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Single-Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India

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  • Single-Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India

    A good news :
    free full texte here : http://content.nejm.org/cgi/content/full/362/6/504
    Single-Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India
    <!-- AUTHOR_DISPLAY --> <center> Shyam Sundar, M.D., Jaya Chakravarty, M.D., Dipti Agarwal, M.D., Madhukar Rai, M.D., and Henry W. Murray, M.D.


    </center>ABSTRACT Background Some 50% of patients with visceral leishmaniasis<sup> </sup>(kala-azar) worldwide live in the Indian state of Bihar. Liposomal<sup> </sup>amphotericin B is an effective treatment when administered in<sup> </sup>short courses. We wanted to determine whether the efficacy of<sup> </sup>a single infusion of liposomal amphotericin B was inferior to<sup> </sup>conventional parenteral therapy, consisting of 15 alternate-day<sup> </sup>infusions of amphotericin B deoxycholate.<sup> </sup>
    Methods In this open-label study, we randomly assigned 412 patients<sup> </sup>in a 3:1 ratio to receive either liposomal amphotericin B (liposomal-therapy<sup> </sup>group) or amphotericin B deoxycholate (conventional-therapy<sup> </sup>group). Liposomal amphotericin B (at a dose of 10 mg per kilogram<sup> </sup>of body weight) was given once, and patients were discharged<sup> </sup>home 24 hours later. Amphotericin B deoxycholate, which was<sup> </sup>administered in 15 infusions of 1 mg per kilogram, was given<sup> </sup>every other day during a 29-day hospitalization. We determined<sup> </sup>the cure rate 6 months after treatment.<sup> </sup>
    Results A total of 410 patients 304 of 304 patients<sup> </sup>(100%) in the liposomal-therapy group and 106 of 108 patients<sup> </sup>(98%) in the conventional-therapy group had apparent<sup> </sup>cure responses at day 30. Cure rates at 6 months were similar<sup> </sup>in the two groups: 95.7% (95% confidence interval [CI], 93.4<sup> </sup>to 97.9) in the liposomal-therapy group and 96.3% (95% CI, 92.6<sup> </sup>to 99.9) in the conventional-therapy group. Adverse events in<sup> </sup>the liposomal-therapy group were infusion-related fever or rigors<sup> </sup>(in 40%) and increased anemia or thrombocytopenia (in 2%); such<sup> </sup>events in the conventional-therapy group were fever or rigors<sup> </sup>(in 64%), increased anemia (in 19%), and hypokalemia (in 2%).<sup> </sup>Nephrotoxicity or hepatotoxicity developed in no more than 1%<sup> </sup>of patients in each group.<sup> </sup>
    Conclusions A single infusion of liposomal amphotericin B was<sup> </sup>not inferior to and was less expensive than conventional therapy<sup> </sup>with amphotericin B deoxycholate. (ClinicalTrials.gov number,<sup> </sup>NCT00628719<!-- HIGHWIRE EXLINK_ID="362:6:504:1" VALUE="NCT00628719" TYPEGUESS="CLINTRIALGOV" --> [ClinicalTrials.gov] <!-- /HIGHWIRE -->.)<sup> </sup>
    <sup> </sup>

    Source Information
    From the Kala-Azar Medical Research Center, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India (S.S., J.C., D.A., M.R.); and the Department of Medicine, Weill Cornell Medical College, New York (H.W.M.).
    Address reprint requests to Dr. Sundar at the Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221 005, India, or at drshyamsundar@hotmail.com<script type="text/javascript"><!-- var u = "drshyamsundar", d = "hotmail.com"; document.getElementById("em0").innerHTML = '<a href="mailto:' + u + '@' + d + '">' + u + '@' + d + '<\/a>'//--></script>.
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