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Single-Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India

Anne

Senior Moderator
A good news :
free full texte here : http://content.nejm.org/cgi/content/full/362/6/504
[FONT=Arial, Helvetica, sans-serif][SIZE=+2]Single-Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India[/SIZE][/FONT]
<!-- AUTHOR_DISPLAY --> <center>[SIZE=+1] Shyam Sundar, M.D., Jaya Chakravarty, M.D., Dipti Agarwal, M.D., Madhukar Rai, M.D., and Henry W. Murray, M.D.


[/SIZE]</center>[FONT=arial, helvetica][SIZE=+1]ABSTRACT[/SIZE][/FONT] [FONT=arial, helvetica] 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>[/FONT]
[FONT=arial, helvetica]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>[/FONT]
[FONT=arial, helvetica]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>[/FONT]
[FONT=arial, helvetica]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>[/FONT]
[FONT=arial, helvetica]<sup> </sup>[/FONT]

[FONT=arial, helvetica][SIZE=+1]Source Information[/SIZE][/FONT]
[SIZE=-1] 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.). [/SIZE]
[SIZE=-1]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>.[/SIZE]
 
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