Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia
Addition of the immunomodulator pentoxifylline (PTX) to antimonial treatment of mucosal leishmaniasis has shown increased efficacy. This randomized, double-blind, placebo-controlled trial evaluated whether addition of pentoxifylline to meglumine antimoniate (MA) treatment improves therapeutic respon...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-03-01
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| Series: | Pathogens |
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| Online Access: | https://www.mdpi.com/2076-0817/11/3/378 |
| _version_ | 1797443752655060992 |
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| author | Maria del Mar Castro Alexandra Cossio Adriana Navas Olga Fernandez Liliana Valderrama Lyda Cuervo-Pardo Ricardo Marquez-Oñate María Adelaida Gómez Nancy Gore Saravia |
| author_facet | Maria del Mar Castro Alexandra Cossio Adriana Navas Olga Fernandez Liliana Valderrama Lyda Cuervo-Pardo Ricardo Marquez-Oñate María Adelaida Gómez Nancy Gore Saravia |
| author_sort | Maria del Mar Castro |
| collection | DOAJ |
| description | Addition of the immunomodulator pentoxifylline (PTX) to antimonial treatment of mucosal leishmaniasis has shown increased efficacy. This randomized, double-blind, placebo-controlled trial evaluated whether addition of pentoxifylline to meglumine antimoniate (MA) treatment improves therapeutic response in cutaneous leishmaniasis (CL) patients. Seventy-three patients aged 18–65 years, having multiple lesions or a single lesion ≥ 3 cm were randomized to receive: intramuscular MA (20 mg/kg/day × 20 days) plus oral PTX 400 mg thrice daily (intervention arm, <i>n</i> = 36) or MA plus placebo (control arm, <i>n</i> = 37), between 2012 and 2015. Inflammatory gene expression was evaluated by RT-qPCR in peripheral blood mononuclear cells from trial patients, before and after treatment. Intention-to-treat failure rate was 35% for intervention vs. 25% for control (OR: 0.61, 95% CI: 0.21–1.71). Per-protocol failure rate was 32% for PTX, and 24% for placebo (OR: 0.50, 95% CI: 0.13–1.97). No differences in frequency or severity of adverse events were found (PTX = 142 vs. placebo = 140). Expression of inflammatory mediators was unaltered by addition of PTX to MA. However, therapeutic failure was associated with significant overexpression of <i>il1β</i> and <i>ptgs2</i> (<i>p</i> < 0.05), irrespective of study group. No clinical benefit of addition of PTX to standard treatment was detected in early mild to moderate CL caused by <i>Leishmania</i> (<i>V</i>.) <i>panamensis</i>. |
| first_indexed | 2024-03-09T13:01:59Z |
| format | Article |
| id | doaj.art-ad40c693575e4c2f813d66c2bd58e19d |
| institution | Directory Open Access Journal |
| issn | 2076-0817 |
| language | English |
| last_indexed | 2024-03-09T13:01:59Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pathogens |
| spelling | doaj.art-ad40c693575e4c2f813d66c2bd58e19d2023-11-30T21:53:12ZengMDPI AGPathogens2076-08172022-03-0111337810.3390/pathogens11030378Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in ColombiaMaria del Mar Castro0Alexandra Cossio1Adriana Navas2Olga Fernandez3Liliana Valderrama4Lyda Cuervo-Pardo5Ricardo Marquez-Oñate6María Adelaida Gómez7Nancy Gore Saravia8Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali 760031, ColombiaAddition of the immunomodulator pentoxifylline (PTX) to antimonial treatment of mucosal leishmaniasis has shown increased efficacy. This randomized, double-blind, placebo-controlled trial evaluated whether addition of pentoxifylline to meglumine antimoniate (MA) treatment improves therapeutic response in cutaneous leishmaniasis (CL) patients. Seventy-three patients aged 18–65 years, having multiple lesions or a single lesion ≥ 3 cm were randomized to receive: intramuscular MA (20 mg/kg/day × 20 days) plus oral PTX 400 mg thrice daily (intervention arm, <i>n</i> = 36) or MA plus placebo (control arm, <i>n</i> = 37), between 2012 and 2015. Inflammatory gene expression was evaluated by RT-qPCR in peripheral blood mononuclear cells from trial patients, before and after treatment. Intention-to-treat failure rate was 35% for intervention vs. 25% for control (OR: 0.61, 95% CI: 0.21–1.71). Per-protocol failure rate was 32% for PTX, and 24% for placebo (OR: 0.50, 95% CI: 0.13–1.97). No differences in frequency or severity of adverse events were found (PTX = 142 vs. placebo = 140). Expression of inflammatory mediators was unaltered by addition of PTX to MA. However, therapeutic failure was associated with significant overexpression of <i>il1β</i> and <i>ptgs2</i> (<i>p</i> < 0.05), irrespective of study group. No clinical benefit of addition of PTX to standard treatment was detected in early mild to moderate CL caused by <i>Leishmania</i> (<i>V</i>.) <i>panamensis</i>.https://www.mdpi.com/2076-0817/11/3/378cutaneous leishmaniasispentoxifyllinemeglumine antimoniateclinical trial |
| spellingShingle | Maria del Mar Castro Alexandra Cossio Adriana Navas Olga Fernandez Liliana Valderrama Lyda Cuervo-Pardo Ricardo Marquez-Oñate María Adelaida Gómez Nancy Gore Saravia Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia Pathogens cutaneous leishmaniasis pentoxifylline meglumine antimoniate clinical trial |
| title | Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia |
| title_full | Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia |
| title_fullStr | Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia |
| title_full_unstemmed | Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia |
| title_short | Pentoxifylline in the Treatment of Cutaneous Leishmaniasis: A Randomized Clinical Trial in Colombia |
| title_sort | pentoxifylline in the treatment of cutaneous leishmaniasis a randomized clinical trial in colombia |
| topic | cutaneous leishmaniasis pentoxifylline meglumine antimoniate clinical trial |
| url | https://www.mdpi.com/2076-0817/11/3/378 |
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