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Injectable paromomycin for Visceral leishmaniasis in India
Shyam Sundar1, T K Jha, Chandreshwar P Thakur
1Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. drshyamsundar@hotmail.com
The New England Journal of Medicine
|June 22, 2007
Summary
Paromomycin is a viable alternative to amphotericin B for treating visceral leishmaniasis (kala-azar) in India. This study found paromomycin to be noninferior to amphotericin B, offering a potentially safer and more accessible treatment option.
Area of Science:
- Tropical medicine
- Infectious diseases
- Clinical pharmacology
Background:
- Visceral leishmaniasis (kala-azar) disproportionately affects underserved populations in endemic regions.
- Current therapies for visceral leishmaniasis face challenges regarding safety, efficacy, and cost.
- There is a critical need for novel and improved therapeutic agents.
Purpose of the Study:
- To compare the efficacy and safety of paromomycin with amphotericin B for visceral leishmaniasis treatment.
- To evaluate paromomycin as a potential alternative to the current standard of care.
- To assess cure rates and adverse events in a phase 3 clinical trial.
Main Methods:
- A randomized, controlled, open-label, phase 3 study was conducted in four visceral leishmaniasis treatment centers in India.
- 667 patients (ages 5-55) with confirmed visceral leishmaniasis were randomized (3:1) to receive either paromomycin (11 mg/kg daily for 21 days) or amphotericin B (1 mg/kg every other day for 30 days).
- Noninferiority testing was used to compare 6-month cure rates, with a 10% noninferiority margin. Safety was monitored through clinical and laboratory evaluations.
Main Results:
- Paromomycin demonstrated noninferiority to amphotericin B, with cure rates of 94.6% and 98.8%, respectively.
- Mortality rates were low (<1%) in both treatment groups.
- Adverse events were more frequent with paromomycin (6%) than amphotericin B (2%), but included more injection-site pain and transient liver enzyme elevations. Amphotericin B was associated with higher rates of nephrotoxicity, fever, rigors, and vomiting.
Conclusions:
- Paromomycin is a noninferior treatment option to amphotericin B for visceral leishmaniasis in the studied Indian population.
- Paromomycin offers a potentially favorable safety profile compared to amphotericin B, with fewer severe adverse events.
- The findings support the use of paromomycin as an accessible and effective therapy for visceral leishmaniasis.
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