OBJECTIVE -To assess the cardiovascular risk profile, the degree of insulin resistance, and -cell secretion in a cohort of subjects with different categories of impaired glucose regulation (IGR): impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and combined IFG/ IGT.RESEARCH DESIGN AND METHODS -We studied 902 nondiabetic subjects between 30 and 80 years of age, recruited from a cross-sectional population-based study in Telde, Gran Canaria Island, Spain. Categories of glucose tolerance were defined according to 2003 modified American Diabetes Association criteria. Risk factors for cardiovascular disease, the presence of the metabolic syndrome, and indirect measures of both insulin resistance and -cell function were analyzed.RESULTS -A total of 132 (14.6%) participants had isolated IFG, 59 (6.5%) isolated IGT, and 48 (5.3%) combined IFG/IGT. Groups with normal glucose tolerance (NGT) and combined IFG/IGT had, respectively, the most favorable and unfavorable levels of cardiovascular risk factors, metabolic syndrome rates, and measures of insulin resistance. Subjects with IFG and IGT showed an intermediate profile between NGT and IFG/IGT categories. We found no significant differences between IFG and IGT in cardiovascular risk factors, metabolic syndrome prevalence, or insulin resistance. The IFG group exhibited a more impaired insulin secretion than those with IGT or IFG/IGT. I n 1997, the American Diabetes Association (ADA) issued new diagnostic criteria for diabetes and established a new category of impaired glucose regulation (IGR) called impaired fasting glucose (IFG), a fasting category analogous to impaired glucose tolerance (IGT) and defined as a fasting plasma glucose (FPG) between 6.1 and 6.9 mmol/l (1). In 2003, based on epidemiological predictive data from different populations showing that decreasing the lower limit of IFG would optimize its sensitivity and specificity for predicting future diabetes, the ADA established a new cutoff point of 5.6 mmol/l (2). CONCLUSIONSAlthough both IFG and IGT are risk factors for diabetes and cardiovascular disease (CVD) (3), IGT is more consistently associated with an increase in cardiovascular-related and all-cause mortality (4 -9). Moreover, evidence that interventions may reduce progression to diabetes is limited to IGT (10 -12).To explain a different prognostic value of IFG and IGT on the risk of diabetes and CVD, different studies have analyzed the prevalence of cardiovascular risk factors, insulin sensitivity, and -cell function among subjects with different categories of IGR (13-22). However, results have been discordant, and most studies were performed before the introduction of the 2003 ADA criteria.Here, we have compared the cardiovascular risk profile (traditional and new risk factors), the prevalence of the metabolic syndrome, as well as different indexes for the assessment of insulinglucose homeostasis in subjects with normal glucose tolerance (NGT) and IGR that participated in the Telde Study, a population-based survey performed in Gr...
PurposeThe main objective of this study was to assess quality of life (QoL) and treatment satisfaction in a group of patients with type 1 diabetes (T1D) and explore their needs regarding and their perception of QoL living with diabetes.Materials and methodsPatients with type 1 diabetes attending the outpatient endocrinology clinics of a reference hospital were invited to participate in a cross-sectional study. Clinical and sociodemographic data were obtained (interview and clinical records), and diabetes-related QoL was assessed using a standardized questionnaire. In 67 participants, satisfaction with treatment was also assessed, and an open interview was performed, assessing the impact of diabetes, long-term worries, flexibility, restrictions, and self-perception of QoL. Descriptive statistical analysis, bivariate analysis, and multivariate analysis were performed in order to find factors associated with QoL. Interviews were analyzed and summarized questionwise.ResultsMean patient age was 31.4±11.6 years, diabetes duration 14.2±9.3 years, and glycated hemoglobin (HbA1c) 8.5%±1.9% (69±20.8 mmol/mol International Federation of Clinical Chemistry [IFCC]). The questionnaires showed good average QoL scores (94.6+22.9) and treatment satisfaction scores (25.7±6.7). QoL worsened with increasing HbA1c, female sex, severity of complications, and lower education (r2=0.283, P<0.005). In the open interview, 68.5% of the patients reported that diabetes had changed their lives, 83.5% identified complications as their most important long-term concern, and 59.7% said that they needed more training to manage the disease.ConclusionPoor glycemic control, lower education, complications, and female sex are associated with worse QoL. Semi-structured interviews identified aspects not included in the standardized questionnaires.
IntroductionHomozygous familial hypercholesterolaemia (HoFH) is a rare, autosomal disease affecting the clearance of low-density lipoprotein cholesterol (LDL-C) from circulation, and leading to early-onset atherosclerotic cardiovascular disease (ASCVD). Treatment consists mainly of statins, lipoprotein apheresis (LA) and, more recently, the microsomal triglyceride transfer protein inhibitor lomitapide. Lomitapide is not licensed for use in children, but has been made available through an expanded access programme or on a named patient basis.MethodsThis case series includes 11 HoFH patients in 10 different centres in eight countries, less than 18 years of age (mean 11.6 ± 1.1 years, 64% male), with signs of ASCVD, and who have received treatment with lomitapide (mean dose 24.5 ± 4.3 mg/day; mean exposure 20.0 ± 2.9 months). Background lipid-lowering therapy was given according to local protocols. Lomitapide was commenced with a stepwise dose escalation from 2.5 mg or 5 mg/day; dietary advice and vitamin supplements were provided as per the product label for adults. Laboratory analysis was conducted as part of regular clinical care.ResultsIn the 11 cases, mean baseline LDL-C was 419 ± 74.6 mg/dL and was markedly reduced by lomitapide to a nadir of 176.7 ± 46.3 mg/dL (58.4 ± 6.8% decrease). Six patients achieved recommended target levels for children below 135 mg/dL, five of whom had LA frequency reduced. In one case, LDL-C levels were close to target when lomitapide was started but remained stable despite 75% reduction in LA frequency (from twice weekly to biweekly). Adverse events were mainly gastrointestinal in nature, occurred early in the treatment course and were well managed. Three patients with excursions in liver function tests were managed chiefly without intervention; two patients had decreases in lomitapide dose.ConclusionsLomitapide demonstrated promising effectiveness in paediatric HoFH patients. Adverse events were manageable, and the clinical profile of the drug is apparently similar to that in adult patients.FundingAmryt Pharma.
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