# Automated reporting of primaquine dose efficacy, tolerability and safety for Plasmodium vivax malaria using a systematic review and individual patient data meta-analysis

## TL;DR

This paper presents automated reports on the effectiveness and safety of primaquine doses for treating P. vivax malaria, using data from 41 studies to help guide treatment policies.

## Contribution

The study introduces an automated reporting system using a large database and R Shiny app to analyze primaquine dose effects in different regions.

## Key findings

- 9,270 patient records from 41 studies were pooled into a standardized database.
- Automated reports provide region-specific insights into primaquine efficacy and safety.
- The system supports policy decisions by analyzing dose effects on relapse, haemolysis, and tolerability.

## Abstract

The antirelapse efficacy of primaquine is related to the total dose administered, whereas the risks of haemolysis and gastrointestinal intolerance are associated with the daily dose administered. National Malaria Control Programmes require local information on efficacy, tolerability and safety to optimize antimalarial treatment policies for Plasmodium vivax malaria control and elimination efforts.

A living systematic review identified efficacy studies of uncomplicated P. vivax malaria including patients treated with daily primaquine regimens, published since January 1, 2000. Available data were pooled and an R Shiny app was developed to integrate statistical analyses performed using R and Stata that assessed the impact of primaquine mg/kg dose on efficacy, hematological safety and gastrointestinal tolerability.

As of January 16, 2025, a total of 9,270 individual patient data records from 41 studies have been collated into the standardized repository. Open-access automated reports were generated for user-selected countries or regions to investigate location specific effects of primaquine dose on efficacy, safety and tolerability. The reports include visual and tabular displays of the outcomes.

These automated reports leverage a large database to provide accessible data for national and regional policy makers and researchers to assess the clinical consequences of different primaquine regimens in different endemic settings. The reports will inform local and regional policy decisions and research priorities in vivax-endemic areas.