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This large-scale systematic review and meta-analysis aimed to collate all reported serious adverse events in visceral leishmaniasis clinical trials and quantify the incidence of mortality during the first 30 days of therapy. The analyses, which included clinical data from more than 35,000 patients, found that mortality following treatment was an extremely rare event and serious adverse events following treatments were poorly reported.

Female patient get a check up in a healthcentre in India © Curt Carnemark, World Bank

Visceral leishmaniasis (VL) is a poverty-related infectious disease that causes up to 30,000 deaths per year, with over 600 million people at risk. The disease causes fever, weight loss and spleen and liver enlargement. If left untreated, it can cause death within two years. Existing treatments are often lengthy, painful, costly and poorly tolerated. However, despite antileishmanial drugs being associated with poor tolerability, a comprehensive library on different safety events following these therapies is lacking.

The authors conducted a comprehensive review of the clinical literature to document reports of serious adverse events (SAEs) following antileishmanial chemotherapies. Overall, mortality following antileishmanial treatment is a rare event reported in clinical trials. Some variation in mortality rates are seen across geographic regions and patient sub-groups, for example, patients with HIV co-infection.

Prabin Dahal and colleagues found that reporting of SAEs was inconsistent in the published literature. The timing, cause and frequency of these were often poorly reported. Furthermore, just over two-thirds of the studies did not provide the standards used to assess the severity of SAEs.

IDDO is working with the VL research community in a new global collaboration to develop a set of freely-available universal standards for the collection of VL data. This collaboration, involving representatives from the VL research community, the pharmaceutical industry, drug regulators, key national and global health partners and CDISC aims to set guidelines that will benefit current and future research into the disease.

The full story is available on the IDDO website

Read the publication: Serious adverse events and mortality following treatment of Visceral Leishmaniasis: A systematic review and meta-analysis. PLOS Neglected Tropical Diseases

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