Editorial
Metformin and sodium-glucose cotransporter inhibitors as therapy for type 1 diabetes mellitus: Handle with care
Metformina e inhibidores del cotransportador sodio-glucosa en el tratamiento de la diabetes mellitus tipo 1: manéjese con cuidado
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Ena, R. Gómez-Huelgas" "autores" => array:2 [ 0 => array:4 [ "nombre" => "J." "apellidos" => "Ena" "email" => array:1 [ 0 => "ena_jav@gva.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "R." "apellidos" => "Gómez-Huelgas" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Servicio de Medicina Interna, Hospital Marina Baixa, Villajoyosa, Alicante, España" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Departamento de Medicina, Hospital Regional Universitario de Málaga, Málaga, España" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Autor para correspondencia." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Metformina e inhibidores del cotransportador sodio-glucosa en el tratamiento de la diabetes mellitus tipo 1: manéjese con cuidado" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Type 1 diabetes mellitus (DM1) is a heterogeneous disease caused by a complete defect in insulin secretion due to the destruction of pancreatic beta cells. Most cases of DM1 are due to autoimmune destruction of beta cells (DM1a), while a small percentage are caused by nonautoimmune destruction or failure of beta cells (DM1b). DM1 represents 5–10% of all cases of diabetes worldwide.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> In contrast, DM2 is characterized by a combination of insulin resistance and an inadequate compensatory response to the action of insulin.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">1</span></a> Although DM1 can present at any age, it characteristically affects children and adolescents. Recently, however, the prevalence of DM2 has increased in young people.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Studies with euglycemic clamps have discovered that patients with DM1 have higher insulin resistance than patients without diabetes,<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a> which could partly explain this population's excessive cardiovascular risk. It is believed that insulin resistance can be caused by a negative regulation of insulin receptors, by the presence of glucotoxicity, by increased secretion and growth hormone action and by the presence of hyperandrogenism in women. Patients with DM1 and greater insulin resistance have been confirmed to present greater coronary calcification.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">3</span></a> Recent studies have shown that patients with DM1 have a hazard ratio of 3.26 for myocardial infarction, 2.68 for heart failure and 2.61 for ischemic stroke compared with the reference population without diabetes.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">4</span></a> The factors related to a greater risk of cardiovascular disease and mortality are glycated hemoglobin levels, duration of the diabetes mellitus, systolic blood pressure and low-density lipoprotein cholesterol values. These risk factors have been reproduced in several studies.<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">5,6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Metformin is an antihyperglycemic that improves insulin sensitivity and constitutes the first-line therapy for patients with DM2. The United Kingdom Prospective Diabetes Study showed that metformin therapy reduced the risk of macrovascular disease in patients with obesity and DM2.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">7</span></a> Metformin has also been shown to improve insulin sensitivity in patients with DM1 and has been observed to improve vascular function in children with DM1 and could therefore be considered a cardioprotective drug for this patient group.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">8</span></a> However, the results of the Reducing With Metformin Vascular Adverse Lesions in Type 1 Diabetes 2 (REMOVAL 2, the broadest clinical trial to evaluate the effects of metformin in patients with DM1) were not conclusive, obtaining only small effects on glycemic control, a modest weight reduction and ambiguous results for carotid intima-media thickness.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">9</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Sodium-glucose cotransporter-2 inhibitors (SGLT2i) block glucose and sodium reabsorption in the proximal tubule, producing glycosuria and natriuresis. Dual sodium-glucose cotransporter-2 and 1 inhibitors (SGLT2/1i), such as sotagliflozin, have an additional SGLT inhibitor effect at the gastrointestinal level, delaying glucose and galactose absorption in the gastrointestinal tract.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The use of SGLT2i is recommended for patients with DM2 and established cardiovascular disease or moderate chronic renal failure to prevent major cardiovascular events (including cardiovascular mortality, myocardial infarction, stroke and hospitalizations for heart failure) and renal function impairment. The recommendations are based on cardiovascular safety studies conducted with empagliflozin (EMPA-REG OUTCOME), canagliflozin (CANVAS) and dapagliflozin (DECLARE).<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">10</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">In the current issue of <span class="elsevierStyleSmallCaps">Revista Clínica Española</span>, Zhang et al.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">11</span></a> conducted a meta-analysis of 20 studies with 5868 patients to assess the use of metformin and SGLT2i in treating DM1. The study showed that SGLT2i are more potent than metformin in reducing glycated hemoglobin levels (-0.4% vs. -0.08%, respectively) and body weight (-3.56<span class="elsevierStyleHsp" style=""></span>kg vs. -2.02<span class="elsevierStyleHsp" style=""></span>kg, respectively), while the reduction in insulin requirements was equivalent for the two drugs (-6.94 units/day vs.-3.88 units/day, respectively). In terms of safety issues, the hypoglycemia risk was similar for SGLT2i and metformin (odds ratio [OR], 0.89 vs. 1.25, respectively), while the risk of diabetic ketoacidosis was higher for SGLT2i than for metformin (OR, 9.21 vs. 1.00).</p><p id="par0035" class="elsevierStylePara elsevierViewall">Based on the results of the REMOVAL 2 study, metformin is unlikely to make headway in the treatment of DM1; however, the use of SGLT inhibitors is progressively increasing beyond its indication for patients with DM1.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">12</span></a> Several SGLT2i and SGLT2/1i are undergoing evaluation by the US Food and Drug Administration and the European Medicines Agency as a joint treatment with insulin for DM1. The drugs in the most advanced evaluation phases are sotagliflozin (SGLT2/1i) and dapagliflozin (SGLT2i). Ipragliflozin (SGLT2i) has recently been approved in Japan for treating DM1 in combination with insulin.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">13</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Combined therapy with insulin and SGLT inhibitors is a promising treatment option for DM1 because it can facilitate glycemic control without a greater risk of hypoglycemia, decreasing glycemic variability, reducing insulin doses, preventing insulin treatment-associated weight gain and, potentially, preventing cardiorenal morbidity and mortality in this population. However, this therapy is associated with a greater risk of severe ketoacidosis. The use of this combination should therefore be restricted to expert physicians and selected patients. Consensus documents have been developed to alert the medical community and mitigate the risk of diabetic ketoacidosis associated with use of SGLT inhibitors in patients with DM1.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">14</span></a> The document describes the criteria necessary for starting treatment with SGLT inhibitors in patients with DM1 and preventing ketoacidosis (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). When ketonemia or ketonuria values are high, patients should be instructed to discontinue the SGLT inhibitor treatment until the values return to normal. Treatment to correct the ketosis should start swiftly to prevent severe ketoacidosis and hospitalization. The key to treating ketosis is to maintain good hydration, consume carbohydrates and continue administering insulin. SGLT inhibitors should be discontinued for intercurrent acute processes, surgery and scheduled procedures, until the patient can restart oral intake.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Ena J, Gómez-Huelgas R. Metformina e inhibidores del cotransportador sodio-glucosa en el tratamiento de la diabetes mellitus tipo 1: manéjese con cuidado. Rev Clin Esp. 2020. https://doi.org/10.1016/j.rce.2019.09.001.</p>" ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Abbreviations: DM, diabetes mellitus; SGLTi, sodium-glucose cotransporter inhibitors.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Older than 18 years \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Good compliance to the treatment prescribed for diabetes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Capable/willing to perform all self-care measures \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Able to perform glucose self-monitoring or willing to use continuous glucose meter \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Having undergone education and training in ketonemia monitoring and management after determining the result \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Having access to materials to measure ketonemia \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Having immediate access to medical consultation in case of presenting ketonemia \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• Refrain from drinking alcohol or drinking alcohol moderately. Refrain from using illicit drugs \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• No cognitive impairment \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">• No pregnancy and no desire to become pregnant \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2237765.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Criteria for Patients with Type 1 Diabetes Mellitus to Undergo Sodium-Glucose Cotransporter-2 Inhibitor Therapy.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:14 [ 0 => array:3 [ "identificador" => "bib0075" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Classification and diagnosis of diabetes: Standards of medical care in diabetes-2019" "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "American Diabetes Association" "etal" => false ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.2337/dc19-S002" "Revista" => array:7 [ "tituloSerie" => "Diabetes Care." 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