RESUMO
BACKGROUND: Standard treatment of cutaneous leishmaniasis (CL) in Suriname entails three injections of pentamidine isethionate (PI) 4 mg/kg per injection in 7 days (7 day regimen). Compliance to treatment is low and may contribute to increasing therapy failure. A 3 day regimen, including 2 injections of 7 mg/kg in 3 days may increase compliance. METHODS: In a randomized, single-blinded non-inferiority trial conducted in Suriname, 84 CL patients received the 7 day regimen and 79 CL patients received the 3 day regimen. Primary objective was the proportion of patients clinically cured at 6 weeks follow-up. Secondary objectives were clinical cure at 12 weeks follow-up; parasitological cure at 6 and 12 weeks; adverse and drug related toxicity events recorded one week after the end of treatment and health related quality of life. The non-inferiority margin was set at 15%, 1 sided test, α = 0.1. RESULTS: At 6 weeks follow-up 31 (39%) patients in the 3 day regimen and 41 (49%) patients in the 7 day regimen were clinically cured. Intention to treat (ITT) analyses showed that the difference in proportion clinically cured was -9.6% (90% Confidence Interval (CI): -22.3% to 3.2%). Per protocol (PP) analysis showed that the difference in proportion clinically cured was 0.2% (90% CI: -14.6% to 15.2%). ITT analysis showed that the difference in proportion parasitological cured at 6 weeks was -15.2% (90% CI:-28.0% to -2.5%). PP analyses showed similar results. Non-inferiority could not be concluded for all adverse and toxicological events. CONCLUSION: We cannot conclude that the 3 day regimen is non-inferior to the 7 day regimen regarding proportion clinically and parasitological cured. Therefore there is no evidence to change the current standard practice of the 7 day regimen for the treatment of CL in Suriname.
Assuntos
Leishmaniose Cutânea/tratamento farmacológico , Pentamidina/administração & dosagem , Pentamidina/farmacologia , Adulto , Idoso , Relação Dose-Resposta a Droga , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente , Qualidade de Vida , Suriname , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: In Suriname, pentamidine isethionate (PI) is the only drug available for the treatment of cutaneous leishmaniasis (CL). Recently, local dermatologists have observed an increase in CL patients not responding adequately to the standard doses. METHODS: In this study, patient compliance to PI treatment was assessed, and its efficacy was evaluated by comparing the clinical criteria and parasitologic load in week 3 of treatment. Skin biopsies were collected before, during and at the end of therapy and tested by quantitative nucleic acid sequence-based amplification. RESULTS: In total, 67 patients with suspected CL were enrolled during the recruitment period, of which only 23 patients with confirmed CL were followed until the end of treatment. All 23 patients were found to be infected with Leishmania (Viannia) guyanensis. A lower cure rate (76-78%) was estimated than that obtained previously (90%), and only 50% of the recruited CL patients finished the complete treatment schedule. CONCLUSIONS: As one-half of the CL patients were treated insufficiently, a much shorter treatment protocol should be considered to improve the inadequate follow-up.