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Efficacy and Safety of Semaglutide for the Management of Obese Patients With Type 2 Diabetes and Chronic Heart Failure in Real-World Clinical Practice.
Pérez-Belmonte, LM, Sanz-Cánovas, J, García de Lucas, MD, Ricci, M, Avilés-Bueno, B, Cobos-Palacios, L, Pérez-Velasco, MA, López-Sampalo, A, Bernal-López, MR, Jansen-Chaparro, S, et al
Frontiers in endocrinology. 2022;:851035
Abstract
BACKGROUND The impact of glucagon-like peptide-1 receptor agonists on patients with heart failure has not been fully described. Our main objective was to evaluate the safety and clinical and glycemic efficacy of once-weekly semaglutide in obese patients with type 2 diabetes and heart failure. METHODS In this observational, retrospective, real-world study, we enrolled outpatients with type 2 diabetes, obesity, and heart failure who started semaglutide and were followed-up on at 3, 6, and 12 months. RESULTS A total of 136 patients were included. From baseline to 12 months, there was a significant improvement on the Kansas City Cardiomyopathy Questionnaire total symptom score (59.0 ± 24.1 vs 79.9 ± 28.4 points, p<0.01), a reduction in the proportion of patients with New York Heart Association functional class III (40.4% to 16.2%, p<0.01), and a reduction in N-terminal pro-brain natriuretic peptide levels (969.5 ± 653.5 vs 577.4 ± 322.1 pg/mL, p<0.01). Emergency department visits due to heart failure, hospitalizations due to heart failure, and all-cause hospitalizations also declined. Additionally, significant reductions in glycated hemoglobin (-1.4%) and body weight (-12.7 kilograms) were observed as well as a de-intensification of antidiabetic therapy. Moreover, semaglutide was safe and well-tolerated. CONCLUSION In obese patients with type 2 diabetes and heart failure, the use of once-weekly semaglutide was safe and clinically efficacious, improving health and functional status. Nevertheless, more strong evidence on glucagon-like peptide-1 receptor agonists in heart failure is required.
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Clinical benefits of empagliflozin in very old patients with type 2 diabetes hospitalized for acute heart failure.
Pérez-Belmonte, LM, Sanz-Cánovas, J, Millán-Gómez, M, Osuna-Sánchez, J, López-Sampalo, A, Ricci, M, Jiménez-Navarro, M, López-Carmona, MD, Bernal-López, MR, Barbancho, MA, et al
Journal of the American Geriatrics Society. 2022;(3):862-871
Abstract
BACKGROUND There is little evidence on the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in older patients with heart failure. This work analyzed the clinical efficacy and safety of empagliflozin continuation in very old patients with type 2 diabetes hospitalized for acute decompensated heart failure. METHODS We conducted a real-world observational study between September 2015 and June 2021. Patients ≥80 years were grouped by antihyperglycemic regimen: (1) continuation of preadmission empagliflozin combined with basal insulin regimen and (2) conventional basal-bolus insulin regimen. A propensity score matching analysis matched patients in both groups in a 1:1 manner. The primary outcome was differences in clinical efficacy measured by the visual analogue scale dyspnea score, NT-proBNP levels, diuretic response, and cumulative urine output. Safety endpoints such as adverse events, worsening heart failure, discontinuation of empagliflozin, length of hospital stay, and in-hospital deaths were also analyzed. RESULTS After propensity score matching, 79 patients were included in each group. At discharge, the N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were lower in the empagliflozin continuation group than in the insulin group (1699 ± 522 vs. 2303 ± 598 pg/ml, p = 0.021). Both the diuretic response and cumulative urine output were greater in patients treated with empagliflozin than in patients with basal-bolus insulin during the hospitalization (at discharge: -0.14 ± -0.06 vs. -0.24 ± -0.10, p = 0.044; and 16,100 ± 1510 vs. 13,900 ± 1220 ml, p = 0.037, respectively). No differences were observed in safety outcomes. CONCLUSIONS In very old patients with type 2 diabetes hospitalized for acute heart failure, continuing preadmission empagliflozin reduced NT-proBNP levels and increased diuretic response and urine output compared to a basal-bolus insulin regimen. The empagliflozin regimen also showed a good safety profile.
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Management of Type 2 Diabetes Mellitus in Elderly Patients with Frailty and/or Sarcopenia.
Sanz-Cánovas, J, López-Sampalo, A, Cobos-Palacios, L, Ricci, M, Hernández-Negrín, H, Mancebo-Sevilla, JJ, Álvarez-Recio, E, López-Carmona, MD, Pérez-Belmonte, LM, Gómez-Huelgas, R, et al
International journal of environmental research and public health. 2022;(14)
Abstract
The life expectancy of the population is increasing worldwide due to improvements in the prevention, diagnosis, and treatment of diseases. This favors a higher prevalence of type 2 diabetes mellitus (T2DM) in the elderly. Sarcopenia and frailty are also frequently present in aging. These three entities share common mechanisms such as insulin resistance, chronic inflammation, and mitochondrial dysfunction. The coexistence of these situations worsens the prognosis of elderly patients. In this paper, we review the main measures for the prevention and management of sarcopenia and/or frailty in elderly patients with T2DM.
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Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors for cardiovascular and renal protection: A treatment approach far beyond their glucose-lowering effect.
Gómez-Huelgas, R, Sanz-Cánovas, J, Cobos-Palacios, L, López-Sampalo, A, Pérez-Belmonte, LM
European journal of internal medicine. 2022;:26-33
Abstract
Findings from cardiovascular outcome trials on certain newer glucose-lowering drugs have shown clear cardiovascular and renal benefits. In this review, we provide an updated overview of glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter 2 (SGLT-2) inhibitors in terms of cardiovascular and renal protection. Both drugs have been described as diabetes/disease-modifying drugs. There is robust evidence on the benefits of GLP-1 receptor agonists in renal disease and atherosclerotic cardiovascular disease-especially in stroke-which are mainly explained by their antiproteinuric effect. However, this class of drugs has only shown neutral effects on heart failure and further studies are necessary in order to assess their role in this disease. SGLT-2 inhibitors have shown strong benefits in heart failure hospitalizations and renal outcomes, mainly through limiting glomerular filtration rate deterioration, regardless of the presence of diabetes. Nonetheless, their effect on the prevention of major adverse atherosclerotic cardiovascular events and cardiovascular mortality seems to be limited to patients with type 2 diabetes and established cardiovascular disease. Evidence on the cardiovascular and renal benefits of GLP-1 receptor agonists and SGLT-2 inhibitors have significantly modified management plans and treatment choices for patients with type 2 diabetes. There is now a focus on a multifactorial approach that goes beyond the glucose-lowering effect of these drugs, which are the preferred choice in routine clinical practice. According to the current evidence, a patient-focused approach that includes both individualized glycemic control and cardiorenal prevention using GLP-1 receptor agonists and SGLT-2 inhibitors with proven cardiovascular and renal benefits is believed to be the best strategy for achieving the treatment goals of patients with type 2 diabetes. Despite the strong cardiovascular and renal benefits of these drugs, further research is required in order to clarify questions that remain unanswered.
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De-Intensification of Antidiabetic Treatment Using Canagliflozin in Patients with Heart Failure and Type 2 Diabetes: Cana-Switch-HF Study.
Pérez-Belmonte, LM, Ricci, M, Sanz-Cánovas, J, Cobos-Palacios, L, López-Carmona, MD, Ruiz-Moreno, MI, Millán-Gómez, M, Bernal-López, MR, Jansen-Chaparro, S, Gómez-Huelgas, R
Journal of clinical medicine. 2021;(9)
Abstract
Canagliflozin is a sodium-glucose co-transporter 2 inhibitor that reduces glycemia as well as the risk of cardiovascular events. Our main objective was to analyze antidiabetic treatment de-intensification and the glycemic efficacy of replacing antidiabetic agents (excluding metformin) with canagliflozin in patients with heart failure and type 2 diabetes with poor glycemic control. In this observational, retrospective, real-world study, we selected patients treated with metformin in combination with ≥2 non-insulin antidiabetic agents or metformin in combination with basal insulin plus ≥1 non-insulin antidiabetic agent. Non-insulin antidiabetic agents were replaced with canagliflozin. Patients were followed-up on at three, six, and 12 months after the switch and a wide range of clinical variables were recorded. A total of 121 patients were included. From baseline to 12 months, the number of antidiabetic agents (3.1 ± 1.0 vs. 2.1 ± 0.8, p < 0.05), basal insulin dose (20.1 ± 9.8 vs. 10.1 ± 6.5 units, p < 0.01), and percentage of patients who used basal insulin (47.9% vs. 31.3%, p < 0.01) decreased. The proportion of patients who used diuretics also declined significantly. In addition, we observed improvement in glycemic control, with an increase in the proportion of patients with glycated hemoglobin <7% from 16.8% at three months to 63.5% at 12 (p < 0.001). Canagliflozin use was also beneficial in terms of body weight, blood pressure, heart failure status, functional class, and cardiovascular-renal risk. There were also reductions in the number of emergency department visits and hospitalizations for heart failure. Moreover, canagliflozin was well-tolerated, with a low rate of drug-related discontinuation. Mounting evidence from randomized controlled trials and real-world studies point to the beneficial profile of sodium-glucose co-transporter type 2 inhibitors such as canagliflozin in patients with heart failure.
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Calcifediol Treatment and Hospital Mortality Due to COVID-19: A Cohort Study.
Alcala-Diaz, JF, Limia-Perez, L, Gomez-Huelgas, R, Martin-Escalante, MD, Cortes-Rodriguez, B, Zambrana-Garcia, JL, Entrenas-Castillo, M, Perez-Caballero, AI, López-Carmona, MD, Garcia-Alegria, J, et al
Nutrients. 2021;(6)
Abstract
CONTEXT Calcifediol has been proposed as a potential treatment for COVID-19 patients. OBJECTIVE To compare the administration or not of oral calcifediol on mortality risk of patients hospitalized because of COVID-19. DESIGN Retrospective, multicenter, open, non-randomized cohort study. SETTINGS Hospitalized care. PATIENTS Patients with laboratory-confirmed COVID-19 between 5 February and 5 May 2020 in five hospitals in the South of Spain. INTERVENTION Patients received calcifediol (25-hydroxyvitamin D3) treatment (0.266 mg/capsule, 2 capsules on entry and then one capsule on day 3, 7, 14, 21, and 28) or not. MAIN OUTCOME MEASURE In-hospital mortality during the first 30 days after admission. RESULTS A total of 537 patients were hospitalized with COVID-19 (317 males (59%), median age, 70 years), and 79 (14.7%) received calcifediol treatment. Overall, in-hospital mortality during the first 30 days was 17.5%. The OR of death for patients receiving calcifediol (mortality rate of 5%) was 0.22 (95% CI, 0.08 to 0.61) compared to patients not receiving such treatment (mortality rate of 20%; p < 0.01). Patients who received calcifediol after admission were more likely than those not receiving treatment to have comorbidity and a lower rate of CURB-65 score for pneumonia severity ≥ 3 (one point for each of confusion, urea > 7 mmol/L, respiratory rate ≥ 30/min, systolic blood pressure < 90 mm Hg or diastolic blood pressure ≤ 60 mm Hg, and age ≥ 65 years), acute respiratory distress syndrome (moderate or severe), c-reactive protein, chronic kidney disease, and blood urea nitrogen. In a multivariable logistic regression model, adjusting for confounders, there were significant differences in mortality for patients receiving calcifediol compared with patients not receiving it (OR = 0.16 (95% CI 0.03 to 0.80). CONCLUSION Among patients hospitalized with COVID-19, treatment with calcifediol, compared with those not receiving calcifediol, was significantly associated with lower in-hospital mortality during the first 30 days. The observational design and sample size may limit the interpretation of these findings.
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Prior Treatment with Statins is Associated with Improved Outcomes of Patients with COVID-19: Data from the SEMI-COVID-19 Registry.
Torres-Peña, JD, Pérez-Belmonte, LM, Fuentes-Jiménez, F, López Carmona, MD, Pérez-Martinez, P, López-Miranda, J, Carrasco Sánchez, FJ, Vargas Núñez, JA, Del Corral Beamonte, E, Magallanes Gamboa, JO, et al
Drugs. 2021;(6):685-695
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Abstract
BACKGROUND The impact of statins on COVID-19 outcomes is important given the high prevalence of their use among individuals at risk for severe COVID-19. Our aim is to assess whether patients receiving chronic statin treatment who are hospitalized with COVID-19 have reduced in-hospital mortality if statin therapy is maintained during hospitalization. METHODS This work is a cross-sectional, observational, retrospective multicenter study that analyzed 2921 patients who required hospital admission at 150 Spanish centers included in the nationwide SEMI-COVID-19 Network. We compared the clinical characteristics and COVID-19 disease outcomes between patients receiving chronic statin therapy who maintained this therapy during hospitalization versus those who did not. Propensity score matching was used to match each statin user whose therapy was maintained during hospitalization to a statin user whose therapy was withdrawn during hospitalization. RESULTS After propensity score matching, continuation of statin therapy was associated with lower all-cause mortality (OR 0.67, 0.54-0.83, p < 0.001); lower incidence of acute kidney injury (AKI) (OR 0.76,0.6-0.97, p = 0.025), acute respiratory distress syndrome (ARDS) (OR 0.78, 0.69- 0.89, p < 0.001), and sepsis (4.82% vs 9.85%, p = 0.008); and less need for invasive mechanical ventilation (IMV) (5.35% vs 8.57, p < 0.001) compared to patients whose statin therapy was withdrawn during hospitalization. CONCLUSIONS Patients previously treated with statins who are hospitalized for COVID-19 and maintain statin therapy during hospitalization have a lower mortality rate than those in whom therapy is withdrawn. In addition, statin therapy was associated with a decreased probability that patients with COVID-19 will develop AKI, ARDS, or sepsis and decreases the need for IMV.
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Functional objective parameters which may discriminate patients with mild cognitive impairment from cognitively healthy individuals: a systematic review and meta-analysis using an instrumented kinematic assessment.
Fuentes-Abolafio, IJ, Stubbs, B, Pérez-Belmonte, LM, Bernal-López, MR, Gómez-Huelgas, R, Cuesta-Vargas, A
Age and ageing. 2021;(2):380-393
Abstract
BACKGROUND a systematic review in 2015 showed kinematic gait and balance parameters which can discriminate patients with mild cognitive impairment (MCI) from cognitively healthy individuals. OBJECTIVE this systematic review and meta-analysis aims to summarise and synthesise the evidence published after the previous review about the functional objective parameters obtained by an instrumented kinematic assessment which could discriminate patients with MCI from cognitively healthy individuals, as well as to assess the level of evidence per outcome. METHODS major electronic databases were searched from inception to August 2019 for cross-sectional studies published after 2015 examining kinematic gait and balance parameters, which may discriminate patients with MCI from cognitively healthy individuals. Meta-analysis was carried out for each parameter reported in two or more studies. RESULTS Ten cross-sectional studies with a total of 1,405 patients with MCI and 2,277 cognitively healthy individuals were included. Eight of the included studies reported a low risk of bias. Patients with MCI showed a slower gait speed than cognitively healthy individuals. Thus, single-task gait speed (d = -0.44, 95%CI [-0.60 to -0.28]; P < 0.001), gait speed at fast pace (d = -0.48, 95%CI [-0.72 to -0.24]; P < 0.001) and arithmetic dual-task gait speed (d = -1.20, 95%CI [-2.12 to -0.28]; P = 0.01) were the functional objective parameters which best discriminated both groups. CONCLUSION the present review shows kinematic gait parameters which may discriminate patients with MCI from cognitively healthy individuals. Most of the included studies reported a low risk of bias, but the grading of recommendations assessment, development and evaluation criteria showed a low level of evidence per outcome.
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Functional parameters indicative of mild cognitive impairment: a systematic review using instrumented kinematic assessment.
Fuentes-Abolafio, IJ, Stubbs, B, Pérez-Belmonte, LM, Bernal-López, MR, Gómez-Huelgas, R, Cuesta-Vargas, A
BMC geriatrics. 2020;(1):282
Abstract
BACKGROUND Patients with mild cognitive impairment (MCI) experience alterations of functional parameters, such as an impaired balance or gait. The current systematic review set out to investigate whether functional objective performance may predict a future risk of MCI; to compare functional objective parameters in patients with MCI and a control group; and to assess changes in these parameters after different physical activity interventions. METHODS Electronic databases, including PubMed, AMED, CINAHL, EMBASE, PEDro and Web of Science as well as grey literature databases, were searched from inception to February 2020. Cohort studies and Randomized Controlled Trials (RCTs) were included. The risk of bias of the included studies was assessed independently by reviewers using quality assessment checklists. The level of evidence per outcome was assessed using the GRADE criteria. RESULTS Seventeen studies met inclusion criteria including patients with MCI. Results from RCTs suggested that gait speed, gait variability and balance may be improved by different physical activity interventions. Cohort studies showed that slower gait speed, above all, under Dual Task (DT) conditions, was the main impaired parameter in patients with MCI in comparison with a Control Gorup. Furthermore, cohort studies suggested that gait variability could predict an incident MCI. Although most of included cohort studies reported low risk of bias, RCTs showed an unclear risk of bias. CONCLUSIONS Studies suggest that gait variability may predict an incident MCI. Moreover, different gait parameters, above all under DT conditions, could be impaired in patients with MCI. These parameters could be improved by some physical activity interventions. Although cohort studies reported low risk of bias, RCTs showed an unclear risk of bias and GRADE criteria showed a low level of evidence per outcome, so further studies are required to refute our findings. PROSPERO CRD42019119180.
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Mortality and other adverse outcomes in patients with type 2 diabetes mellitus admitted for COVID-19 in association with glucose-lowering drugs: a nationwide cohort study.
Pérez-Belmonte, LM, Torres-Peña, JD, López-Carmona, MD, Ayala-Gutiérrez, MM, Fuentes-Jiménez, F, Jorge Huerta, L, Muñoz, JA, Rubio-Rivas, M, Madrazo, M, Garcia, MG, et al
BMC medicine. 2020;(1):359
Abstract
BACKGROUND Limited evidence exists on the role of glucose-lowering drugs in patients with COVID-19. Our main objective was to examine the association between in-hospital death and each routine at-home glucose-lowering drug both individually and in combination with metformin in patients with type 2 diabetes mellitus admitted for COVID-19. We also evaluated their association with the composite outcome of the need for ICU admission, invasive and non-invasive mechanical ventilation, or in-hospital death as well as on the development of in-hospital complications and a long-time hospital stay. METHODS We selected all patients with type 2 diabetes mellitus in the Spanish Society of Internal Medicine's registry of COVID-19 patients (SEMI-COVID-19 Registry). It is an ongoing, observational, multicenter, nationwide cohort of patients admitted for COVID-19 in Spain from March 1, 2020. Each glucose-lowering drug user was matched with a user of other glucose-lowering drugs in a 1:1 manner by propensity scores. In order to assess the adequacy of propensity score matching, we used the standardized mean difference found in patient characteristics after matching. There was considered to be a significant imbalance in the group if a standardized mean difference > 10% was found. To evaluate the association between treatment and study outcomes, both conditional logit and mixed effect logistic regressions were used when the sample size was ≥ 100. RESULTS A total of 2666 patients were found in the SEMI-COVID-19 Registry, 1297 on glucose-lowering drugs in monotherapy and 465 in combination with metformin. After propensity matching, 249 patients on metformin, 105 on dipeptidyl peptidase-4 inhibitors, 129 on insulin, 127 on metformin/dipeptidyl peptidase-4 inhibitors, 34 on metformin/sodium-glucose cotransporter 2 inhibitor, and 67 on metformin/insulin were selected. No at-home glucose-lowering drugs showed a significant association with in-hospital death; the composite outcome of the need of intensive care unit admission, mechanical ventilation, or in-hospital death; in-hospital complications; or long-time hospital stays. CONCLUSIONS In patients with type 2 diabetes mellitus admitted for COVID-19, at-home glucose-lowering drugs showed no significant association with mortality and adverse outcomes. Given the close relationship between diabetes and COVID-19 and the limited evidence on the role of glucose-lowering drugs, prospective studies are needed.