EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://doi.org/10.29021/spdv.72.4.317 |
Resumo: | Introduction: Actinic keratosis is the most common premalignant lesion. The therapeutic approach to patients with multiple lesions involves field-directed treatment.Objective: To evaluate the efficacy and safety of ingenol mebutato, a new drug treatment for topical field-directed treatment of actinic keratosis.Design: Systematic review and meta-analysis of randomized controlled trials (RCTs) trials.Data sources: Medline and Cochrane Library (June 2014).Study selection: Two reviewers independently searched for studies and retrieved their characteristics and data estimates.Data synthesis: Random-effects meta-analysis. Heterogeneity was assessed with the I2 test.Results: Six trials (n = 1,492) versus placebo were included. The odds of a patient experiencing complete removal of the lesions was 17 (95%CI: 9 to 31, I2 = 0%) and 8.5 (95% CI: 5 to 15, I2 = 0%) times higher, compared to placebo, in the face/scalp and trunk/extremities, respectively. The incidence of adverse events related to treatment was higher in the group of mebutato ingenol (+23%, 95%CI: 11 to 35%), with no differences between groups in the discontinuation rate due to adverse events.Conclusions: Mebutato of ingenol is efficacious in the treatment of actinic keratosis. Compared to other field-directed treatments available in Portugal, its therapeutic value comes from the favourable safety profile and tolerability, simplicity and short duration of the treatment regimen and the possibility of different treatment to injuries according to anatomical location (individualization of therapy). Future studies should directly compare the different therapeutic options and evaluate the effectiveness of the same in the real world. |
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EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSISEFICÁCIA E SEGURANÇA DE MEBUTATO DE INGENOL NO TRATAMENTO DA QUERATOSE ACTÍNICA − REVISÃO SISTEMÁTICA E META-ANÁLISEDiterpenesKeratosisactinicMeta-analysisRandomized controlled trialsDiterpenesQueratose actínicaEnsaios clínicos controlados e aleatorizadoMeta-análiseIntroduction: Actinic keratosis is the most common premalignant lesion. The therapeutic approach to patients with multiple lesions involves field-directed treatment.Objective: To evaluate the efficacy and safety of ingenol mebutato, a new drug treatment for topical field-directed treatment of actinic keratosis.Design: Systematic review and meta-analysis of randomized controlled trials (RCTs) trials.Data sources: Medline and Cochrane Library (June 2014).Study selection: Two reviewers independently searched for studies and retrieved their characteristics and data estimates.Data synthesis: Random-effects meta-analysis. Heterogeneity was assessed with the I2 test.Results: Six trials (n = 1,492) versus placebo were included. The odds of a patient experiencing complete removal of the lesions was 17 (95%CI: 9 to 31, I2 = 0%) and 8.5 (95% CI: 5 to 15, I2 = 0%) times higher, compared to placebo, in the face/scalp and trunk/extremities, respectively. The incidence of adverse events related to treatment was higher in the group of mebutato ingenol (+23%, 95%CI: 11 to 35%), with no differences between groups in the discontinuation rate due to adverse events.Conclusions: Mebutato of ingenol is efficacious in the treatment of actinic keratosis. Compared to other field-directed treatments available in Portugal, its therapeutic value comes from the favourable safety profile and tolerability, simplicity and short duration of the treatment regimen and the possibility of different treatment to injuries according to anatomical location (individualization of therapy). Future studies should directly compare the different therapeutic options and evaluate the effectiveness of the same in the real world.Introdução: A queratose actínica é a lesão pré-maligna mais frequente. A abordagem terapêutica dos doentes com múltiplas lesões envolve terapêuticas de campo.Objetivo: Avaliar a eficácia e segurança de mebutato de ingenol, um novo medicamento destinado à terapêutica tópica de campo.Desenho: Revisão sistemática e meta-análise dos ensaios clínicos controlados e aleatorizados (RCTs).Fontes bibliográficas: Medline e Cochrane Library (junho 2014).Seleção dos estudos: A seleção e avaliação dos RCTs foram feitas de forma independente.Análise quantitativa: Meta-análise de efeitos aleatórios. A heterogeneidade foi avaliada com o teste I2.Resultados: Foram incluídos 6 ensaios (n=1.492) versus placebo. Mebutato de ingenol esteve associado a uma possibilidade de um doente ter remoção completa das lesões 17 (IC95%: 9 a 31; I2=0%) e 8,5 (IC95%: 5 a 15; I2=0%) vezes superior, comparativamente ao placebo, no rosto/couro cabeludo e no tronco/extremidades, respetivamente. A incidência de eventos adversos relacionados com o tratamento foi superior no grupo mebutato de ingenol (+23%, IC95%: 11 a 35%), sem diferenças entre grupos na taxa de abandono por eventos adversos.Conclusões: Mebutato de ingenol é eficaz no tratamento da queratose actínica. Comparativamente às restantes terapêuticas de campo disponíveis em Portugal, o seu valor terapêutico advém do favorável perfil de segurança e tolerabilidade, da simplicidade e curta duração do esquema terapêutico e da possibilidade de tratar de forma diferenciada as lesões de acordo com a localização anatómica (individualização da terapêutica). Estudos futuros deveriam comparar diretamente as diferentes opções terapêuticas e avaliar a efetividade das mesmas no mundo real.Sociedade Portuguesa de Dermatologia e Venereologia2015-04-13T00:00:00Zjournal articleinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://doi.org/10.29021/spdv.72.4.317oai:ojs.revista.spdv.com.pt:article/317Journal of the Portuguese Society of Dermatology and Venereology; Vol 72 No 4 (2014): Outubro - Dezembro; 481-492Revista da Sociedade Portuguesa de Dermatologia e Venereologia; v. 72 n. 4 (2014): Outubro - Dezembro; 481-4922182-24092182-2395reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttps://revista.spdv.com.pt/index.php/spdv/article/view/317https://doi.org/10.29021/spdv.72.4.317https://revista.spdv.com.pt/index.php/spdv/article/view/317/291Costa, JoãoSousa, RitaAlarcão, JoanaVaz-Carneiro, AntónioFilipe, Pauloinfo:eu-repo/semantics/openAccess2022-10-06T12:34:50Zoai:ojs.revista.spdv.com.pt:article/317Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:10:50.070639Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS EFICÁCIA E SEGURANÇA DE MEBUTATO DE INGENOL NO TRATAMENTO DA QUERATOSE ACTÍNICA − REVISÃO SISTEMÁTICA E META-ANÁLISE |
title |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS |
spellingShingle |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS Costa, João Diterpenes Keratosis actinic Meta-analysis Randomized controlled trials Diterpenes Queratose actínica Ensaios clínicos controlados e aleatorizado Meta-análise |
title_short |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS |
title_full |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS |
title_fullStr |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS |
title_full_unstemmed |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS |
title_sort |
EFFICACY AND SAFETY OF INGENOL MEBUTATE IN THE TREATMENT OF ACTINIC KERATOSIS − A SYSTEMATIC REVIEW AND META-ANALYSIS |
author |
Costa, João |
author_facet |
Costa, João Sousa, Rita Alarcão, Joana Vaz-Carneiro, António Filipe, Paulo |
author_role |
author |
author2 |
Sousa, Rita Alarcão, Joana Vaz-Carneiro, António Filipe, Paulo |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Costa, João Sousa, Rita Alarcão, Joana Vaz-Carneiro, António Filipe, Paulo |
dc.subject.por.fl_str_mv |
Diterpenes Keratosis actinic Meta-analysis Randomized controlled trials Diterpenes Queratose actínica Ensaios clínicos controlados e aleatorizado Meta-análise |
topic |
Diterpenes Keratosis actinic Meta-analysis Randomized controlled trials Diterpenes Queratose actínica Ensaios clínicos controlados e aleatorizado Meta-análise |
description |
Introduction: Actinic keratosis is the most common premalignant lesion. The therapeutic approach to patients with multiple lesions involves field-directed treatment.Objective: To evaluate the efficacy and safety of ingenol mebutato, a new drug treatment for topical field-directed treatment of actinic keratosis.Design: Systematic review and meta-analysis of randomized controlled trials (RCTs) trials.Data sources: Medline and Cochrane Library (June 2014).Study selection: Two reviewers independently searched for studies and retrieved their characteristics and data estimates.Data synthesis: Random-effects meta-analysis. Heterogeneity was assessed with the I2 test.Results: Six trials (n = 1,492) versus placebo were included. The odds of a patient experiencing complete removal of the lesions was 17 (95%CI: 9 to 31, I2 = 0%) and 8.5 (95% CI: 5 to 15, I2 = 0%) times higher, compared to placebo, in the face/scalp and trunk/extremities, respectively. The incidence of adverse events related to treatment was higher in the group of mebutato ingenol (+23%, 95%CI: 11 to 35%), with no differences between groups in the discontinuation rate due to adverse events.Conclusions: Mebutato of ingenol is efficacious in the treatment of actinic keratosis. Compared to other field-directed treatments available in Portugal, its therapeutic value comes from the favourable safety profile and tolerability, simplicity and short duration of the treatment regimen and the possibility of different treatment to injuries according to anatomical location (individualization of therapy). Future studies should directly compare the different therapeutic options and evaluate the effectiveness of the same in the real world. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-04-13T00:00:00Z |
dc.type.driver.fl_str_mv |
journal article info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://doi.org/10.29021/spdv.72.4.317 oai:ojs.revista.spdv.com.pt:article/317 |
url |
https://doi.org/10.29021/spdv.72.4.317 |
identifier_str_mv |
oai:ojs.revista.spdv.com.pt:article/317 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://revista.spdv.com.pt/index.php/spdv/article/view/317 https://doi.org/10.29021/spdv.72.4.317 https://revista.spdv.com.pt/index.php/spdv/article/view/317/291 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Sociedade Portuguesa de Dermatologia e Venereologia |
publisher.none.fl_str_mv |
Sociedade Portuguesa de Dermatologia e Venereologia |
dc.source.none.fl_str_mv |
Journal of the Portuguese Society of Dermatology and Venereology; Vol 72 No 4 (2014): Outubro - Dezembro; 481-492 Revista da Sociedade Portuguesa de Dermatologia e Venereologia; v. 72 n. 4 (2014): Outubro - Dezembro; 481-492 2182-2409 2182-2395 reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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