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Vargas, Laura, Rispau, Ariadna, Rada, Gabriel, Bendersky, Josefina, Urrutia, Gerard, Verdugo, Francisca, Open Science Framework |
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Title: Effectiveness and safety of GLP-1 receptor analogues versus rapid-acting insulin added to basal insulin therapy in patients with type 2 diabetes mellitus: A living systematic review. Authors: María Soledad Isern de Val ORCID: https://orcid.org/0000-0002-1303-706X Afilliation: Instituto Aragonés de Ciencias de la Salud (IACS), Zaragoza, España Patricia Gavín Benavent ORCID: https://orcid.org/0000-0002-2949-5735 Afilliation: Instituto Aragonés de Ciencias de la Salud (IACS), Zaragoza, España Pilar Calvo Pérez Afilliation: Instituto Aragonés de Ciencias de la Salud (IACS), Zaragoza, España Corresponding author: María Soledad Isern de Val Email address: msisern.iacs@aragon.es Postal address: Instituto Aragonés de Ciencias de la Salud (IACS) Avda. San Juan Bosco, 13. 50009. Zaragoza. España Funding sources/sponsors: This work is part of a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No MSCA-IF-EF-ST #894990 (to María Ximena Rojas). This work is also supported by Instituto Aragonés de Ciencias de la Salud-IACS. The funders and institutions did not take any part in the development of this study. Conflicts of interest: Authors have declared no conflict of interest. ABSTRACT: Objective This living systematic review aims to provide a timely, rigorous and continuously updated summary of the evidence available on the effectiveness and safety of Glucagon-like peptide-1 analogues compared to rapid-acting insulin added to basal insulin therapy in patients with type 2 diabetes mellitus. Design Living systematic review. Database The Epistemonikos-L.OVE platform was used for evidence identification, screening, and selection. This platform has been validated as a repository for COVID-19, and proved to be a highly comprehensive source of evidence. The main search source for the L.OVE platform is the Epistemonikos database (https://www.epistemonikos.org), a comprehensive database that collates information from multiple sources to identify systematic reviews and their included primary studies, including Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, DARE, HTA Database, Campbell database, JBI Database of Systematic Reviews and Implementation Reports, EPPI-Centre Evidence Library. The team maintaining the Epistemonikos-L·OVE platform devised the literature search, using the following approach: i) Identification of terms relevant to the population and intervention components of the search strategy, using Word2vec technology to the corpus of documents available in Epistemonikos Database; ii) Discussion of search terms with methods experts to identify relevant, irrelevant and missing terms, iii) Creation of a sensitive boolean strategy encompassing all the relevant terms. The results of the literature searches were automatically incorporated into the L·OVE platform (automated retrieval) and organized in the corresponding L.OVE of “Glucagon-like peptide analogues and agonists for diabetes mellitus”. Methods The CPG Development Group agreed by consensus the questions included in the guideline. The questions were formulated in PICO (Population, Intervention, Comparison, Outcome) format. We sought to identify systematic reviews and randomised clinical trials evaluating the effect of GLP-1 receptor analogues versus. rapid-acting insulin added to basal insulin therapy (combined or not with oral antidiabetics) in patients with type 2 diabetes mellitus. The outcome variables were prioritized in a patient-oriented way by the CPG Development Group, following the GRADE system (scale 1-9), in order to select critical or key variables (between 7-9 points) for decision-making. The prioritized outcomes were: cardiovascular mortality, total mortality (all-cause), non-fatal infarction, non-fatal stroke, serious adverse events, severe hypoglycaemia, and quality of life. The GRADE approach was applied to assess the certainty of the evidence for each outcome. This is the first update report since our previous baseline evidence synthesis report. The last search date was 01/06/2022. Results Since the beginning of this living review in september 2021, searches have retrieved 1262 RCTs, 697 SRs and 82 non-classified studies to the L·OVE platform. The initial baseline report included 6 randomized clinical trials that evaluated the use of GLP-1 RA compared to the use of rapid-acting insulin in patients with type 2 diabetes mellitus treated with basal insulin requiring treatment intensification. Of the outcomes of interest, we obtained information on quality of life and severe hypoglycaemia. For this update, we reviewed 4 RCTs and 3 SRs in full text. A new randomised clinical trial assessing both quality of life and severe hypoglycaemia was included for this update. No information was found for cardiovascular endpoints and serious adverse events, including this update. The GRADE quality of the evidence for the main outcomes was low. Compared with rapid-acting insulin added to basal insulin therapy, the GLP-1 RA drugs liraglutide and semaglutide plus basal insulin showed different effects in quality of life. The health survey SF- 36 did not show changes in liraglutide nor insulin aspart; the questionnaire D-QOL showed better improvements in diabetes-related quality of life and treatment satisfaction for the treatment regimen consisting of liraglutide plus basal insulin. On the other side, improvements with semaglutide were recorded in SF-36v2 and DQLCTQ-R questionnaires compared with insulin aspart. Semaglutide showed significant improvements in physical functioning, general health, vitality and social functioning of the health survey SF-36v2; and in the eight domains of DQLCTQ-R questionnaire compared with insulin aspart. The frequency of severe episodes of hypoglycaemia were very low for both therapeutic strategies, addition of GLP-1 RA or rapid-acting insulin to basal insulin in the management of patients with T2DM. The effect estimator favours GLP-1 therapy, but the confidence interval (95%) is very wide. Conclusions The evidence on severe hypoglycaemia and quality of life is inconclusive and insufficient to choose the best treatment alternative. Larger trials are needed to study the key outcomes for which there is no information at this time: cardiovascular mortality, all-cause mortality, non-fatal heart attack, non-fatal stroke, and serious adverse events. These findings support the decision to have established and continue a living evidence process for this question. © 2022 IACS, Spain/ EU H2020, Living Evidence to Inform Health Decisions Project. All rights reserved. |
