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Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trialCommentary: cost and resistance remain issues

BMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7310.419 (Published 25 August 2001) Cite this as: BMJ 2001;323:419

Footnotes

  • Accepted 14 May 2001

Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial

  1. Shyam Sundar, professora (shyams_vns{at}satyam.net.in),
  2. G Agrawal, residenta,
  3. Madhukar Rai, lecturera,
  4. M K Makharia, medical officera,
  5. Henry W Murray, professorb
  1. a Kala-Azar Medical Research Centre, Banaras Hindu University, Department of Medicine, Institute of Medical Sciences, Varanasi-211005, India,
  2. b Department of Medicine, Weill Medical College of Cornell University, New York NY 10021, USA
  3. Hospital for Tropical Diseases, London WC1E 6AU
  1. Correspondence to: Dr Sundar

    Abstract

    Objective: To test short course, low dose liposomal amphotericin B as single or daily infusion treatment in Indian visceral leishmaniasis (kala-azar).

    Design: Randomised, open label study.

    Setting: Inpatient unit for leishmaniasis in Bihar, India.

    Participants: 91 adults and children with splenic aspirate positive for infection.

    Interventions: Total dose of 5 mg/kg of liposomal amphotericin B given as a single infusion (n=46) or as once daily infusions of 1 mg/kg for five days (n=45).

    Main outcome measures: Clinical and parasitological cure assessed 14 days after treatment and long term definitive cure (healthy, no relapse) at six months.

    Results: All but one person in each group had an initial apparent cure. During six months of follow up, three patients in the single dose group and two in the five dose group relapsed. Complete response (definitive cure) was therefore achieved in 84 of 91 subjects (92%): 42 of 46 patients in the single dose group (91%, 95% confidence interval 79% to 98%) and 42 of 45 in the five dose group (93%, 82% to 99%). Response rates in the two groups were not significantly different.

    Conclusion: Low dose liposomal amphotericin B (5 mg/kg), given either as a five day course or as a single infusion, seems to be effective for visceral leishmaniasis and warrants further testing.

    Footnotes

    • Funding The Sitaram Memorial trust provided partial financial support for this study, and NeXstar provided the AmBisome. NeXstar had no role in gathering or interpreting the data or in deciding if the study was to be submitted for publication.

    • Competing interests SS has been reimbursed by NeXstar for attending several conferences. SS has also served as principal investigator for two trials of AmBisome funded by NeXstar in India.

      Commentary: cost and resistance remain issues

      1. Diana N J Lockwood, consultant physician (Diana.Lockwood{at}lshtm.ac.uk)
      1. a Kala-Azar Medical Research Centre, Banaras Hindu University, Department of Medicine, Institute of Medical Sciences, Varanasi-211005, India,
      2. b Department of Medicine, Weill Medical College of Cornell University, New York NY 10021, USA
      3. Hospital for Tropical Diseases, London WC1E 6AU

        Footnotes

        • Competing interests None declared.

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