Treatment of cutaneous leishmaniasis with a sequential scheme of pentamidine and tamoxifen in an area with a predominance of Leishmania (Viannia) guyanensis: A randomised, non‐inferiority clinical trial

• Published in: Tropical medicine & international health Vol. 28; no. 12; pp. 871 - 880
• Main Authors: Pennini, Silmara Navarro, Oliveira Guerra, Jorge Augusto, Rebello, Paula Frassinetti Bessa, Abtibol‐Bernardino, Marília Rosa, Castro, Luigui Lima, Silva Balieiro, Antonio Alcirley, Oliveira Ferreira, Cynthia, Noronha, Ariani Batista, Santos da Silva, Camila Gurgel, Leturiondo, André Luiz, Vital de Jesus, Denison, Araújo Santos, Felipe Jules, Chrusciak‐Talhari, Anette, Guerra, Maria Das Graças Vale Barbosa, Talhari, Sinésio
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.12.2023
• Subjects: Antiprotozoal Agents; Clinical outcomes; clinical trial; Clinical trials; Cutaneous leishmaniasis; Healing; Humans; Leishmania; Leishmania guyanensis; Leishmaniasis, Cutaneous - drug therapy; Leishmaniasis, Cutaneous - pathology; Parasitic diseases; Patients; PCR; Pentamidine; Pentamidine - therapeutic use; Tamoxifen; Tamoxifen - therapeutic use; Telemedicine; treatment; Vector-borne diseases; Western Amazon; clinical trial; telemedicine; treatment; Western Amazon; cutaneous leishmaniasis; PCR; tamoxifen
• ISSN: 1360-2276; 1365-3156; 1365-3156
• DOI: 10.1111/tmi.13943

Objective To determine whether a combination of a single intramuscular (IM) dose of pentamidine (7 mg/kg) followed by oral tamoxifen 40 mg/day for 20 days is non‐inferior to three IM doses of pentamidine 7 mg/kg in the treatment of cutaneous leishmaniasis with a margin of 15%. Methods Phase II, randomised, controlled, open‐label, non‐inferiority clinical trial. Primary outcome was the complete healing of the lesions 6 months after starting treatment. Secondary outcomes were healing 3 months after starting treatment and determining the presence and severity of adverse effects (AE). Results The research was concluded with 49 patients; Leishmania (Viannia) guyanensis was the most frequent species isolated. In the primary outcome, 18 (72%) (95% CI: 52.4%–85.7%) of the 25 patients allocated to the intervention group and 24 (100%) (95% CI: 86.2%–100%) of the control group (p = 0.015) met the established criteria of cure. There was no AE with tamoxifen. Conclusion Although a 72% cure rate presented by the combination of tamoxifen and pentamidine was lower than in the control group that achieved a 100% cure, it is still a safe and is a clinically relevant result. It indicates that the therapeutic scheme evaluated may be a promising option for populations in remote areas, however it should be further studied, in order to include a larger number of patients.