Evaluation of clinical and antidiabetic treatment characteristics of different sub-groups of patients with type 2 diabetes : Data from a Mediterranean population database

Altres ajuts: Institut Universitari d'Investigació en Atenció Primària Jordi GolAltres ajuts: MSD Spain 4R16/062-1Aims: To describe the characteristics and antidiabetic treatment among type 2 diabetes patients according to the clinical conditions prioritized in the Spanish 2020 RedGDPS (Primary Care Diabetes Study Groups Network) therapeutic algorithm: obesity, older than 75 years, chronic kidney disease, cardiovascular disease, and heart failure. Methods: Retrospective, cross-sectional study. Clinical characteristics, the use of antidiabetic drugs and the KDIGO renal risk categories at 31.12.2016 were retrieved from the SIDIAP (Information System for Research in Primary Care) database (Catalonia, Spain). Results: From a total of 373,185 type 2 diabetes patients, 37% were older than 75 years, 45% obese, 33% had chronic kidney disease, 23.2% cardiovascular disease and 6.9% heart failure. Insulin was more frequently prescribed in chronic kidney disease, cardiovascular disease and heart failure whereas Sodium-Glucose cotransporter 2 inhibitors and Glucagon Like Peptide 1 receptor agonists were scarcely prescribed (2.6% and 1.4%, respectively). Among patients with severe renal failure, contraindicated drugs like metformin (16%) and sulfonylureas (6.1%) were still in use. The 2012 KDIGO renal risk categories distribution was: Low: 60.9%, Moderate: 21.6%, High: 9.8% and Very high: 7.7%. Conclusions: Almost 80% of our T2DM patients meet one of the five clinical conditions that should be considered for treatment individualization. Importantly, a relevant number of patients with severe renal failure were found to use contraindicated drugs

Prevalence of pre-diabetes and undiagnosed diabetes in the Mollerussa prospective observational cohort study in a semi-rural area of Catalonia

Objectives: To assess the prevalence of undiagnosed diabetes and pre-diabetes in the healthy population in the Mollerussa cohort. As a secondary objective, to identify the variables associated with these conditions and to describe the changes in glycaemic status after 1 year of follow-up in subjects with pre-diabetes. Design: Prospective observational cohort study. Setting: General population from a semi-rural area. Participants: The study included 583 participants without a diagnosis of diabetes recruited between March 2011 and July 2014. Results: The prevalence of undiagnosed diabetes was 20, 3.4% (95% CI 2.6 to 4.2) and that of pre-diabetes was 229, 39.3% (37.3 to 41.3). Among those with pre-diabetes, 18.3% had isolated impaired fasting plasma glucose (FPG) (FPG: 100 to <126 mg/dL), 58.1% had isolated impaired glycated haemoglobin (HbA1c) (HbA1c 5.7 to <6.5) and 23.6% fulfilled both criteria. Follow-up data were available for 166 subjects; 41.6%(37.8 to 45.4) returned to normoglycaemia, 57.6% (57.8 to 61.4) persisted in pre-diabetes and 0.6% (0 to 1.2) progressed to diabetes. Individuals with pre-diabetes had worse cardiometabolic risk profiles and sociodemographic features than normoglycaemic subjects. In the logistic regression model, variables significantly associated with pre-diabetes were older age (OR; 95% CI) (1.033; 1.011 to 1.056), higher physical activity (0.546; 0.360 to 0.827), body mass index (1.121; 1.029 to 1.222) and a family history of diabetes (1.543; 1.025 to 2.323). The variables significantly associated with glycaemic normalisation were older age (0.948; 0.916 to 0.982) and body mass index (0.779; 0.651 to 0.931). Conclusions: Among adults in our region, the estimated prevalence of undiagnosed diabetes was 3.4% and that of pre-diabetes was 39.3%. After a 1-year follow-up, a small proportion of subjects (0.6%) with pre-diabetes progressed to diabetes, while a high proportion (41.6%) returned to normoglycaemia. Individuals with pre-diabetes who returned to normoglycaemia were younger and had a lower body mass inde

Analysis of the Adherence and Safety of Second Oral Glucose-Lowering Therapy in Routine Practice From the Mediterranean Area : A Retrospective Cohort Study

Altres ajuts: AstraZeneca/ESR-16-12628Altres ajuts: Applied Research Collaboration East Midlands (ARC EM)Altres ajuts: National Institute for Health Research (NIHR)Altres ajuts: Imperial Biomedical Research Centre (NIHR)The aims of our study was compare adherence measured by the medical possession ratio (MPR), time until discontinuation and describe adverse events after adding a DPP-4i, SGLT-2i, or sulfonylureas (SU) to metformin in a primary care population with insufficient glycemic control. We used routinely-collected health data from the SIDIAP database. The included subjects were matched by propensity score. The follow-up period was up to 24 months or premature discontinuation. The primary outcomes were the percentage of subjects with good adherence, treatment discontinuation and adverse events among treatment groups. The proportion of patients with good adherence (MPR> 0.8) after the addition of DPP-4i, SGLT-2i or SU was 53.6%, 68.7%, and 43.0%, respectively. SGLT-2i users were 1.7 times more likely to achieve good adherence compared with DPP-4i users (odds ratio [OR]:1.72, 98% confidence interval [CI]:1.51, 1.96), and 2.8 times more likely compared with SU users (OR: 0.35, 98% CI: 0.07, 0.29). The discontinuation hazard ratios were 1.43 (98%CI: 1.26; 1.62) and 1.60 (98%CI: 1.42; 1.81) times higher among SGLT-2i and SU users than DPP-4i users during the follow-up period. No differences were observed for adverse events among the treatment groups. In conclusion, in our real-world setting, the combination of SGLT-2i with metformin was associated with better adherence. The mean time until discontinuation was longer in the SGLT-2i group in comparison with the DPP-4i or SU groups

How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area

Altres ajuts: This study was funded by the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol). CIBER of Diabetes and Associated Metabolic Diseases (CIBERDEM) is an initiative from Instituto de Salud Carlos III, Madrid, Spain.Objective. Regulatory agencies require the assessment of cardiovascular (CV) safety for new type 2 diabetes (T2D) therapies through CV outcome trials (CVOTs). However, patients included in CVOTs assessing sodium-glucose cotransporter-2 inhibitors (SGLT2i) might not be representative of those seen in clinical practice. This study examined the proportion of patients that would have been enrolled into three main SGLT2i CVOTs to determine whether these trials' eligibility criteria can be applied to a real-world Mediterranean T2D population. Methods. Cross-sectional, retrospective, cohort study of T2D patients registered in primary care centres of the Catalan Institute of Health using medical records from a population database (SIDIAP) that includes approximately 74% of the population in Catalonia (Spain). Eligibility criteria were according to those of three SGLT2i CVOTs: EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin), and DECLARE-TIMI 58 (dapagliflozin). Results. By the end of 2016, the database included 373,185 patients with T2D with a mean age of 70±12 years, 54.9% male, with a mean duration of T2D of 9±6 years, and a mean glycated haemoglobin (HbA1c) of 7.12%±1.32 (59% with HbA1c<7%). Of these, 86,534 (23%) had established CV disease and 28% chronic renal failure (estimated glomerular filtration<60 ml/min/1.73m2). Among all included patients, only 8.2% would have qualified for enrolment into the EMPA-REG OUTCOME trial, 29.6% into the CANVAS program, and 38% into the DECLARE-TIMI 58 trial. The main limiting factors for inclusion would have been a previous history of CV disease and the baseline HbA1c value. Conclusion. The external validity of the analysed CVOTs is clearly limited when applying the same eligibility criteria to a T2D Mediterranean population

Prevalence and risk factors of diabetic foot disease among the people with type 2 diabetes using real-world practice data from Catalonia during 2018

Altres ajuts: 8a Convocatòria d'Ajuts a projectes de Institut Català de la Salut with SIDIAP (financing code 4R18/187-1 and file number SIDIAP-18/7).Background: Our study aimed to assess the prevalence of diabetic foot disease (DFD) and its associated risk factors among subjects attending primary care centers in Catalonia (Spain). Methods: We undertook a cross-sectional analysis of data from the primary health care (SIDIAP) database. The presence of comorbidities and concomitant medication were analyzed for subjects with or without DFD. DFD prevalence was estimated from 1st January 2018 to 31st December 2018. Results: During the 12-month observational period, out of 394,266 people with type 2 diabetes, we identified 3,277 (0.83%) active episodes of DFD in the database. The majority of these episodes were foot ulcers (82%). The mean age of patients with DFD was 70.3 (± 12.5) years and 55% were male. In the multivariable descriptive models, male gender, diabetes duration, hypertension, macrovascular, microvascular complications, and insulin and antiplatelet agents were strongly associated with DFD. A previous history of DFD was the stronger risk factor for DFD occurrence in subjects with T2DM (OR: 13.19, 95%CI: 11.81; 14.72). Conclusions: In this real-world primary care practice database, we found a lower prevalence of DFD compared to similar previous studies. Risk factors such as male sex, duration of diabetes, diabetes complications and previous history of DFD were associated with the presence of DFD

¿Adelantan el diagnóstico de la diabetes tipo 2 los nuevos criterios de la Asociación Americana de Diabetes?

ObjetivoAnalizar el intervalo temporal entre la primera hiperglucemia basal ocasional (HBO) y el diagnóstico de diabetes mellitus tipo 2 (DM2) al aplicar los criterios de la OMS y de la Asociación Americana de Diabetes (ADA).DiseñoEstudio observacional, retrospectivo. Ámbito del estudio. Centro de atención primaria urbano.SujetosUn total de 104 pacientes con DM2, diagnosticados entre 1991 y 1995, con antecedentes de HBO.Mediciones o intervencionesEdad, género y otros factores de riesgo, fechas de la primera HBO (glucemia basal 3 110 mg/dl), del diagnóstico según criterios OMS (2 glucemias basales 3 140 mg/dl o 3 200 mg/dl a las 2 horas de la sobrecarga oral de glucosa [SOG]) y aplicando criterios ADA (2 glucemias basales 3 126 mg/dl) y los intervalos en meses entre ellas.ResultadosDe los 222 pacientes diagnosticados, 104 (47%) presentaban antecedentes de HBO. La edad en el momento del diagnóstico fue 60,8 años (DE, 10,1), siendo un 53% mujeres. En 51 casos (49%) se realizó SOG. La mediana (rango) del intervalo entre la primera HBO y el diagnóstico fue de 16 meses (0–101) en los que se realizó la SOG y de 45 (1–104) en los que no se practicó (p = 0,003). En estos últimos, los criterios ADA lo redujeron a 31 meses (0–97) (p < 0,001) y en 27 de ellos que no cumplían ambos criterios a la vez el intervalo fue de sólo 10 meses (0–93) (p < 0,001). Conclusiones. La no realización de la SOG comporta un retraso en el diagnóstico que puede ser contrarrestado con la aplicación de los criterios de la ADA.ObjectiveTo analyze the period of time between the first occasional fasting hyperglycaemia (OFH) and the diagnosis of type 2 diabetes mellitus (DM2), using the World Health Organization (WHO) criteria or the American Diabetes Association (ADA) criteria.DesignRetrospective, observational study.SettingUrban primary care centre.Subjects104 patients with DM2 diagnosed between 1991 and 1995 who had a previous OFH.MeasurementsAge, gender and other risk factors, dates of the first OFH (fasting plasma glucose 3 110 mg/dl), the diagnosis according to WHO criteria (2 fasting plasma glucose 3 140 mg/dl or 3 200 mg/dl two hours after the oral glucose test tolerance (OGTT)) or with the ADA criteria (2 fasting plasma glucose 3 126 mg/dl), and the intervals in months between them.ResultsOf the 222 diagnosed patients, 104 (47%) had previous OFH. Age at diagnosis was 60.8 (SD 10.1) and 53% were women. OGTT was performed in 51 cases (49%). The median (range) of the interval between the first OFH and diagnosis was 16 months (0–101) for those who were undertaken an OGTT, and 45 months (1–104) for those who were not (p = 0.003). In these last ones, ADA criteria reduced the interval to 31 months (0–97) (p < 0.001). In 27 of these patients who did not satisfy both criteria at the same time, ADA criteria reduced the interval to 10 months (0–93) (p < 0.001).ConclusionsNot performing the OGTT means a delay in diagnosis which can be countered by applying the ADA criteria

Mediterranean diet and healthy eating in subjects with prediabetes from the mollerussa prospective observational cohort study

Altres ajuts: Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol) i Instituto de Salud Carlos III (Plan Nacional de I+D+I i Fondo Europeo de Desarrollo Regional).We aimed to assess differences in dietary patterns (i.e., Mediterranean diet and healthy eating indexes) between participants with prediabetes and those with normal glucose tolerance. Secondarily, we analyzed factors related to prediabetes and dietary patterns. This was a cross-sec-tional study design. From a sample of 594 participants recruited in the Mollerussa study cohort, a total of 535 participants (216 with prediabetes and 319 with normal glucose tolerance) were in-cluded. The alternate Mediterranean Diet score (aMED) and the alternate Healthy Eating Index (aHEI) were calculated. Bivariable and multivariable analyses were performed. There was no dif-ference in the mean aMED and aHEI scores between groups (3.2 (1.8) in the normoglycemic group and 3.4 (1.8) in the prediabetes group, p = 0.164 for the aMED and 38.6 (7.3) in the normoglycemic group and 38.7 (6.7) in the prediabetes group, p = 0.877 for the aHEI, respectively). Nevertheless, women had a higher mean of aMED and aHEI scores in the prediabetes group (3.7 (1.9), p = 0.001 and 40.5 (6.9), p < 0.001, respectively); moreover, they had a higher mean of aHEI in the group with normoglycemia (39.8 (6.6); p = 0.001). No differences were observed in daily food intake between both study groups; consistent with this finding, we did not find major differences in nutrient intake between groups. In the multivariable analyses, the aMED and aHEI were not associated with pre-diabetes (odds ratio (OR): 1.19, 95% confidence interval (CI): 0.75-1.87; p = 0.460 and OR: 1.32, 95% CI: 0.83-2.10; p = 0.246, respectively); however, age (OR: 1.04, 95% CI: 1.02-1.05; p < 0.001), dyslipidemia (OR: 2.02, 95% CI: 1.27-3.22; p = 0.003) and body mass index (BMI) (OR: 1.09, 95% CI: 1.05-1.14; p < 0.001) were positively associated with prediabetes. Physical activity was associated with a lower frequency of prediabetes (OR: 0.48, 95% CI: 0.31-0.72; p = 0.001). In conclusion, subjects with prediabetes did not show a different dietary pattern compared with a normal glucose tolerance group. However, further research is needed on this issue

Trends in HbA1c thresholds for initiation of hypoglycemic agents:Impact of changed recommendations for older and frail patients

Aims: Less strict glycated hemoglobin (HbA1c) thresholds have been recommended in older and/or frail type 2 diabetes (T2D) patients than in younger and less frail patients for initiating hypoglycemic agents since 2011. We aimed to assess trends in HbA1c thresholds at initiation of a first hypoglycemic agent(s) in T2D patients and the influence of age and frailty on these trends. Materials and methods: The groningen initiative to analyze type 2 diabetes treatment (GIANTT) database was used, which includes primary care T2D patients from the north of the Netherlands. Patients initiating a first non-insulin hypoglycemic agent(s) between 2008 and 2014 with an HbA1c measurement within 120 days before initiation were included. The influence of calendar year, age, or frailty and the interaction between calendar year and age or frailty were assessed using multilevel regression analyses adjusted for confounders. Results: We included 4588 patients. The mean HbA1c threshold at treatment initiation was 7.4% up to 2010, decreasing to 7.1% in 2011 and increasing to 7.4% in 2014. This quadratic change over the years was significant (P 0.05). Conclusions: HbA1c thresholds at initiation of a first hypoglycemic agent(s) changed significantly over time, showing a decrease after 2010 and an increase after 2012. The HbA1c threshold at initiation was not influenced by age or frailty, which is in contrast with recommendations for more personalized treatment

SIREs: searching for iron-responsive elements

The iron regulatory protein/iron-responsive element regulatory system plays a crucial role in the post-transcriptional regulation of gene expression and its disruption results in human disease. IREs are cis-acting regulatory motifs present in mRNAs that encode proteins involved in iron metabolism. They function as binding sites for two related trans-acting factors, namely the IRP-1 and -2. Among cis-acting RNA regulatory elements, the IRE is one of the best characterized. It is defined by a combination of RNA sequence and structure. However, currently available programs to predict IREs do not show a satisfactory level of sensitivity and fail to detect some of the functional IREs. Here, we report an improved software for the prediction of IREs implemented as a user-friendly web server tool. The SIREs web server uses a simple data input interface and provides structure analysis, predicted RNA folds, folding energy data and an overall quality flag based on properties of well characterized IREs. Results are reported in a tabular format and as a schematic visual representation that highlights important features of the IRE. The SIREs (Search for iron-responsive elements) web server is freely available on the web at http://ccbg.imppc.org/sires/index.htm