Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis

Detalhes bibliográficos
Autor(a) principal: Lays Pires Marra
Data de Publicação: 2016
Outros Autores: Vânia Eloisa de Araújo Silva, Thales Brendon Castano Silva, Leonardo Maurício Diniz, Augusto Afonso Guerra Júnior, Francisco de Assis Acurcio, Brian Godman, Juliana Alvares Teodoro
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFMG
Texto Completo: https://doi.org/10.1007/s13300-016-0166-y
http://hdl.handle.net/1843/57790
Resumo: Introduction: The use of insulin analogs for the treatment of type 1 diabetes mellitus (T1DM) is widespread; however, the therapeutic benefits still require further evaluation given their higher costs. The objective of this study was to evaluate the effectiveness and safety of analog insulin glargine compared to recombinant DNA (rDNA) insulin in patients with T1DM in observational studies, building on previous reviews of randomized controlled trials comparing neutral protamine Hagedorn insulin and insulin glargine. Methods: A systematic review with a meta-analysis was performed. The review included cohort studies and registries available on PubMed, LILACS, and the Cochrane Central Register of Controlled Trials (CENTRAL), as well as manual and gray literature searches. The meta-analysis was conducted in Review Manager 5.3 software. The primary outcomes were glycated hemoglobin (Hb1Ac), weight gain, and hypoglycemia. Methodological quality was assessed using the Newcastle-Ottawa scale. Results: Out of 796 publications, 11 studies were finally included. The meta-analysis favored insulin glargine in HbA1c outcomes (adult patients) and hypoglycemic episodes (P < 0.05), but without reaching glycemic control (Hb1Ac to approximately 7%). The methodological quality of the studies was moderate, noting that 45% of studies were funded by pharmaceutical companies. Conclusion: Given the high heterogeneity of the studies, the discrete value presented by the estimated effect on effectiveness and safety, potential conflicts of interest of the studies, and the appreciable higher cost of insulin glargine, there is still no support for recommending first-line therapy with analogs. The role of analogs in the treatment of T1DM could be better determined by further observational studies of good methodological quality to assess their long-term effectiveness and safety, as well as their cost-effectiveness.
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spelling 2023-08-14T13:49:40Z2023-08-14T13:49:40Z2016-0672241258https://doi.org/10.1007/s13300-016-0166-y1869-6961http://hdl.handle.net/1843/57790Introduction: The use of insulin analogs for the treatment of type 1 diabetes mellitus (T1DM) is widespread; however, the therapeutic benefits still require further evaluation given their higher costs. The objective of this study was to evaluate the effectiveness and safety of analog insulin glargine compared to recombinant DNA (rDNA) insulin in patients with T1DM in observational studies, building on previous reviews of randomized controlled trials comparing neutral protamine Hagedorn insulin and insulin glargine. Methods: A systematic review with a meta-analysis was performed. The review included cohort studies and registries available on PubMed, LILACS, and the Cochrane Central Register of Controlled Trials (CENTRAL), as well as manual and gray literature searches. The meta-analysis was conducted in Review Manager 5.3 software. The primary outcomes were glycated hemoglobin (Hb1Ac), weight gain, and hypoglycemia. Methodological quality was assessed using the Newcastle-Ottawa scale. Results: Out of 796 publications, 11 studies were finally included. The meta-analysis favored insulin glargine in HbA1c outcomes (adult patients) and hypoglycemic episodes (P < 0.05), but without reaching glycemic control (Hb1Ac to approximately 7%). The methodological quality of the studies was moderate, noting that 45% of studies were funded by pharmaceutical companies. Conclusion: Given the high heterogeneity of the studies, the discrete value presented by the estimated effect on effectiveness and safety, potential conflicts of interest of the studies, and the appreciable higher cost of insulin glargine, there is still no support for recommending first-line therapy with analogs. The role of analogs in the treatment of T1DM could be better determined by further observational studies of good methodological quality to assess their long-term effectiveness and safety, as well as their cost-effectiveness.Introdução: O uso de análogos de insulina para o tratamento do diabetes mellitus tipo 1 (DM1) é amplamente difundido; no entanto, os benefícios terapêuticos ainda requerem uma avaliação mais aprofundada devido aos seus custos mais elevados. O objetivo deste estudo foi avaliar a eficácia e a segurança da insulina glargina análoga em comparação com a insulina de DNA recombinante (rDNA) em pacientes com DM1 em estudos observacionais, com base em revisões anteriores de ensaios clínicos randomizados comparando a insulina protamina neutra Hagedorn e a insulina glargina. Métodos: Foi realizada uma revisão sistemática com meta-análise. A revisão incluiu estudos de coorte e registros disponíveis no PubMed, LILACS e Cochrane Central Register of Controlled Trials (CENTRAL), bem como pesquisas manuais e literatura cinza. A metanálise foi realizada no software Review Manager 5.3. Os desfechos primários foram hemoglobina glicada (Hb1Ac), ganho de peso e hipoglicemia. A qualidade metodológica foi avaliada por meio da escala de Newcastle-Ottawa. Resultados: De 796 publicações, 11 estudos foram finalmente incluídos. A meta-análise favoreceu a insulina glargina nos resultados de HbA1c (pacientes adultos) e episódios de hipoglicemia (P < 0,05), mas sem atingir o controle glicêmico (Hb1Ac para aproximadamente 7%). A qualidade metodológica dos estudos foi moderada, observando que 45% dos estudos foram financiados por empresas farmacêuticas. Conclusão: Dada a alta heterogeneidade dos estudos, o valor discreto apresentado pelo efeito estimado na eficácia e segurança, potenciais conflitos de interesse dos estudos e o custo apreciável mais alto da insulina glargina, ainda não há suporte para recomendar a primeira linha terapia com análogos. O papel dos análogos no tratamento do DM1 poderia ser melhor determinado por estudos observacionais adicionais de boa qualidade metodológica para avaliar sua eficácia e segurança a longo prazo, bem como seu custo-efetividade.CNPq - Conselho Nacional de Desenvolvimento Científico e TecnológicoengUniversidade Federal de Minas GeraisUFMGBrasilFAR - DEPARTAMENTO DE FARMÁCIA SOCIALDiabetes TherapyDiabetes mellitus tipo 1Pesquisa comparativa da efetividadeInsulina glarginaMetanáliseRevisão sistemáticaComparative effectiveness researchGlargineInsulinMeta-analysisSystematic reviewType 1 diabetes mellitusClinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysisinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://link.springer.com/journal/13300/volumes-and-issues/7-2Lays Pires MarraVânia Eloisa de Araújo SilvaThales Brendon Castano SilvaLeonardo Maurício DinizAugusto Afonso Guerra JúniorFrancisco de Assis AcurcioBrian GodmanJuliana Alvares Teodoroapplication/pdfinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; charset=utf-82042https://repositorio.ufmg.br/bitstream/1843/57790/1/License.txtfa505098d172de0bc8864fc1287ffe22MD51ORIGINALClinical effectiveness and safety of analog glargine in type 1 diabetes a systematic review and meta-analysis.pdfClinical effectiveness and safety of analog glargine in type 1 diabetes a systematic review and meta-analysis.pdfapplication/pdf1771500https://repositorio.ufmg.br/bitstream/1843/57790/2/Clinical%20effectiveness%20and%20safety%20of%20analog%20glargine%20in%20type%201%20diabetes%20a%20systematic%20review%20and%20meta-analysis.pdf086f176a92a275400091bf43c2a75e16MD521843/577902023-08-17 19:03:15.85oai:repositorio.ufmg.br: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Repositório de PublicaçõesPUBhttps://repositorio.ufmg.br/oaiopendoar:2023-08-17T22:03:15Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false
dc.title.pt_BR.fl_str_mv Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
title Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
spellingShingle Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
Lays Pires Marra
Comparative effectiveness research
Glargine
Insulin
Meta-analysis
Systematic review
Type 1 diabetes mellitus
Diabetes mellitus tipo 1
Pesquisa comparativa da efetividade
Insulina glargina
Metanálise
Revisão sistemática
title_short Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
title_full Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
title_fullStr Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
title_full_unstemmed Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
title_sort Clinical effectiveness and safety of analog glargine in type 1 diabetes: a systematic review and meta-analysis
author Lays Pires Marra
author_facet Lays Pires Marra
Vânia Eloisa de Araújo Silva
Thales Brendon Castano Silva
Leonardo Maurício Diniz
Augusto Afonso Guerra Júnior
Francisco de Assis Acurcio
Brian Godman
Juliana Alvares Teodoro
author_role author
author2 Vânia Eloisa de Araújo Silva
Thales Brendon Castano Silva
Leonardo Maurício Diniz
Augusto Afonso Guerra Júnior
Francisco de Assis Acurcio
Brian Godman
Juliana Alvares Teodoro
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Lays Pires Marra
Vânia Eloisa de Araújo Silva
Thales Brendon Castano Silva
Leonardo Maurício Diniz
Augusto Afonso Guerra Júnior
Francisco de Assis Acurcio
Brian Godman
Juliana Alvares Teodoro
dc.subject.por.fl_str_mv Comparative effectiveness research
Glargine
Insulin
Meta-analysis
Systematic review
Type 1 diabetes mellitus
topic Comparative effectiveness research
Glargine
Insulin
Meta-analysis
Systematic review
Type 1 diabetes mellitus
Diabetes mellitus tipo 1
Pesquisa comparativa da efetividade
Insulina glargina
Metanálise
Revisão sistemática
dc.subject.other.pt_BR.fl_str_mv Diabetes mellitus tipo 1
Pesquisa comparativa da efetividade
Insulina glargina
Metanálise
Revisão sistemática
description Introduction: The use of insulin analogs for the treatment of type 1 diabetes mellitus (T1DM) is widespread; however, the therapeutic benefits still require further evaluation given their higher costs. The objective of this study was to evaluate the effectiveness and safety of analog insulin glargine compared to recombinant DNA (rDNA) insulin in patients with T1DM in observational studies, building on previous reviews of randomized controlled trials comparing neutral protamine Hagedorn insulin and insulin glargine. Methods: A systematic review with a meta-analysis was performed. The review included cohort studies and registries available on PubMed, LILACS, and the Cochrane Central Register of Controlled Trials (CENTRAL), as well as manual and gray literature searches. The meta-analysis was conducted in Review Manager 5.3 software. The primary outcomes were glycated hemoglobin (Hb1Ac), weight gain, and hypoglycemia. Methodological quality was assessed using the Newcastle-Ottawa scale. Results: Out of 796 publications, 11 studies were finally included. The meta-analysis favored insulin glargine in HbA1c outcomes (adult patients) and hypoglycemic episodes (P < 0.05), but without reaching glycemic control (Hb1Ac to approximately 7%). The methodological quality of the studies was moderate, noting that 45% of studies were funded by pharmaceutical companies. Conclusion: Given the high heterogeneity of the studies, the discrete value presented by the estimated effect on effectiveness and safety, potential conflicts of interest of the studies, and the appreciable higher cost of insulin glargine, there is still no support for recommending first-line therapy with analogs. The role of analogs in the treatment of T1DM could be better determined by further observational studies of good methodological quality to assess their long-term effectiveness and safety, as well as their cost-effectiveness.
publishDate 2016
dc.date.issued.fl_str_mv 2016-06
dc.date.accessioned.fl_str_mv 2023-08-14T13:49:40Z
dc.date.available.fl_str_mv 2023-08-14T13:49:40Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/1843/57790
dc.identifier.doi.pt_BR.fl_str_mv https://doi.org/10.1007/s13300-016-0166-y
dc.identifier.issn.pt_BR.fl_str_mv 1869-6961
url https://doi.org/10.1007/s13300-016-0166-y
http://hdl.handle.net/1843/57790
identifier_str_mv 1869-6961
dc.language.iso.fl_str_mv eng
language eng
dc.relation.ispartof.none.fl_str_mv Diabetes Therapy
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
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dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.publisher.initials.fl_str_mv UFMG
dc.publisher.country.fl_str_mv Brasil
dc.publisher.department.fl_str_mv FAR - DEPARTAMENTO DE FARMÁCIA SOCIAL
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFMG
instname:Universidade Federal de Minas Gerais (UFMG)
instacron:UFMG
instname_str Universidade Federal de Minas Gerais (UFMG)
instacron_str UFMG
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reponame_str Repositório Institucional da UFMG
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