Background: Many donor organs come from youths involved in alcohol-related accidental death. The use of cardiac allografts for transplantation from donors after acute poisoning is still under discussion while acute ethanol intoxication is associated with myocardial functional and morphological changes. The aims of this work were 1) to evaluate in rats the time-course cardiac effects of acute ethanol-exposure and 2) to explore how its abuse by donors might affect recipients in cardiac pump function after transplantation.
The aim of this study was to evaluate the long-term adverse effect (AE) profile of azathioprine (AZA) plus methylprednisolone combined immunosuppressive treatment in myasthenia gravis (MG) in a larger patient cohort. A prospective, open, observational study was conducted on 163 MG patients treated with combined immunosuppressive medication for a mean duration of 35.5 months (range 9-79 months). During the treatment course, AEs occurred in 61.4% of patients; 18% of these patients developed both steroid- and AZA-related AE, 15% had purely AZA-related AE and 67% had steroid-associated AEs. Severe AEs were encountered in only 6.7% of patients in whom treatment had to be discontinued. The clinical severity of MG at the start of the immunosuppressive treatment was positively correlated with the frequency and severity of AEs during the treatment, and patients with severe MG were found to be at higher risk of developing AEs during the combined immunosuppressive treatment. Combined immunosuppressive treatment of MG patients is well tolerated, and severe AEs requiring treatment cessation are rare. The incidence of steroid-related AEs is high during long-time therapy which underlines the importance of its combination with AZA. The probability of developing AEs seems to correlate with the severity of MG at the beginning of the treatment.
The terminal complement inhibitor eculizumab was shown to improve myasthenia gravis-related symptoms in the 26-week, phase 3, randomized, double-blind, placebo-controlled REGAIN study (NCT01997229). In this 52week sub-analysis of the open-label extension of REGAIN (NCT02301624), eculizumab's efficacy and safety were assessed in 11 Japanese and 88 Caucasian patients with anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis. For patients who had received placebo during REGAIN, treatment with openlabel eculizumab resulted in generally similar outcomes in the Japanese and Caucasian populations. Rapid improvements were maintained for 52 weeks, assessed by change in score from open-label extension baseline to week 52 (mean [standard error]) using the following scales (in Japanese and Caucasian patients, respectively): Myasthenia Gravis Activities of Daily Living (−2.4 [1.34] and − 3.3 [0.65]); Quantitative Myasthenia Gravis (−2.9 [1.98] and − 4.3 [0.79]); Myasthenia Gravis Composite (−4.5 [2.63] and − 4.9 [1.19]); and Myasthenia Gravis Quality of Life 15-item questionnaire (−8.6 [5.68] and − 6.5 [1.93]). Overall, the safety of eculizumab was consistent with its known safety profile. In this interim sub-analysis, the efficacy and safety of eculizumab in Japanese and Caucasian patients were generally similar, and consistent with the overall REGAIN population.
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