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Background <p>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 <i>Plasmodium vivax</i> malaria control and elimination efforts.</p> Methods <p>A living systematic review identified efficacy studies of uncomplicated <i>P. vivax</i> 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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月14日

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  • Peta Edler,
  • Megha Rajasekhar,
  • David J. Price,
  • Ishag Adam,
  • Ghulam Rahim Awab,
  • Bridget E. Barber,
  • Larissa W. Brasil,
  • Nathália N. Chamma-Siqueira,
  • Cindy S. Chu,
  • Liwang Cui,
  • André Daher,
  • Margarete do Socorro M. Gomes,
  • Lilia Gonzalez-Ceron,
  • Matthew J. Grigg,
  • Harin Karunajeewa,
  • Marcus V. G. Lacerda,
  • Simone Ladeia-Andrade,
  • Toby Leslie,
  • Benedikt Ley,
  • Kartini Lidia,
  • Alejandro Llanos-Cuentas,
  • Rhea J. Longley,
  • Laurens Manning,
  • Daniel Abebe Mekonnen,
  • Wuelton Marcelo Monteiro,
  • Brioni R. Moore,
  • Francois Nosten,
  • Ayodhia Pitaloka Pasaribu,
  • Dhelio B. Pereira,
  • Jeanne Rini Poespoprodjo,
  • Sasithon Pukrittayakamee,
  • Komal Raj Rijal,
  • Kavitha Saravu,
  • André M. Siqueira,
  • Inge Sutanto,
  • Walter R. J. Taylor,
  • Pham Vinh Thanh,
  • Kamala Thriemer,
  • José Luiz F. Vieira,
  • Nicholas J. White,
  • Asnakew K. Yeshiwondim,
  • Lina M. Zuluaga-Idarraga,
  • Philippe J. Guerin,
  • Julie A. Simpson,
  • Ric N. Price,
  • Robert J. Commons,
  • Tesfay Abreha,
  • Bipin Adhikari,
  • Mohammad Shafiul Alam,
  • Nicholas M. Anstey,
  • Ashenafi Assefa,
  • J. Kevin Baird,
  • Sarah C. Boyd,
  • Nguyen Hoang Chau,
  • Nicholas P. J. Day,
  • Tamiru Shibiru Degaga,
  • Arjen M. Dondorp,
  • Annette Erhart,
  • Marcelo U. Ferreira,
  • Endalamaw Gadisa,
  • Najia Ghanchi,
  • Prakash Ghimire,
  • Justin A. Green,
  • Mohammad Anwar Hassanzai,
  • Jimee Hwang,
  • Wasif Ali Khan,
  • Gavin C. K. W. Koh,
  • Rishikesh Kumar,
  • Asrat Hailu Mekuria,
  • Ivo Mueller,
  • Mohammad Nader Naadim,
  • Suaine C. Negreiros,
  • Erni J. Nelwan,
  • Anielle de Pina-Costa,
  • Mark Rowland,
  • Jetsumon Sattabongkot,
  • Guilherme Suarez-Kurtz,
  • Fitsum G. Tadesse,
  • Giselle M. R. Viana,
  • Lorenz von Seidlein,
  • Timothy William,
  • Charles J. Woodrow,
  • Sze-Ann Woon,
  • Adugna Woyessa

摘要

Background

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.

Methods

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.

Results

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.

Conclusions

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.