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"titulo" => "Hacia un manejo integral del paciente con diabetes y obesidad. Posicionamiento de la SEMI, SED, redGDPS, SEC, SEEDO, SEEN, SEMERGEN y SEMFYC"
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"en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Antidiabetic treatment in the patient with type 2 diabetes and obesity.</p>"
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"textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Obesity and diabetes are worldwide epidemics and constitute a public health problem of the greatest magnitude. The close relationship between obesity and diabetes and its complications has been widely demonstrated and has clear implications for treating these types of patients. This positioning statement of the Spanish Society of Internal Medicine (SEMI), the Spanish Society of Diabetes (SED), the Network of Groups of Study of the Diabetes in Primary Care (redGEDAPS), the Spanish Society of Cardiology (SEC), the Spanish Society for the Study of Obesity (SEEDO), the Spanish Society of Endocrinology and Nutrition (SEEN), the Spanish Society of Primary Care Physicians (SEMERGEN) and the Spanish Society of Family and Community Medicine (SEMFYC) concisely reviews the key aspects of this relationship and makes specific recommendations for health professionals involved in the diagnostic and therapeutic activities when dealing with patients with diabetes and obesity. The document does not seek to replace the national or international clinical practice guidelines on treating patients with diabetes. On the contrary, the document is based on these guidelines. It is expected that the document can, in some way, complement or at least reinforce the guidelines in this specific issue of the disease.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Obesity and excess weight are the main preventable risk factors of type 2 diabetes (DM2)</span><p id="par0010" class="elsevierStylePara elsevierViewall">The prevalence of obesity and excess weight is steadily growing. It has been estimated that the overall body mass index (BMI) has increased by a mean of 0.4<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span> per decade in the last 30 years.<a class="elsevierStyleCrossRef" href="#bib0470"><span class="elsevierStyleSup">1</span></a> According to the Overall Burden of Disease Study, the percentage of adults worldwide with BMIs of 25<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span> or more has increased during the 1980–2013 period from 29% to 37% for men and from 30% to 38% for women.<a class="elsevierStyleCrossRef" href="#bib0475"><span class="elsevierStyleSup">2</span></a> In Spain, the prevalence of obesity in the adult population is 23% (24% for men and 21% for women), to which we must add a prevalence of excess weight of 39% (46% for men and 33% for women).<a class="elsevierStyleCrossRef" href="#bib0480"><span class="elsevierStyleSup">3</span></a> These figures place Spain among the European countries with the highest rates of obesity and excess weight.<a class="elsevierStyleCrossRef" href="#bib0485"><span class="elsevierStyleSup">4</span></a> To this already worrying situation, we must add the fact that four of every 10 young Spaniards between the ages of 8 and 17 years are obese or have excess weight.<a class="elsevierStyleCrossRef" href="#bib0490"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">In addition to significantly contributing to the burden of coronary artery disease and some cancers, obesity and excess weight are responsible for 44% of the burden of diabetes,<a class="elsevierStyleCrossRef" href="#bib0495"><span class="elsevierStyleSup">6</span></a> thereby accounting for the primary modifiable risk factor for this disease. Programs aimed at reducing excess weight and obesity, such as the Diabetes Prevention Program Study and the Diabetes in Europe – Prevention Using Lifestyle, Physical Activity and Nutritional Intervention, have shown that reducing weight with lifestyle changes is associated with a pronounced reduction in the development of diabetes,<a class="elsevierStyleCrossRefs" href="#bib0500"><span class="elsevierStyleSup">7,8</span></a> even greater than that achieved with pharmacological measures.<a class="elsevierStyleCrossRef" href="#bib0500"><span class="elsevierStyleSup">7</span></a> According to the results of the Di@betes study,<a class="elsevierStyleCrossRef" href="#bib0510"><span class="elsevierStyleSup">9</span></a> the prevalence of obesity and abdominal obesity in Spaniards with known diabetes is 50% and 68%, respectively.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">When diagnosing type 2 diabetes, clinicians should establish the degree of obesity based on BMI and, for patients with excess weight, by measuring waist circumference</span><p id="par0020" class="elsevierStylePara elsevierViewall">The impact of obesity on the progression of diabetes has been widely documented, hence the importance of its assessment in all patients with diabetes, both at the time of the diagnosis and during follow-up. Among the tools available in daily clinical practice for assessing a patient's weight status, the BMI is the most widely used. BMI readings greater than 25<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span> and greater than 30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span> are indicative of overweight and obesity, respectively.</p><p id="par0025" class="elsevierStylePara elsevierViewall">However, BMI underestimates the prevalence of excess weight and obesity when estimating total body adiposity.<a class="elsevierStyleCrossRef" href="#bib0515"><span class="elsevierStyleSup">10</span></a> The increase in intraabdominal or visceral fat is more closely related to the development of diabetes and other cardiovascular disease risk factors.<a class="elsevierStyleCrossRefs" href="#bib0520"><span class="elsevierStyleSup">11,12</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">Waist circumference is a simple measure that predicts visceral fat as well as its changes with weight loss. This measure has been shown to be an independent marker of BMI and of other risk factors for developing type 2 diabetes (DM2) and cardiovascular diseases.<a class="elsevierStyleCrossRef" href="#bib0520"><span class="elsevierStyleSup">11</span></a> It has also been observed that this association is stronger than that of the waist/hip index.<a class="elsevierStyleCrossRef" href="#bib0530"><span class="elsevierStyleSup">13</span></a> This relationship between waist circumference (and therefore intraabdominal or visceral adiposity) and the development of comorbidities has been observed even in patients without obesity, which reinforces the importance of its measurement in daily clinical practice in patients with diabetes and excess weight/obesity when implementing the necessary therapeutic strategies for achieving metabolic and cardiovascular control.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">The proper treatment of DM2 requires a simultaneous approach to excess weight/obesity and the other cardiovascular risk factors</span><p id="par0035" class="elsevierStylePara elsevierViewall">For all patients with excess weight/obesity who have or who are at risk of DM2, the American Diabetes Association recommends a healthy diet with reduced energy intake to reduce weight.<a class="elsevierStyleCrossRef" href="#bib0535"><span class="elsevierStyleSup">14</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The benefits of weight loss in patients with DM2 are numerous. Lifestyle changes should be the basis of DM2 treatment. It is important to advise patients on how to achieve realistic weight loss goals, avoiding unrealistic expectations that create anxiety and frustration.</p><p id="par0045" class="elsevierStylePara elsevierViewall">For individuals with excess weight/obesity and diabetes, especially those with a recent diagnosis, even small weight losses can decrease insulin resistance and facilitate glycemic control.<a class="elsevierStyleCrossRef" href="#bib0540"><span class="elsevierStyleSup">15</span></a> Significant weight loss, such as those associated with metabolic surgery, can achieve DM2 remission.<a class="elsevierStyleCrossRef" href="#bib0545"><span class="elsevierStyleSup">16</span></a> Additionally, weight loss can provide other clinical benefits such as improved cardiovascular risk factors (e.g., dyslipidemia, arterial hypertension) and delay the need for starting treatment with hypoglycemic agents.<a class="elsevierStyleCrossRefs" href="#bib0540"><span class="elsevierStyleSup">15,17,18</span></a> This is an important issue, given that patients with diabetes frequently have other cardiovascular risk factors, and these in turn are a risk factor for the development or progression of the microvascular and macrovascular complications of diabetes. Since the publication of the UKPDS study, it has been known that the risk of vascular complications in individuals with diabetes is strongly associated with an increase in systolic blood pressure and that strict blood pressure control for patients with diabetes is associated with a significant reduction in diabetes-related mortality and complications.<a class="elsevierStyleCrossRefs" href="#bib0560"><span class="elsevierStyleSup">19–21</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">Regarding dyslipidemia in patients with diabetes, the beneficial effects of hypolipidemic agents, especially statins, in reducing LDL cholesterol and the resulting reduction in cardiovascular events have been well demonstrated.<a class="elsevierStyleCrossRefs" href="#bib0575"><span class="elsevierStyleSup">22–25</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Moreover, the prevalence of smoking, one of the most important cardiovascular risk factors, is high in patients with diabetes.<a class="elsevierStyleCrossRef" href="#bib0510"><span class="elsevierStyleSup">9</span></a> The effects of smoking on the arterial wall, the reduction in HDL-C and the increase in platelet aggregation and tissue hypoxia significantly contribute to atherosclerotic disease. All patients with diabetes should be informed of the harmful effects of smoking and undergo active counseling on smoking cessation.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Globally, the STENO study and other subsequent studies have demonstrated that for patients with DM2 and high vascular risk the greatest benefits are achieved with a multiple intervention, especially for cardiovascular risk factors.<a class="elsevierStyleCrossRefs" href="#bib0595"><span class="elsevierStyleSup">26,27</span></a></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Nondrug interventions (e.g., diet and exercise) with proven benefits in preventing and treating patients with DM2 and excess weight/obesity should follow an individual and multidisciplinary approach, with structured programs equipped with specific resources</span><p id="par0065" class="elsevierStylePara elsevierViewall">The treatment and prevention guidelines for DM2 unanimously recommend lifestyle changes as the first required step for treating the disease.<a class="elsevierStyleCrossRefs" href="#bib0535"><span class="elsevierStyleSup">14,28–31</span></a> However, scientific evidence supporting nutrition management and the practice of physical exercise in preventing and treating DM2 show that effective interventions are those that are integrated into structured programs; simple medical counseling is insufficient.<a class="elsevierStyleCrossRefs" href="#bib0625"><span class="elsevierStyleSup">32,33</span></a> A recent meta-analysis evaluated the results of 20 randomized, prospective intervention studies with lifestyle measures using educational programs and structured follow-up developed by specialized personnel, for patients with or at risk of developing DM2.<a class="elsevierStyleCrossRef" href="#bib0635"><span class="elsevierStyleSup">34</span></a> This study confirmed the effectiveness of a comprehensive approach with lifestyle changes in reducing the incidence of DM2 in high-risk patients, although a reduction in cardiovascular mortality or for any cause in patients with DM2 could not be demonstrated.</p><p id="par0070" class="elsevierStylePara elsevierViewall">One of the most ambitious studies aimed at proving the efficacy of lifestyle changes in reducing cardiovascular risk in patients with DM2 (the most common cause of mortality in this group) was the Look Ahead study.<a class="elsevierStyleCrossRef" href="#bib0540"><span class="elsevierStyleSup">15</span></a> Look Ahead was a randomized clinical trial funded by the United States National Institutes of Health, designed to examine the effects of weight loss on long-term health in individuals with DM2 and excess weight/obesity, following a structured intervention that included diet, increased physical activity and behavior intervention. The study was stopped early after an intermediate analysis showed that the incidence of cardiovascular events had not been reduced during an average follow-up of 9.6 years in the intensive lifestyle change group compared with the control group.<a class="elsevierStyleCrossRef" href="#bib0540"><span class="elsevierStyleSup">15</span></a> Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% in a year; 6% vs. 3.5% at the end of the study). The lifestyle intervention also produced greater reductions in glycosylated hemoglobin A1c (HbA1c) (−0.6% the first year and −0.22% the following 10 years, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001), in physical condition and in all cardiovascular risk factors, with the exception of LDL cholesterol levels.</p><p id="par0075" class="elsevierStylePara elsevierViewall">The Look Ahead study, despite the inconclusive results of its main objective of reducing cardiovascular risk, did show several important consequences regarding obesity and its associated problems<a class="elsevierStyleCrossRef" href="#bib0640"><span class="elsevierStyleSup">35</span></a>:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0080" class="elsevierStylePara elsevierViewall">Significant weight loss can be maintained long-term. Thus, 50% of the participants in the intensive intervention maintained a weight loss of 5% in year 8, and 27% maintained a weight loss of more than 10%.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0085" class="elsevierStylePara elsevierViewall">The weight loss was comparable regardless of sex, racial or ethnic group.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0090" class="elsevierStylePara elsevierViewall">The individuals who used insulin were able to lose weight, with weight losses that were not significantly different from those of individuals who did not use insulin.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0095" class="elsevierStylePara elsevierViewall">The intervention was beneficial for varying degrees of obesity and excess weight.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0100" class="elsevierStylePara elsevierViewall">The elderly participants (66–76 years of age) had the greatest weight loss and program compliance.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0105" class="elsevierStylePara elsevierViewall">In addition to weight reduction, the intensive intervention with lifestyle changes increased the possibility of achieving DM2 remission, improving the obstructive sleep apnea syndrome indices and reducing movement restriction, depressive symptoms, erectile dysfunction and urinary incontinence.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">•</span><p id="par0110" class="elsevierStylePara elsevierViewall">This intervention reduced medical costs, including those related to hospitalization and medication.</p></li></ul></p><p id="par0115" class="elsevierStylePara elsevierViewall">It is widely accepted that lifestyle changes should form part of any individual treatment of DM2 and that these should be reinforced on a regular basis.<a class="elsevierStyleCrossRefs" href="#bib0535"><span class="elsevierStyleSup">14,28–31</span></a> However, it should be taken into account that for the intervention to be effective, it should be equipped with professional resources and sufficient financial resources and be integrated into a structured intervention program.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Iatrogenic weight gain associated with antidiabetic treatment can impede glycemic control and reduce treatment adherence</span><p id="par0120" class="elsevierStylePara elsevierViewall">Epidemiological data from clinical studies have confirmed that patients with DM2, as a whole, increase their weight, even when their treatment includes lifestyle changes. Weight gain, in addition to limiting patient treatment adherence, represents a clear barrier for achieving treatment effectiveness. Morgan et al., using data from 350 primary care centers in the United Kingdom on 10 million patients, of whom 184,474 had DM2, assessed the trend in weight progression from 1995 to 2010. The authors found that both preexisting and incident cases of diabetes showed an overall increase in weight over time.<a class="elsevierStyleCrossRef" href="#bib0645"><span class="elsevierStyleSup">36</span></a> When the study authors broke down the weight evolution according to the treatment employed, the differences among the treatments were evident: the use of insulin was associated with an increase of up to 6<span class="elsevierStyleHsp" style=""></span>kg of weight in 2 years, while treatment that included a GLP-1 (glucagon like peptide 1) agonist reduced weight by up to 8.7<span class="elsevierStyleHsp" style=""></span>kg. In the same 2-year period, however, HbA1c levels did not improve in the patients treated with insulin (8.3%). Similarly, several observational studies have been able to evolutionarily correlate weight gain with poorer glycemic control in DM2.<a class="elsevierStyleCrossRef" href="#bib0650"><span class="elsevierStyleSup">37</span></a></p><p id="par0125" class="elsevierStylePara elsevierViewall">The actual possibility of optimizing DM2 treatment is limited by patient-dependent factors, both psychological and cultural. One of these factors is the lack of treatment compliance. One of its potential causes is weight gain.<a class="elsevierStyleCrossRef" href="#bib0655"><span class="elsevierStyleSup">38</span></a> A systematic review analyzed the determinants of patient preferences for the various noninsulin drugs<a class="elsevierStyleCrossRef" href="#bib0660"><span class="elsevierStyleSup">39</span></a> and concluded that weight maintenance/reduction along with glycemic control are the attributes that most determine the patients’ preferences when assessing the treatment.</p><p id="par0130" class="elsevierStylePara elsevierViewall">Therefore, weight gain associated with antidiabetic treatment represents a barrier to achieving appropriate compliance and reaching glycemic control objectives. The recent incorporation of new treatments, such as dipeptidyl peptidase 4 inhibitors (DPPi-4), GLP-1 receptor agonists and sodium-dependent glucose cotransporter 2 inhibitors (SGLT2i), with neutral or reducing effects on body weight, can help minimize these limitations.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Iatrogenic weight gain associated with antidiabetic treatment worsens patients’ vascular risk profile and can limit cardiovascular benefits</span><p id="par0135" class="elsevierStylePara elsevierViewall">Several hypoglycemic drugs have the secondary effect of changing body weight (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). Insulin increases weight between 1.8 and 6.6<span class="elsevierStyleHsp" style=""></span>kg, sulfonylureas between −0.3 and 4.0<span class="elsevierStyleHsp" style=""></span>kg and thiazolidinediones between 0.18 and 1.5<span class="elsevierStyleHsp" style=""></span>kg.<a class="elsevierStyleCrossRef" href="#bib0665"><span class="elsevierStyleSup">40</span></a> In contrast, other drugs are practically neutral, such as DPPi-4 (−0.7 to +0.6<span class="elsevierStyleHsp" style=""></span>kg, depending on the drug),<a class="elsevierStyleCrossRefs" href="#bib0670"><span class="elsevierStyleSup">41,42</span></a> and can even cause weight loss,<a class="elsevierStyleCrossRef" href="#bib0680"><span class="elsevierStyleSup">43</span></a> such as metformin (−2<span class="elsevierStyleHsp" style=""></span>kg when compared with placebo),<a class="elsevierStyleCrossRef" href="#bib0685"><span class="elsevierStyleSup">44</span></a> GLP-1 agonists (−2.9<span class="elsevierStyleHsp" style=""></span>kg when compared with placebo, oral diabetic drugs or insulin)<a class="elsevierStyleCrossRef" href="#bib0690"><span class="elsevierStyleSup">45</span></a> and SLGT2i (−1.8 to −2.3<span class="elsevierStyleHsp" style=""></span>kg when compared with placebo).<a class="elsevierStyleCrossRef" href="#bib0695"><span class="elsevierStyleSup">46</span></a></p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0140" class="elsevierStylePara elsevierViewall">If a drug increases the insulin concentration regardless of blood glucose levels (which occurs with sulfonylureas, glinides and, of course, insulin), there is a risk of both hypoglycemia and weight gain,<a class="elsevierStyleCrossRef" href="#bib0700"><span class="elsevierStyleSup">47</span></a> in both cases due to an overinsulinization mechanism. Incretin-based therapies do not involve this risk, because they increase insulin secretion only when the glycemia concentration is high and decrease it when the glycemia level is low. Moreover, SGLT2i causes weight loss due to the caloric loss associated with glycosuria.</p><p id="par0145" class="elsevierStylePara elsevierViewall">In the long term, weight gain can be an obstacle to achieving benefits in cardiovascular morbidity and mortality and can even worsen the course of diabetes in general,<a class="elsevierStyleCrossRef" href="#bib0705"><span class="elsevierStyleSup">48</span></a> although the latter issue has not been formally proven. In fact, a number of drugs that increase weight have been associated with a poorer cardiovascular prognosis. This is the case with many sulfonylureas when compared with metformin<a class="elsevierStyleCrossRef" href="#bib0710"><span class="elsevierStyleSup">49</span></a> and with rosiglitazone.<a class="elsevierStyleCrossRef" href="#bib0715"><span class="elsevierStyleSup">50</span></a> The results with insulin are, however, inconsistent.<a class="elsevierStyleCrossRef" href="#bib0720"><span class="elsevierStyleSup">51</span></a> Treatment intensification for patients with DM2 has been associated with weight gain. The Action to Control Cardiovascular Risk in Diabetes study was stopped early due to an increase in mortality risk with intensive treatment.<a class="elsevierStyleCrossRef" href="#bib0725"><span class="elsevierStyleSup">52</span></a> The increase in weight and the frequency of hypoglycemia are the two factors that have been primarily associated with this result.<a class="elsevierStyleCrossRef" href="#bib0730"><span class="elsevierStyleSup">53</span></a> The analysis of factors associated with weight gain in this study showed significant differences according to the treatments employed. Patients undergoing intensive treatment who did not use insulin or thiazolidinediones decreased their weight by 2.9<span class="elsevierStyleHsp" style=""></span>kg; however, patients in the same group who used both treatments increased their weight between 4.6 and 5.3<span class="elsevierStyleHsp" style=""></span>kg.<a class="elsevierStyleCrossRef" href="#bib0735"><span class="elsevierStyleSup">54</span></a></p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Avoiding weight gain associated with antidiabetic treatment is cost-effective</span><p id="par0150" class="elsevierStylePara elsevierViewall">Lifestyle changes, with an appropriate program that includes dieting, physical exercise and psychological support, constitute the most cost-effective therapeutic strategy for preventing DM2.<a class="elsevierStyleCrossRefs" href="#bib0500"><span class="elsevierStyleSup">7,55</span></a> Weight loss was the most notable effect in clinical trials conducted with lifestyle intervention or with drugs to prevent or delay the onset of diabetes.<a class="elsevierStyleCrossRefs" href="#bib0500"><span class="elsevierStyleSup">7,56</span></a> Studies performed with administrative databases have shown that reducing weight in patients with DM2 is associated with a reduction in the diabetes-related costs,<a class="elsevierStyleCrossRefs" href="#bib0750"><span class="elsevierStyleSup">57,58</span></a> especially for patients with obesity.<a class="elsevierStyleCrossRef" href="#bib0750"><span class="elsevierStyleSup">57</span></a> In our community, an observational retrospective study of 738 patients with DM2 who were followed-up for 12 months found that those patients who reduced their BMI by one point showed a benefit in terms of reduced healthcare costs of 9.4% if they were obese and 2.7% if they were not.<a class="elsevierStyleCrossRef" href="#bib0760"><span class="elsevierStyleSup">59</span></a></p><p id="par0155" class="elsevierStylePara elsevierViewall">The most cost-effective and recommended drug in all guidelines as the first therapeutic option for treating DM2 is metformin, which has a good profile in terms of body weight (weight reduction or neutral effect).<a class="elsevierStyleCrossRefs" href="#bib0685"><span class="elsevierStyleSup">44,60</span></a> For the selection of the second drug, the key is individualization. One of the factors to consider is the effect on weight, which, as was stated earlier, differs for the various therapeutic options.<a class="elsevierStyleCrossRefs" href="#bib0770"><span class="elsevierStyleSup">61,62</span></a> Analyses that use pharmacoeconomic models have shown that GLP-1 analogues are cost-effective when compared with other common interventions for patients with DM2.<a class="elsevierStyleCrossRefs" href="#bib0780"><span class="elsevierStyleSup">63,64</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">Moreover, the costs of diabetes are very high (approximately 11% of worldwide healthcare expenditures).<a class="elsevierStyleCrossRef" href="#bib0790"><span class="elsevierStyleSup">65</span></a> It has been estimated that the cost derived from treating the complications represent more than 50% of the total cost.<a class="elsevierStyleCrossRef" href="#bib0795"><span class="elsevierStyleSup">66</span></a> Although it has been shown that the reduction in HbA1c associated with any hypoglycemic drug reduces microvascular complications, the cardiovascular benefits of antidiabetic treatment have only been partially confirmed in the case of metformin. For incretin-based treatment (DPP-4i and GLP-1 analogues) and treatment using new glycosuric drugs, benefits have not been demonstrated from the cardiovascular point of view. Given that these drugs have recently been marketed, their long-term safety is not well known, and they have a high cost.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Antidiabetic drugs with benefits in terms of body weight have also demonstrated their advantages for patients with BMIs <30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span></span><p id="par0165" class="elsevierStylePara elsevierViewall">The definition of obesity and its varying degrees of severity are based on BMI, a highly inaccurate and arbitrary parameter. We now know that individuals with a BMI <30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span> but with abdominal obesity have a high degree of comorbidities and need treatment to reverse this situation.<a class="elsevierStyleCrossRefs" href="#bib0515"><span class="elsevierStyleSup">10,67</span></a> These individuals have excess omental and visceral fat. The coexistence of hepatic steatosis is highly relevant and is a source of many of the pathogenic processes of DM2. Treating the hepatic steatosis itself should be specifically approached using effective drugs to improve or reverse the condition. Doing so will provide a potential vascular benefit, given that there is a strong correlation between hepatic steatosis and the quantified amount of omental fat on one hand and the various markers of subclinical vascular disease on the other, markers such as the carotid intima-media thickness and the number and type of plaques in this arterial territory.</p><p id="par0170" class="elsevierStylePara elsevierViewall">GLP-1 receptor agonists and SGLT2 inhibitors can also present highly significant pleiotropic effects in patients with DM2 (nephroprotective effects, effects on cardiovascular function, effects on hepatic steatosis and neuroprotective effects), which are currently the subject of specific research.<a class="elsevierStyleCrossRefs" href="#bib0805"><span class="elsevierStyleSup">68–71</span></a> Therefore, when excess weight cannot be corrected through diet and exercise, it can be corrected with the drugs listed above, which will result in cardiometabolic benefits associated with a reduction in body adiposity.<a class="elsevierStyleCrossRef" href="#bib0825"><span class="elsevierStyleSup">72</span></a></p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Clinical trials on DM2 intervention should consider combined objectives that include not only glycemic control but also other variables such as the risk of hypoglycemia and the effect of treatment on body weight</span><p id="par0175" class="elsevierStylePara elsevierViewall">The concept of personalized DM2 therapy involves an approach in clinical decision making that is applied to each patient and takes into account as a prerequisite the phenotype of the individual with diabetes, as well as their personal circumstances. The therapy's final objective is to optimize the therapeutic response and improve tolerability and compliance.</p><p id="par0180" class="elsevierStylePara elsevierViewall">In line with this personalized therapy, we should assess various aspects related to the drug before choosing it, such as<a class="elsevierStyleCrossRefs" href="#bib0535"><span class="elsevierStyleSup">14,28,73,74</span></a> its action on the pathophysiological disorders that produce hyperglycemia, the evidence on its ability to reduce macrovascular and microvascular complications, its potency in reducing HbA1c levels, the preferential impact on baseline or prandial glycemia, the associated complications and diseases, the risk of inducing hypoglycemia, its influence on weight and other metabolic disorders, the risk of other drug-related adverse effects its tolerance and its cost.</p><p id="par0185" class="elsevierStylePara elsevierViewall">The onset of drug-induced hypoglycemia is one of the main limiting factors to achieving proper metabolic control of DM2. Hypoglycemia is associated with excess morbidity and mortality, including cardiovascular, and increases the costs associated with treating DM and entails a loss of productivity for the patients with DM.<a class="elsevierStyleCrossRefs" href="#bib0840"><span class="elsevierStyleSup">75–79</span></a> Hypoglycemia is also associated with an increased risk of fractures<a class="elsevierStyleCrossRefs" href="#bib0865"><span class="elsevierStyleSup">80,81</span></a> and the onset of cognitive impairment.<a class="elsevierStyleCrossRefs" href="#bib0875"><span class="elsevierStyleSup">82–84</span></a></p><p id="par0190" class="elsevierStylePara elsevierViewall">Therefore, clinical trials for diabetes intervention, in addition to assessing the effects on glycemic control, should consider the impact the effects have on other relevant variables, such as the frequency of hypoglycemia, the effect on weight and, of course, the cardiovascular results.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">The treatment of patients with DM2 and obesity will depend both on the degree of obesity and the associated comorbidity</span><p id="par0195" class="elsevierStylePara elsevierViewall">The diabetes treatment guidelines, both those prepared by specialists<a class="elsevierStyleCrossRef" href="#bib0605"><span class="elsevierStyleSup">28</span></a> and by primary care physicians,<a class="elsevierStyleCrossRef" href="#bib0890"><span class="elsevierStyleSup">85</span></a> establish weight as one of the differentiating variables in the therapeutic decision. In addition to obesity, these guidelines include impaired renal function, age, frailty and drug contraindication as determinants in the therapeutic decision.</p><p id="par0200" class="elsevierStylePara elsevierViewall">Treatments should be adjusted according to the individualized glycemic control objective agreed upon with each patient. For patients with comorbidity, advanced age (>75 years) or long-standing diabetes (>10 years), we should avoid establishing very strict HbA1c goals, given that these can increase cardiovascular mortality.<a class="elsevierStyleCrossRef" href="#bib0895"><span class="elsevierStyleSup">86</span></a></p><p id="par0205" class="elsevierStylePara elsevierViewall">An additional benefit on blood pressure has been observed with antidiabetic drugs that reduce weight. In the case of GLP-1 agonists, a reduction in systolic blood pressure of 2.22<span class="elsevierStyleHsp" style=""></span>mm<span class="elsevierStyleHsp" style=""></span>Hg (95% CI 2.97–1.47)<a class="elsevierStyleCrossRef" href="#bib0900"><span class="elsevierStyleSup">87</span></a> and in SGLT2 inhibitors of −4.45<span class="elsevierStyleHsp" style=""></span>mm<span class="elsevierStyleHsp" style=""></span>Hg (95% CI −5.73–3.18) was observed.<a class="elsevierStyleCrossRef" href="#bib0905"><span class="elsevierStyleSup">88</span></a> These drugs also have a reduced risk of hypoglycemia due to their mechanism of action.</p><p id="par0210" class="elsevierStylePara elsevierViewall">Lastly, we know that weight gain has a negative effect on compliance<a class="elsevierStyleCrossRef" href="#bib0910"><span class="elsevierStyleSup">89</span></a> and that compliance increases when the patient with diabetes participates in the decision making, as recommended in the recent strategies on dealing with chronicity.<a class="elsevierStyleCrossRefs" href="#bib0915"><span class="elsevierStyleSup">90,91</span></a> Several studies that assessed patients’ opinion have shown that weight gain and hypoglycemia are, along with glycemic control, factors of considerable relevance in the preferences for an antidiabetic treatment.<a class="elsevierStyleCrossRefs" href="#bib0925"><span class="elsevierStyleSup">92,93</span></a></p><p id="par0215" class="elsevierStylePara elsevierViewall">In summary, obesity is a factor that is frequently associated with diabetes. Although the earliest drugs for treating diabetes (insulin, sulfonylureas, glinides and glitazones) produced weight gain and increased the risk of hypoglycemia, innovation in the field of diabetes has provided new drugs that improve the effect on weight, with a reduced risk of hypoglycemia.</p><p id="par0220" class="elsevierStylePara elsevierViewall">Therefore, after the start of treatment, the therapeutic decision for patients with diabetes and obesity should include an assessment with metformin on the usefulness of neutral drugs (DPP-4i) and weight reducers (GLP-1 agonists and SGLT2 inhibitors) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>), reaching the decision by consensus with the informed patient.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Conflicts of interest</span><p id="par0225" class="elsevierStylePara elsevierViewall">Dr. Gómez Huelgas has worked as an advisor for Sanofi, Novo Nordisk, Janssen and GSK. He has participated in research studies for Sanofi, Novo Nordisk, Boehringer Ingelheim, GSK and Lilly. He has given paid lectures for Sanofi, Novo Nordisk, Boehringer Ingelheim, MSD and AstraZeneca.</p><p id="par0230" class="elsevierStylePara elsevierViewall">Dr. Gómez Huelgas has worked as an advisor for Sanofi and Novo Nordisk Inc and has participated in research studies for Sanofi, Novo Nordisk Inc., Boehringer Ingelheim Pharmaceuticals Inc. and Lilly. He has given lectures for Sanofi, Novo Nordisk Inc., Boehringer Ingelheim Pharmaceuticals Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company and Lilly.</p><p id="par0235" class="elsevierStylePara elsevierViewall">Dr. Carrillo Fernández declares that she has no conflicts of interest.</p><p id="par0240" class="elsevierStylePara elsevierViewall">Dr. Galve declares that he has no conflicts of interest.</p><p id="par0245" class="elsevierStylePara elsevierViewall">Dr. Casanueva declares that he has no conflicts of interest.</p><p id="par0250" class="elsevierStylePara elsevierViewall">Dr. Puig Domingo has worked as an advisor for Janssen, Sanofi and Lilly. He has given lectures for Janssen, AstraZeneca, Lilly, Novo Nordisk and Sanofi and has participated in research studies for Novo Nordisk, Sanofi, AstraZeneca.</p><p id="par0255" class="elsevierStylePara elsevierViewall">Dr. Mediavilla Bravo declares that he has no conflicts of interest.</p><p id="par0260" class="elsevierStylePara elsevierViewall">Dr. Orozco Beltrán has participated in training and research projects sponsored by Novo Nordisk, MSD, Lilly, Novartis and Sanofi.</p><p id="par0265" class="elsevierStylePara elsevierViewall">Dr. Ena Muñoz declares that she has no conflicts of interest.</p><p id="par0270" class="elsevierStylePara elsevierViewall">Dr. Menéndez Torre has given lectures for Sanofi, Novo Nordisk, AstraZeneca Pharmaceuticals and Lilly and has participated in research studies for Sanofi.</p><p id="par0275" class="elsevierStylePara elsevierViewall">Dr. Sara Artola Menéndez has collaborated scientifically with Lilly-Boehringher, Sanofi, MSD, Novartis, AstraZeneca, GSK and Jansse-Cilag.</p><p id="par0280" class="elsevierStylePara elsevierViewall">Dr. Pilar Mazón Ramos declares that she has no conflicts of interest but has received funding from AstraZeneca, Bayer, Boehriger-Ingleheim, MSD, Novartis, Pfizer, Rovi and Takeda for participating in consulting, giving lectures and attending scientific congresses.</p><p id="par0285" class="elsevierStylePara elsevierViewall">Dr. Monereo Megías declares that he has no conflicts of interest.</p><p id="par0290" class="elsevierStylePara elsevierViewall">Dr. Caixas Pedrágos has worked as an advisor for Novo Nordisk and participated in conferences for Novo Nordisk, Lilly, Sanofi, AstraZeneca and MSD.</p><p id="par0295" class="elsevierStylePara elsevierViewall">Dr. Flora López Simarro declares that she has no conflicts of interest.</p><p id="par0300" class="elsevierStylePara elsevierViewall">Dr. Fernando Álvarez Guisasola has participated in advisory tasks for Sanofi Aventis, Novo Nordisk, AstraZeneca and Janssen. He has received research grants from Sanofi Aventis and has participated as speaker for Merck Sharp and Dohme, Sanofi. Aventis, Eli Lilly, AstraZeneca and Novo Nordisk.</p></span></span>"
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"resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Obesity and excess weight are the main preventable causes of type 2 diabetes (DM2). When diagnosing type 2 diabetes, clinicians should establish the degree of obesity according to the body mass index (BMI) and, for patients with excess weight, measure the waist circumference. The proper treatment of DM2 requires a simultaneous approach to excess weight/obesity and the other cardiovascular risk factors, such as hypertension, dyslipidaemia and smoking. Nondrug interventions (e.g., diet and exercise) have proven benefits in preventing and treating patients with DM2 and excess weight/obesity and should follow an individual and multidisciplinary approach, with structured programs equipped with specific resources. Weight gain associated with antidiabetic treatment can hinder glycaemic control, compromise treatment adherence, worsen the vascular risk profile and limit the cardiovascular benefits of treatment. Therefore, it is significant to avoid weight gain, a measure that can be cost-effective. Antidiabetic drugs with benefits in body weight have also demonstrated their benefit in patients with BMIs <30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span>. In general, the treatment of patients with DM2 and obesity will depend both on the degree of obesity and the associated comorbidity. Clinical trials on DM2 intervention should consider combined objectives that include not only glycaemic control but also other variables such as the risk of hypoglycaemia and the effect of treatment on body weight.</p></span>"
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"resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">La obesidad y el sobrepeso constituyen la principal causa modificable de diabetes tipo 2 (DM2). En el momento del diagnóstico de la diabetes tipo 2 se debe establecer el grado de obesidad según el índice de masa corporal y, en los pacientes con sobrepeso, determinar el perímetro de la cintura. El adecuado tratamiento de la DM2 requiere un abordaje simultáneo del sobrepeso/obesidad y el resto de factores de riesgo cardiovascular, como la hipertensión, la dislipemia o el tabaquismo. Las intervenciones no farmacológicas (dieta, ejercicio) con beneficio demostrado en la prevención y tratamiento del paciente con DM2 y sobrepeso/obesidad deben seguir un enfoque individualizado y multidisciplinario, con programas estructurados dotados de recursos específicos. La ganancia de peso asociada al tratamiento antidiabético puede dificultar el control glucémico, comprometer la adherencia al tratamiento, empeorar el perfil de riesgo vascular de los pacientes y limitar los beneficios cardiovasculares del tratamiento. Por ello, es importante evitarla; una medida que resulta coste-efectiva. Los fármacos antidiabéticos con beneficios sobre el peso corporal también han demostrado su beneficio en pacientes con un índice de masa corporal<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>30<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span>. Globalmente, el tratamiento del paciente con DM2 y obesidad dependerá tanto del grado de obesidad como de la comorbilidad asociada. Los ensayos clínicos de intervención en DM2 deben contemplar objetivos combinados que incluyan no solo el control glucémico, sino otras variables como el riesgo de hipoglucemia y el efecto del tratamiento sobre el peso corporal.</p></span>"
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"leyenda" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Abbreviations: DPP-4, dipeptidyl peptidase 4; GLP-1, glucagon-like peptide-1; SGLT2, sodium-dependent glucose cotransporter 2.</p>"
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\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Insulin \t\t\t\t\t\t\n
\t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Metformin \t\t\t\t\t\t\n
\t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n
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