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BACKGROUND: Metabolically healthy obese (MHO) phenotype may present with distinct characteristics compared with those with a metabolically unhealthy obese phenotype. Epidemiologic data on the distribution of these conditions in the working population are lacking. We aimed to evaluate the prevalence and clinical characteristics of MHO and other obese/non-obese metabolic phenotypes in a working population. METHODS: Cross-sectional analysis of all subjects who had undergone a medical examination with Ibermutuamur Prevention Society from May 2004 to December 2007. Participants were classified into 5 categories according to their body mass index (BMI); within each of these categories, participants were further classified as metabolically healthy (MH) or metabolically unhealthy (MUH) according to the modified NCEP-ATPIII criteria. A logistic regression analysis was performed to evaluate some clinically relevant factors associated with a MH status. RESULTS: In the overall population, the prevalence of the MHO phenotype was 8.6%. The proportions of MH individuals in the overweight and obese categories were: 87.1% (overweight) and 55.5% (obese I-III [58.8, 40.0, and 38.7% of the obese I, II, and III categories, respectively]). When the overweight and obese categories were considered, compared with individuals who were MUH, those who were MH tended to be younger and more likely to be female or participate in physical exercise; they were also less likely to smoke, or to be a heavy drinker. In the underweight and normal weight categories, compared with individuals who were MH, those who were MUH were more likely to be older, male, manual (blue collar) workers, smokers and heavy drinkers. Among participants in the MUH, normal weight group, the proportion of individuals with a sedentary lifestyle was higher relative to those in the MH, normal weight group. The factors more strongly associated with the MUH phenotype were BMI and age, followed by the presence of hypercholesterolemia, male sex, being a smoker, being a heavy drinker, and lack of physical exercise. CONCLUSIONS: The prevalence of individuals with a MHO phenotype in the working population is high. This population may constitute an appropriate target group in whom to implement lifestyle modification initiatives to reduce the likelihood of transition to a MUH phenotype.
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Obesidade/epidemiologia , Obesidade/fisiopatologia , Adulto , Fatores Etários , Consumo de Bebidas Alcoólicas/epidemiologia , Índice de Massa Corporal , Colesterol/sangue , Estudos Transversais , Exercício Físico , Feminino , Comportamentos Relacionados com a Saúde , Nível de Saúde , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Sobrepeso/epidemiologia , Sobrepeso/fisiopatologia , Fenótipo , Prevalência , Comportamento Sedentário , Fatores Sexuais , Fumar/epidemiologiaRESUMO
BACKGROUND: Obesity is associated with the onset of type 2 diabetes mellitus (T2D), but reports conflict regarding the association between obesity and macrovascular complications. In this study, we investigated associations between cardiovascular risk factors and body mass index (BMI) and glycemic control in non-insulin-treated patients with T2D. METHODS: Authors gathered cross-sectional data from five observational studies performed in Spain. Generalized logit models were used to analyze the relationship between cardiovascular risk factors (independent variables) and 5 BMI strata (<25 kg/m2, 25 to <30 kg/m2, 30 to <35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2) and 5 glycated hemoglobin (HbA1c) strata (≤6.5%, >6.5-7%, >7-8%, >8-9%, >9%) (dependent outcomes). RESULTS: In total, data from 6442 patients were analyzed. Patients generally had mean values of investigated cardiovascular risk factors outside recommended thresholds. Younger patients had higher BMI, triglyceride levels and HbA1c than their older counterparts. Diastolic blood pressure, systolic blood pressure and triglyceride levels were directly correlated with BMI strata, whereas an inverse correlation was observed between BMI strata and high-density lipoprotein cholesterol (HDL-C) levels, patient age, and duration of T2D. Increased duration of T2D and total cholesterol levels, and decreased HDL-C levels were associated with a higher HbA1c category. BMI and HbA1c levels were not associated with each other. CONCLUSIONS: As insulin-naïve patients with T2D became more obese, cardiovascular risk factors became more pronounced. Higher BMI was associated with younger age and shorter duration of T2D, consistent with the notion that obesity at an early age may be key to the current T2D epidemic. Glycemic control was independent of BMI but associated with abnormal lipid levels. Further efforts should be done to improve modifiable cardiovascular risk factors.
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Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Hipoglicemiantes/administração & dosagem , Obesidade/epidemiologia , Administração Oral , Adulto , Fatores Etários , Idoso , Biomarcadores/sangue , Glicemia/metabolismo , Pressão Sanguínea , Índice de Massa Corporal , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/fisiopatologia , HDL-Colesterol/sangue , Estudos Transversais , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/fisiopatologia , Feminino , Hemoglobinas Glicadas/análise , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Obesidade/sangue , Obesidade/diagnóstico , Obesidade/fisiopatologia , Fatores de Risco , Espanha/epidemiologia , Triglicerídeos/sangueRESUMO
BACKGROUND: Type 2 diabetes (T2D) is strongly associated with cardiovascular risk and requires medications that improve glycemic control and other cardiovascular risk factors. The authors aimed to assess the relative effectiveness of pioglitazone (Pio), metformin (Met) and any sulfonylurea (SU) combinations in non-insulin-treated T2D patients who were failing previous hypoglycemic therapy. METHODS: Over a 1-year period, two multicenter, open-labeled, controlled, 1-year, prospective, observational studies evaluated patients with T2D (n = 4585) from routine clinical practice in Spain and Greece with the same protocol. Patients were eligible if they had been prescribed Pio + SU, Pio + Met or SU + Met serving as a control cohort, once they had failed with previous therapy. Anthropometric measurements, lipid and glycemic profiles, blood pressure, and the proportions of patients at microvascular and macrovascular risk were assessed. RESULTS: All study treatment combinations rendered progressive 6-month and 12-month lipid, glycemic, and blood pressure improvements. Pio combinations, especially Pio + Met, were associated with increases in HDL-cholesterol and decreases in triglycerides and in the atherogenic index of plasma. The proportion of patients at high risk decreased after 12 months in all study cohorts. Minor weight changes (gain or loss) and no treatment-related fractures occurred during the study. The safety profile was good and proved similar among treatments, except for more hypoglycemic episodes in patients receiving SU and for the occurrence of edema in patients using Pio combinations. Serious cardiovascular events were rarely reported. CONCLUSIONS: In patients with T2D failing prior hypoglycemic therapies, Pio combinations with SU or Met (especially Pio + Met) improved blood lipid and glycemic profiles, decreasing the proportion of patients with a high microvascular or macrovascular risk. The combination of Pio with SU or Met may therefore be recommended for T2D second-line therapy in the routine clinical practice, particularly in patients with dyslipidemia.
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Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Compostos de Sulfonilureia/uso terapêutico , Tiazolidinedionas/uso terapêutico , Idoso , Biomarcadores/sangue , Glicemia/efeitos dos fármacos , Pressão Sanguínea , Índice de Massa Corporal , Peso Corporal , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/fisiopatologia , Distribuição de Qui-Quadrado , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/fisiopatologia , Quimioterapia Combinada , Feminino , Hemoglobinas Glicadas/metabolismo , Grécia , Humanos , Hipoglicemiantes/efeitos adversos , Lipídeos/sangue , Modelos Logísticos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade , Pioglitazona , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Espanha , Compostos de Sulfonilureia/efeitos adversos , Tiazolidinedionas/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10-15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice. METHODS: In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively. RESULTS: The IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively. CONCLUSION: In real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs.
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Diabetes Mellitus Tipo 2 , Adulto , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Insulina , Insulina Glargina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , EspanhaRESUMO
INTRODUCTION: Information on experience/management of severe hypoglycaemic events (SHEs) among people with insulin-treated diabetes (PWD) and caregivers (CGs) providing care to PWD was sought. MATERIALS AND METHODS: An online cross-sectional survey was conducted in eight countries. INCLUSION CRITERIA: PWD (aged≥18 years; self-reported type 1 [T1D] or insulin-treated type 2 [T2D] diabetes; experienced ≥1 SHE [hypoglycaemia requiring external assistance] in past 3 years); CGs (layperson aged ≥18 years; caring for PWD meeting all criteria above except age [≥4 years]). This descriptive analysis provides data from Spain. SHE-associated data relate to the most recent SHE. RESULTS: Across all groups (T1D PWD, n=106; T2D PWD, n=88, T1D CG, n=87; T2D CG, n=96), 76-89% reported that the SHE occurred at home; most common cause was eating less than planned (38-53%). Most usual action during the SHE was to intake carbohydrates (67-84%); glucagon use was low (9-36%). Discussion of the SHE with their healthcare provider (HCP) was reported by 70-75% of PWD. During the SHE, 35-69% of PWD/CGs reported feeling scared, unprepared and/or helpless. CONCLUSIONS: Most SHEs occurred outside the healthcare setting; treatment therefore depends greatly on CGs. SHEs have a negative emotional impact on PWD/CGs, underscoring the need for HCPs to discuss SHEs with PWD/CGs, and to provide tools and strategies to prevent and effectively manage SHEs.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglicemia , Adolescente , Adulto , Cuidadores , Pré-Escolar , Estudos Transversais , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , InsulinaRESUMO
AIMS: To determine the early benefit:risk balance of dulaglutide versus insulin glargine in patients with type 2 diabetes mellitus (T2DM). METHODS: This post hoc analysis used data from a randomized, open-label study (AWARD-2; modified intention-to-treat group) in which suboptimally controlled metforminâ¯+â¯glimepiride-treated patients received dulaglutide 1.5â¯mg (nâ¯=â¯273) or insulin glargine (nâ¯=â¯262). Two composite endpoints were used: for weeks 2-20, fasting serum glucose (FSG) <130â¯mg/dL (<7.2â¯mmol/L) without hypoglycemia (blood glucose ≤70â¯mg/dL [≤3.9â¯mmol/L] or severe hypoglycemia); at week 26, patients with glycated hemoglobin (HbA1c) <7.0% (<53.0â¯mmol/mol) or reduction from baseline ≥1.0% (≥10.9â¯mmol/mol), no hypoglycemia (as defined above) and no weight gain. Odds ratios (ORs) were generated using logistic regression analysis. RESULTS: The probability of reaching the FSG target without hypoglycemia was higher with dulaglutide than with insulin glargine at weeks 4 (OR 1.78; 95% confidence interval [CI] 1.22-2.60) and 8 (OR 1.69; 95% CI 1.15-2.48). The proportion of patients achieving the 26-week endpoint was higher with dulaglutide (37.4% vs. 10.3%; OR 5.28; 95% CI 3.28-8.48). CONCLUSIONS: Dulaglutide's balanced efficacy-to-safety profile compares favorably with that of insulin glargine and is apparent soon after treatment initiation and after 6â¯months of therapy.
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Diabetes Mellitus Tipo 2 , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Insulina Glargina/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Esquema de Medicação , Quimioterapia Combinada , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemia/prevenção & controle , Hipoglicemiantes/administração & dosagemRESUMO
INTRODUCTION: To evaluate clinical inertia in patients with type 2 diabetes mellitus (T2DM), obesity and poor glycaemic control in routine clinical practice. METHODS: This was a retrospective, observational study based on the analysis of medical records from the BIG-PAC® database. Subjects who required medical care in 2013 with the following characteristics were enrolled in the study: age ≥ 30 years, diagnosis of T2DM, glycosylated haemoglobin (HbA1c) ≥ 8%, obesity (body mass index [BMI] ≥ 30 kg/m2) and treatment with ≥ 2 oral antidiabetic drugs (OADs). Inertia was evaluated by time (days) to the first intensification during the period while HbA1c levels were ≥ 8% and percentage of patients whose treatment was not intensified at 6 months, 1, 2 and 3 years and the end of follow-up. The minimum length of follow-up was 4 years. Descriptive analyses and Kaplan-Meier survival curves were performed. RESULTS: A total of 13,824 patients with T2DM receiving ≥ 2 OADs were identified; of these 2709 (19.6%) had HbA1c ≥ 8% and BMI ≥ 30 kg/m2, thus fulfilling the inclusion criteria. Of these 2709 patients, the mean age was 65.5 (standard deviation [SD] 12.0) years; 54.9% were male, mean HbA1c level was 9.2% (SD 1.3%); mean BMI was 32.1 (SD 0.9) kg/m2; and mean time from diagnosis was 8.2 (SD 3.0) years. HbA1c remained ≥ 8% for a median of 440 (95% confidence interval [CI] 421-459) days. The median time to first intensification was 456 (95% CI 429-483) days. No intensification had occurred in 77.8, 59.5, 41.5, 28.1 and 22.4% of patients at 6 months, 1, 2, 3 years and the end of follow-up, respectively. CONCLUSIONS: The patients with T2DM analysed in this study had a mean HbA1c of 9.2% at baseline, and this remained at ≥ 8% for > 1 year. The time to the first treatment intensification was longer than that recommended by guidelines. Treatment was not intensified in a large percentage of patients, with almost 60% of patients not receiving intensification at 1 year of follow-up.
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OBJECTIVE: To compare healthcare resource use (HRU) and annual costs in type 2 diabetes mellitus (T2DM) patients with poor glycaemic control and obesity versus good glycaemic control without obesity. METHODS: Observational retrospective study based on the analysis of electronic medical records from the BIG-PAC database, with one year of follow-up. T2DM patients aged ≥30 years who requested medical care during 2013 were included. Annual HRU and costs per patient were compared between a reference group (HbA1c ≥ 8%, BMI ≥30 kg/m2, receiving ≥2 oral antidiabetic drugs [OADs]) and a control group (HbA1c < 7% and BMI <30 kg/m2). Direct and indirect costs (lost productivity) were analysed. Cost comparisons across groups were made using the analysis of covariance (ANCOVA) for each cost component, with age, sex, time from diagnosis, Charlson comorbidity index, OAD number and sex by group interaction as covariates. RESULTS: During the follow-up, patients in the reference group (N = 2709) had a greater HRU than those in the control group (N = 5266), especially in the number of primary care (PC) visits (11.8 vs. 9.8; 95%CI: 11.5-12.1 vs. 9.6-10.0) and days of hospitalization (1.1 vs 0.6; 95%CI: 1.0-1.2 vs. 0.5-0.7). The main components of the total cost were hospital admissions (24.5%), productivity losses (16.3%), complementary tests (14.4%), PC visits (14.2%) and medication (13.6%) in the reference group and medication (19.6%), hospital admissions (18.7%) and PC visits (18.2%) in the control group. The corrected mean annual cost per patient was higher in the reference than in the control group: 1804 vs. 1309; p < .001. CONCLUSIONS: Poor glycaemic control and obesity in T2DM patients were associated with increased HRU and costs in routine clinical practice.
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Diabetes Mellitus Tipo 2/economia , Custos de Cuidados de Saúde , Recursos em Saúde , Hipoglicemiantes/uso terapêutico , Obesidade/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Controle Glicêmico , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Obesidade/tratamento farmacológico , Atenção Primária à Saúde , Estudos RetrospectivosRESUMO
The aim of this systematic literature review (SLR) was to provide an overview of the Spanish research landscape of observational studies conducted with antidiabetic drugs in T2DM patients, published in the last five years, with special focus on the objectives, methodology and main research areas. Twenty-two articles, corresponding to 20 studies, were included in the analysis. Around 82% of the studies employed a longitudinal study design, collected data retrospectively (72.7%), and were based on secondary data use (63.6%). Pharmacotherapeutical groups most frequently studied were insulin (31.8%) and DPP4i (13.6%). Analytic design was employed most in the studies (68.2%), followed by descriptive analysis (22.7%). In the top five of the most studied variables are those related to effectiveness assessed according to glycaemic control (91%), treatment patterns (82%), safety (hypoglycaemia) (59%), the identification of effectiveness predictive factors (45%) and effectiveness according to other control measures such as anthropometric control or cardiovascular risk factors (36%).
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Estudos Observacionais como Assunto , Doenças Cardiovasculares/prevenção & controle , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Estudos Longitudinais , Estudos Observacionais como Assunto/estatística & dados numéricos , Fatores de Risco , Espanha , Resultado do TratamentoRESUMO
OBJECTIVE: To assess the burden of hypoglycemia in patients with diabetes mellitus (DM) in Spain, including epidemiological data and information relating to healthcare resource utilization (HRU) and costs, and patients' quality of life (QoL). METHODS: A systematic literature review (SLR) was conducted to identify studies that included original information on epidemiology, HRU and costs, and/or QoL associated with hypoglycemia in patients with DM in Spain, published in either Spanish or English, between January 2007 and April 2017. RESULTS: Fifteen articles, involving 14 studies, were identified in the SLR and included in the analysis. The estimated rate of severe hypoglycemia (SH) events per patient per year ranged from 0.90 to 1.50 in patients with type 1 DM (T1DM) and from 0.30 to 0.63 in patients with type 2 DM (T2DM). The data on HRU differed extensively between studies, making it difficult to draw a conclusion. Total costs per SH event ranged from 409.97 in patients with T1DM to 713.10 in patients with DM. Work absence was reported in 11.80-18% of the working patients. Further, patients who experienced hypoglycemic events expressed a higher fear and had a poorer QoL than those who did not report these events. CONCLUSION: Although the data included in the SLR were difficult to synthesize due to heterogeneity of the study designs and patient characteristics in the 14 studies, our search identified a high burden associated with hypoglycemic events in terms of HRU and costs, and patients' QoL. Further research is recommended to reach a consensus on hypoglycemia definition and study design to provide robust evidence on the burden of hypoglycemia and to accurately weigh the impact of this acute complication in Spain. FUNDING: Eli Lilly and Company.
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Insulin replacement therapy is a fundamental treatment for glycemic control for managing diabetes. The engineering of insulin analogues has focused on providing formulations with action profiles that mimic as closely as possible the pattern of physiological insulin secretion that normally occurs in healthy individuals without diabetes. Hence, it may be helpful to practitioners to visualize insulin concentration profiles and associated glucose action profiles. Expanding on a previous analysis that established a pharmacokinetic (PK) model to describe typical profiles of insulin concentration over time following subcutaneous administration of various insulin formulations, the goal of the current analysis was to link the PK model to an integrated glucose-insulin (IGI) systems pharmacology model. After the pharmacokinetic-pharmacodynamic (PK-PD) model was qualified by comparing model predictions with clinical observations, it was used to project insulin (PK) and glucose (PD) profiles of common insulin regimens and dosing scenarios. The application of the PK-PD model to clinical scenarios was further explored by incorporating the impact of several hypothetical factors together, such as changing the timing or frequency of administration in a multiple-dosing regimen over the course of a day, administration of more than 1 insulin formulation, or insulin dosing adjusted for carbohydrates in meals. Visualizations of insulin and glucose profiles for commonly prescribed regimens could be rapidly generated by implementing the linked subcutaneous insulin PK-IGI model using the R statistical program (version 3.4.4) and a contemporary web-based interface, which could enhance clinical education on glycemic control with insulin therapy.
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Glicemia/efeitos dos fármacos , Insulina/farmacologia , Insulina/farmacocinética , Adulto , Animais , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Esquema de Medicação , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Pessoa de Meia-Idade , Modelos BiológicosRESUMO
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are well established as effective treatments for patients with type 2 diabetes. GLP-1 RAs augment insulin secretion and suppress glucagon release via the stimulation of GLP-1 receptors. Although all GLP-1 RAs share the same underlying mechanism of action, they differ in terms of formulations, administration, injection devices and dosages. With six GLP-1 RAs currently available in Europe (namely, immediate-release exenatide, lixisenatide, liraglutide; prolonged-release exenatide, dulaglutide and semaglutide), each with its own characteristics and administration requirements, physicians caring for patients in their routine practice face the challenge of being cognizant of all this information so they are able to select the agent that is most suitable for their patient and use it in an efficient and optimal way. The objective of this review is to bring together practical information on the use of these GLP-1 RAs that reflects their approved use.Funding: Eli Lilly and Company.Plain Language Summary: Plain language summary available for this article.
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INTRODUCTION: Our objective was to evaluate the incidence of type 2 diabetes mellitus (T2DM) in a working population in Spain and to assess associations between its development and several risk factors. METHODS: The ICARIA (Ibermutuamur CArdiovascular RIsk Assessment) cohort (n = 627,523) includes ~3% of Spanish workers. This analysis was undertaken in individuals whose glycaemic status during the index period (May 2004-December 2007) was determined to be normal or indicative of prediabetes [fasting plasma glucose (FPG) 100-125 mg/dl] and who had at least one FPG measurement taken 9 months after a first measurement during follow-up (May 2004-June 2014) (n = 380,366). T2DM patients were defined as those with an FPG ≥ 126 mg/day and those who had already been diagnosed with T2DM or were taking antihyperglycaemic medications. RESULTS: The incidence rate of T2DM was 5.0 [95% confidence interval (CI) 4.9-5.1] cases per 1000 person-years. Under multivariate logistic regression analysis, the factor showing the strongest association with the occurrence of T2DM was the baseline FPG level, with the likelihood of T2DM almost doubling for every 5 mg/dl increase in baseline FPG between 100 and < 126 mg/dl. The presence of other cardiometabolic risk factors and being a blue-collar worker were also significantly associated with the occurrence of T2DM. CONCLUSIONS: The incidence of T2DM in the working population was within the range encountered in the general population and prediabetes was found to be the strongest risk factor for the development of diabetes. The workplace is an appropriate and feasible setting for the assessment of easily measurable risk factors, such as the presence of prediabetes and other cardiometabolic factors, to facilitate the early detection of individuals at higher risk of diabetes and the implementation of diabetes prevention programmes. FUNDING: Eli Lilly and Co.
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Objectives: This study assessed the health-related quality of life (HRQOL) of pediatric patients with type 1 diabetes mellitus (T1DM) and their caregivers.Methods: CHRYSTAL was an observational cross-sectional study conducted in Spain in 2014 on 275 patients under 18 years old diagnosed with T1DM. Patient/caregiver pairs were stratified by patients' HbA1c level (≥7.5% versus <7.5%) and by presence or absence of T1DM complications and/or comorbidities. EQ-5D and PedsQL questionnaires were administered to patients and caregivers.Results: On the EQ-5D, according to caregivers' perception, 17.7% of children experienced moderate pain or discomfort, 9.7% suffered problems performing usual activities, and 13.2% demonstrated moderate anxiety or depression. Mean EQ-5D index score was 0.95 and mean visual analog scale (VAS) score was 86.1. By HbA1c level (≥7.5% versus <7.5%), mean index scores were 0.94 and 0.95, and mean VAS scores were 82.8 and 89.2, respectively. Mean index scores were 0.91 for children with complications and/or comorbidities and 0.96 for children without. Mean VAS scores were 83.7 and 87.2, respectively. HRQOL per the PedsQL tool ranged from 68.1 (ages 2-4) to 73.1 (ages 13-18). EQ-5D index and VAS scores were significantly correlated (rho = 0.29-0.43) with several age groups of the PedsQL. EQ-5D scales showed significant moderate correlation between EQ-5D-Y and EQ-5D-3L proxy VAS score (rho = 0.45; p < .001).Conclusions: Patients with few complications and controlled HbA1c reported a relatively high HRQOL. The results suggest that parent-proxy EQ-5D ratings are valid for use as part of an overall health outcomes assessment in clinical studies of T1DM in pediatric patients.
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Cuidadores/psicologia , Diabetes Mellitus Tipo 1/psicologia , Qualidade de Vida , Adolescente , Criança , Estudos Transversais , Diabetes Mellitus Tipo 1/sangue , Feminino , Hemoglobinas Glicadas/análise , Humanos , Masculino , Inquéritos e QuestionáriosRESUMO
BACKGROUND AND OBJECTIVE: Pioglitazone has been reported to improve common cardiovascular risk factors in addition to glycemic control in patients with type 2 diabetes mellitus (T2DM). The changes in cardiovascular risk profile were evaluated comparatively in large cohorts either treated or not with pioglitazone-containing combinations in the current clinical setting within Spain. PATIENTS AND METHOD: A nationwide prospective, controlled, observational cohort clinical study was performed in 2294 patients with T2DM who started, at the criterion of the treating physician, oral antihyperglycemic treatment with either pioglitazone plus a sulfonylurea (Pio+SU; n=851), pioglitazone plus metformin (Pio+Met; n=723) or a sulfonylurea plus metformin (SU+Met; n=720) due to inadequate control with previous therapy. Serum cholesterol, blood glucose, hemoglobin A1C, blood pressure and certain anthropometric parameters were measured at baseline and after 6 months of treatment. RESULTS: Serum high density lipoprotein-cholesterol increased in average (mg/dl) 2.08 with Pio+SU, 2.06 with Pio+Met and 0.67 with SU+Met; while triglycerides decreased (mg/dl) 26.6, 30.6 and 17.6 in the same cohorts. Inter-group differences were significant (p<0.001 in both parameters). Total cholesterol decreased significantly more with SU+Met than in the pioglitazone cohorts. Mean fasting plasma glucose and hemoglobin A1C reductions were significantly greater in the pioglitazone cohorts than in the SU+Met cohort: 27.74, 28.94 and 23.46 mg/dl (p=0.012); and 0.80, 0.87 and 0.71% (p=0.016) with Pio+SU, Pio+Met and SU+Met, respectively. Slight, but significant variations of body weight were also registered in the Pio+SU (+1.4 kg) and SU+Met (-0.7 kg) groups. CONCLUSIONS: Treatment with pioglitazone was associated with significant improvements of lipid and glycemic parameters that are linked to insulin resistance and cardiovascular risk in patients with T2DM in their routine clinical care. The non-randomised allocation of patients to treatments, inherent to its observational design, is an important limitation of the present study.
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Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Compostos de Sulfonilureia/uso terapêutico , Tiazolidinedionas/uso terapêutico , Adulto , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Quimioterapia Combinada , Feminino , Hemoglobinas Glicadas , Humanos , Hipoglicemiantes/administração & dosagem , Resistência à Insulina/fisiologia , Masculino , Metformina/administração & dosagem , Pioglitazona , Estudos Prospectivos , Compostos de Sulfonilureia/administração & dosagem , Tiazolidinedionas/administração & dosagemRESUMO
OBJECTIVES: Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) < 7%, but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an expanded HbA1c measure was used to identify responders to insulin therapy. METHODS: Analysis included 4,908 patients (IDB) and 1,134 patients (RWE) with T2D treated with any insulin regimen with a baseline and ≥1 post-baseline HbA1c. Responders were defined as patients with endpoint HbA1c < 7% (cut point [CP]) and/or either ≥1% absolute (ABS) decrease, and/or ≥10% relative (REL) decrease in HbA1c from baseline. The percentage of responders with CP vs ABS and concordance between ABS and REL were calculated. As the ABS and REL measures were highly correlated (94%), the ABS measure was used to compare characteristics of responders and non-responders by age, diabetes duration, race/ethnicity, baseline HbA1c, and insulin regimen at 24 weeks. RESULTS: In both databases, more responders were identified with ABS or REL (>62%) than CP (<41%). More ABS responders had a baseline HbA1c ≥ 9% and a shorter diabetes duration than non-responders. Basal insulin-treated patients in the IDB had 78.2% responders at 24 weeks, compared to 69.7% with basal/bolus or pre-mixed insulin (75.4%). Results were similar in the IDB and RWE. CONCLUSION: Composite HbA1c measures identified more patients with clinically meaningful responses to therapy than the broadly accepted HbA1c < 7% and may be useful in assessing clinical trials, clinical care, and quality measures.
Assuntos
Diabetes Mellitus Tipo 2 , Hemoglobinas Glicadas/análise , Insulina Lispro , Idoso , Biomarcadores/análise , Bases de Dados Factuais/estatística & dados numéricos , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Monitoramento de Medicamentos/métodos , Determinação de Ponto Final/métodos , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Insulina Lispro/administração & dosagem , Insulina Lispro/efeitos adversos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/métodosRESUMO
Insulin pharmacokinetics following subcutaneous administration were modeled, simulated, and displayed through an interactive and user-friendly interface to illustrate the time course of administered insulins frequently prescribed, providing a simple tool for clinicians through a straightforward visualization of insulin regimens. Pharmacokinetic data of insulin formulations with different onset and duration of action from several clinical studies, including insulin glargine, regular insulin, neutral protamine Hagedorn (NPH), insulin lispro, and premixed preparations of NPH with regular insulin (Mix 70/30), and insulin lispro protamine suspension with insulin lispro (Mix 50/50, Mix 75/25), were used to develop a predictive population pharmacokinetic model of insulins with consideration of factors such as insulin formulation, weight-based dosing, body-weight effect on volume of distribution, and administration time relative to meals, on the insulin time-action profile. The model-predicted insulin profile of each insulin was validated and confirmed to be comparable to observed data via an external validation method. Model-based simulations of clinically relevant insulin-dosing scenarios to cater to specific initial patient and prescribing conditions were then implemented with differential equations using the R statistical program (version 3.2.2). The R package Shiny was subsequently applied to build a web browser interface to execute and visualize the model simulation outputs. The application of insulin pharmacokinetic modeling enabled informative visualization of insulin time-action profiles and provided an efficient and intuitive educational tool to quickly convey and interactively explore many insulin time-action profiles to ease the understanding of insulin formulations in clinical practice.
Assuntos
Hipoglicemiantes/farmacocinética , Insulinas/farmacocinética , Modelos Biológicos , Adolescente , Adulto , Relação Dose-Resposta a Droga , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Injeções Subcutâneas , Insulinas/administração & dosagem , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
AIMS: To estimate the social-economic costs of Type 1 Diabetes Mellitus (T1DM) in patients aged 0-17years in Spain from a social perspective. METHODS: We conducted a cross-sectional observational study in 2014 of 275 T1DM pediatric outpatients distributed across 12 public health centers in Spain. Data on demographic and clinical characteristics, healthcare utilization and informal care were collected from medical records and questionnaires completed by clinicians and patients' caregivers. RESULTS: A valid sample of 249 individuals was analyzed. The average annual cost for a T1DM patient was 27,274. Direct healthcare costs were 4070 and direct non-healthcare cost were 23,204. Informal (familial) care represented 83% of total cost, followed by medical material (8%), outpatient and primary care visits (3.1%) and insulin (2.1%). Direct healthcare cost per patient statistically differed by glycated haemoglobin (HbA1c) level [mean cost 4704 in HbA1c ≥7.5% (≥58mmol/mol) group vs. 3616 in HbA1c<7.5% (<58mmol/mol) group)]; and by the presence or absence of complications and comorbidities (mean cost 5713 in group with complications or comorbidities vs. 3636 in group without complications or comorbidities). CONCLUSIONS: T1DM amongst pediatric patients incurs in considerable societal costs. Informal care represents the largest cost category.
Assuntos
Diabetes Mellitus Tipo 1/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Adolescente , Criança , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Fatores Socioeconômicos , Espanha , Inquéritos e QuestionáriosRESUMO
Diabetes and frailty are two conditions that frequently occur concurrently and are increasingly prevalent in the older patient. We review the concept, epidemiology and consequences of frailty, and the implications of the presence of frailty in the management of diabetes. Frailty is associated with decreased quality of life, a risk of falls, new or increased disability, hospitalization, and increased mortality. All of these factors affect the management of diabetes in older patients. It is important to rule out frailty in all diabetic patients aged >70 years; if frailty is suspected, a comprehensive and multidisciplinary medical and functional assessment of the patient should be conducted to develop an individualized treatment plan. This plan should include nutritional measures, physical activity, and education on self-care and diabetes; drugs should not be used without a clear indication. Antihyperglycemic drugs that may cause excessive weight loss and/or are associated with a high risk of hypoglycemia should be avoided.
Assuntos
Diabetes Mellitus/epidemiologia , Fadiga/epidemiologia , Idoso Fragilizado , Debilidade Muscular/epidemiologia , Magreza/epidemiologia , Idoso , Terapia Combinada , Comorbidade , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/fisiopatologia , Diabetes Mellitus/terapia , Fadiga/etiologia , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Masculino , Pessoa de Meia-Idade , Debilidade Muscular/diagnóstico , Educação de Pacientes como Assunto , Exame Físico , Psicologia , Qualidade de Vida , Risco , Autocuidado , Magreza/etiologia , Redução de Peso/efeitos dos fármacosRESUMO
INTRODUCTION: To report the prevalence of impaired fasting glucose (IFG), undiagnosed and diagnosed diabetes, and their association to occupational categories in a representative sample of working population in Spain. MATERIALS AND METHODS: A cross-sectional study of workers who attended routine medical check-ups from January 2007 to December 2007. A structured questionnaire was completed, and physical examinations and routine serum biochemical tests were performed. IFG was defined as fasting glucose levels ranging from 100 to 125 mg/dl with no diagnosis of T1DM or T2DM; T1DM was defined as previous diagnosis of T1DM; and T2DM as previous diagnosis of T2DM, treatment with oral antidiabetic drugs or insulin or fasting glucose levels ≥126 mg/dl, according to ADA criteria. RESULTS: Of the 371,997 participants (median age 35 [interquartile range 29-44] years), 72.4% were male. Raw prevalence rates (95% CI) of IFG, undiagnosed (UKDM), and previously known type 2 (KDM2) and type 1 (KDM1) diabetes were 10.4% (10.3-10.5%), 1.3% (1.2-1.3%), 1.1% (1.1-1.2%), and 0.3% (0.3-0.3%), respectively. With the exception of KDM1, prevalence of these conditions increased with age and was greater among manual/blue-collar workers (12.1%, 1.5%, 1.3% and 0.3%, respectively) as compared to non-manual/white-collar workers (7.3%, 0.8%, 0.8% and 0.3%, respectively). Age- and sex-adjusted prevalence rates of IFG, UKDM and KDM2 were 13.1%, 2.0% and 2.4%, respectively. DISCUSSION: In this sample of Spanish working population, impaired glycemic profiles were common. Prevalence rates of IFG and T2DM were high among blue-collar workers (except for T1DM). These data emphasize the need for earlier structured preventive schemes.