Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Batel-Marques F

PROVIDER: S-EPMC6756359 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

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 F Pereira Diogo D Mendes Diogo D Alves Carlos C Penedones Ana A

BMJ open 20190917 9

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>This systematic review will include randomised controlle ...[more]

PMID: 31530624

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Project description:BackgroundType 2 diabetes mellitus (T2DM) results from insulin resistance and relative insulin deficiency. T2DM treatment is a step-wise approach beginning with lifestyle modifications (for example, diet, exercise), followed by the addition of oral hypoglycemic agents (for example, metformin). Patients who do not respond to first-line therapy are offered second-line therapy (for example, sulfonylureas). Third-line therapy may include insulin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors.It is unclear whether DPP-4 inhibitors are safer and more effective than intermediate acting insulin for third-line management of T2DM. As such, our objective is to evaluate the comparative effectiveness, safety and cost-effectiveness of DPP-4 inhibitors versus intermediate acting insulin for T2DM patients who have failed both first- and second-line diabetes treatments.Design/methodsElectronic searches of MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, and grey literature (for example, trial registries, public health websites) will be conducted to identify studies examining DPP-4 inhibitors compared with each other, intermediate acting insulin, no treatment, or placebo for adults with T2DM. The outcomes of interest include glycosylated hemoglobin (A1C) (primary outcome), as well as emergency department visits, physician visits, hospital admissions, weight gain, quality of life, microvascular complications, macrovascular complications, all-cause mortality, and cost (secondary outcomes). Randomized clinical trials (RCTs), quasi-RCTs, non-RCTs, controlled before-after, interrupted time series, cohort studies, and cost studies reporting data on these outcomes will be included. Eligibility will not be restricted by publication status, language of dissemination, duration of study follow-up, or time period of study conduct.Two reviewers will screen the titles and abstracts resulting from the literature search, as well as potentially relevant full-text articles, in duplicate. Data will be abstracted and quality will be appraised by two team members independently. Conflicts at all levels of screening and abstraction will be resolved through team discussion.Our results will be described narratively. Random effects meta-analysis and network meta-analysis will be conducted, if feasible and appropriate.DiscussionOur systematic review results can be used to determine the most effective, safe and cost-effective third-line strategies for managing T2DM. This information will be of great use to health policy-makers and clinicians, as well as patients living with T2DM and their families.Trial registrationPROSPERO registry number: CRD42013003624.

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Publications

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

Similar Datasets

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