Brain Disorders & Therapy

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

7^th International Conference on Neurological Disorders & Stroke

September 20-21, 2018 | Rome, Italy

Yasutoshi Koga

Kurume University, Japan

Posters & Accepted Abstracts: Brain Disord Ther

Abstract:

Background: Pharmacotherapy with L-arginine has been suggested to be promising for patients with a predominant clinical phenotype of Melas. Methods: Fifteen and Ten patients at 10 medical institutions in Japan were enrolled into 2-year, open label clinical trials of oral and intravenous L-arginine, respectively. The primary end point 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 trials were registered. (JMACTR-IIA00023and JMACTRIIA00025). Findings: Patients, enrolled from December 2008 were followed up until May 2017. Thirteen patients with interictal Melas (age: 8 to 47) were assessed for the efficacy and safety of oral L-arginine (0.3-0.5 g/kg/day, TID) for 96 weeks; 10 with acute Melas (age: 9 to 24) were 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?mol/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. Interpretation: The therapeutic regimen using oral and intravenous L-arginine appropriately may be therapeutically beneficial and clinically useful for patients with Melas.

Biography :

E-mail: yasukoga@med.kurume-u.ac.jp