A double-blind, randomized, placebo-controlled phase 2 trial evaluating the selective dihydroorotate dehydrogenase inhibitor vidofludimus calcium in relapsing-remitting multiple sclerosis.

OBJECTIVE: Inhibition of dihydroorotate dehydrogenase suppresses magnetic resonance imaging brain lesions and disease activity in multiple sclerosis but has limiting tolerability. We assessed the safety and efficacy of vidofludimus calcium, a novel, selective dihydroorotate dehydrogenase inhibitor, in patients with relapsing-remitting multiple sclerosis. METHODS: This double-blind, 24 weeks, placebo-controlled, phase 2 trial (EMPhASIS) enrolled patients 18-55 years with relapsing-remitting multiple sclerosis. Eligible patients were randomly assigned (1:1:1) to once-daily vidofludimus calcium (30 mg or 45 mg) or placebo. The primary endpoint was the cumulative number of combined unique active lesions to week 24 between vidofludimus calcium 45 mg and placebo (clinicalTrials.gov number NCT03846219; EudraCT 2018-001896-19). RESULTS: After 24 weeks, the mean cumulative number of combined unique active lesions was 6.4 (95% CI: 2.8-13.9) with placebo compared to 2.4 (95% CI: 1.1-4.9) with vidofludimus calcium 45 mg (rate ratio 0.38, 95% CI: 0.22-0.64; p = 0.0002); the rate ratio between vidofludimus calcium 30 mg and placebo was 0.30 (95% CI: 0.17-0.53; p < 0.0001). Treatment-emergent adverse events occurred in 30 (44%) of patients assigned placebo and 60 (43%) of patients assigned vidofludimus calcium. Serious adverse events occurred in one (1%) assigned placebo and two (1%) assigned vidofludimus calcium. No increased incidence of infectious, hepatic, or renal treatment-emergent adverse events or serious adverse events was observed. INTERPRETATION: Treatment with vidofludimus calcium led to a reduction in new magnetic resonance imaging lesions in patients with relapsing-remitting multiple sclerosis and was well tolerated with a favorable safety profile. Assessment in longer, larger trials is justified.

The Effect of Recreational Swimming on the Health of Students with Poor Somatic Health in Physical Education Classes at University.

BACKGROUND: The physical education of students who have a deviation in their state of health requires a joint effort from teachers and doctors. AIM: The aim of the study was to substantiate the necessity of swimming classes as an effective means of physical rehabilitation in students with health disorders within the physical education curriculum classes. METHODS: Students with low-level somatic health (54 students) were grouped into the Basic Group (BG, 27 students) and the Control Group (CG, 27 students). The Basic Group students were offered special swimming classes aimed at their physical rehabilitation. At the beginning of the study and after 24 training classes the authors assessed the somatic health, physical and mental endurance, and adaptation abilities of the autonomic nervous system. RESULTS: Implementation of the method into the curriculum of the BG students resulted in a significant improvement (by 48.1%) of their somatic health. A reliable re-distribution of the students with "poor" and "lower than average" somatic health to the "average" and "higher than average" health group was noted (p < 0.05). The students' physical characteristics improved by 36.4%. CONCLUSION: The conducted research proved the necessity of using sectional swimming activities as a means of physical rehabilitation of students with low health.