The efficacy of oral adenosine A2A antagonist istradefylline for the treatment of moderate to severe Parkinson's disease

Expert Review of Neurotherapeutics

Volumn 15, Issue 12, 2015, Pages 1383-1390

  Vorovenci, Ruxandra Julia ^a,b   Antonini, Angelo ^b  

^a VICTOR BABES UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^b IRCCS SAN CAMILLO HOSPITAL   (Italy)

Author keywords

A2A receptor antagonist; dyskinesia; istradefylline; levodopa add on therapy; motor fluctuations; off time; Parkinson's disease; treatment

Indexed keywords

ISTRADEFYLLINE; LEVODOPA; ANTIPARKINSON AGENT; CATECHOL METHYLTRANSFERASE INHIBITOR; MONOAMINE OXIDASE INHIBITOR; PURINE DERIVATIVE;

ARTICLE; COGNITION; DEPRESSION; DISEASE SEVERITY; DIZZINESS; DRUG EFFICACY; DRUG HALF LIFE; DYSKINESIA; HALLUCINATION; HUMAN; MOTOR CONTROL; NAUSEA; NEUROPROTECTION; OUTCOME ASSESSMENT; PARKINSON DISEASE; PHARMACODYNAMICS; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT INDICATION; JAPAN;

ANTIPARKINSON AGENTS; CATECHOL O-METHYLTRANSFERASE INHIBITORS; HUMANS; JAPAN; LEVODOPA; MONOAMINE OXIDASE INHIBITORS; PARKINSON DISEASE; PURINES;

EID: 84948977536     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/14737175.2015.1113131     Document Type: Article

References (53)

1. Jenner P. Istradefylline, a novel adenosine A2A receptor antagonist, for the treatment of Parkinson's disease. Expert Opin Investig Drugs. 2005;14(6):729-738.
2. Kalia LV, Brotchie JM, Fox SH. Novel nondopaminergic targets for motor features of Parkinson's disease: review of recent trials. Mov Disord. 2013;28 (2):131-144.
3. Antonini A, Poewe W. Adenosine A2A receptor antagonists in Parkinson's disease: still in the running. Lancet Neurol. 2014;13(8):748-749.
4. Le Witt PA, Guttman M, Tetrud JW, et al. Adenosine A2A receptor antagonist istradefylline (KW-6002) reduces "off" time in Parkinson's disease: a doubleblind, randomized, multicenter clinical trial (6002-US-005). Ann Neurol. 2008;63(3):295-302.
5. Rosin DL, Hettinger BD, Lee A, et al. Anatomy of adenosine A2A receptors in brain: morphological substrates for integration of striatal function. Neurology. 2003;61(11 Suppl 6):S12-S18.
6. Fernandez HH, Greeley DR, Zweig RM, et al. Istradefylline as monotherapy for Parkinson disease: results of the 6002-US- 051 trial. Parkinsonism Relat Disord. 2010;16(1):16-20.
7. 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):2177-2185.
8. Ochi M, Shiozaki S, Kase H. Adenosine A2A receptor-mediated modulation of GABA and glutamate release in the output regions of the basal ganglia in a rodent model of Parkinson's disease. Neuroscience. 2004;127(1):223-231.
9. 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):322-335.
10. Mishina M, Ishiwata K, et al. Adenosine A(2A) receptors measured with [C]TMSX PET in the striata of Parkinson's disease patients. PLoS One. 2011;6(2):e17338.
11. Barret O, Hannestad J, Vala C, et al. Characterization in humans of 18FMNI- 444, a PET radiotracer for brain adenosine 2A receptors. J Nucl Med. 2015;56(4):586-591.
12. Rodriguez-Oroz MC, Jahanshahi M, Krack P, et al. Initial clinical manifestations of Parkinson's disease: features and pathophysiological mechanisms. Lancet Neurol. 2009;8(12):1128-1139.
13. Hauser RA. Future treatments for Parkinson's disease: surfing the PD pipeline. Int J Neurosci. 2011;121(Suppl 2):53-62.
14. Mizuno Y, Kondo T. Adenosine A2A receptor antagonist istradefylline reduces daily OFF time in Parkinson's disease. Mov Disord. 2013;28(8):1138-1141.
15. Dungo R, Deeks ED. Istradefylline: first global approval. Drugs. 2013;73 (8):875-882.
16. Pinna A. Adenosine A2A receptor antagonists in Parkinson's disease: progress in clinical trials from the newly approved istradefylline to drugs in early development and those already discontinued. CNS Drugs. 2014;28(5):455-474.
17. Jenner P. An overview of adenosine A2A receptor antagonists in Parkinson's disease. Int Rev Neurobiol. 2014;119:71-86.
18. Hauser RA, Cantillon M, Pourcher E, et al. Preladenant in patients with Parkinson's disease and motor fluctuations: a phase 2, double-blind, randomised trial. Lancet Neurol. 2011;10 (3):221-229.
19. Merck. Merck provides update on phase III clinical program for preladenant, the company's investigational Parkinson's disease medicine. 2013 May 23. Available from: http://www.businesswire.com/news/home/20130523006358/en/Merck-Update-Phase-III-Clinical-Program-Preladenant#.VcZawPntmko.
20. Hauser RA, Olanow CW, Kieburtz KD, et al. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014;13(8):767-776.
21. Perez-lloret S, Merello M. Two new adenosine receptor antagonists for the treatment of Parkinson's disease: istradefylline versus tozadenant. Expert Opin Pharmacother. 2014;15 (8):1097-1107.
22. Kondo T, Mizuno Y. A long-term study of istradefylline safety and efficacy in patients with Parkinson disease. Clin Neuropharmacol. 2015;38(2):41-46.
23. Chen W, Wang H, Wei H, et al. Istradefylline, an adenosine A□A receptor antagonist, for patients with Parkinson's Disease: a meta-analysis. J Neurol Sci. 2013;324(1-2):21-28.
24. Pierri M, Vaudano E, Sager T, et al. KW- 6002 protects from MPTP induced dopaminergic toxicity in the mouse. Neuropharmacol. 2005;48(4):517-524.
25. Ikeda K, Kurokawa M, Aoyama S, et al. Neuroprotection by adenosine A2A receptor blockade in experimental models of Parkinson's disease. J Neurochem. 2002;80(2):262-270.
26. 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.
27. 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):1437-1443.
28. Bara-Jimenez W, Sherzai A, Dimitrova T, et al. Adenosine A(2A) receptor antagonist treatment of Parkinson's disease. Neurology. 2003;61(3):293-296.
29. Hauser RA, Hubble JP, Truong DD. Randomized trial of the adenosine A(2A) receptor antagonist istradefylline in advanced PD. Neurology. 2003;61 (3):297-303.
30. Stacy M, Silver D, Mendis T, et al. A 12-week, placebo-controlled study (6002-US- 006) of istradefylline in Parkinson disease. Neurology. 2008;70(23):2233-2240.
31. 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):178-184.
32. Goetz CG, Wuu J, Mcdermott MP, et al. Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. Mov Disord. 2008;23(5):690-699.
33. Kyowa Hakko Kogyo Co. Ltd. Results of phase-III clinical studies of an anti-Parkinson's disease drug Istradefylline/KW-6002 conducted overseas [media release]. 2006 Mar 7. Available from: http://www.kyowa.co.jp.
34. Kyowa Hakko Kirin Co. Ltd. Kyowa Hakko Kirin announces results of phase III clinical study of KW-6002 (istradefylline) for Parkinson's disease in Japan [media release]. 2011 May 10. Available from: http://www.kyowa-kirin.co.jp.
35. Zhu C, Wang G, Li J, et al. Adenosine A2A receptor antagonist istradefylline 20 versus 40 mg/day as augmentation for Parkinson's disease: a meta-analysis. Neurol Res. 2014;36(11):1028-1034.
36. Tao Y, Liang G. Efficacy of adenosine A2A receptor antagonist istradefylline as augmentation for Parkinson's disease: a meta-analysis of randomized controlled trials. Cell Biochem Biophys. 2015;71 (1):57-62.
37. Matsuura K, Tomimoto H. Istradefylline is recommended for morning use: a report of 4 cases. Intern Med. 2015;54(5):509-511.
38. Factor S, Mark MH, Watts R, et al. A long-term study of istradefylline in subjects with fluctuating Parkinson's disease. Parkinsonism Relat Disord. 2010;16 (6):423-426.
39. Knebel W, Rao N, Uchimura T, et al. Population pharmacokinetic-pharmacodynamic analysis of istradefylline in patients with Parkinson disease. J Clin Pharmacol. 2012;52(10):1468-1481.
40. Müller T. The safety of istradefylline for the treatment of Parkinson's disease. Expert Opin Drug Saf. 2015;14 (5):769-775.
41. Nomoto M, Nagai M, Nishikawa N. Clinical nonmotor aspect of A2A antagonist in PD treatment. Int Rev Neurobiol. 2014;119:191-194.
42. Uchida S, Kadowaki-horita T, Kanda T. Effects of the adenosine A2A receptor antagonist on cognitive dysfunction in Parkinson's disease. Int Rev Neurobiol. 2014;119:169-189.
43. Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004;19(2):203-214.
44. Sandoval-Rincón M, Sáenz-farret M, Miguel-Puga A, et al. Rational pharmacological approaches for cognitive dysfunction and depression in Parkinson's disease. Front Neurol. 2015;6:71.
45. Hu X, Song X, Yuan Y, et al. Abnormal functional connectivity of the amygdala is associated with depression in Parkinson's disease. Mov Disord. 2015;30(2):238-244.
46. El Yacoubi M, Ledent C, Parmentier M, et al. Adenosine A2A receptor antagonists are potential antidepressants: evidence based on pharmacology and A2A receptor knockout mice. Br J Pharmacol. 2001;134(1):68-77.
47. Yamada K, Kobayashi M, Shiozaki S, et al. Antidepressant activity of the adenosine A2A receptor antagonist, istradefylline (KW-6002) on learned helplessness in rats. Psychopharmacology (Berl). 2014;231(14):2839-2849.
48. Corsi C, Melani A, Bianchi L, et al. Striatal A2A adenosine receptor antagonism differentially modifies striatal glutamate outflow in vivo in young and aged rats. Neuroreport. 2000;11 (11):2591-2595.
49. Kalda A, Yu L, Oztas E, et al. Novel neuroprotection by caffeine and adenosine A(2A) receptor antagonists in animal models of Parkinson's disease. J Neurol Sci. 2006;248(1-2):9-15.
50. Chen JF, Xu K, Petzer JP, et al. Neuroprotection by caffeine and A(2A) adenosine receptor inactivation in a model of Parkinson's disease. J Neurosci. 2001;21(10):RC143.
51. Yu L, Shen HY, Coelho JE, et al. Adenosine A2A receptor antagonists exert motor and neuroprotective effects by distinct cellular mechanisms. Ann Neurol. 2008;63(3):338-346.
52. Stocchi F, Rascol O, Kieburtz K, et al. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDEPD study. Ann Neurol. 2010;68 (1):18-27.
53. Gyoneva S, Shapiro L, Lazo C, et al. Adenosine A2A receptor antagonism reverses inflammation-induced impairment of microglial process extension in a model of Parkinson's disease. Neurobiol Dis. 2014;67:191-202.