Cargando…

Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review

INTRODUCTION: Data supporting the use of oral antidiabetic drugs mainly rely on data from premarketing clinical trials. Real-world data studies are crucial to evaluate effectiveness of drugs. The aim of this systematic review is to compare the results obtained for efficacy and effectiveness endpoint...

Descripción completa

Detalles Bibliográficos
Autores principales: Batel-Marques, Francisco, Pereira, Diogo, Mendes, Diogo, Alves, Carlos, Penedones, Ana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756359/
https://www.ncbi.nlm.nih.gov/pubmed/31530624
http://dx.doi.org/10.1136/bmjopen-2019-032522
_version_ 1783453383567343616
author Batel-Marques, Francisco
Pereira, Diogo
Mendes, Diogo
Alves, Carlos
Penedones, Ana
author_facet Batel-Marques, Francisco
Pereira, Diogo
Mendes, Diogo
Alves, Carlos
Penedones, Ana
author_sort Batel-Marques, Francisco
collection PubMed
description INTRODUCTION: Data supporting the use of oral antidiabetic drugs mainly rely on data from premarketing clinical trials. Real-world data studies are crucial to evaluate effectiveness of drugs. The aim of this systematic review is to compare the results obtained for efficacy and effectiveness endpoints on clinical trials and those obtained from routine clinical practice of dipeptidyl peptidase-4 inhibitors. METHODS AND ANALYSIS: This systematic review will include randomised controlled trials and observational studies evaluating the efficacy and effectiveness of dipeptidyl peptidase-4 inhibitors, respectively. A literature search will be performed at Medline, Embase, Cochrane Controlled Register of Trials and ClinicalTrials.gov. Search terms comprised the drug name (including the pharmacotherapeutic class and the international non-proprietary name). Data on haemoglobin A1C, blood glucose and body weight will be retrieved. The risk of bias will be independently assessed according to the checklist proposed by Downs and Black. Data will be analysed using descriptive statistics and meta-analysis when applicable. ETHICS AND DISSEMINATION: Ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings.
format Online
Article
Text
id pubmed-6756359
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-67563592019-10-07 Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review Batel-Marques, Francisco Pereira, Diogo Mendes, Diogo Alves, Carlos Penedones, Ana BMJ Open Diabetes and Endocrinology INTRODUCTION: Data supporting the use of oral antidiabetic drugs mainly rely on data from premarketing clinical trials. Real-world data studies are crucial to evaluate effectiveness of drugs. The aim of this systematic review is to compare the results obtained for efficacy and effectiveness endpoints on clinical trials and those obtained from routine clinical practice of dipeptidyl peptidase-4 inhibitors. METHODS AND ANALYSIS: This systematic review will include randomised controlled trials and observational studies evaluating the efficacy and effectiveness of dipeptidyl peptidase-4 inhibitors, respectively. A literature search will be performed at Medline, Embase, Cochrane Controlled Register of Trials and ClinicalTrials.gov. Search terms comprised the drug name (including the pharmacotherapeutic class and the international non-proprietary name). Data on haemoglobin A1C, blood glucose and body weight will be retrieved. The risk of bias will be independently assessed according to the checklist proposed by Downs and Black. Data will be analysed using descriptive statistics and meta-analysis when applicable. ETHICS AND DISSEMINATION: Ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings. BMJ Publishing Group 2019-09-17 /pmc/articles/PMC6756359/ /pubmed/31530624 http://dx.doi.org/10.1136/bmjopen-2019-032522 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Diabetes and Endocrinology
Batel-Marques, Francisco
Pereira, Diogo
Mendes, Diogo
Alves, Carlos
Penedones, Ana
Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
title Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
title_full Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
title_fullStr Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
title_full_unstemmed Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
title_short Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
title_sort effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review
topic Diabetes and Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756359/
https://www.ncbi.nlm.nih.gov/pubmed/31530624
http://dx.doi.org/10.1136/bmjopen-2019-032522
work_keys_str_mv AT batelmarquesfrancisco effectivenessinclinicalpracticeversusefficacyofdipeptidylpeptidase4inhibitorsinclinicaltrialsfortype2diabetesprotocolforsystematicreview
AT pereiradiogo effectivenessinclinicalpracticeversusefficacyofdipeptidylpeptidase4inhibitorsinclinicaltrialsfortype2diabetesprotocolforsystematicreview
AT mendesdiogo effectivenessinclinicalpracticeversusefficacyofdipeptidylpeptidase4inhibitorsinclinicaltrialsfortype2diabetesprotocolforsystematicreview
AT alvescarlos effectivenessinclinicalpracticeversusefficacyofdipeptidylpeptidase4inhibitorsinclinicaltrialsfortype2diabetesprotocolforsystematicreview
AT penedonesana effectivenessinclinicalpracticeversusefficacyofdipeptidylpeptidase4inhibitorsinclinicaltrialsfortype2diabetesprotocolforsystematicreview