1. Short-Course Paromomycin Treatment of Visceral Leishmaniasis in India: 14-Day vs 21-Day Treatment.
- Author
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Sundar, Shyam, Agrawal, Neha, Arora, Rakesh, Agarwal, Dipti, Rai, Madhukar, and Chakravarty, Jaya
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VISCERAL leishmaniasis , *LEISHMANIASIS , *ENZYMES , *PROTOZOAN diseases , *PAIN , *INJECTIONS , *MEDICAL care , *PUBLIC health - Abstract
Background. Treatment of visceral leishmaniasis (VL) is far from satisfactory. There is an urgent need for a therapy that is efficacious, safe, affordable, and of short duration. Methods. A randomized open-label study was conducted to assess the efficacy and safety of 2 regimens of paromomycin administered intramuscularly. Group A received 11 mg/kg/day for 14 days (n = 217 ) and group B received 11 mg/kg/day for 21 days (n = 112) for the treatment of VL in India. Results. Mild grade injection site pain was the most common adverse event. There was no nephrotoxicity, but 4 patients in group A had to discontinue treatment because of grade 3 elevation of hepatic enzymes. Initial cure was observed in 91.2% and 96.4% of patients in group A and group B, respectively. Definitive cure at 6 months of follow up was seen in 82% of patients in group A and 92% of patients in group B by intention-to-treat analysis and in 84.3% of patients in group A and 92.8% of patients in group B by per protocol analysis. Conclusions. Although the cure rate in the group of patients who received the 14-day regimen was not optimal, the results with respect to initial cure were encouraging. Further studies that combine a short course of paromomycin with treatment with another antileishmanial agent are warranted. [ABSTRACT FROM AUTHOR]
- Published
- 2009
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