Costs and where to find them: identifying unit costs for health economic evaluations of diabetes in France, Germany and Italy.

BACKGROUND: Health economic evaluations require cost data as key inputs. Many countries do not have standardized reference costs so costs used often vary between studies, thereby reducing transparency and transferability. The present review provided a comprehensive overview of cost sources and suggested unit costs for France, Germany and Italy, to support health economic evaluations in these countries, particularly in the field of diabetes. METHODS: A literature review was conducted across multiple databases to identify published unit costs and cost data sources for resource items commonly used in health economic evaluations of antidiabetic therapies. The quality of unit cost reporting was assessed with regard to comprehensiveness of cost reporting and referencing as well as accessibility of cost sources from published cost-effectiveness analyses (CEA) of antidiabetic medications. RESULTS: An overview of cost sources, including tariff and fee schedules as well as published estimates, was developed for France, Germany and Italy, covering primary and specialist outpatient care, emergency care, hospital treatment, pharmacy costs and lost productivity. Based on these sources, unit cost datasets were suggested for each country. The assessment of unit cost reporting showed that only 60% and 40% of CEAs reported unit costs and referenced them for all pharmacy items, respectively. Less than 20% of CEAs obtained all pharmacy costs from publicly available sources. CONCLUSIONS: This review provides a comprehensive account of available costs and cost sources in France, Germany and Italy to support health economists and increase transparency in health economic evaluations in diabetes.

Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.

We evaluated patient-reported outcome (PRO) measures from the Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes (AWARD) clinical trial programme for dulaglutide (1.5 mg and 0.75 mg) in patients with type 2 diabetes (T2D). The Impact of Weight on Self-Perception (IW-SP), Impact of Weight on Ability to Perform Physical Activities of Daily Living (APPADL), Impact of Weight on Quality of Life-Lite, EQ-5D, Diabetes Treatment Satisfaction Questionnaire (DTSQ), Diabetes Symptom Checklist-Revised and Adult Low Blood Sugar Survey were administered and analysed for changes from baseline in one or more AWARD studies. Significant within-group changes from baseline to the primary time point were observed for several PRO measures across all studies. Compared with insulin glargine, significantly greater improvements in the IW-SP score were observed with dulaglutide 1.5 mg and with both dulaglutide doses in the APPADL score. Both dulaglutide doses resulted in significantly greater improvement in DTSQ scores (all subscales) compared with exenatide. Dulaglutide 1.5 mg also resulted in significantly greater improvement on the DTSQ hyperglycaemia subscale compared with metformin. Overall, these PRO results suggest that dulaglutide is beneficial in the treatment of T2D.

Estimated glomerular filtration rate progression in UK primary care patients with type 2 diabetes and diabetic kidney disease: a retrospective cohort study.

AIMS: To examine the rates of diabetic kidney disease (DKD) progression and associated factors, we undertook a study of estimated glomerular filtration rate (eGFR) in a historical cohort of UK primary care patients with type 2 diabetes mellitus (T2DM) and associated DKD from the Clinical Practice Research Datalink. METHODS: Our eligible population were patients with definitive T2DM from a recorded diagnostic code with either a diagnosis of chronic kidney disease (CKD) or renal function test values and renal abnormalities consistent with a CKD diagnosis, identified between 1 October 2006 and 31 December 2011. Only patients with albuminuria results reported in mg/l were used for the longitudinal statistical analyses of the eGFR rate of change using multilevel models. RESULTS: We identified 111,030 patients with T2DM. Among them 58.6% (95% confidence interval (CI): 58.3-58.9) had CKD and 37.2% (95% CI: 36.9-37.5%) had presumed DKD at baseline. Only 19.4% of patients had urinary albumin test results expressed as mg/l in the year prior to index date. Almost two-thirds (63.8%) of patients with T2DM and presumed DKD received prescriptions for angiotensin-converting enzyme (ACE) inhibitors or angiotensin type 1 receptor blockers (ARB) or both. Time-dependent variables that predict subsequent eGFR decline include increased albuminuria, time from index date and older age. CONCLUSION: Only a minority of diabetic patients with DKD had quantitative albuminuria assessments. The relatively low proportion of DKD patients with ACEi or ARB prescriptions suggests a gap between healthcare practice and available scientific evidence during the study period. Increased albuminuria and older age were the most consistent predictors of subsequent eGFR decline.

Is the current standard of care leading to cost-effective outcomes for patients with type 2 diabetes requiring insulin? A long-term health economic analysis for the UK.

AIMS: The aim of the analysis was to investigate whether insulin intensification, based on the use of intensive insulin regimens as recommended by the current standard of care in routine clinical practice, would be cost-effective for patients with type 2 diabetes in the UK. METHODS: Clinical data were derived from a retrospective analysis of 3185 patients with type 2 diabetes on basal insulin in The Health Improvement Network (THIN) general practice database. In total, 48% (614 patients) intensified insulin therapy, defined by adding bolus or premix insulin to a basal regimen, which was associated with a reduction in HbA1c and an increase in body mass index. Projections of clinical outcomes and costs (2011 GBP) over patients' lifetimes were made using a recently validated type 2 diabetes model. RESULTS: Immediate insulin intensification was associated with improvements in life expectancy, quality-adjusted life expectancy and time to onset of complications versus no intensification or delaying intensification by 2, 4, 6, or 8 years. Direct costs were higher with the insulin intensification strategy (due to the acquisition costs of insulin). Incremental cost-effectiveness ratios for insulin intensification were GBP 32,560, GBP 35,187, GBP 40,006, GBP 48,187 and GBP 55,431 per QALY gained versus delaying intensification 2, 4, 6 and 8 years, and no intensification, respectively. CONCLUSIONS: Although associated with improved clinical outcomes, insulin intensification as practiced in the UK has a relatively high cost per QALY and may not lead to cost-effective outcomes for patients with type 2 diabetes as currently defined by UK cost-effectiveness thresholds.

Multi-country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED).

AIM: To describe the characteristics and management of patients with diabetes who chose to fast during Ramadan in 2010. METHODS: This was a multi-country, retrospective, observational study, supplemented with physician and patient questionnaires, with data captured before, during and after Ramadan. A total of 508 physicians in 13 countries enrolled 3777 patients and a total of 3394 evaluable cases were analysed. We report on the subset of patients with Type 2 diabetes, which included 3250 patients (95.8%). RESULTS: Oral anti-hyperglycaemic therapy was the predominant pre-Ramadan therapy for most patients (76.6%). The treatment regimen was modified before Ramadan for 39.3% of all patients (34.9% for patients on oral drugs alone, 47.1% for patients on injectable drugs alone). Almost all physicians (96.2%) reported providing fasting-specific advice to patients and 62.6% report using guidelines or recommendations for the management of diabetes during Ramadan. In all, 64% of patients reported fasting everyday of Ramadan and 94.2% fasted for at least 15 days. CONCLUSIONS: Physicians have increasingly adopted multiple approaches to the management of fasting during Ramadan, including the adoption of international and/or national guidelines, providing fasting-specific advice and adjusting treatment regimens, such that patients are able to fast for a greater number of days without acute complications. Additional research is needed to explore physician and patient beliefs and practices to inform the evidence-based management of diabetes while fasting, both during and outside of Ramadan, and to identify and address barriers to the universal uptake of techniques to facilitate that management.

Rates and risk of hospitalisation among patients with type 2 diabetes: retrospective cohort study using the UK General Practice Research Database linked to English Hospital Episode Statistics.

AIMS: To investigate the rates and risk of hospitalisations in patients with type 2 diabetes (T2D) mellitus in England. METHODS: This retrospective population-based cohort study used computerised records from the General Practice Research Database linked to Hospital Episode Statistics data in England. Patients with T2D from January 2006 to December 2010 were selected. Primary outcome measures were all-cause, non-diabetes-related, diabetes-related and hypoglycaemia-related hospitalisations. Factors associated with all-cause and diabetes-related hospitalisations were investigated with Cox's proportional hazards models. RESULTS: Amongst 97,689 patients with T2D, approximately 60% had at least one hospitalisation during the 4-year study period. Rates of hospitalisation were as follows: all-cause, 33.9 per 100 patient-years (pt-yrs); non-diabetes-related, 29.1 per 100 pt-yrs; diabetes-related, 18.8 per 100 pt-yrs and hypoglycaemia, 0.3 per 100 pt-yrs. The risk of all-cause hospitalisation increased with hospitalisation in the previous year, insulin use and the presence of major comorbidities. The risk of a diabetes-related hospitalisation increased with age, female gender, insulin use, chronic renal insufficiency, hypoglycaemia (as diagnosed by a general practitioner) and diabetes-related hospitalisation in the previous year. CONCLUSIONS: Patients with T2D are hospitalised at a considerably high rate for causes directly related with diabetes complications and stay longer in hospital. History of hospitalisation and complications of diabetes were found to be predictive of inpatient hospitalisations suggesting previous hospitalisation episodes could serve as points of intervention. This study highlights important areas for healthcare intervention and provides a reminder for vigilance when risk factors for hospitalisation in patients with T2D are present.

Development of a disease-specific version of the EQ-5D-5L for use in patients suffering from psoriasis: lessons learned from a feasibility study in the UK.

OBJECTIVES: The EuroQol five-dimensional (EQ-5D) questionnaire is a generic measure widely used for the assessment of health status. Research has suggested that it may be insensitive to the burdens associated with particular conditions. This study was designed to explore the feasibility of developing and valuing a disease-specific "bolt-on" version of the EQ-5D questionnaire for use in psoriasis. METHODS: A series of steps were undertaken to develop, test, and evaluate dimensions for a psoriasis-specific version of the EQ-5D questionnaire (hereafter referred to as the EQ-PSO questionnaire). Candidate dimensions were explored through a review of published literature, in-depth qualitative interviews with patients, and consultation with a clinical expert. A psychometric validation exercise was then undertaken to establish how well dimensions functioned. Two dimensions were selected for inclusion in a draft measure alongside the existing EQ-5D questionnaire dimensions: "skin irritation" and "self-confidence." Last, a time trade-off valuation exercise was conducted with 300 members of the UK general public to derive utilities for health states described by the measure. RESULTS: The psychometric analyses indicated that the two new candidate dimensions captured additional variance over and above the existing five dimensions. Data from the valuation exercise were analyzed by using different models. A collapsed random effects model was put forward as a parsimonious and accurate approach. Based on this model, estimated utilities ranged from 0.98 ± 0.02 for state "1111111" to 0.03 ± 0.29 for state "5555555." CONCLUSIONS: This study has developed the EQ-PSO questionnaire to support future psoriasis research and has informed the development of future bolt-on versions of the EQ-5D questionnaire.

Preferences for medication attributes among patients with type 2 diabetes mellitus in the UK.

AIM: To examine preferences for oral medication attributes among participants with early and advanced type 2 diabetes mellitus (T2DM) in the UK using a discrete choice experiment (DCE). METHODS: A web-based DCE was administered where participants indicated which medication they preferred from two different hypothetical oral anti-diabetic (OAD) medication profiles, each composed of differing levels of seven attributes (efficacy, hypoglycaemic events, weight change, gastrointestinal/nausea side effects, urinary tract infection and genital infection, blood pressure and cardiovascular risk) for 20 sets of pair-wise comparisons. A random effects multinomial logit regression model was used to estimate the preference weight (PW) for each of the attribute levels, and the relative importance (RI) of each attribute was calculated. Analyses were conducted for the overall sample and for medication and gender subgroups. RESULTS: The final sample included 100 participants with a mean age of 62.9 (SD 11.1) years and comparable numbers of participants of each gender (51% male, 49% female). The majority of the participants were White-British (92%). The total PW and corresponding RI were highest for four of the seven attributes: hypoglycaemic events (PW = 1.98; RI = 24.7%), weight change (PW = 1.65; RI = 20.6%), gastrointestinal/nausea side effects (PW = 1.49; RI = 18.6%) and efficacy (PW = 1.44; RI = 18.0%). The RI values differed for some attributes across gender and number of current T2DM medication subgroups. CONCLUSION: The results suggest that hypoglycaemia, weight change, gastrointestinal side effects and efficacy are of primary importance to patients in their OAD preferences in T2DM. These four attributes comprised over 80% of the RI.

A network meta-analysis to compare glycaemic control in patients with type 2 diabetes treated with exenatide once weekly or liraglutide once daily in comparison with insulin glargine, exenatide twice daily or placebo.

AIMS: The glucagon-like peptide-1 receptor agonists (GLP-1 RAs) exenatide once weekly (ExQW) and liraglutide once daily (QD) are indicated to improve glycaemic control in patients with type 2 diabetes. Although glycaemic control with ExQW versus liraglutide QD 1.8 mg has been directly compared, no studies have compared ExQW with liraglutide QD 1.2 mg or determined the probable relative efficacies of various injectable therapies for glycaemic control; therefore, a network meta-analysis was performed to address these questions. METHODS: A systematic review identified randomized controlled trials of ≥24 weeks that compared ExQW, liraglutide QD (1.2 mg, 1.8 mg), insulin glargine, exenatide twice daily (ExBID), or placebo. Twenty-two studies evaluating 11 049 patients were included in the network meta-analysis. Mean differences in HbA1c relative to placebo or each other and probability rankings were estimated. RESULTS: Estimated mean differences in HbA1c versus placebo were -1.15% (95% CrI: -1.31 to -1.00) for ExQW, -1.01% (95% CrI: -1.18 to -0.85) for liraglutide 1.2 mg, and -1.18% (95% CrI: -1.32 to -1.04) for liraglutide 1.8 mg. HbA1c differences for ExQW versus liraglutide 1.2 mg and 1.8 mg were -0.14% (95% CrI: -0.34 to 0.06) and 0.03% (95% CrI: -0.14 to 0.18), respectively. The estimated mean difference in HbA1c between liraglutide 1.2 mg and 1.8 mg was 0.17% (95% CrI: 0.02-0.30). Results were consistent when adjusted for background antihyperglycaemic medications and diabetes duration. CONCLUSIONS: This network meta-analysis did not identify meaningful differences in HbA1c lowering between ExQW and both liraglutide doses, suggesting that these GLP-1 RAs have similar glycaemic effects.

Cardiovascular outcomes associated with a new once-weekly GLP-1 receptor agonist vs. traditional therapies for type 2 diabetes: a simulation analysis.

AIM: The effect of glucose-lowering agents on diabetes-related complications including cardiovascular (CV) events is of major importance. In the absence of a long-term study, we simulated such a trial using a mathematical model where subjects were given exenatide once-weekly (EQW), which has been shown to improve glycaemic control and reduce weight, systolic blood pressure (SBP) and lipids in patients with type 2 diabetes mellitus (T2DM). METHODS: Using the Archimedes Model, we followed a simulated population derived from individuals with T2DM in NHANES who were drug-naïve or on oral agents only. We modelled the effects of four treatment strategies including standard care (SC, maintaining levels of control seen in NHANES), intensive glycaemic control (IGC, target HbA1c < 7% with conventional antidiabetic agents) and two versions of EQW added to SC: one with glycaemic and weight reduction only (EQW-1) and one with additional improvements in SBP and lipids (EQW-2). EQW strategies were derived from 52-week clinical trial data. Endpoints included macrovascular and microvascular outcomes. RESULTS: Simulated EQW treatment resulted in earlier benefit and 2-3 times greater relative reductions in major adverse CV events than IGC when compared to SC (6% relative reduction by year 20 for IGC vs. 12 and 17% for the EQW strategies). For microvascular complications, EQW showed comparable benefit to IGC for neuropathy but significantly greater impact on renal complications. CONCLUSIONS: This analysis shows that the novel drug EQW has the potential to greatly reduce CV events through its combined effects on glycaemia, weight and other CV risk factors.

Anti-CD3 monoclonal antibody treatment in newly diagnosed Type 1 diabetes patients: a hypothetical modelling analysis.

AIMS: Although limited clinical data exist for anti-CD3 monoclonal antibody therapies, it is believed that they may influence glycaemic control, endogenous insulin secretion and hypoglycaemic event rates in individuals newly diagnosed with Type 1 diabetes. In the absence of suitable empirical evidence, the objective of this study was to estimate the potential long-term clinical outcomes associated with treatment via a hypothetical modelling analysis. METHODS: Analyses were performed using a published and validated computer simulation model of diabetes in a hypothetical US cohort based on published literature and expert opinion. The efficacy of anti-CD3 monoclonal antibody treatment was estimated from clinical data and expert opinion and simulations were performed over a 60-year time horizon. The impact on quality of life associated with treatment was also captured via published utility values. RESULTS: Assuming that a treatment course of an anti-CD3 monoclonal antibody produced an initial reduction in glycated haemoglobin of -0.8%, and that the effects persisted for up to 5 years, treatment was projected to lead to an increase in undiscounted life expectancy of 0.43 years and an increase in quality-adjusted life expectancy of 0.36 quality-adjusted life years compared with conventional exogenous insulin. CONCLUSIONS: A course of a hypothetical anti-CD3 monoclonal antibody treatment associated with improved glycaemic control and, potentially, the preservation of pancreatic beta-cell function was estimated to lead to improved life expectancy and quality-adjusted life expectancy compared with conventional treatment in patients with newly diagnosed Type 1 diabetes.

Six-month outcomes on A1C and cardiovascular risk factors in patients with type 2 diabetes treated with exenatide in an ambulatory care setting.

AIM: This study evaluated changes in clinical effectiveness measures of patients with type 2 diabetes initiating exenatide therapy in a real-world setting. METHODS: Eligible patients identified in the General Electric (GE) electronic medical record (EMR) research database from 1 January 2000 through 31 December 2007 were > or =18 years old with type 2 diabetes. Patients had prescription orders in the previous 395 days for metformin, a sulfonylurea, or a thiazolidinedione as monotherapy or in combination, and had at least 6 months of follow-up activity. Baseline clinical measures were documented from 45 days prior up to 15 days after exenatide initiation and follow-up measures documented at 6 months +/- 45 days. RESULTS: A total of 1709 patients were identified for study inclusion. The overall mean A1C reduction (s.e.m.) at 6 months was -0.8% (0.05) (p<0.001), weight loss was -3.2 kg (0.14) (p<0.001), blood pressure (BP) lowering was -1.9 mmHg (0.46) systolic blood pressure (SBP) (p<0.001) and -0.5 mmHg (0.27) diastolic blood pressure (DBP) (p = 0.078). Changes in low-density lipoprotein (LDL), triglycerides and HDL were -7.4 mg/dl (1.7) (p<0.001), -23.2 mg/dl (6.7) (p = 0.001) and -0.8 mg/dl (0.33) (p = 0.012) respectively. In a quartile analysis by weight loss, mean A1C reduction ranged from -1.1 to -0.65% in the highest to lowest weight loss quartiles respectively. CONCLUSIONS: In a real-world setting, exenatide initiation is associated with significant improvements in the measures of clinical effectiveness for type 2 diabetes. These reductions were comparable to those reported in randomized, controlled registration trials after 6 months of therapy.

An estimation of the long-term clinical and economic benefits of insulin lispro in Type 1 diabetes in the UK.

AIMS: To determine the long-term health economic benefits associated with lispro vs. regular human insulin (RHI) in UK Type 1 diabetic (T1DM) patients using the previously published and validated CORE Diabetes Model. METHODS: A literature review designed to capture clinical benefits associated with lispro and T1DM cohort characteristics specific to UK was undertaken. Clinical benefits were derived from a Cochrane meta-analysis. The estimated difference (weighted mean) in glycated haemoglobin (HbA(1c)) was -0.1% (95% confidence interval -0.2 to 0.0%) for lispro vs. RHI. Severe hypoglycaemia rates for lispro and RHI were 21.8 and 46.1 events per 100 patient years, respectively. Costs and disutilities were accounted for severe hypoglycaemia rates. All costs were accounted in 2007 poundUK from a National Health Service (NHS) perspective. Future costs and clinical benefits were discounted at 3.5% annually. RESULTS: In the base-case analysis, lispro was projected to be dominant compared with RHI. Lispro was associated with improvements in quality-adjusted life expectancy (QALE) of approximately 0.10 quality-adjusted life years (QALYs) vs. RHI (7.60 vs. 7.50 QALYs). Lifetime direct medical costs per patient were lower with lispro treatment, pound70 576 vs. pound72 529. Severe hypoglycaemia rates were the key driver in terms of differences in QALE and lifetime costs. Sensitivity analyses with assumptions around time horizon, discounting rates and benefits in terms of glycaemic control or hypoglycaemic event rates revealed that lispro remained dominant. CONCLUSIONS: Our findings suggest that lispro is likely to improve QALE, reduce frequency of diabetes-related complications and lifetime medical costs compared with RHI.

Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily.

AIMS: To assess treatment satisfaction and weight-related quality of life (QOL) in subjects with Type 2 diabetes treated with exenatide once weekly (QW) or twice daily (BID). METHODS: In this 52-week randomized, multi-centre, open-label study, 295 subjects managed with diet and exercise and/or oral glucose-lowering medications received either exenatide QW or BID during weeks 1-30; thereafter, subjects receiving exenatide BID were switched to exenatide QW, with 258 total subjects receiving exenatide QW during weeks 30-52. Diabetes Treatment Satisfaction Questionnaire-status (DTSQ-s) and Impact of Weight on Quality of Life-Lite (IWQOL-Lite) were assessed at baseline and weeks 30 and 52. Mean group changes from baseline to week 30 were estimated by ancova; changes from week 30 to week 52 were assessed by Student's t-test. RESULTS: Statistically significant improvements from baseline to week 30 were observed in both treatment groups for DTSQ-s and IWQOL-Lite measures, with significantly greater reduction in perceived frequency of hyperglycaemia and greater satisfaction with continuing treatment in the QW group compared with the BID group. Effect sizes for change in DTSQ-s total scores were 0.84 QW, 0.64 BID; for IWQOL-Lite: 0.96 QW, 0.82 BID. Treatment satisfaction and QOL improved significantly between weeks 30 and 52 for those switching from BID to QW. Occurrence of adverse events did not affect patients' improvements in treatment satisfaction and QOL. CONCLUSIONS: Patients treated with exenatide QW or BID experienced significant and clinically meaningful improvements in treatment satisfaction and QOL. Patients who switched from exenatide BID to exenatide QW administration reported further significant improvements.

Healthcare charges and utilization associated with diabetic neuropathy: impact of Type 1 diabetes and presence of other diabetes-related complications and comorbidities.

AIMS: The aim was to examine the impact of Type 1 diabetes and having any other diabetes-related complication or comorbidity on healthcare charges and utilization in patients with diabetic neuropathy (DN). METHODS: We selected individuals aged < 65 years who continuously enrolled in a large US commercial plan from July 2004 to June 2006 and who received at least one diagnosis of DN at any time from July 2004 to June 2005. We compared the prevalence of other diabetes-related complications or comorbidities between patients with Type 1 and with Type 2 diabetes. In patients with DN with or without any other diabetes-related complication or comorbidity, we used multivariate regression to assess the marginal contribution of Type 1 diabetes on healthcare charges and utilization from July 2005 until June 2006. RESULTS: The majority of DN patients had at least one other diabetes-related complication or comorbidity. Most of the DN patients had Type 2 diabetes. DN patients with Type 1 diabetes had more comorbid medical conditions than those with Type 2 diabetes. Compared with Type 2, Type 1 patients had a higher prevalence of each individual non-DN diabetes-related complication or comorbidity, except heart disease. Controlling for comorbidities, Type 1 and Type 2 patients with DN but no other diabetes-related complication or comorbidity had similar healthcare utilization. However, Type 1 patients had significantly higher charges than those with any other diabetes-related complication or comorbidity. CONCLUSIONS: Many patients with DN have Type 1 diabetes and other common diabetes-related complications or comorbidities, which can have a significant impact on healthcare charges and utilization.

[The impact of obesity in the management and evolution of diabetes mellitus]. / El impacto de la obesidad en el manejo y evolución de la diabetes mellitus.

OBJECTIVES: To assess both management and evolution of diabetes mellitus type 2 (DM2) in Primary Care centers in Spain and the related factors, especially obesity. METHODOLOGY: Epidemiological, cross-sectional, multicenter, retrospective study. PATIENTS: Patients suffering from DM2, over 20 years of age, were consecutively enrolled from 30 Primary Care centers in 16 autonomous communities. Métodos. Data was collected on age, gender, educational level, DM2 duration, HbA1c, treatment and body measurement index (BMI). RESULTS: A total of 294 patients, 50% male, with a mean age (SD) of 67.5 years (10.2) and BMI 28.9 (4.5) kg/m(2) were included. Of them, 58.16% had HbA1c levels >6.5%, 38% being obese or severely obese. A total of 93.9% were under drug treatment for DM2. Significant differences in the mean value of HbA1c were shown between the over-weight and severely obese groups (Tukey-Kramer test). Differences were observed in the presence of macrovascular complications between patients with normal weight and patients with obesity (p=0.006). Patients with low educational level had 3.39 more probability of being obese or severely obese than patients with secondary school or university studies (p=0.0041; 95% CI 1.47-7.80), and patients with primary school 2.22 more probability (p= 0.038; 95% CI 1.04-4.73). A total of 47.8% reported high compliance. Obese and severely obese patients showed 2.2 more probability of having low or mild compliance than non-obese patients (p=0.002; 95% CI 1.31-3.74). CONCLUSIONS: Results obtained in this population suggest that obesity is related with more macro-vascular complications, worst metabolic control and worst compliance.

El impacto de la obesidad en el manejo y evolución de la diabetes mellitus / The impact of obesity in the management and evolution of diabetes mellitus

Objetivo. Estudiar el manejo y evolución de ladiabetes mellitus tipo 2 (DM2) en Atención Primaria(AP) en España y los factores implicados,especialmente la obesidad.Diseño. Estudio epidemiológico, transversal,multicéntrico, retrospectivo.Participantes. Se incluyeron pacientes con DM2mayores de 20 años seleccionadosconsecutivamente en 30 centros de AP, en16 comunidades autónomas (CCAA).Métodos. Se recogió información sobre edad, sexo,nivel educativo, duración de DM2, HbA1c,tratamiento e índice de masa corporal (IMC).Resultados. De un total de 294 pacientes, 50%hombres, con edad media (DE) 67,5 años (10,2) eIMC 28,9 (4,5) kg/m2, el 58,16% presentabanniveles de HbA1c >6,5%, el 38% era obeso oseveramente obeso. El 93,9% seguía tratamientofarmacológico para su diabetes. Se mostrarondiferencias significativas en el valor medio deHbA1c entre el grupo con sobrepeso y el grupocon obesidad severa (test de Tukey-Kramer).Se observaron diferencias en la presencia decomplicaciones macrovasculares entrepacientes con peso normal y pacientes obesos(p=0,006). Pacientes con menor grado dealfabetización mostraron 3,39 más probabilidad deser obesos o severamente obesos que pacientescon estudios secundarios o universitarios(p=0,0041; 95% intervalo de confianza [IC] 1,47-7,80), y los pacientes con estudios primarios 2,22veces más (p=0,038; 95% IC 1,04-4,73). Un47,8% refirieron un cumplimiento elevado. Losobesos y severamente obesos presentaron 2,2veces más probabilidad de presentar cumplimientobajo o moderado que los no obesos (p=0,002;95% IC 1,31-3,74 ).Conclusiones. Los resultados obtenidos en estapoblación sugieren que la variable obesidad serelaciona con más complicaciones macrovasculares,peor control metabólico y peor cumplimiento

Objectives. To assess both management andevolution of diabetes mellitus type 2 (DM2) inPrimary Care centers in Spain and the relatedfactors, especially obesity.Methodology. Epidemiological, cross-sectional,multicenter, retrospective study.Patients. Patients suffering from DM2, over 20years of age, were consecutively enrolled from 30Primary Care centers in 16 autonomouscommunities.Métodos. Data was collected on age, gender,educational level, DM2 duration, HbA1c, treatmentand body measurement index (BMI).Results. A total of 294 patients, 50% male, with amean age (SD) of 67.5 years (10.2) and BMI 28.9(4.5) kg/m2 were included. Of them, 58.16% hadHbA1c levels >6.5%, 38% being obese or severelyobese. A total of 93.9% were under drug treatmentfor DM2. Significant differences in the mean valueof HbA1c were shown between the over-weight andseverely obese groups (Tukey-Kramer test).Differences were observed in the presence ofmacrovascular complications between patients withnormal weight and patients with obesity (p=0.006).Patients with low educational level had 3.39 moreprobability of being obese or severely obese thanpatients with secondary school or university studies(p=0.0041; 95% CI 1.47-7.80), and patients withprimary school 2.22 more probability (p= 0.038;95% CI 1.04-4.73). A total of 47.8% reported highcompliance. Obese and severely obese patientsshowed 2.2 more probability of having low or mildcompliance than non-obese patients (p=0.002; 95%CI 1.31-3.74).Conclusions. Results obtained in this populationsuggest that obesity is related with more macrovascularcomplications, worst metabolic control andworst compliance