Cookies on this website
We use cookies to ensure that we give you the best experience on our website. If you click 'Continue' we'll assume that you are happy to receive all cookies and you won't see this message again. Click 'Find out more' for information on how to change your cookie settings.

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

Similar stories

Peter Horby receives prestigious award for outstanding service to public health

The Faculty of Public Health has awarded its prestigious Alwyn Smith Prize to Professor Sir Peter Horby for 2020/2021 in recognition of his outstanding service to public health as a global leader in epidemic science.

Lack of evidence is key barrier to using portable devices to detect poor quality medicines

A series of papers which reviewed portable devices to detect poor quality medicines has concluded major gaps in scientific evidence remain a key barrier for regulators to implement surveillance systems using such devices.

RECOVERY Trial paper on dexamethasone wins BMJ’s 2021 UK Research Paper of the Year Award

A RECOVERY Collaborative Group paper has been announced as the 2021 winner of The British Medical Journal’s prestigious UK Research Paper of the Year Award. This award recognises original UK research that has the potential to contribute significantly to improving health and healthcare. The paper, “Dexamethasone in Hospitalized Patients with Covid-19”, published in the New England Journal of Medicine, described the discovery in June 2020 of the world’s first effective, readily available treatment for COVID-19 – the inexpensive steroid, dexamethasone.

Tropical Medicine DPhil Students awarded NDM Prize

Every year, the Nuffield Department of Medicine awards NDM Prizes to our most outstanding students. This year, Mo yin and Rebecca Inglis (both at MORU) were highly commended in the category NDM Overall Prize, for conducting research with an outstanding impact. Will Schilling (MORU) received a prize as first year DPhil student, and Mohammad Ali (OCGHR) as second year DPhil student. Our warmest congratulations to you all!

New study alerts to the risk of poor quality medicines used to prevent and treat cardiovascular disease

There are important but neglected issues with substandard and falsified medicines and medical products used to prevent and treat cardiovascular diseases. From limited available data, MORU and IDDO scientists found about one fifth of medicines reported as sampled in the literature were substandard or falsified. This systematic review suggests that more and better quality data and data sharing are needed to better understand the global burden of this problem and inform interventions.

Systematic review identifies research gaps for Chagas disease

A new, large-scale systematic review published in PLOS Neglected Tropical Diseases has identified clear, significant research gaps in the diagnosis and treatment of Chagas disease. The paper also highlights significant differences in study design, diagnostic methods, duration of follow-up, and the timing of outcome assessment used by investigators even in the last decade.