An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive Pulmonary Disease (COPD) During Therapy with Spiolto® Respimat® in Everyday Clinical Practice: The Greek ELLACTO Study.

INTRODUCTION: Patients with chronic obstructive pulmonary disease (COPD) often report deteriorated functional status and poor health-related quality of life, both core aspects of their overall health status. The study objective was to assess tiotropium/olodaterol Respimat® effects on health and functional status of COPD patients requiring long-acting dual bronchodilation treatment in the real world. METHODS: ELLACTO was an open-label, observational, prospective study conducted in Greece, measuring changes on health and functional status of COPD patients treated with a fixed dose of tiotropium/olodaterol Respimat® for approximately 6 weeks. The primary endpoint was "therapeutic success" defined as a ≥ 0.4-point decrease in the Clinical COPD Questionnaire (CCQ) score at week 6. Secondary endpoints included absolute changes in the CCQ and the functional subscale CCQ-4 at week 6, patient general condition measured by Physician's Global Evaluation (PGE) score at baseline and week 6, patient satisfaction and preference with Respimat® device (assessed by the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ)) at week 6 and treatment continuation with tiotropium/olodaterol Respimat® after the study. RESULTS: After approximately 6 weeks of treatment with tiotropium/olodaterol Respimat®, therapeutic success was achieved by 64.3% of 1332 patients included in the final analysis [95% confidence interval [CI] 62-67]. Mean [standard deviation (SD)] absolute changes in CCQ and CCQ-4 scores at week 6 were - 0.63 (0.635) and - 0.59 (0.714) points, respectively. Patient general condition improved and more than 77.4% of patients were satisfied or very satisfied with the use of the Respimat® device. Among patients previously using the HandiHaler® device (n = 254), 85.4% expressed a preference for Respimat® over 6.7% for HandiHaler®. Most patients (95.7%) were willing to continue treatment with tiotropium/olodaterol Respimat® after the study. CONCLUSIONS: Treatment with tiotropium/olodaterol Respimat® led to an improved health status in Greek COPD patients. Most patients also expressed a preference for the Respimat® device and willingness to continue treatment with it. TRIAL REGISTRATION: ClinicalTrials.gov NCT03419962.

Incidence and cost of bleeding events requiring hospitalization in patients with atrial fibrillation treated with acenocoumarol in Greece.

BACKGROUND: To estimate the incidence of hemorrhagic events in patients with atrial fibrillation (AF) treated with acenocoumarol, and the management cost of those requiring hospitalization in Greece. METHODS: A nationwide telephone survey was conducted between December 2017 and January 2018, to identify cardiologists who treat AF patients with acenocoumarol. A total of 300 cardiologists were selected and reported the number of AF acenocoumarol-treated patients during the past 12 months and the number of those who experienced a hemorrhagic event. The hospital charges to sickness fund and the cost of resource utilization of AF patients hospitalized between January 2013 and June 2017 at a tertiary hospital in Athens due to acenocoumarol-related bleedings were retrieved. RESULTS: Out of 48,255 AF patients, 12,633 (26.2%) were treated with acenocoumarol. In all, 5.1% of patients experienced a hemorrhagic event with the incidence of bleeding requiring hospitalization being 1.7%. The most common bleeding site was the gastrointestinal system (51.5%). The mean (95% CI) management cost per bleeding event requiring hospitalization was €1,202 (€1,058-€1,420). The higher cost was that of intracranial bleeding €3,887 (€2,700-€5,046). The expected annual economic burden for the management of bleedings related to acenocoumarol and requiring hospitalization was estimated at €1,463,955. CONCLUSIONS: The incidence of bleeding events in AF acenocoumarol-treated patients in Greece as well as the estimated annual economic burden for the management of bleeding events requiring hospitalization, emphasize the need to comply with the current guidelines and to optimize therapeutic strategies for the management of AF side effects with oral anticoagulants, particularly in patients with high bleeding risk.

A contemporary cross-sectional study on dyslipidemia management, cardiovascular risk status, and patients' quality of life in Greece: The CHALLENGE study.

BACKGROUND: Prior studies conducted in Greece consistently indicate that dyslipidemia is suboptimally managed, while the burden of cardiovascular disease (CVD) and related risk factors is rising. METHODS: CHALLENGE was a multicenter, cross-sectional study carried out following the publication of guidelines advocating stricter low-density lipoprotein cholesterol (LDL-C) targets. It primarily aimed to depict LDL-C target attainment, and to assess the cardiovascular risk status and quality of life (QoL) of patients treated in a primary or secondary CVD prevention setting who had received any medical intervention for cardiovascular risk modification within 6months of enrollment. RESULTS: Between December 2012 and April 2013, 500 patients (55% males) aged (mean±SD) 62.0±11.7years, participated in the study. Cardiovascular risk according to the 2011 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines was 'very high', 'high', and 'moderate' in 61.2%, 23.4%, and 15.4%, respectively. Overall, 92.0% of patients were on lipid-lowering treatment, yet only 23.3% had attained their ESC/EAS-defined LDL-C target. LDL-C target attainment was more likely among 'moderate' versus 'very high' cardiovascular risk patients (odds ratio: 4.04; 95% confidence interval: 2.32-7.06; p<0.001). QoL improved as cardiovascular risk decreased (EQ-VAS 71.8±16.2 in the 'very high' versus 78.3±15.1 and 80.3±15.7 in the 'high' and 'moderate' risk groups; p<0.001). Time constraints and difficulties in implementation in daily practice were the investigator's main barriers for guideline utilization. CONCLUSIONS: During contemporary management of dyslipidemia in Greece, LDL-C target attainment is suboptimal. There is an undoubted need for improvement and implementation of cardiovascular risk assessment in routine clinical practice.

Effects of benchmarking on the quality of type 2 diabetes care: results of the OPTIMISE (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment) study in Greece.

OBJECTIVES: To investigate the effect of benchmarking on the quality of type 2 diabetes (T2DM) care in Greece. METHODS: The OPTIMISE (Optimal Type 2 Diabetes Management Including Benchmarking and Standard Treatment) study [ClinicalTrials.gov identifier: NCT00681850] was an international multicenter, prospective cohort study. It included physicians randomized 3:1 to either receive benchmarking for glycated hemoglobin (HbA1c), systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) treatment targets (benchmarking group) or not (control group). The proportions of patients achieving the targets of the above-mentioned parameters were compared between groups after 12 months of treatment. Also, the proportions of patients achieving those targets at 12 months were compared with baseline in the benchmarking group. RESULTS: In the Greek region, the OPTIMISE study included 797 adults with T2DM (570 in the benchmarking group). At month 12 the proportion of patients within the predefined targets for SBP and LDL-C was greater in the benchmarking compared with the control group (50.6 versus 35.8%, and 45.3 versus 36.1%, respectively). However, these differences were not statistically significant. No difference between groups was noted in the percentage of patients achieving the predefined target for HbA1c. At month 12 the increase in the percentage of patients achieving all three targets was greater in the benchmarking (5.9-15.0%) than in the control group (2.7-8.1%). In the benchmarking group more patients were on target regarding SBP (50.6% versus 29.8%), LDL-C (45.3% versus 31.3%) and HbA1c (63.8% versus 51.2%) at 12 months compared with baseline (p < 0.001 for all comparisons). CONCLUSION: Benchmarking may comprise a promising tool for improving the quality of T2DM care. Nevertheless, target achievement rates of each, and of all three, quality indicators were suboptimal, indicating there are still unmet needs in the management of T2DM.

Glycaemic control, treatment satisfaction and quality of life in type 2 diabetes patients in Greece: The PANORAMA study Greek results.

AIM: To provide an update on glycaemic control in European patients with type 2 diabetes mellitus (T2DM). We present the Greek population data of the study. METHODS: An observational multicenter, cross-sectional study evaluating glycaemic control and a range of other clinical and biological measures as well as quality of life (QoL) and treatment satisfaction in 375 patients with T2DM enrolled by 25 primary care sites from Greece. RESULTS: The mean age of the patients was 63.5 years and the male/female ratio 48.9%/51.1%. 79.7% of the patients exerted none or light physical activity, 82.4% were overweight or obese and 32.9% did not meet HbA1c target of less than 7.0% (53 mmol/mol). Patients reported high satisfaction to continue with treatment, high satisfaction with administered treatment and increased willingness to recommend treatment to others (mean Diabetes Treatment Satisfaction Questionnaire score 29.1 ± 5.6). However, 80% of the patients reported that their QoL would be better without diabetes. Finally, the most challenging parameter reported was the lack of freedom to eat and drink. CONCLUSION: This analysis of the Greek Panorama study results showed that a considerable percentage of T2DM patients in Greece do not achieve glycaemic target levels, despite the favourably reported patient satisfaction from administered therapy. Additionally, the majority of primary care T2DM patients in Greece depict the negative effect of the disease in their QoL.

Prevalence of peripheral arterial disease in subjects at moderate cardiovascular risk: Greek results of the PANDORA study.

INTRODUCTION: Peripheral arterial disease (PAD) is a form of atherosclerotic disease that confers a cardiovascular (CV) risk equivalent to that of coronary heart disease. Despite its association with high CV risk, PAD is potentially underdiagnosed. The primary objective of the study was to assess the prevalence of asymptomatic PAD through measurement of the ankle-brachial index (ABI) in subjects at moderate CV risk. Secondary objectives included the assessment of the prevalence of CV risk factors and lifestyle habits in the total population and in subjects with or without PAD, as well as the identification of factors associated with PAD. METHODS: PANDORA (NCT00689377) was a cross-sectional study conducted in 6 European countries. The study required a single visit in which males aged 45 or females 55 years, with at least 1 additional risk factor, but no overt CV disease or diabetes, underwent ABI measurement. Data on patient demographics, vital signs, CV risk factors, lipid levels and current treatment were recorded. RESULTS: Eight hundred forty subjects (789 evaluable) were enrolled by 120 office-based physicians across Greece. Age was 62.1 ± 9.1 years and body-mass index 29.6 ± 4.3 kg/m(2); 61.2% of the subjects were male, 47% were smokers, and 73.5% hypertensive. The prevalence of asymptomatic PAD, defined as ABI0.90, was 28.0% (95% CI: 24.88-31.14). In logistic regression analysis, hypertension (OR: 2.48, 95% CI: 1.58-3.89, p<0.0001), low high-density lipoprotein cholesterol (OR: 2.27, 95% CI: 1.55-3.32, p<0.0001), and divorced marital status (OR: 2.63, 95% CI: 1.14-6.07, p=0.023), were found to be strong determinants for PAD. CONCLUSIONS: Asymptomatic PAD was highly prevalent in subjects with moderate CV risk treated by officebased physicians in Greece. ABI measurement is a significant tool for identifying subjects at higher risk who may require earlier and possibly more aggressive intervention.

Primary prevention of cardiovascular disease in Greece: Greek results of the EURIKA study.

INTRODUCTION: The EURIKA study was designed to describe the control of cardiovascular disease (CVD) risk factors in a real-world primary prevention setting in Europe, to estimate residual CVD risk, and to assess physicians' attitudes to and perceptions of risk factor management. The present manuscript reports the EURIKA results from Greece. METHODS: EURIKA was a multinational, cross-sectional study conducted in 12 European countries. Randomly selected physicians completed a questionnaire regarding their demographics and CVD prevention beliefs and practices. Consenting patients who were free of CVD, aged 50 years, and with 1 CVD risk factor, were recruited. Risk factor definition and treatment goals were based on the 2007 European guidelines on CVD prevention. Global CVD risk was estimated using the SCORE equation. In addition, each patient provided a fasting blood sample for measurement of serum lipids, and HbA1c. RESULTS: Overall, 620 evaluable patients (male/female 46%/54%) were enrolled by 63 physicians (13 hospital-based, 50 office-based) across Greece. Almost one-third of the patients (27.3%) were classified as highrisk (SCORE5%). Blood pressure, dyslipidaemia and diabetes were controlled in 47.5%, 37.4% and 43.8% of the population who were treated for the respective risk factors, with more than one-fourth of the controlled patients remaining at high risk. The ESC 2007 and ESC/ESH 2007 guidelines were the most popular (44.4% and 38.1% respectively), while the ESC/ESH tool was most frequently reported to be used by physicians for global CVD risk calculation (42%), followed by SCORE (36%), and Framingham (36%). The major barriers to the use of guidelines and risk calculation tools were the plethora of guidelines and time constraints (87.5% and 69.2% respectively). CONCLUSIONS: Control of key CVD risk factors appears to be suboptimal in primary prevention patients in Greece, with a remarkable proportion of controlled patients remaining at high risk. Although guidelines and global risk calculation tools are reported to be adopted by the majority of physicians, the plethora of available guidelines and time constraints are the major barriers to their utilisation.

Rationale, design and baseline patient characteristics of the optimal type 2 diabetes management including benchmarking and standard treatment study in Greece.

AIM: To describe baseline data of the optimal type 2 diabetes management including benchmarking and standard treatment (OPTIMISE) study in Greece. METHODS: "Benchmarking" is the process of receiving feedback comparing one's performance with that of others. The OPTIMISE (NCT00681850) study is a multinational, multicenter study assessing, at a primary care level, whether using "benchmarking" can help to improve the quality of patient care, compared with a set of guideline-based reference values ("non-benchmarking"). In the Greek region, 797 outpatients (457 men, mean age 63.8 years) with type 2 diabetes were enrolled by 84 office-based physicians. Baseline characteristics of this population are presented. RESULTS: Hypertension was the most prevalent concomitant disorder (77.3%) and coronary heart disease was the most frequent macrovascular complication of diabetes (23.8%). Most patients were overweight or obese (body mass index 29.6 ± 5 kg/m(2)), exhibiting mostly abdominal obesity (waist circumference 102.6 ± 13.6 cm). Biguanides were the most prevalent prescribed drugs for the management of diabetes (70.1% of all prescriptions), whereas statins (93.5% of all prescriptions) and angiotensin receptor blockers (55.8% of all prescriptions) were the most prevalent prescribed drugs for hyperlipidemia and hypertension, respectively. Only 37.4% of patients were on aspirin. Despite treatment, pre-defined targets for fasting plasma glucose (< 110 mg/dL), glycated hemoglobin (< 7%), systolic blood pressure (< 130 mmHg and < 125 mmHg for patients with proteinuria) and low density lipoprotein cholesterol levels (< 100 mg/dL and < 70 mg/dL for patients with coronary heart disease) were reached in a relatively small proportion of patients (29%, 53%, 27% and 31%, respectively). In a Greek population with type 2 diabetes, the control of glycemia or concomitant disorders which increase cardiovascular risk remains poor. CONCLUSION: Despite relevant treatment, there is a poor control of diabetes, hypertension and hyperlipidemia in Greek outpatients with type 2 diabetes.

Centralized Pan-European survey on the undertreatment of hypercholesterolemia in patients using lipid lowering drugs--the CEPHEUS-Greece survey.

Surveys evaluating plasma lipid goal attainment in patients with coronary heart disease (CHD) show that hypercholesterolemia is inadequately treated. CEPHEUS (CEntralized Pan-European survey on tHE Undertreatment of hypercholeSterolemia)-Greece was part of a European multicenter, cross-sectional survey to evaluate the proportion of patients on lipid-lowering drugs (LLDs) for >or=3 months, without dose modifications for at least 6 weeks, who reach their low-density lipoprotein-cholesterol (LDL-C) target. A total of 1321 Greek patients comprised the full analysis set (FAS); 28% were smokers, while 60.7%, 35.4%, 32.1%, and 25.1% had a history of hypertension, CHD, metabolic syndrome, and diabetes mellitus, respectively; 49.7% of the study population reached the Third Joint European Task Force (TJETF) LDL-C goals and 49.3% achieved the 2004-updated National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) targets. Hypercholesterolemia is suboptimally managed in Greece, with almost 50% of patients on LLDs not reaching the LDL-C target.