Skip to main content
Erschienen in:

01.05.2020 | Current Opinion

Istradefylline: a novel drug for ‘off’ episodes in Parkinson’s disease

verfasst von: Ajaya Kumar Sahoo, Dhyuti Gupta, Alok Singh

Erschienen in: Drugs & Therapy Perspectives | Ausgabe 5/2020

Einloggen, um Zugang zu erhalten

Abstract

Istradefylline, a selective adenosine A2A receptor antagonist, has recently been approved for the treatment of ‘off’ episodes in patients with Parkinson’s disease (PD) who are already receiving treatment with levodopa/carbidopa. The aim of the article is to review the efficacy, safety and tolerability of istradefylline in the management of ‘off’ episodes of PD, based on English language articles on this topic indexed in PubMed or in the National Institute of Health clinical trials registry during 2003–2019. Based on the beneficial outcomes of phase 2 or 3 clinical trials and a post-marketing surveillance study in Japan, istradefylline is a promising option for treating ‘off’ episodes in PD patients already receiving levodopa/carbidopa. The important adverse effects observed in the clinical trials were dyskinesia and hallucination. Head-to-head clinical trials are required to compare the efficacy of istradefylline with other classes of drugs, so as to ascertain its relative efficacy in managing the ‘off’ phase of PD.
Literatur
1.
Zurück zum Zitat Tysnes OB, Storstein A. Epidemiology of Parkinson’s disease. J Neural Transm. 2017;124(8):901–5.CrossRef Tysnes OB, Storstein A. Epidemiology of Parkinson’s disease. J Neural Transm. 2017;124(8):901–5.CrossRef
2.
Zurück zum Zitat Kinoshita KI, Tada Y, Muroi Y, et al. Selective loss of dopaminergic neurons in the substantia nigra pars compacta after systemic administration of MPTP facilitates extinction learning. Life Sci. 2015;137:28–36.CrossRef Kinoshita KI, Tada Y, Muroi Y, et al. Selective loss of dopaminergic neurons in the substantia nigra pars compacta after systemic administration of MPTP facilitates extinction learning. Life Sci. 2015;137:28–36.CrossRef
3.
Zurück zum Zitat Ganguly U, Chakrabarti SS, Kaur U, et al. Alpha-synuclein, proteotoxicity and Parkinson's disease: search for neuroprotective therapy. Curr Neuropharmacol. 2018;16(7):1086–97.CrossRef Ganguly U, Chakrabarti SS, Kaur U, et al. Alpha-synuclein, proteotoxicity and Parkinson's disease: search for neuroprotective therapy. Curr Neuropharmacol. 2018;16(7):1086–97.CrossRef
4.
Zurück zum Zitat Khan TS. Off spells and dyskinesias: pharmacologic management of motor complications. Clevel Clin J Med. 2012;79(Suppl 2):S8–S13.CrossRef Khan TS. Off spells and dyskinesias: pharmacologic management of motor complications. Clevel Clin J Med. 2012;79(Suppl 2):S8–S13.CrossRef
5.
Zurück zum Zitat Aquino CC, Fox SH. Clinical spectrum of levodopa-induced complications. Mov Disord. 2015;30(1):80–9.CrossRef Aquino CC, Fox SH. Clinical spectrum of levodopa-induced complications. Mov Disord. 2015;30(1):80–9.CrossRef
6.
Zurück zum Zitat Chou KL, Stacy M, Simuni T, et al. The spectrum of “off” in Parkinson’s disease: what have we learned over 40 years? Park Relat Disord. 2018;51:9–16.CrossRef Chou KL, Stacy M, Simuni T, et al. The spectrum of “off” in Parkinson’s disease: what have we learned over 40 years? Park Relat Disord. 2018;51:9–16.CrossRef
7.
Zurück zum Zitat Calabresi P, Ghiglieri V, Mazzocchetti P, et al. Levodopa-induced plasticity: a double-edged sword in Parkinson's disease? Philos Trans R Soc. 2015;370(1672):20140184.CrossRef Calabresi P, Ghiglieri V, Mazzocchetti P, et al. Levodopa-induced plasticity: a double-edged sword in Parkinson's disease? Philos Trans R Soc. 2015;370(1672):20140184.CrossRef
8.
Zurück zum Zitat Nazario LR, da Silva RS, Bonan CD. Targeting adenosine signaling in Parkinson’s disease: from pharmacological to non-pharmacological approaches. Front Neurosci. 2017;11:658.CrossRef Nazario LR, da Silva RS, Bonan CD. Targeting adenosine signaling in Parkinson’s disease: from pharmacological to non-pharmacological approaches. Front Neurosci. 2017;11:658.CrossRef
9.
Zurück zum Zitat Svenningsson P, Hall H, Sedvall G, et al. Distribution of adenosine receptors in the postmortem human brain: an extended autoradiographic study. Synapse. 1997;27(4):322–35.CrossRef Svenningsson P, Hall H, Sedvall G, et al. Distribution of adenosine receptors in the postmortem human brain: an extended autoradiographic study. Synapse. 1997;27(4):322–35.CrossRef
10.
Zurück zum Zitat Fink JS, Weaver DR, Rivkees SA, et al. Molecular cloning of the rat A2 adenosine receptor: selective co-expression with D2 dopamine receptors in rat striatum. Mol Brain Res. 1992;14(3):186–95.CrossRef Fink JS, Weaver DR, Rivkees SA, et al. Molecular cloning of the rat A2 adenosine receptor: selective co-expression with D2 dopamine receptors in rat striatum. Mol Brain Res. 1992;14(3):186–95.CrossRef
11.
Zurück zum Zitat Pollack AE, Fink JS. Adenosine antagonists potentiate D2 dopamine-dependent activation of Fos in the striatopallidal pathway. Neuroscience. 1995;68(3):721–8.CrossRef Pollack AE, Fink JS. Adenosine antagonists potentiate D2 dopamine-dependent activation of Fos in the striatopallidal pathway. Neuroscience. 1995;68(3):721–8.CrossRef
12.
Zurück zum Zitat Soliman AM, Fathalla AM, Moustafa AA. Adenosine role in brain functions: pathophysiological influence on Parkinson’s disease and other brain disorders. Pharmacol Rep. 2018;70(4):661–7.CrossRef Soliman AM, Fathalla AM, Moustafa AA. Adenosine role in brain functions: pathophysiological influence on Parkinson’s disease and other brain disorders. Pharmacol Rep. 2018;70(4):661–7.CrossRef
13.
Zurück zum Zitat Dungo R, Deeks ED. Istradefylline: first global approval. Drugs. 2013;73(8):875–82.CrossRef Dungo R, Deeks ED. Istradefylline: first global approval. Drugs. 2013;73(8):875–82.CrossRef
15.
Zurück zum Zitat Rao N, Uchimura T, Mori A. Evaluation of safety, tolerability, and multiple-dose pharmacokinetics of istradefylline in Parkinson's disease patients [abstract no. PIII-88]. Clin Pharmacol Ther. 2008;83(Suppl 1):S99. Rao N, Uchimura T, Mori A. Evaluation of safety, tolerability, and multiple-dose pharmacokinetics of istradefylline in Parkinson's disease patients [abstract no. PIII-88]. Clin Pharmacol Ther. 2008;83(Suppl 1):S99.
17.
Zurück zum Zitat Mukai M, Uchimura T, Zhang X, et al. Effects of rifampin on the pharmacokinetics of a single dose of istradefylline in healthy subjects. J Clin Pharmacol. 2018;58(2):193–201.CrossRef Mukai M, Uchimura T, Zhang X, et al. Effects of rifampin on the pharmacokinetics of a single dose of istradefylline in healthy subjects. J Clin Pharmacol. 2018;58(2):193–201.CrossRef
18.
Zurück zum Zitat Rao N, Dvorchik B, Sussman N, et al. A study of the pharmacokinetic interaction of istradefylline, a novel therapeutic for Parkinson’s disease, and atorvastatin. J Clin Pharmacol. 2008;48(9):1092–8.CrossRef Rao N, Dvorchik B, Sussman N, et al. A study of the pharmacokinetic interaction of istradefylline, a novel therapeutic for Parkinson’s disease, and atorvastatin. J Clin Pharmacol. 2008;48(9):1092–8.CrossRef
19.
Zurück zum Zitat LeWitt PA, Guttman M, Tetrud JW, et al. Adenosine A2A receptor antagonist istradefylline (KW-6002) reduces off time in Parkinson’s disease: a double-blind, randomized, multicenter clinical trial (6002-US-005). Ann Neurol. 2008;63(3):295–3020.CrossRef LeWitt PA, Guttman M, Tetrud JW, et al. Adenosine A2A receptor antagonist istradefylline (KW-6002) reduces off time in Parkinson’s disease: a double-blind, randomized, multicenter clinical trial (6002-US-005). Ann Neurol. 2008;63(3):295–3020.CrossRef
20.
Zurück zum Zitat Mizuno Y, Hasegawa K, Kondo T, et al. Clinical efficacy of istradefylline (KW-6002) in Parkinson’s disease: a randomized, controlled study. Mov Disord. 2010;25(10):1437–43.CrossRef Mizuno Y, Hasegawa K, Kondo T, et al. Clinical efficacy of istradefylline (KW-6002) in Parkinson’s disease: a randomized, controlled study. Mov Disord. 2010;25(10):1437–43.CrossRef
21.
Zurück zum Zitat Mizuno Y, Kondo T. Adenosine A2A receptor antagonist istradefylline reduces daily OFF time in Parkinson’s disease. Mov Disord. 2013;28(8):1138–41.CrossRef Mizuno Y, Kondo T. Adenosine A2A receptor antagonist istradefylline reduces daily OFF time in Parkinson’s disease. Mov Disord. 2013;28(8):1138–41.CrossRef
22.
Zurück zum Zitat Hauser RA, Shulman LM, Trugman JM, et al. Study of istradefylline in patients with Parkinson’s disease on levodopa with motor fluctuations. Mov Disord. 2008;23(15):2177–85.CrossRef Hauser RA, Shulman LM, Trugman JM, et al. Study of istradefylline in patients with Parkinson’s disease on levodopa with motor fluctuations. Mov Disord. 2008;23(15):2177–85.CrossRef
23.
Zurück zum Zitat Pourcher E, Fernandez HH, Stacy M, et al. Istradefylline for Parkinson's disease patients experiencing motor fluctuations: results of the KW-6002-US-018 study. Parkinsonism Relat Disord. 2012;18(2):178–84.CrossRef Pourcher E, Fernandez HH, Stacy M, et al. Istradefylline for Parkinson's disease patients experiencing motor fluctuations: results of the KW-6002-US-018 study. Parkinsonism Relat Disord. 2012;18(2):178–84.CrossRef
24.
Zurück zum Zitat Takahashi M, Fujita M, Asai N, et al. Safety and effectiveness of istradefylline in patients with Parkinson’s disease: interim analysis of a post-marketing surveillance study in Japan. Expert Opin Pharmacother. 2018;19(15):1635–42.CrossRef Takahashi M, Fujita M, Asai N, et al. Safety and effectiveness of istradefylline in patients with Parkinson’s disease: interim analysis of a post-marketing surveillance study in Japan. Expert Opin Pharmacother. 2018;19(15):1635–42.CrossRef
26.
Zurück zum Zitat Poewe WH, Deuschl G, Gordin A, et al. Efficacy and safety of entacapone in Parkinson’s disease patients with suboptimal levodopa response: a 6-month randomized placebo controlled double blind study in Germany and Austria (Celomen study). Acta Neurol Scand. 2002;105(4):245–55.CrossRef Poewe WH, Deuschl G, Gordin A, et al. Efficacy and safety of entacapone in Parkinson’s disease patients with suboptimal levodopa response: a 6-month randomized placebo controlled double blind study in Germany and Austria (Celomen study). Acta Neurol Scand. 2002;105(4):245–55.CrossRef
27.
Zurück zum Zitat Schwid SR. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005;62(2):241–8.CrossRef Schwid SR. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005;62(2):241–8.CrossRef
28.
Zurück zum Zitat Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa in patients with Parkinson’s disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. Lancet. 2005;365(9463):947–54.CrossRef Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa in patients with Parkinson’s disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. Lancet. 2005;365(9463):947–54.CrossRef
29.
Zurück zum Zitat Robertson ED. Treatment of central nervous system degenerative disorders. In: Brunton L, Knollmann B, Hilal-Dandan R, editors. Goodman and Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw Hill; 2018. p. 327–338. Robertson ED. Treatment of central nervous system degenerative disorders. In: Brunton L, Knollmann B, Hilal-Dandan R, editors. Goodman and Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw Hill; 2018. p. 327–338.
30.
Zurück zum Zitat Vorovenci RJ, Antonini A. The efficacy of oral adenosine A2A antagonist istradefylline for the treatment of moderate to severe Parkinson’s disease. Expert Rev Neurother. 2015;15(12):1383–90.CrossRef Vorovenci RJ, Antonini A. The efficacy of oral adenosine A2A antagonist istradefylline for the treatment of moderate to severe Parkinson’s disease. Expert Rev Neurother. 2015;15(12):1383–90.CrossRef
Metadaten
Titel
Istradefylline: a novel drug for ‘off’ episodes in Parkinson’s disease
verfasst von
Ajaya Kumar Sahoo
Dhyuti Gupta
Alok Singh
Publikationsdatum
01.05.2020
Verlag
Springer International Publishing
Erschienen in
Drugs & Therapy Perspectives / Ausgabe 5/2020
Print ISSN: 1172-0360
Elektronische ISSN: 1179-1977
DOI
https://doi.org/10.1007/s40267-020-00718-w