Results of Open-Label, Randomized, Controlled, Parallel-Group Clinical Trial on the Efficacy and Tolerability of Neurocitin in Patients with Acute Ischemic Stroke
The article presents data from a study evaluating the comparative efficacy and tolerability of Neurocitin, solution for infusions, manufactured by «Yuria-Farm» Ltd. and Ceraxon, solution for injections, manufactured by «Ferrer Internacional S.A.» in patients with acute ischemic stroke. The objective of this work — the evaluation of therapeutic equivalence of the drugs Neurocitin and Ceraxon. Materials and methods. The clinical study included 108 patients with acute ischemic stroke, who, based on the method of simple randomization in the ratio 1: 1, were divided in the study (n = 54) and control (n = 54) groups. Patients of the study group received Neurocitin, solution for infusions, patients from the control group — reference product Ceraxon, solution for injections. The course of treatment was 3 weeks, followed by a 3-week observation. Treatment efficacy was determined by the main variable — reduction in the score on the NIHSS, the severity of stroke scale, compared with baseline. Safety of the drug was evaluated based on monitoring the patient’s condition, the incidence and nature of adverse events, the data of laboratory examination, assessment of the subjective condition of the patient. Results. The study shows that Neurocitin is highly effective and on its properties is therapeutically equivalent to foreign analogue — the drug Ceraxon. During the treatment, no severe or unexpected adverse events were detected, laboratory parameters did not undergo negative changes that allowed to consider the tolerability in both groups as good one. Conclusions. Based on these findings, Neurocitin, solution for infusions, manufactured by «Yuria-Pharm» Ltd. can be recommended as an effective and safe drug in patients with acute ischemic stroke.
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Гусев Е.И., Скворцова В.И. Ишемия головного мозга. — М.: Медицина, 2001.
Adibhatla R.M., Hatcher J.F. Citicoline mechanisms and clinical efficacy in cerebral ischemia // J. Neurosci.Res. 2002; 70: 133-139.
Saver J., Wilterdink J. Choline precursors in acute and subacute human stroke: a meta-analysis // Stroke 2002; 33: 353.
Adibhatla R.M., Hatcher J.F., Dempsey R.J. Effects of citicoline on phospholopid and glutathione levels in transient cerebral ischemia // Stroke 2001; 32: 2376-2382.
Secades J.J., Alvarez-Sabin J. et al. Citicoline in intracerebral haemorrhage: a double-blind, randomized, placebo-controlled, multi-centre pilot study // Cerebrovasc. Dis. 2006; 21: 380-385.
Hurtado O., Moro M.A., Cardenas A. et al. Neuroprotection afforded by prior citicoline administration in experimental brain ischemia: effects on glutamate transport // Neurobiol. Dis. 2005; 18: 336-345.
Krupinski J., Ferrer I. et al. CDP-choline reduces pro-caspase and cleaved caspase‑3 expression, nuclear DNA fragmentation, and specific PARPcleaved products of caspase activation following middle cerebral artery occlusion in the rat // Neuropharmacology 2002; 42: 846-854.
Alonso de Lecinana M., Gutierrez M. et al. Effect of combined therapy with thrombolysis and citicoline in a rat model of embolic stroke // J. Neurol. Sci. 2006; 247: 121-129.
Clark W., Gunion-Rinker L. et al. Citicoline treatment for experimental intracerebral hemorrhage in mice // Stroke 1998; 29: 2136-2140.
Petkov V.D., Kehayov R.A. et al. Effects of citidine diphosphate choline on rats with memory deficits // Arzneimittelforschung 1993; 43: 822-828.
Tazaki Y., Sakai F. et al. Treatment of acute cerebral infarction with a choline precusor in a multicenter double-blind placebo-controlled study // Stroke 1988; 19: 211-216.
Clark W.M., Warach S.J. et al. A randomized dose-response trial of citicoline in acute ischemic stroke patients. Citicoline Stroke Study Group // Neurology 1997; 49: 671-678.
Clark W.M., Wiliams B.J. et al. A randomized efficacy trial of citicoline in patients with acute ischemic stroke // Stroke 1999; 30: 2592-2597.
Clark W.M., Wechsler L.R. et al. Citicoline Stroke Study Group. A phase III randomized efficacy trial of 2000 mg citicoline in acute ischemic stroke patients // Neurology 2001; 57: 1595-1602.
Davalos A., Castilo J. et al. Oral citicoline in acute ischemic stroke: an individual patient data pooling analysis of clinical trials // Stroke 2002; 33: 2850-2857.
Warach S., Harnett K. Dose dependent reduction in infarct growth with citicoline treatment: evidence of neuroprotection in human stroke? // Stroke 2002; 33: 354.
Fioravanti M., Yanagi M. Cytidinediphosphocholine (CDP-choline) for cognitive and behavioural disturbances associated with chronic cerebral disorders in the elderly // Cochrane Database Syst. Rev. 2005; 2: 000269.
Davalos A., Alvarez-Sabin J., Castillo J. et al. Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial) // Lancet 2012; 380: 349-57.
Hankey G.J. How effective is citicoline for acute ischaemic stroke? // Lancet 2012; 380: 318-20.
Lozano Fernandez R. Efficacy and safety of oral CDP-choline. Drug surveillance study in 2817 cases // Arzneimittelforsch 1983; 33: 1073-80.
Conant R., Schauss A.G. Therapeutic Applications of Citicoline for Stroke and Cognitive Dysfunction in the Elderly: A Review of the Literature // Altern. Med. Rev. 2004; 9: 17-31.
Schabitz W.R., W eber J., Takano K. et al. The effects of prolonged treatment with citicoline in temporary experimental focal ischemia // J. Neurol. Sci. 1996; 138: 21-5.
Hurtado O., Cardenas A., Pradillo J.M. et al. A chronic treatment with CDP-choline improves functional recovery and increases neuronal plasticity after experimental stroke // Neurobiol. Dis. 2007; 26: 105-11.
Andersen M., Overgaard K., Meden P. et al. Effects of citicoline combined with thrombolytic therapy in a rat embolic stroke model // Stroke 1999; 30: 1464-71.
Gutierrez-Fernandez M., Lecinana M.A., Rodriguez-Frutos B. et al. CDP-choline at high doses is as effective as i.v. thrombolysis in experimental animal stroke // Neurol. Res. 2012; 34(7): 649-56.
European Stroke Organization (ESO) Executive Committee; ESO Writing Committee. Guidelines for management of ischaemic stroke and transient ischaemic attack // Cerebrovasc. Dis. 2008; 25: 457-507.
Adams H.P., del Zoppo G. Jr, Alberts M.J. Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association. American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists // Stroke 2007; 38: 1655-711.
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