Erratum: Safety, tolerability and pharmacokinetics of MCI-186 in patients with acute ischemic stroke: New formulation and dosing regimen (Cerebrovascular Diseases (2013) 36 (196-204) DOI: 10.1159/000353680);Safety, tolerability and pharmacokinetics of mci-186 in patients with acute ischemic stroke: New formulation and dosing regimen

Cerebrovascular Diseases

Volumn 36, Issue 3, 2013, Pages 196-204

  Kaste, Markku ^a   Murayama, Satoru ^b   Ford, Gary A ^c   Dippel, Diederik W J ^e   Walters, Matthew R ^d   Tatlisumak, Turgut ^a  

^a HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^b MITSUBISHI TANABE PHARMA CORPORATION   (Japan)

^c NEWCASTLE UNIVERSITY   (United Kingdom)

^d WESTERN INFIRMARY   (United Kingdom)

^e ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

Dosing regimen; Ischemic stroke; Neuroprotective agents; Plasma concentrations

Indexed keywords

NORPHENAZONE; PLACEBO; GLUCURONIDE; SULFATE;

ADULT; AGED; ARTICLE; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CLINICAL ARTICLE; CONNECTIVE TISSUE DISEASE; CONSTIPATION; CONTROLLED STUDY; DEATH; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; EYE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; HEADACHE; HEART ATRIUM FIBRILLATION; HEART DISEASE; HEMIPARESIS; HUMAN; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPERTENSION; INFECTION; INFESTATION; INJECTION SITE REACTION; KIDNEY DISEASE; LOADING DRUG DOSE; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; METABOLIC DISORDER; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NAUSEA; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN DISEASE; SPEECH DISORDER; THORAX DISEASE; TRANSIENT ISCHEMIC ATTACK; URINARY TRACT DISEASE; VASCULAR DISEASE; ATRIAL FIBRILLATION; BARTHEL INDEX; BRADYCARDIA; COMPUTER ASSISTED TOMOGRAPHY; CONTINUOUS INFUSION; DISABILITY; DISABILITY SEVERITY; DRUG INDUCED HEADACHE; FATIGUE; GASTROINTESTINAL SYMPTOM; HYPERTRANSAMINASEMIA; HYPOTENSION; INJECTION SITE INFECTION; INJECTION SITE PHLEBITIS; PERIPHERAL NEUROPATHY; VOMITING;

AGED; AGED, 80 AND OVER; ANTIPYRINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; STROKE; TREATMENT OUTCOME;

EID: 84886425792     PISSN: 10159770     EISSN: 14219786     Source Type: Journal    
DOI: 10.1159/000356819     Document Type: Erratum

References (32)

1. Langhorne P, de Villiers L, Pandian JD: Applicability of stroke-unit care to low-income and middle-income countries. Lancet Neurol 2012; 11: 341-348.
2. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group: Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995; 333: 1581-1587.
3. Hacke W, Kaste M, Bluhmki E, Brozman M, Dvalos A, Guidetti D, et al, ECASS Investigators: Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008; 359: 1317-1329.
4. Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, et al: Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet 2010; 375: 1695-1703.
5. Sandercock P, Wardlaw JM, Lindley RI, Dennis M, Cohen G, Murray G, et al: The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the Third International Stroke Trial [IST-3]): a randomised controlled trial. Lancet 2012; 379: 2352-2363.
6. Wardlaw JM, Murray V, Berge E, Del Zoppo GJ: Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev 2009;(4):CD000213.
7. Kaste M: Is the door open again for neuroprotection trials in stroke? Lancet Neurol 2012; 11: 930-931.
8. Diener HC, Cortens M, Ford G, Grotta J, Hacke W, Kaste M, et al: Lubeluzole in acute ischemic stroke treatment: a double-blind study with an 8-hour inclusion window comparing a 10-mg daily dose of lubeluzole with placebo. Stroke 2000; 31: 2543-2551.
9. Enlimomab Acute Stroke Trial Investigators: Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial. Neurology 2001; 57: 1428-1434.
10. Bogousslavsky J, Victor S, Salinas E, Pallay A, Donnan G, Fieschi C, et al, European-Australian Fiblast (Trafermin) in Acute Stroke Group: Fiblast (trafermin) in acute stroke: results of the European-Australian phase II/III safety and efficacy trial. Cerebrovasc Dis 2002; 14: 239-251.
11. Walters MR, Kaste M, Lees KR, Diener HC, Hommel M, de Keyser J, et al: The AMPA antagonist ZK 200775 in patients with acute ischaemic stroke: a double-blind, multicentre, placebo-controlled safety and tolerability study. Cerebrovasc Dis 2005; 20: 304-309.
12. Warach S, Kaufman D, Chiu D, Devlin T, Luby M, Rashid A, et al, GAIN Americas and GAIN International MRI Investigators: Effect of the glycine antagonist gavestinel on cerebral infarcts in acute stroke patients, a randomized placebo-controlled trial: the GAIN MRI Substudy. Cerebrovasc Dis 2006; 21: 106-111.
13. Teal P, Davis S, Hacke W, Kaste M, Lyden PD, mRECT Study Investigators, Fierus M, Bayer HealthCare AG: A randomized, doubleblind, placebo-controlled trial to evaluate the efficacy, safety, tolerability, and pharmacokinetic/ pharmacodynamic effects of a targeted exposure of intravenous repinotan in patients with acute ischemic stroke: modified Randomized Exposure Controlled Trial (mRECT). Stroke 2009; 40: 3518-3525.
14. Edaravone Acute Brain Infarction Study Group: Effect of a novel free radical scavenger, edaravone (MCI-186), on acute brain infarction: randomized, placebo-controlled, double-blind study at multicenters. Cerebrovasc Dis 2003; 15: 222-229.
15. Mitsubishi Tanabe Pharma Co: The package insert of RADICUT injection 30 mg, edaravone. Japanese pharmaceutical reference. http://www.e-search.ne.jp/? jpr/PDF/MT18. PDF (available March 25, 2013).
16. Watanabe T, Morita I, Nishi H, Murota S: Preventive effects of MCI-186 on 15-HPETE induced vascular endothelial cell injury in vitro. Prostagrandins Leukot Essent Fatty Acids 1998; 33: 81-87.
17. Abe K, Yuki S, Kogure K: Strong attenuation of ischemic and postischemic brain edema in rats by a novel free radical scavenger. Stroke 1988; 19: 480-485.
18. Nishi H, Watanabe T, Sakurai H, Yuki S, Ishibashi A: Effect of MCI-186 on brain edema in rats. Stroke 1989; 20: 1236-1240.
19. Watanabe T, Yuki S, Egawa M, Nishi H: Protective effects of MCI-186 on cerebral ischemia: possible involvement of free radical scavenging and antioxidant actions. J Pharmacol Exp Ther 1994; 268: 1597-1604.
20. Kawai H, Nakai H, Suga M, Yuki S, Watanabe T, Saito K: Effects of a novel free radical scavenger, MCI-186, on ischemic brain damage in the rat distal middle cerebral artery occlusion model. J Pharmacol Exp Ther 1997; 281: 921-927.
21. Mizuno A, Umemura K, Nakashima M: Inhibitory effect of MCI-186, a free radical scavenger, on cerebral ischaemia following rat middle cerebral artery occlusion. J Gen Pharmacol 1998; 30: 575-578.
22. Yuki S, Akira T, Kondo H, Osajima T, Tashiro T: Effect of edaravone, a neuroprotectant approved in Japan for indications of acute ischemic stroke, in rodent and primate stroke models. Stroke 2007; 38: P335.
23. Yamamoto Y, Yanagisawa M, Nyou WT, Watanabe K, Takahashi C, Fujisawa A, et al: Repeated edaravone treatment reduces oxidative cell damage in rat brain induced by middle cerebral artery occlusion. Redox Rep 2009; 14: 1-8.
24. Yamaguchi T, Yamada T, Hirota T, Tanabashi N: Reducing frequency of symptomatic intracranial hemorrhage in patients with acute ischemic stroke treated by recombinant tissue-plasminogen activator; interim result of a prospective observational cohort study. Stroke 2013; 44:A195.
25. Shibata H, Arai S, Izawa M, Murasaki M, Takamatsu Y, Izawa O, et al: Phase I clinical study of MCI-186 (edaravone, 3-methyl- 1-phenyl-2-pyrazolin-5- one) in healthy volunteers: safety and pharmacokinetics of single and multiple administrations. Japanese J Clin Pharmacol Ther 1998; 29: 863-876.
26. World Medical Association Declaration of Helsinki. http://www.wma.net/en/ 30publications/10policies/b3/17c.pdf (current version, 2008).
27. Cornblath DR, Chaudhry V, Carter K, Lee D, Seysedadr M, Miernicki M, Joh T: Total neuropathy score: validation and reliability study. Neurology 1999; 53: 1660-1664.
28. Shinohara Y, Saito I, Kobayashi S, Uchiyama S: Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO Trial). Cerebrovasc Dis 2009; 27: 485-492.
29. Fisher M, Feuerstein G, Howells DW, Hurn PD, Kent TA, Savitz SI, Lo EH, STAIR Group: Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke 2009; 40: 2244-2250.
30. Hishida A: Clinical analysis of 207 patients who developed renal disorders during and after treatment with edaravone reported during post-marketing surveillance. Clin Exp Nephrol 2007; 11: 292-296.
31. Hishida A: Determinants for the prognosis of acute renal disorders that developed during or after treatment with edaravone. Clin Exp Nephrol 2009; 13: 118-122.
32. Hirano M: Clinical evaluation of liver injury in patients with acute ischemic brain stroke treated with edaravone. Hepatol Res 2011; 41: 142-150.