Efficacy and Safety of Combination of Sodium Stibogluconate and Paromomycin for Treatment of Visceral Leishmaniasis and Factors Associated with Poor Treatment Outcomes. A Retrospective Study, North West Ethiopia
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Date
2020-06
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Addis Abeba University
Abstract
Background: Visceral leishmaniasis is among the most neglected tropical infectious
disease caused by the protozoan parasite of the genius lesihmania. The incidence of VL is
estimated to be 0.2 to 0.4 million cases /year worldwide. It is fatal if left untreated.
Objective: The objective of this study was to assess efficacy and safety of combination
of SSG (20mg/kg/day) and paromomycin (15mg/kg/day) and associated factors for poor
treatment outcomes.
Methods: A retrospective cohort study design was used. Medical record review of VL
patients treated with combination of sodium stibogluconate and Paromomycin between
2012 and 2019 was conducted.
Results: In total, 1000 VL patients were included. The overall initial cure was achieved
in 924 (92.4%). Treatment failure, treatment interruptions, default and deaths respectively
were noted in 30(3%), 25 (2.5%), 13 (1.3%) and 8(0.8%). The efficacy of SSG/PM
(186/208, 89.4%) Vs (738/792, 93.2%) was not different respectively for patients with
weight ≤ 42.5kg and >42.5kg (p=0.07). The most common adverse events were raised
liver transaminases 351(35.1%), injection site pain 291(29.1%) and increased in serum
alpha-amylase 291 (29.1%). The frequency of cardiac arrhythmia 6(0.6%) and clinical
pancreatitis 21(2.1%) were low. Factors associated with poor treatment outcomes were
sepsis (OR= 7.6, 95% CI: 1.86 - 31.03, P = 0.005), clinical pancreatitis (OR= 4, 95% CI:
1.21 – 13.43, P= 0.02), and cardiac arrhythmia (OR=13, 95% CI: 2.30 – 84.34, P: 0.004).
Patients’ body weight had no effect on poor treatment outcome (OR = 1.6, 95% CI: 0.89
– 3.06). Of patients who attended six-month visit, cure was achieved in 259/276 (93.8%).
Post kala-azar dermal leishmaniasis was 13 (1.3%).
Conclusion and Recommendations. The efficacy of SSG at 20mg/kg with upper
maximum dose limit (850mg/day) and PM at 15mg/kg was 92.4%. Our data affirms
effectiveness of SSG/PM, as presently used in Eastern African countries, and no issues of
concern have been identified. The continued use of the combination therapy is warranted.
Similar studies are recommended in the countries affected by the disease. Sepsis,
pancreatitis and cardiac arrhythmias should be identified and managed as per VL
management protocol to prevent poor treatment outcomes .
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Keywords
Sodium Stibogluconate , Paromomycin , Visceral Leishmaniasis