Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: A multicentre, randomized, blinded, placebo-controlled, 40-week extension
The Lancet Aug 07, 2019
Wesson DE, Mathur V, Tangri N, et al. - Via a multicentre, randomized, blinded, placebo-controlled, 40-week extension of a 12-week parent study at 29 sites in seven countries (Bulgaria, Georgia, Hungary, Serbia, Slovenia, Ukraine, and the USA) on 217 individuals were those with chronic kidney disease and metabolic acidosis who finished the 12-week parent study, researchers intended to determine the long-term safety and efficiency of veverimer in such individuals. Fewer individuals on the veverimer discontinued treatment prematurely, and no individuals on the veverimer discontinued due to an adverse event, in comparison with the placebo. In 2% and 5% of veverimer-treated and placebo individuals, respectively, severe adverse events were noted. In 8% and 15% in the veverimer and placebo groups, respectively, renal system adverse events were observed. At week 52, more individuals on veverimer vs placebo had an elevation in bicarbonate and at all time points starting at week 1, greater bicarbonate concentrations were noted with the veverimer vs placebo. With a mean placebo-subtracted difference at end of treatment of 12·1 points, veverimer led to betterment in patient-reported physical functioning in comparison with the placebo. Time to do the repeated chair stand test progressed by 4·3s on veverimer vs 1·4s on placebo. Therefore, the veverimer safely and efficiently fixed metabolic acidosis and improved subjective and objective measures of physical function, in individuals with chronic kidney disease and metabolic acidosis.
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