by Singh-Phulgenda S, Dahal P, Ngu R, Maguire BJ, Hawryszkiewycz A, Rashan S, Brack M, Halleux CM, Alves F, Stepniewska K, Olliaro PL, Guerin PJ. PLOS Neglected Tropical Diseases 2021;15(3): e0009302. doi: 10.1371/journal.pntd.0009302
Summary: This update of an earlier systematic review of all published clinical trials in visceral leishmaniasis from 1980 to 2019 documents any reported serious adverse events. Authors identified 157 published studies enrolling 35,376 patients in 347 treatment arms and carried out a meta-analysis to quantify the incidence rate of death within 30 days of treatment initiation. Mortality within the first 30 days of visceral leishmaniasis treatment initiation was a rarely reported event in clinical trials with an overall estimated rate of 0.068 deaths per 1,000 person-days at risk, varying across regions and populations, which could serve as a benchmark for future trials for prospective and pharmacovigilance studies.
