Blog
About

5
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Quais os benefícios para o doente da associação de metformina com dapagliflozina comparativamente a outros antidiabéticos orais?: Uma revisão baseada na evidência Translated title: Combined metformin and dapagliflozin therapy in diabetes: an evidence based review

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Objetivo: Comparar os efeitos da associação de dapagliflozina à metformina relativamente a outros antidiabéticos orais, em doentes com controlo inadequado com metformina em monoterapia. Fontes de dados: Base de dados MEDLINE e sítios eletrónicos de medicina baseada na evidência. Métodos de revisão: Pesquisa de estudos publicados entre janeiro de 2007 e março de 2017, em português, inglês e espanhol, utilizando os termos MeSH dapagliflozin; diabetes mellitus, type 2 e metformin. Para avaliação da qualidade dos estudos e força de recomendação foi utilizada a escala Strength of Recommendation Taxonomy, da American Family Physician (SORT). Resultados: Da pesquisa obtiveram-se 59 artigos, dos quais oito preencheram os critérios de inclusão: uma revisão sistemática, uma meta-análise, cinco ensaios clínicos e uma norma de orientação clínica. Pela análise destes estudos observou-se que a associação de dapagliflozina é eficaz na redução da hemoglobina glicada e do peso corporal, comparativamente a outras classes de antidiabéticos orais, sem aumento do risco de desenvolvimento de hipoglicemia. Os efeitos secundários mais frequentemente descritos, com a utilização deste fármaco, foram o aumento da prevalência de infeções do trato urinário e do trato genital, principalmente em mulheres. A dapagliflozina parece ter um efeito neutro em temos de morbimortalidade cardiovascular. Não está ainda clarificada a relação da sua utilização com o aumento do risco de desenvolvimento de cancro. Conclusões: Não foram encontrados dados suficientes que permitam afirmar que a associação de dapagliflozina à metformina seja superior à associação de metformina com as restantes classes de antidiabéticos orais existentes no mercado em termos de benefícios para o doente (SORT C). São necessários mais estudos que permitam avaliar a longo prazo os efeitos da dapagliflozina em termos de eficácia, segurança e morbimortalidade, assim como a manutenção dos resultados obtidos com esta associação de fármacos

          Translated abstract

          Objectives: To compare the effect of the combination of metformin and dapagliflozin compared with metformin and other oral anti-diabetics as an add-on therapy in patients inadequately controlled with metformin alone. Data sources: MEDLINE and other evidence-based medicine databases Review methods: A review was made of meta-analyses, systematic reviews, randomized controlled clinical trials and clinical guidelines, published between January 2007 and March 2017, in Portuguese, English and Spanish, using the MeSH terms ‘dapagliflozin', ‘diabetes mellitus type 2', and ‘metformin'. The American Family Physician Strength of Recommendation Taxonomy (SORT) was used to establish the quality of the studies and to define the strength of recommendations. Results: There were 59 articles found. Eight met the inclusion criteria. These included one meta-analysis, one systematic review, five randomized controlled clinical trials, and one clinical guideline. There is evidence that dual therapy with metformin and dapagliflozin is effective in reducing glycosylated haemoglobin and body weight, when compared to other oral anti-diabetics, without increasing the risk of hypoglycemic episodes. The most frequent adverse effects related to this drug were urinary tract and genital infections, especially in women (SORT C). Dapagliflozin seems to be neutral regarding cardiovascular risk and its association with cancer is yet to be clarified. Conclusions: There was not enough evidence to support the claim that dapagliflozin combined with metformin is more effective or better for the patient when compared to other oral anti-diabetics (SORT C). Given these limitations, we conclude that more controlled studies are required to determine the effects of dapagliflozin in terms of efficacy, safety, morbidity and mortality, as well as the maintenance of the results with this combination of drugs

          Related collections

          Most cited references 22

          • Record: found
          • Abstract: not found
          • Article: not found

          Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial.

            Correction of hyperglycaemia and prevention of glucotoxicity are important objectives in the management of type 2 diabetes. Dapagliflozin, a selective sodium-glucose cotransporter-2 inhibitor, reduces renal glucose reabsorption in an insulin-independent manner. We assessed the efficacy and safety of dapagliflozin in patients who have inadequate glycaemic control with metformin. In this phase 3, multicentre, double-blind, parallel-group, placebo-controlled trial, 546 adults with type 2 diabetes who were receiving daily metformin (>/=1500 mg per day) and had inadequate glycaemic control were randomly assigned to receive one of three doses of dapagliflozin (2.5 mg, n=137; 5 mg, n=137; or 10 mg, n=135) or placebo (n=137) orally once daily. Randomisation was computer generated and stratified by site, implemented with a central, telephone-based interactive voice response system. Patients continued to receive their pre-study metformin dosing. The primary outcome was change from baseline in haemoglobin A(1c)(HbA(1c)) at 24 weeks. All randomised patients who received at least one dose of double-blind study medication and who had both a baseline and at least one post-baseline measurement (last observation carried forward) were included in the analysis. Data were analysed by use of ANCOVA models. This trial is registered with ClinicalTrials.gov, number NCT00528879. 534 patients were included in analysis of the primary endpoint (dapagliflozin 2.5 mg, n=135; dapagliflozin 5 mg, n=133; dapagliflozin 10 mg, n=132; placebo, n=134). At week 24, mean HbA(1c) had decreased by -0.30% (95% CI -0.44 to -0.16) in the placebo group, compared with -0.67% (-0.81 to -0.53, p=0.0002) in the dapagliflozin 2.5 mg group, -0.70% (-0.85 to -0.56, p<0.0001) in the dapagliflozin 5 mg group, and -0.84% (-0.98 to -0.70, p<0.0001) in the dapagliflozin 10 mg group. Symptoms of hypoglycaemia occurred in similar proportions of patients in the dapagliflozin (2-4%) and placebo groups (3%). Signs, symptoms, and other reports suggestive of genital infections were more frequent in the dapagliflozin groups (2.5 mg, 11 patients [8%]; 5 mg, 18 [13%]; 10 mg, 12 [9%]) than in the placebo group (seven [5%]). 17 patients had serious adverse events (four in each of the dapagliflozin groups and five in the placebo group). Addition of dapagliflozin to metformin provides a new therapeutic option for treatment of type 2 diabetes in patients who have inadequate glycaemic control with metformin alone. Bristol-Myers Squibb and AstraZeneca. Copyright 2010 Elsevier Ltd. All rights reserved.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis.

              Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of antidiabetic drugs. To assess the efficacy and safety of SGLT2 inhibitors in adults with type 2 diabetes. MEDLINE, EMBASE, and the Cochrane Library from inception through April 2013 without language restrictions; regulatory authorities' reports; and gray literature. Randomized trials comparing SGLT2 inhibitors with placebo or other medication for type 2 diabetes. Three reviewers extracted or checked data for study characteristics, outcomes of interest, and risk of bias, and 3 reviewers summarized strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. Sodium-glucose cotransporter 2 inhibitors were compared with placebo in 45 studies (n = 11 232) and with active comparators in 13 studies (n = 5175). They had a favorable effect on hemoglobin A1c level (mean difference vs. placebo, -0.66% [95% CI, -0.73% to -0.58%]; mean difference vs. active comparators, -0.06% [CI, -0.18% to 0.05%]). Sensitivity analyses incorporating unpublished data showed similar effect estimates. Compared with other agents, SGLT2 inhibitors reduced body weight (mean difference, -1.80 kg [CI, -3.50 to -0.11 kg]) and systolic blood pressure (mean difference, -4.45 mm Hg [CI, -5.73 to -3.18 mm Hg]). Urinary and genital tract infections were more common with SGLT2 inhibitors (odds ratios, 1.42 [CI, 1.06 to 1.90] and 5.06 [CI, 3.44 to 7.45], respectively). Hypoglycemic risk was similar to that of other agents. Results for cardiovascular outcomes and death were inconclusive. An imbalance in incidence of bladder and breast cancer was noted with dapagliflozin compared with control. Most trials were rated as high risk of bias because of missing data and last-observation-carried-forward methods. Sodium-glucose cotransporter 2 inhibitors may improve short-term outcomes in adults with type 2 diabetes, but effects on long-term outcomes and safety are unclear. None.
                Bookmark

                Author and article information

                Affiliations
                orgnameACeS do Alto Ave orgdiv1USF Serzedelo
                Braga orgnameACeS do Cávado I - Braga orgdiv1USF S. Lourenço
                Famalicão orgnameACeS do Ave Famalicão orgdiv1USF Terras do Ave
                Famalicão orgnameACeS do Ave Famalicão orgdiv1USF S. Miguel-o-Anjo
                orgnameACeS Marão e Douro Norte orgdiv1USF Nova Mateus
                Famalicão orgnameACeS do Ave Famalicão orgdiv1USF Ribeirão
                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                rpmgf
                Revista Portuguesa de Medicina Geral e Familiar
                Rev Port Med Geral Fam
                Associação Portuguesa de Medicina Geral e Familiar (Lisboa, , Portugal )
                2182-5173
                July 2017
                : 33
                : 3
                : 210-220
                S2182-51732017000300006

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                Counts
                Figures: 0, Tables: 0, Equations: 0, References: 22, Pages: 11
                Product
                Product Information: SciELO Portugal

                Comments

                Comment on this article