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Published in: Journal of Neurology 2/2018

Open Access 01-02-2018 | Original Communication

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

Authors: Masahiro Nomoto, Hirotaka Iwaki, Hiroyuki Kondo, Masaya Sakurai

Published in: Journal of Neurology | Issue 2/2018

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Abstract

Rotigotine—a non-ergot dopamine agonist—has two advantages; it can stimulate all dopamine receptors (D1–D5) like innate dopamine, and its transdermal administration provides continuous dopaminergic stimulation. The age of the patient impacts the effect and adverse events of anti-parkinsonian treatment. We conducted a post hoc analysis on three randomized, double-blind, placebo-controlled trials performed in Japan to clarify the difference of anti-parkinsonian treatment in elderly and non-elderly patients. Data from two combination therapy trials (with levodopa) in advanced stage Parkinson’s disease patients and one monotherapy trial in early stage patients were pooled and grouped by age (non-elderly aged < 70, elderly aged 70 +). In each age group, efficacy of rotigotine was compared to placebo. In the combination therapy, total Unified Parkinson’s Disease Rating Scale Part III scores and some subtotal scores, including those for tremor, akinesia and gait disturbance, significantly improved in both elderly and non-elderly patients. Regarding safety, the incidence of total adverse event tended to be lower in elderly patients than non-elderly patients, although it was not significant. No difference was observed in maintenance dosage of rotigotine between the two groups. In conclusion, the improvement in motor symptoms and frequency of adverse events were shown to be similar in elderly and non-elderly patients with rotigotine–levodopa combination therapy. Further, there was no major difference in maintenance dosage of rotigotine between the age groups. These results suggest good tolerability of rotigotine among elderly patients.
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Literature
2.
go back to reference Takahashi R, Ito H, Kashihara K, Kikuchi S, Kondo T, Sawada H, Takeda A, Nomoto M, Hashimoto T, Hasegawa K, Hattori N, Hayashi A, Murata M, Muramatsu S (2011) Clinical practice guideline for Parkinson’s disease 2011. Japanese Society of Neurology, Igaku-Shoin Takahashi R, Ito H, Kashihara K, Kikuchi S, Kondo T, Sawada H, Takeda A, Nomoto M, Hashimoto T, Hasegawa K, Hattori N, Hayashi A, Murata M, Muramatsu S (2011) Clinical practice guideline for Parkinson’s disease 2011. Japanese Society of Neurology, Igaku-Shoin
3.
go back to reference Kuzuhara S (2001) Drug-induced psychotic symptoms in Parkinson’s disease. Problems, management and dilemma. J Neurol 248:III28–III31CrossRefPubMed Kuzuhara S (2001) Drug-induced psychotic symptoms in Parkinson’s disease. Problems, management and dilemma. J Neurol 248:III28–III31CrossRefPubMed
4.
go back to reference Ismail MS, Richard IH (2004) A reality test: how well do we understand psychosis in Parkinson’s disease? J Neuropsychiatry Clin Neurosci 16:8–18CrossRefPubMed Ismail MS, Richard IH (2004) A reality test: how well do we understand psychosis in Parkinson’s disease? J Neuropsychiatry Clin Neurosci 16:8–18CrossRefPubMed
5.
go back to reference Engber TM, Susel Z, Juncos JL, Chase TN (1989) Continuous and intermittent levodopa differentially affect rotation induced by D-1 and D-2 dopamine agonists. Eur J Pharmacol 168:291–298CrossRefPubMed Engber TM, Susel Z, Juncos JL, Chase TN (1989) Continuous and intermittent levodopa differentially affect rotation induced by D-1 and D-2 dopamine agonists. Eur J Pharmacol 168:291–298CrossRefPubMed
6.
go back to reference Nutt JG, Obeso JA, Stocchi F (2000) Continuous dopamine-receptor stimulation in advanced Parkinson’s disease. Trends Neurosci 23:S109–S115CrossRefPubMed Nutt JG, Obeso JA, Stocchi F (2000) Continuous dopamine-receptor stimulation in advanced Parkinson’s disease. Trends Neurosci 23:S109–S115CrossRefPubMed
7.
go back to reference Olanow CW, Obeso JA, Stocchi F (2006) Continuous dopamine-receptor treatment of Parkinson’s disease: scientific rationale and clinical implications. Lancet Neurol 5:677–687CrossRefPubMed Olanow CW, Obeso JA, Stocchi F (2006) Continuous dopamine-receptor treatment of Parkinson’s disease: scientific rationale and clinical implications. Lancet Neurol 5:677–687CrossRefPubMed
8.
go back to reference Boroojerdi B, Wolff HM, Braun M, Scheller DK (2010) Rotigotine transdermal patch for the treatment of Parkinson’s disease and restless legs syndrome. Drugs Today (Barc) 46:483–505CrossRef Boroojerdi B, Wolff HM, Braun M, Scheller DK (2010) Rotigotine transdermal patch for the treatment of Parkinson’s disease and restless legs syndrome. Drugs Today (Barc) 46:483–505CrossRef
9.
go back to reference Jenner P (2013) Wearing off, dyskinesia, and the use of continuous drug delivery in Parkinson’s disease. Neurol Clin 31:S17–S35CrossRefPubMed Jenner P (2013) Wearing off, dyskinesia, and the use of continuous drug delivery in Parkinson’s disease. Neurol Clin 31:S17–S35CrossRefPubMed
10.
go back to reference Wood M, Dubois V, Scheller D, Gillard M (2015) Rotigotine is a potent agonist at dopamine D1 receptors as well as at dopamine D2 and D3 receptors. Br J Pharmacol 172:1124–1135CrossRefPubMedPubMedCentral Wood M, Dubois V, Scheller D, Gillard M (2015) Rotigotine is a potent agonist at dopamine D1 receptors as well as at dopamine D2 and D3 receptors. Br J Pharmacol 172:1124–1135CrossRefPubMedPubMedCentral
11.
go back to reference Fasano A, Guidubaldi A, De Nigris F, Bentivoglio AR (2011) Safety and efficacy of rotigotine in individuals with Parkinson’s disease aged 75 and older. J Am Geriatr Soc 59:2386–2387CrossRefPubMed Fasano A, Guidubaldi A, De Nigris F, Bentivoglio AR (2011) Safety and efficacy of rotigotine in individuals with Parkinson’s disease aged 75 and older. J Am Geriatr Soc 59:2386–2387CrossRefPubMed
12.
go back to reference Lauretani F, Ceda GP, Scaglioni A, Nardelli A (2013) Comparison of continuous versus pulsatile dopaminergic therapy in the elderly with Parkinson’s disease. Sci Res 2:43–46 Lauretani F, Ceda GP, Scaglioni A, Nardelli A (2013) Comparison of continuous versus pulsatile dopaminergic therapy in the elderly with Parkinson’s disease. Sci Res 2:43–46
13.
go back to reference Oertel W, LeWitt P, Giladi N, Ghys L, Grieger F, Boroojerdi B (2013) Treatment of patients with early and advanced Parkinson’s disease with rotigotine transdermal system: age-relationship to safety and tolerability. Parkinsonism Relat Disord 19:37–42CrossRefPubMed Oertel W, LeWitt P, Giladi N, Ghys L, Grieger F, Boroojerdi B (2013) Treatment of patients with early and advanced Parkinson’s disease with rotigotine transdermal system: age-relationship to safety and tolerability. Parkinsonism Relat Disord 19:37–42CrossRefPubMed
14.
go back to reference Olanow CW, Watts RL, Koller WC (2001) An algorithm (decision tree) for the management of Parkinson’s disease (2001): treatment guidelines. Neurology 56:S1–S88CrossRefPubMed Olanow CW, Watts RL, Koller WC (2001) An algorithm (decision tree) for the management of Parkinson’s disease (2001): treatment guidelines. Neurology 56:S1–S88CrossRefPubMed
15.
go back to reference Grimes D, Gordon J, Snelgrove B, Lim-Carter I, Fon E, Martin W, Wieler M, Suchowersky O, Rajput A, Lafontaine AL, Stoessl J, Moro E, Schoffer K, Miyasaki J, Hobson D, Mahmoudi M, Fox S, Postuma R, Kumar H, Jog M (2012) Canadian guidelines on Parkinson’s disease introduction. Can J Neurol Sci 39:S1–S30CrossRefPubMed Grimes D, Gordon J, Snelgrove B, Lim-Carter I, Fon E, Martin W, Wieler M, Suchowersky O, Rajput A, Lafontaine AL, Stoessl J, Moro E, Schoffer K, Miyasaki J, Hobson D, Mahmoudi M, Fox S, Postuma R, Kumar H, Jog M (2012) Canadian guidelines on Parkinson’s disease introduction. Can J Neurol Sci 39:S1–S30CrossRefPubMed
16.
go back to reference 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 261:1887–1893CrossRefPubMed 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 261:1887–1893CrossRefPubMed
17.
go back to reference Mizuno Y, Nomoto M, Hasegawa K, Hattori N, Kondo T, Murata M, Takeuchi M, Takahashi M, Tomida T, Rotigotine Trial Group (2014) Rotigotine vs ropinirole in advanced stage Parkinson’s disease: a double-blind study. Parkinsonism Relat Disord 20:1388–1393CrossRefPubMed Mizuno Y, Nomoto M, Hasegawa K, Hattori N, Kondo T, Murata M, Takeuchi M, Takahashi M, Tomida T, Rotigotine Trial Group (2014) Rotigotine vs ropinirole in advanced stage Parkinson’s disease: a double-blind study. Parkinsonism Relat Disord 20:1388–1393CrossRefPubMed
18.
go back to reference Mizuno Y, Nomoto M, Kondo T, Hasegawa K, Murata M, Takeuchi M, Ikeda J, Tomida T, Hattori N, Rotigotine Trial Group (2013) Transdermal rotigotine in early stage Parkinson’s disease: a randomized, double-blind, placebo-controlled trial. Mov Disord 28:1447–1450CrossRefPubMed Mizuno Y, Nomoto M, Kondo T, Hasegawa K, Murata M, Takeuchi M, Ikeda J, Tomida T, Hattori N, Rotigotine Trial Group (2013) Transdermal rotigotine in early stage Parkinson’s disease: a randomized, double-blind, placebo-controlled trial. Mov Disord 28:1447–1450CrossRefPubMed
19.
go back to reference Takahashi K (2005) Gait disorder and postural instability. Mod Phys 25:975–979 (in Japanese) Takahashi K (2005) Gait disorder and postural instability. Mod Phys 25:975–979 (in Japanese)
20.
21.
go back to reference Kim SD, Allen NE, Canning CG, Fung VS (2013) Postural instability in patients with Parkinson’s disease. Epidemiology, pathophysiology and management. CNS Drugs 27:97–112CrossRefPubMed Kim SD, Allen NE, Canning CG, Fung VS (2013) Postural instability in patients with Parkinson’s disease. Epidemiology, pathophysiology and management. CNS Drugs 27:97–112CrossRefPubMed
22.
go back to reference Zeng C, Zhang M, Asico LD, Eisner GM, Jose PA (2007) The dopaminergic system in hypertension. Clin Sci (Lond) 112:583–597CrossRef Zeng C, Zhang M, Asico LD, Eisner GM, Jose PA (2007) The dopaminergic system in hypertension. Clin Sci (Lond) 112:583–597CrossRef
23.
go back to reference Rocchi C, Pierantozzi M, Pisani V, Marfia GA, Di Giorgio A, Stanzione P, Bernardi G, Stefani A (2012) The impact of rotigotine on cardiovascular autonomic function in early Parkinson’s disease. Eur Neurol 68:187–192CrossRefPubMed Rocchi C, Pierantozzi M, Pisani V, Marfia GA, Di Giorgio A, Stanzione P, Bernardi G, Stefani A (2012) The impact of rotigotine on cardiovascular autonomic function in early Parkinson’s disease. Eur Neurol 68:187–192CrossRefPubMed
24.
go back to reference Stowe R, Ives N, Clarke CE, Deane K, van Hilten Wheatley K, Gray R, Handley K, Furmston A (2010) Evaluation of the efficacy and safety of adjuvant treatment to levodopa therapy in Parkinson’s disease patients with motor complications. Cochrane Database Syst Rev 7:CD007166 Stowe R, Ives N, Clarke CE, Deane K, van Hilten Wheatley K, Gray R, Handley K, Furmston A (2010) Evaluation of the efficacy and safety of adjuvant treatment to levodopa therapy in Parkinson’s disease patients with motor complications. Cochrane Database Syst Rev 7:CD007166
25.
go back to reference Ohta K, Osada T (2015) Rotigotine transdermal patch does not make Parkinson disease patients sleepy during daytime. Clin Neuropharmacol 38:231–235CrossRefPubMed Ohta K, Osada T (2015) Rotigotine transdermal patch does not make Parkinson disease patients sleepy during daytime. Clin Neuropharmacol 38:231–235CrossRefPubMed
27.
go back to reference 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 Group (2011) Rotigotine effects on early morning motor function and sleep in Parkinson’s disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord 26:90–99CrossRefPubMed 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 Group (2011) Rotigotine effects on early morning motor function and sleep in Parkinson’s disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord 26:90–99CrossRefPubMed
28.
go back to reference 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 21:140–144CrossRefPubMed 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 21:140–144CrossRefPubMed
29.
go back to reference de la Fuente-Fernández R, Ruth TJ, Sossi V, Schulzer M, Calne DB, Stoessl AJ (2001) Expectation and dopamine release: mechanism of the placebo effect in Parkinson’s disease. Science 293:1164–1166CrossRefPubMed de la Fuente-Fernández R, Ruth TJ, Sossi V, Schulzer M, Calne DB, Stoessl AJ (2001) Expectation and dopamine release: mechanism of the placebo effect in Parkinson’s disease. Science 293:1164–1166CrossRefPubMed
30.
go back to reference Lidstone SC, Schulzer M, Dinelle K, Mak E, Sossi V, Ruth TJ, de la Fuente-Fernández R, Phillips AG, Stoessl AJ (2010) Effects of expectation on placebo-induced dopamine release in Parkinson disease. Arch Gen Psychiatry 67:857–865CrossRefPubMed Lidstone SC, Schulzer M, Dinelle K, Mak E, Sossi V, Ruth TJ, de la Fuente-Fernández R, Phillips AG, Stoessl AJ (2010) Effects of expectation on placebo-induced dopamine release in Parkinson disease. Arch Gen Psychiatry 67:857–865CrossRefPubMed
31.
Metadata
Title
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
Authors
Masahiro Nomoto
Hirotaka Iwaki
Hiroyuki Kondo
Masaya Sakurai
Publication date
01-02-2018
Publisher
Springer Berlin Heidelberg
Published in
Journal of Neurology / Issue 2/2018
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI
https://doi.org/10.1007/s00415-017-8671-0

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