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• W2890182950 abstract "Objective: In order to optimize the therapeutic regimen using oral and intravenous L-arginine for MELAS. Background: Pharmacotherapy with L-arginine has been suggested to be promising for patients with a predominant clinical phenotype of mitochondrial encephalomyopathies - MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes). Design/Methods: Fifteen and 10 patients at 10 medical institutions in Japan were enrolled in two, 2-year, open-label clinical trials of oral and intravenous L-arginine, respectively. The primary endpoint for efficacy in the clinical trial of oral L-arginine was the MELAS stroke scale, while those of intravenous L-arginine were the improvement rates of headache and nausea/vomiting at 2 hours after the completion of the initial intravenous administration. The relationships between the ictuses of stroke-like episodes and plasma arginine concentrations were examined. The trials were registered (JMACTR-IIA00023 and JMACTR-IIA00025). Results: Patients, enrolled from December 2008 through June 2011, were followed up until May 2017. Six and 7 patients with juvenile- or adult-onset, interictal MELAS (age: 8 to 47) were respectively assessed for the efficacy and safety of oral L-arginine (0.3–0.5 g/kg/day, tid) for 96 weeks; 5 and 5 patients with juvenile- or adult-onset, acute MELAS (age: 9 to 24) were respectively assessed for the symptom-improving effect and safety of intravenous L-arginine (0.5 g/kg/dose). Oral L-arginine extended the interictal phase and decreased the incidence and severity of ictuses. Intravenous L-arginine improved headache, nausea/vomiting, impaired consciousness, and visual disturbance. The maximal plasma arginine concentration was 167 μmol/L when an ictus developed. At the completion of the 2-year clinical trials, the bedriddeness and mortality rates were 0% despite the progressively neurodegenerative and eventually life-threatening natures of MELAS, and no treatment-related adverse events occurred. The formulations were well tolerated. Conclusions: The therapeutic regimen using oral and intravenous L-arginine appropriately may be therapeutically beneficial and clinically useful for patients with MELAS. Study Supported by: The Ministry of Health, Labour and Welfare of Japan and the Japan Medical Association Center for Clinical Trials. Disclosure: Dr. Koga has nothing to disclose. Dr. Povalko has nothing to disclose. Dr. Inoue has nothing to disclose. Dr. Nakamura has nothing to disclose. Dr. Ishii has nothing to disclose. Dr. Suzuki has nothing to disclose. Dr. Yoneda has nothing to disclose. Dr. Kanda has nothing to disclose. Dr. Kubota has nothing to disclose. Dr. Okada has nothing to disclose. Dr. Fujii has nothing to disclose." @default.
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• W2890182950 date "2018-04-10" @default.
• W2890182950 modified "2023-09-22" @default.
• W2890182950 title "Therapeutic Regimen of L-arginine for Patients with MELAS: 9-year, Prospective, Multicentre, Clinical Research Integrating the Data from Two 2-year Clinical Trials with 7-year Follow-up (S54.008)" @default.
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