Scientific letter
Liraglutide in clinical practice: Glycemic control, and predictors of good response
Liraglutide en la práctica clínica: control glucémico y predictores de buena respuesta
a Endocrinology and Nutrition Department, Arnau de Vilanova University Hospital, IRB-Lleida, UdL, Lleida, Spain
b Endocrinology and Nutrition Department, Gregorio Marañón University Hospital, Madrid, Spain
c Hospital de Día de Diabetes, Unidad de Investigación Clínica, Virgen Macarena University Hospital, UGC Provincial Endocrinologia y Nutrición, Sevilla, Spain
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Newly approved drugs have broadened treatment options, yet health care practitioners are increasingly uncertain as to the most suitable approach when treating T2D.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> The first once-daily human GLP-1ra, liraglutide, has proven efficacious in the six LEAD (Liraglutide Effect and Action in Diabetes) clinical trials.<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2,3</span></a> However, real-life differs markedly from the clinical trial scenery. Therefore, our objective was to retrospectively investigate the effects of liraglutide in two groups of Spanish patients with T2D in a real-life setting. First, we analyzed data from 210 patients with T2D treated with liraglutide at Hospital Universitario Virgen Macarena (Seville, Spain) in order to evaluate changes in weight and HbA1c after 6 months of treatment, as well as the safety of liraglutide. Second, we evaluated baseline characteristics of patients who achieved and maintained HbA1c<span class="elsevierStyleHsp" style=""></span>≤<span class="elsevierStyleHsp" style=""></span>6.5% after 2 years of follow-up. This population comprised 73 consecutive patients who were followed-up at Hospital General Universitario Gregorio Marañón (Madrid, Spain). Inclusion criteria for both studies were: (i) T2D under treatment with metformin; (ii) age<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>18 years; (iii) BMI<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span>; (iv) HbA1c<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>7.0%, and (v) glomerular filtration rate<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>60<span class="elsevierStyleHsp" style=""></span>ml/min. No pregnant women were included. All participants gave their written informed consent. The initial dose of liraglutide was 0.6<span class="elsevierStyleHsp" style=""></span>mg daily. After 1 week, the dose was titrated to 1.2<span class="elsevierStyleHsp" style=""></span>mg daily, and depending on the metabolic response, to a maximum of 1.8<span class="elsevierStyleHsp" style=""></span>mg.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Data from the first population showed that after 6 months of treatment, HbA1c decreased from 8.5<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.7% to 6.4<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>1.1% (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001), and weight from 106<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>0.3<span class="elsevierStyleHsp" style=""></span>kg to 99.5<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>0.5<span class="elsevierStyleHsp" style=""></span>kg (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.001), with a total reduction of 7.3<span class="elsevierStyleHsp" style=""></span>kg. The most frequent adverse events were of gastrointestinal origin, leading to withdrawal of treatment in 10.4% of patients. Data from second population showed that, after 2 years of treatment, responders tended to be women (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.037), insulin naïve (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.048), and did not need insulin during the follow-up (<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.013).</p><p id="par0015" class="elsevierStylePara elsevierViewall">T2DM therapy guidelines include GLP-1ra as one of the six possible options to be added to lifestyle programs and metformin.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> Although these guidelines will undoubtedly expand the range of conditions these drugs are indicated for, data on the effect of liraglutide in other clinical settings are scarce.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">1–3</span></a> A retrospective analysis performed in the United Kingdom primary care showed that liraglutide was superior to sitagliptin in terms of HbA1c level and weight loss.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a> Similar results were obtained in a clinical practice setting when the effectiveness of liraglutide in obese patients was compared with other incretin-based therapies, including exenatide and dipeptidyl peptidase 4 inhibitors.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">5–7</span></a> A study conducted in the United States on associated economic outcomes in patients with T2D in real-world practice concluded that liraglutide led to significantly greater reductions in HbA1c than sitagliptin without increasing total diabetes-related costs over 6 months of follow-up.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> In this way, data from our first population confirms in Spanish clinical practice what was demonstrated in clinical trials: liraglutide is an optimal approach in obese patients with T2D and leads to significant reductions in both HbA1c and weight.</p><p id="par0020" class="elsevierStylePara elsevierViewall">More intriguing is the association between good or poor responses and a specific antidiabetic agent. In the absence of robust pharmacogenetics data, studies performed in real-life scenarios are of major importance when deciding which patients are more likely to respond to liraglutide. We observed that patients who were good responders, defined as an HbA1c<span class="elsevierStyleHsp" style=""></span>≤<span class="elsevierStyleHsp" style=""></span>6.5%, were women who do not combine insulin with liraglutide at baseline or at any other time during the 2-year follow-up. The INITIATOR study also demonstrated that baseline characteristics impact both on the therapeutic option and on clinical outcomes in patients with T2D who initiated injectable therapy (GLP-1ra or insulin glargine): patients receiving liraglutide had fewer comorbidities, lower HbA1c levels, higher weight and were more often women. In addition, patients taking insulin glargine gained weight and experienced more hypoglycemic events after 1 year of treatment.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> Also a French study observed that the 25.5% of patients who achieved a combined objective (HbA1c reduction >1.0% plus weight reduction >3<span class="elsevierStyleHsp" style=""></span>kg after 1 year of treatment) were younger, with a shorter duration of diabetes and higher BMI.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">In conclusion, previous studies on the effectiveness of liraglutide conducted in real life-scenarios in Europe and the USA have shown liraglutide to be superior to exenatide, sitagliptin, and insulin glargine with respect to reductions in HbA1c and weight loss. In addition, some of the predictors of a better response seem to be younger age, shorter duration of T2D, and higher weight at baseline. Based on a population of patients followed for more than 2 years, we extend the list of predictors by adding female gender, insulin naïve, and absence of the need for insulin during follow-up.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financial and competint interest disclosure</span><p id="par0030" class="elsevierStylePara elsevierViewall">This work was supported by Novo Nordisk. The authors have no other relevant affiliations, financial involvement or financial conflict with the subject matter discussed in the manuscrit. The authors take full responsibility for this paper but are grateful to Manuela Rubio for providing writing assistance in the preparation of this manuscript.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Financial and competint interest disclosure" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0055" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. 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