scholar 

  14. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 339:b2700. https://doi.org/10.1136/bmj.b2700

    Article  PubMed  PubMed Central  Google Scholar 

  15. Zhou CQ, Li SS, Chen ZM, Li FQ, Lei P, Peng GG (2013) Rotigotine transdermal patch in Parkinson’s disease: a systematic review and meta-analysis. PLoS ONE 8(7):e69738. https://doi.org/10.1371/journal.pone.0069738

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Chen F, Jin L, Nie Z (2017) Safety and efficacy of rotigotine for treating Parkinson’s disease: a meta-analysis of randomised controlled trials. J Pharm Pharm Sci 20 (0):285–294. https://doi.org/10.18433/J3Q35D

  17. Asakawa T, Fang H, Sugiyama K, Nozaki T, Kobayashi S, Hong Z, Suzuki K, Mori N, Yang Y, Hua F, Ding G, Wen G, Namba H, Xia Y (2016) Human behavioral assessments in current research of Parkinson’s disease. Neurosci Biobehav Rev 68:741–772. https://doi.org/10.1016/j.neubiorev.2016.06.036

    Article  PubMed  Google Scholar 

  18. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17(1):1–12. https://doi.org/10.1016/0197-2456(95)00134-4

    Article  CAS  PubMed  Google Scholar 

  19. Jiang F, Yang T, Yin H, Guo Y, Namba H, Sun Z, Asakawa T (2018) Evidence for the use of acupuncture in treating Parkinson’s disease: update of information from the past 5 years, a mini review of the literature. Front Neurol 9:596. https://doi.org/10.3389/fneur.2018.00596

    Article  PubMed  PubMed Central  Google Scholar 

  20. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA (2011) The Cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ (Clin Res Ed) 343:d5928. https://doi.org/10.1136/bmj.d5928

    Article  Google Scholar 

  21. Bhidayasiri R, Sringean J, Chaiwong S, Anan C, Penkeaw N, Leaknok A, Boonpang K, Saksornchai K, Rattanachaisit W, Thanawattano C, Jagota P (2017) Rotigotine for nocturnal hypokinesia in Parkinson’s disease: quantitative analysis of efficacy from a randomized, placebo-controlled trial using an axial inertial sensor. Parkinsonism Relat Disord 44:124–128. https://doi.org/10.1016/j.parkreldis.2017.08.010

    Article  PubMed  Google Scholar 

  22. Pierantozzi M, Placidi F, Liguori C, Albanese M, Imbriani P, Marciani MG, Mercuri NB, Stanzione P, Stefani A (2016) Rotigotine may improve sleep architecture in Parkinson’s disease: a double-blind, randomized, placebo-controlled polysomnographic study. Sleep Med 21:140–144. https://doi.org/10.1016/j.sleep.2016.01.016

    Article  PubMed  Google Scholar 

  23. Poewe WH, Rascol O, Quinn N, Tolosa E, Oertel WH, Martignoni E, Rupp M, Boroojerdi B, Investigators SP (2007) Efficacy of pramipexole and transdermal rotigotine in advanced Parkinson’s disease: a double-blind, double-dummy, randomised controlled trial. Lancet Neurol 6(6):513–520. https://doi.org/10.1016/S1474-4422(07)70108-4

    Article  CAS  PubMed  Google Scholar 

  24. Giladi N, Boroojerdi B, Korczyn AD, Burn DJ, Clarke CE, Schapira AH, investigators SP, (2007) Rotigotine transdermal patch in early Parkinson’s disease: a randomized, double-blind, controlled study versus placebo and ropinirole. Mov Disord 22(16):2398–2404. https://doi.org/10.1002/mds.21741

    Article  PubMed  Google Scholar 

  25. Mizuno Y, Nomoto M, Hasegawa K, Hattori N, Kondo T, Murata M, Takeuchi M, Takahashi M, Tomida T, Rotigotine Trial G (2014) Rotigotine vs ropinirole in advanced stage Parkinson’s disease: a double-blind study. Parkinsonism Relat Disord 20(12):1388–1393. https://doi.org/10.1016/j.parkreldis.2014.10.005

    Article  PubMed  Google Scholar 

  26. Hauser RA, Slawek J, Barone P, Dohin E, Surmann E, Asgharnejad M, Bauer L (2016) Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson’s disease. BMC Neurol 16:90. https://doi.org/10.1186/s12883-016-0610-7

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Nicholas AP, Borgohain R, Chana P, Surmann E, Thompson EL, Bauer L, Whitesides J, Elmer LW, Investigators SPS (2014) A randomized study of rotigotine dose response on “off” time in advanced Parkinson’s disease. J Parkinsons Dis 4(3):361–373. https://doi.org/10.3233/JPD-130320

    Article  CAS  PubMed  Google Scholar 

  28. LeWitt PA, Lyons KE, Pahwa R, Group SPS (2007) Advanced Parkinson disease treated with rotigotine transdermal system: PREFER study. Neurology 68(16):1262–1267. https://doi.org/10.1212/01.wnl.0000259516.61938.bb

    Article  CAS  Google Scholar 

  29. Parkinson Study G (2003) A controlled trial of rotigotine monotherapy in early Parkinson’s disease. Arch Neurol 60(12):1721–1728. https://doi.org/10.1001/archneur.60.12.1721

    Article  Google Scholar 

  30. Chung SJ, Asgharnejad M, Bauer L, Ramirez F, Jeon B (2016) Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson’s disease. Expert Opin Pharmacother 17(11):1453–1461. https://doi.org/10.1080/14656566.2016.1202917

    Article  CAS  PubMed  Google Scholar 

  31. Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR (2015) Effects of rotigotine transdermal patch in patients with Parkinson’s disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol 22(10):1400–1407. https://doi.org/10.1111/ene.12757

    Article  CAS  PubMed  Google Scholar 

  32. Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Honczarenko K, Dioszeghy P, Hill D, Anderson T, Myllyla V, Kassubek J, Steiger M, Zucconi M, Tolosa E, Poewe W, Surmann E, Whitesides J, Boroojerdi B, Chaudhuri KR, Recover Study G (2011) Rotigotine effects on early morning motor function and sleep in Parkinson’s disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord 26(1):90–99. https://doi.org/10.1002/mds.23441

    Article  Google Scholar 

  33. Jankovic J, Watts RL, Martin W, Boroojerdi B (2007) Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease. Arch Neurol 64(5):676–682. https://doi.org/10.1001/archneur.64.5.676

    Article  PubMed  Google Scholar 

  34. Mizuno Y, Nomoto M, Kondo T, Hasegawa K, Murata M, Takeuchi M, Ikeda J, Tomida T, Hattori N, Rotigotine Trial G (2013) Transdermal rotigotine in early stage Parkinson’s disease: a randomized, double-blind, placebo-controlled trial. Mov Disord 28(10):1447–1450. https://doi.org/10.1002/mds.25537

    Article  CAS  PubMed  Google Scholar 

  35. Zhang ZX, Shang HF, Hu X, Chen S, Zhao Z, Du X, Surmann E, Bauer L, Asgharnejad M (2016) Rotigotine transdermal patch in Chinese patients with early Parkinson’s disease: a randomized, double-blind, placebo-controlled pivotal study. Parkinsonism Relat Disord 28:49–55. https://doi.org/10.1016/j.parkreldis.2016.04.022

    Article  PubMed  Google Scholar 

  36. Nomoto M, Mizuno Y, Kondo T, Hasegawa K, Murata M, Takeuchi M, Ikeda J, Tomida T, Hattori N (2014) Transdermal rotigotine in advanced Parkinson’s disease: a randomized, double-blind, placebo-controlled trial. J Neurol 261(10):1887–1893. https://doi.org/10.1007/s00415-014-7427-3

    Article  CAS  PubMed  Google Scholar 

  37. Rascol O, Zesiewicz T, Chaudhuri KR, Asgharnejad M, Surmann E, Dohin E, Nilius S, Bauer L (2016) A randomized controlled exploratory pilot study to evaluate the effect of rotigotine transdermal patch on Parkinson’s disease-associated chronic pain. J Clin Pharmacol 56(7):852–861. https://doi.org/10.1002/jcph.678

    Article  CAS  PubMed  Google Scholar 

  38. Pfeiffer RF (2005) A promising new technology for Parkinson’s disease. Neurology 65(2 Suppl 1):S6-10. https://doi.org/10.1212/wnl.65.2_suppl_1.s6

    Article  PubMed  Google Scholar 

  39. Elshoff JP, Cawello W, Andreas JO, Mathy FX, Braun M (2015) An update on pharmacological, pharmacokinetic properties and drug-drug interactions of rotigotine transdermal system in Parkinson’s disease and restless legs syndrome. Drugs 75(5):487–501. https://doi.org/10.1007/s40265-015-0377-y

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  40. Weintraub D, Koester J, Potenza MN, Siderowf AD, Stacy M, Voon V, Whetteckey J, Wunderlich GR, Lang AE (2010) Impulse control disorders in Parkinson disease: a cross-sectional study of 3090 patients. Arch Neurol 67(5):589–595. https://doi.org/10.1001/archneurol.2010.65

    Article  PubMed  Google Scholar 

  41. Ondo WG, Lai D (2008) Predictors of impulsivity and reward seeking behavior with dopamine agonists. Parkinsonism Relat Disord 14(1):28–32. https://doi.org/10.1016/j.parkreldis.2007.05.006

    Article  PubMed  Google Scholar 

  42. Antonini A, Chaudhuri KR, Boroojerdi B, Asgharnejad M, Bauer L, Grieger F, Weintraub D (2016) Impulse control disorder related behaviours during long-term rotigotine treatment: a post hoc analysis. Eur J Neurol 23(10):1556–1565. https://doi.org/10.1111/ene.13078

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  43. Moore TJ, Glenmullen J, Mattison DR (2014) Reports of pathological gambling, hypersexuality, and compulsive shopping associated with dopamine receptor agonist drugs. JAMA Intern Med 174(12):1930–1933. https://doi.org/10.1001/jamainternmed.2014.5262

    Article  PubMed  Google Scholar 

  44. Wingo TS, Evatt M, Scott B, Freeman A, Stacy M (2009) Impulse control disorders arising in 3 patients treated with rotigotine. Clin Neuropharmacol 32(2):59–62. https://doi.org/10.1097/WNF.0B013E3181684542

    Article  CAS  PubMed  Google Scholar 

  45. Schreglmann SR, Gantenbein AR, Eisele G, Baumann CR (2012) Transdermal rotigotine causes impulse control disorders in patients with restless legs syndrome. Parkinsonism Relat Disord 18(2):207–209. https://doi.org/10.1016/j.parkreldis.2011.10.010

    Article  CAS  PubMed  Google Scholar 

  46. Garcia-Ruiz PJ, Martinez Castrillo JC, Alonso-Canovas A, HerranzBarcenas A, Vela L, Sanchez Alonso P, Mata M, Olmedilla Gonzalez N, Mahillo Fernandez I (2014) Impulse control disorder in patients with Parkinson’s disease under dopamine agonist therapy: a multicentre study. J Neurol Neurosurg Psychiatry 85(8):840–844. https://doi.org/10.1136/jnnp-2013-306787

    Article  PubMed  Google Scholar 

  47. Rizos A, Sauerbier A, Antonini A, Weintraub D, Martinez-Martin P, Kessel B, Henriksen T, Falup-Pecurariu C, Silverdale M, Durner G, RokenesKarlsen K, Grilo M, Odin P, Chaudhuri KR, Europar, the IN-M-PDSG, (2016) A European multicentre survey of impulse control behaviours in Parkinson’s disease patients treated with short- and long-acting dopamine agonists. Eur J Neurol 23(8):1255–1261. https://doi.org/10.1111/ene.13034

    Article  CAS  PubMed  Google Scholar 

  48. Asakawa T, Fang H, Sugiyama K, Nozaki T, Hong Z, Yang Y, Hua F, Ding G, Chao D, Fenoy AJ, Villarreal SJ, Onoe H, Suzuki K, Mori N, Namba H, Xia Y (2016) Animal behavioral assessments in current research of Parkinson’s disease. Neurosci Biobehav Rev 65:63–94. https://doi.org/10.1016/j.neubiorev.2016.03.016

    Article  PubMed  Google Scholar 

Download references

Funding

This work was supported in part by the National Foundation of Natural Science of China (Nos. 82074539 and 81704170), Natural Science of Heilongjiang Province (No. LH2020H092), Research Fund Project for Chinese Medicine of Heilongjiang Province (No. ZHY2020-79), and Research Fund for Construction of Evidence Based Medicine for Chinese Medicine (No. 2019XZZX-ZJ005). This work was also supported by grants from the Japan Society for the Promotion of Science (Nos. 20791025, 24592157, 15k10358, and 18K08991).‬‬‬‬‬‬‬‬‬‬‬‬‬

Author information

Authors and Affiliations

Authors

Corresponding authors

Correspondence to Tiansong Yang or Tetsuya Asakawa.

Ethics declarations

Ethics approval

None.

Informed consent

Not applicable.

Conflict of interest

The authors declare no competing interests.

Additional information

Publisher's note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Sun, W., Wang, Q., Yang, T. et al. A meta-analysis evaluating effects of the rotigotine in Parkinson’s disease, focusing on sleep disturbances and activities of daily living. Neurol Sci 43, 5821–5837 (2022). https://doi.org/10.1007/s10072-022-06159-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10072-022-06159-9

Keywords

Navigation