Management of the COVID-19 pandemic in Rhineland-Palatinate hospitals of all levels of care : Results of the COVID-19 Registry RLP.

The COVID-19 pandemic placed a significant burden on the German healthcare system. Based on the experience of severe disease progression of the SARS-CoV­2 infection from neighboring European countries in the early 2020s, with ICU overload and high mortality rates, efforts were made in Germany to increase the capacity of available ICU beds. Subsequently, all documentation and reporting focused on the ICU capacities for COVID-19 patients. It was hypothesized that mainly a few large hospitals provided care for the majority of COVID-19 patients. The COVID-19 Registry RLP of Rhineland-Palatinate documented SARS-CoV­2 inpatients from daily mandatory queries of all hospitals throughout the pandemic from April 2020 to March 2023, distinguishing between patients in ICUs and normal wards. In its 18th Corona Ordinance, the state government required all hospitals to participate in the care of SARS-CoV­2 inpatients. We investigated the participation of hospitals at different levels of care in Rhineland-Palatinate in the management of the COVID-19 pandemic. Nine pandemic waves were documented during the pandemic and exemplary data on the respective pandemic peaks were evaluated. A distinction was made between the burden on hospitals at different levels of care: primary care hospitals, standard care hospitals, specialty hospitals, and maximal care hospitals. Analysis of the data showed that all hospital types participated equally in the care of SARS-CoV-2 patients. The requirement of the Ministry of Health of Rhineland-Palatinate to provide at least 20% of the available capacity was met by all levels of care and there were no disparities between hospitals of different levels of care in the management of the pandemic.Hospitals at all levels of care participated equally in the care of SARS-CoV­2 inpatients and thus contributed significantly to the management of the pandemic in Rhineland-Palatinate.

Low-Density Lipoprotein Cholesterol Target Attainment in Patients Surviving an Acute Coronary Syndrome in Thailand: Results From the Dyslipidaemia International Study (DYSIS) II.

BACKGROUND: Patients suffering an acute coronary syndrome (ACS) are at increased risk for future cardiovascular events. Effective management of hyperlipidaemia in such patients is essential. We aimed to document the use of lipid-lowering therapy (LLT) and low-density lipoprotein cholesterol (LDL-C) target achievement in patients hospitalised with an ACS in Thailand. METHODS: The Dyslipidemia International Study (DYSIS) II was a multinational, observational study that enrolled patients over 18 years of age who were hospitalised with an ACS in 2013-2014 and survived until discharge. Patients were analysed according to whether or not they were treated with LLT prior to hospital admission. A lipid profile was carried forward from blood taken within the first 24 hours after admission, and attainment of the LDL-C target of <70 mg/dL (1.8 mmol/L) for very high-risk subjects was reported. Details of LLTs were collected. Lipid levels, LLT use and cardiovascular events since discharge were collected at a follow-up interview 4 months later. RESULTS: A total of 320 ACS patients were enrolled from seven sites across Thailand, 188 (58.8%) of whom were being treated with LLT prior to the acute event. The mean LDL-C levels of the LLT and no LLT patients were 106.2 ± 39.4 mg/dL (2.75 ± 1.02 mmol/L) and 139.8 ± 46.6 mg/dL (3.62 ± 1.21), respectively, with 15.4% and 4.5% having an LDL-C level below 70 mg/dL (1.8 mmol/L). Lipid-lowering therapy consisted mainly of statins, with an atorvastatin-equivalent daily dosage of 17 ± 13 mg/day. At the 4-month follow-up, LDL-C target attainment remained low at 26.7% for the initial LLT group and 24.1% for the no LLT group. Although most patients were being treated with LLT at this point, the dosage was still low (28 ± 16 mg/day) and there was little use of combination therapy. CONCLUSION: In this cohort of Thai ACS patients, LDL-C levels were highly elevated, placing them at extreme risk of recurrent adverse cardiovascular events. Lipid-lowering therapy was widely used after the ACS; however, treatment was rarely optimised. Huge improvements are required in the management of hyperlipidaemia in Thailand.

Comparison of quality of life measurements: EQ-5D-5L versus disease/treatment-specific measures in pulmonary embolism and deep vein thrombosis.

INTRODUCTION: There is a lack of performance comparisons of the generic quality of life tool EQ-5D-5L against disease- and treatment-specific measures in venous thromboembolism (VTE). The aim of this study was to compare EQ-5D-5L against the pulmonary embolism (PE)-specific PEmb-QoL and the deep vein thrombosis (DVT)-specific VEINES-QOL/Sym, and PACT-Q2 (treatment-specific) questionnaires in five language settings. METHODS: PREFER in VTE was a non-interventional disease registry conducted between 2013 and 2014 in primary and secondary care across seven European countries with five languages, including English, French, German, Italian and Spanish. Consecutive patients with acute PE/DVT were enrolled and followed over 12 months. Only patients who completed all three questionnaires at baseline were included in the study sample. The psychometric properties examined included acceptability (missing, ceiling and floor effects), validity (convergent and known-groups validity), and responsiveness. Known groups validity and responsiveness were assessed using both effect size (Cohen's d) and relative efficiency (F-statistic). All analyses were conducted in each language version and the total sample across all languages. RESULTS: A total of 1054 PE and 1537 DVT patients were included. 14% of PE and 10% of DVT patients had the maximum EQ-5D-5L index score. EQ-5D-5L was low to moderately correlated with other measures (r < 0.5). EQ-5D-5L was associated with larger effect size/relative efficiency in most of known group comparisons in both VTE groups. Similar results were observed for responsiveness. EQ-5D-5L performed relatively better in French, Italian and Spanish language versions. CONCLUSION: Overall EQ-5D-5L is comparable to PEmb-QoL, VEINES-QOL/Sym and PACT-Q2 in terms of acceptability, validity and responsiveness in both PE and DVT populations in English, French, German, Italian and Spanish language version. Nevertheless, it should be noted that each measure is designed to capture different aspects of health-related quality of life.

Individualised treatment targets in patients with type-2 diabetes and hypertension.

AIM: Patients with type-2 diabetes mellitus (T2DM) are at high risk of cardiovascular events, accentuated in the presence of hypertension. At present, it is unclear to what extent the guidelines for the management of T2DM, advocating reduction in HbA1c levels to below target levels, are being adhered to in clinical practice. METHODS: DIALOGUE was a prospective, observational, non-interventional registry performed across multiple centres in Germany. Patients aged 18 years or older who had T2DM and hypertension for whom the treating physician considered blood glucose lowering medication as inadequate and/or not safe/tolerable and chose to add a further oral drug or switch drug treatment were included. Patients were assigned a treatment target HbA1c value (≤ 6.5% [strict]; > 6.5 to ≤ 7.0% [intermediate]; > 7.0 to ≤ 7.5% [lenient]). RESULTS: 8568 patients with T2DM and hypertension were enrolled. 6691 (78.1%) had 12-month follow-up. Patients who were assigned a strict HbA1c treatment target (n = 2644) were younger, had shorter diabetes duration, and less comorbidity in comparison to those with intermediate (n = 2912) or lenient targets (n = 1135). Only 53.1% of patients achieved their HbA1c treatment target (46.2% [strict], 56.8% [intermediate], 59.4% [lenient]). There was little sign of treatment intensification for patients that had not achieved their HbA1c target. CONCLUSIONS: Achievement of treatment targets was poor, leaving many patients with sub-optimal blood glucose levels. The apparent reluctance of physicians to intensify antidiabetic drug therapy is alarming, especially considering the evidence pointing to an association of hyperglycaemia and microvascular complications in patients with T2DM.

Body mass index impacts the choice of lipid-lowering treatment with no correlation to blood cholesterol - Findings from 52 916 patients in the Dyslipidemia International Study (DYSIS).

A high body mass index (BMI) is associated with increased cardiovascular risk. We sought to identify whether BMI influences the choice of lipid-lowering treatment in a large, real-world cohort of 52 916 patients treated with statins. The Dyslipidemia International Study (DYSIS) is a cross-sectional, observational, multicentre study in statin-treated patients ≥45 years of age from 30 countries; 1.1% were underweight (BMI < 18.5 kg/m2 ), 33.1% had normal weight (BMI 18.5-24.9 kg/m2 ), 41.5% were overweight (BMI 25-29.9 kg/m2 ), 17.1% had class I obesity (BMI 30.0-34.9 kg/m2 ), 5.0% had class II obesity (BMI 35-39.9 kg/m2 ), and 2.1% had class III obesity (≥40 kg/m2 ). BMI correlated with high-density lipoprotein cholesterol (HDL-C) and triglycerides (Spearman's ρ: -0.147 and 0.170, respectively; P < 0.0001 for both); however, there was no correlation with low-density lipoprotein cholesterol (LDL-C; ρ: 0.003; P = 0.51). Statin intensity increased with increasing BMI (ρ: 0.13; P < 0.001), an association that held after adjustment for comorbidities (OR: 2.4; 95% CI: 2.0-3.0) on BMI ≥ 30 kg/m2 for atorvastatin equivalent ≥40 mg/d.

Azilsartan compared to ACE inhibitors in anti-hypertensive therapy: one-year outcomes of the observational EARLY registry.

BACKGROUND: Azilsartan medoxomil (AZL-M), has been demonstrated to be more effective than the other sartans currently in use; however, there is insufficient information available comparing it with ACE-inhibitors. Therefore, we aimed to compare the efficacy, safety, and tolerability of AZL-M with that of ACE-inhibitors in a real life clinical setting. METHODS: The EARLY registry is a prospective, observational, national, multicentre registry with a follow-up period of 12 months. There were two principal objectives: 1) documentation of the achievement of target BP values set according to recent national and international guidelines, and 2) description of the safety profile of AZL-M. RESULTS: A total of 3 849 patients with essential arterial hypertension were recruited from primary care offices in Germany. Patients who initiated monotherapy at baseline comprising either AZL-M or an ACE-inhibitor were included at a ratio of seven to three. Results demonstrated that a blood pressure target of <140/90 mmHg was achieved by a significantly greater proportion of patients in the AZL-M group (61.1 %) compared with the ACE-inhibitor group (56.4 %; p < 0.05; OR, 1.21; 95 % CI, 1.03-1.42), with this finding maintained after adjusting for differences in baseline characteristics. AZL-M appeared to have an equivalent safety profile to the ACE-inhibitors, with a similar incidence of adverse events in the two patient groups (p = 0.73). CONCLUSIONS: These data add to the results of previous randomized controlled clinical trials suggesting that, compared with other agents that target the renin-angiotensin system, AZL-M provides statistically significant albeit small improvements in blood pressure control.

Use and outcome of thrombus aspiration in patients with primary PCI for acute ST-elevation myocardial infarction: results from the multinational Euro Heart Survey PCI Registry.

The clinical benefit of thrombus aspiration (TA) in patients presenting with acute ST-elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) is not well defined. Furthermore, there is a large variation in the use of TA in real-world registries. Between 2005 and 2008, a total of 7146 consecutive patients with acute STEMI undergoing primary PCI were prospectively enrolled into the PCI Registry of the Euro Heart Survey Programme. For the present analysis, patients treated additionally with TA (n = 897, 12.6 %) were compared with those without TA (n = 6249, 87.4 %). Patients with hemodynamic instability at initial presentation (15.1 vs. 11.0 %; p < 0.001) and resuscitation prior to PCI (10.4 vs. 7.4 %; p = 0.002) were more frequently treated with TA. TIMI flow grade 0/1 before PCI was more often found among those with TA (73.5 vs. 58.6 %; p < 0.001). After adjustment for confounding factors in the propensity score analysis, TA was not associated with improved in-hospital survival (risk difference -1.1 %, 95 % confidence interval -2.7 to 0.6 %). In this European real-world registry, the rate of TA use was low. Hemodynamically unstable patients were more likely to be treated with TA. Consistent with the results of the TASTE study and the TOTAL trial, TA was not associated with a significant reduction in short-term mortality.

A real world comparison of sulfonylurea and insulin vs. incretin-based treatments in patients not controlled on prior metformin monotherapy.

AIMS: Metformin is the first line drug for patients diagnosed with type-2 diabetes; however, the impact of different treatment escalation strategies after metformin failure has thus far not been investigated in a real world situation. The registry described herein goes some way to clarifying treatment outcomes in such patients. METHODS: DiaRegis is a multicentre registry including 3,810 patients with type-2 diabetes. For the present analysis we selected patients being treated with metformin monotherapy at baseline (n = 1,373), with the subsequent addition of incretin-based drugs (Met/Incr; n = 783), sulfonylureas (Met/SU; n = 255), or insulin (n = 220). RESULTS: After two years 1,110 of the initial 1,373 patients had a complete follow-up (80.8%) and 726 of these were still on the initial treatment combination (65.4%). After treatment escalation, compared to Met/Incr (n = 421), Met/SU (n = 154) therapy resulted in a higher HbA1c reduction vs. baseline (-0.6 ± 1.4% vs. -0.5 ± 1.0%; p = 0.039). Insulin (n = 151) resulted in a stronger reduction in HbA1c (-0.9 ± 2.0% vs. -0.5 ± 1.0%; p = 0.003), and fasting plasma glucose (-24 ± 70 mg/dl vs. -19 ± 42 mg/dl; p = 0.001), but was associated with increased bodyweight (0.8 ± 9.0 kg vs. -1.5 ± 5.0 kg; p = 0.028). Hypoglycaemia rates (any with or without help and symptoms) were higher for patients receiving insulin (Odds Ratio [OR] 8.35; 95% Confidence Interval [CI] 4.84-14.4) and Met/SU (OR 2.70; 95% CI 1.48-4.92) versus Met/Incr. While there was little difference in event rates between Met/Incr and Met/SU, insulin was associated with higher rates of death, major cardiac and cerebrovascular events, and microvascular disease. CONCLUSIONS: Taking the results of DiaRegis into consideration it can be concluded that incretin-based treatment strategies appear to have a favourable balance between glycemic control and treatment emergent adverse effects.

The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry.

BACKGROUND: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. METHODS/DESIGN: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. RESULTS: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. CONCLUSION: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice. TRIAL REGISTRATION: Registered in DRKS register, ID number: DRKS00004795.

Achievement of individualized treatment targets in patients with comorbid type-2 diabetes and hypertension: 6 months results of the DIALOGUE registry.

BACKGROUND: Patients with type-2 diabetes mellitus (T2DM) and hypertension have increased risk of cardiovascular disease (CVD). We studied individualized treatment targets and their achievement in clinical practice. METHODS: DIALOGUE is a prospective, multi-center registry in patients with both T2DM and hypertension. RESULTS: Patients (n = 6,586) had a baseline fasting glucose (8.5 ± 2.8 mmol/l), postprandial glucose (10.9 ± 3.4 mmol/l), and HbA1c (7.8 ± 2.1%) levels indicated poor glycemic control. Baseline systolic and diastolic BP were 140.3 ± 15.7 and 82.6 ± 9.5, respectively. Patients were categorized by HbA1c treatment goals: ≤6.5% (strict), >6.5 to ≤7.0% (medium), and >7.0 to ≤7.5% (loose). When considering systolic BP (SBP) targets (≤130 mmHg [strict], >130 to ≤135 mmHg [medium], and >135 to ≤140 mmHg [loose]), patients with strict SBP treatment goals displayed similar characteristics to those with strict HbA1c targets. Although approximately 70% of patients received both strict HbA1c and SBP targeting, overall treatment goals remained unmet in all HbA1c target groups at the 6-month follow-up. SBP targets were not reached in the strict and medium groups, but were achieved in the loose treatment group. Specific predictors for choosing loose SBP or HbA1c treatment goals were identified, including SBP/HbA1c levels and various comorbidities. CONCLUSIONS: Individualized glucose and BP targets were selected by treating physicians based on patient characteristics and overall comorbidity. While treatment goals were not consistently met using various antidiabetic and antihypertensive therapies, our analyses indicated that the strictly targeted patient populations maintained lower overall HbA1c and SBP levels at 6 months.

Clinical course and outcomes of type-2 diabetic patients after treatment intensification for insufficient glycaemic control - results of the 2 year prospective DiaRegis follow-up.

BACKGROUND: In cases where antidiabetic monotherapy is unable to sufficiently control glucose levels in patients with type-2 diabetes, treatment needs to be intensified. Determining factors that may be predictors for the occurrence of comorbidities in these patients is essential for improving the efficacy of clinical diabetes care. METHODS: The DiaRegis prospective cohort study included 3,810 type-2 diabetics for whom the treating physician aimed to intensify and optimise antidiabetic treatment due to insufficient glucose control. Treatment intensification was defined as increasing the dose of the originally prescribed drug, and/or selecting an alternative drug, and/or prescribing an additional drug. The aims were to monitor the co-morbidity burden of type-2 diabetic patients over a follow-up of two years, and to identify multivariable adjusted predictors for the development of comorbidity and cardiovascular events. RESULTS: A total of 3,058 patients completed the 2 year follow-up. A substantial proportion of these patients had co-morbidities such as vascular disease, neuropathy, and heart failure at baseline. After treatment intensification, there was an increased use of DPP-4 inhibitors, insulin, and GLP-1 analogues, achieving reductions in HbA1c, fasting plasma glucose, and postprandial glucose. During the 2 year period 2.5% of patients (n = 75) died, 3.2% experienced non-fatal macrovascular events, 11.9% experienced microvascular events, and 4.3% suffered onset of heart failure. Predictors for combined macro-/microvascular complications/heart failure/death were found to be age (OR 1.36; 95% CI 1.10-1.68), prior vascular disease (1.73; 1.39-2.16), and history of heart failure (2.78; 2.10-3.68). CONCLUSIONS: Determining the factors that contribute to co-morbidities during intensive glucose-lowering treatment is essential for improving the efficacy of diabetes care. Our results indicate that age, prior vascular disease, and heart failure constitute important predictors of poor cardiovascular outcomes in patients receiving such therapy.

Co-morbidity but not dysglycaemia reduces quality of life in patients with type-2 diabetes treated with oral mono- or dual combination therapy--an analysis of the DiaRegis registry.

BACKGROUND: Type-2 diabetes mellitus has a major impact on health related quality of life (HRQoL). We aimed to identify patient and treatment related variables having a major impact. METHODS: DiaRegis is a prospective diabetes registry. The EQ-5D was used to describe differences in HRQoL at baseline. Odds ratios (OR) with 95% confidence intervals (CI) were determined from univariable regression analysis. For the identification of independent predictors of a low score on the EQ-5D, multivariable unconditional logistic regression analysis was performed. RESULTS: A total of 2,760 patients were available for the present analysis (46.7% female, median age 66.2 years). Patients had considerable co-morbidity (18.3% coronary artery disease, 10.6% heart failure, 5.9% PAD and 5.0% stroke/TIA). Baseline HbA1c was 7.4%, fasting- and postprandial plasma glucose 139 mg/dl and 183 mg/dl.The median EQ-5D was 0.9 (interquartile range [IQR] 0.8-1.0). Independent predictors for a low EQ-5D were age > 66 years (OR 1.49; 95%CI 1.08-2.06), female gender (2.11; 1.55-2.86), hypertension (1.73; 1.03-2.93), peripheral neuropathy (1.62; 0.93-2.84) and clinically relevant depression (11.01; 3.97-30.50). There was no influence of dysglycaemia on the EQ-5D score. CONCLUSION: The present study suggests, that co-morbidity but not average glycaemic control reduces health related quality of life in type 2 diabetes mellitus.

The role of co-morbidity in the selection of antidiabetic pharmacotherapy in type-2 diabetes.

Metformin is, if not contraindicated and if tolerated, usually preferred over other antidiabetic drugs for the first line treatment of type-2 diabetes. The particular decision on which antidiabetic agent to use is based on variables such as efficacy, cost, potential side effects, effects on weight, comorbidities, hypoglycemia, risk, and patient preferences. However, there is no guidance how to consider these in the selection of antidiabetic drug treatment. In this work, we aimed to summarize available evidence and tried to give pragmatic treatment recommendations from a clinical practice perspective.There are clear contraindications for some drugs in those with impaired renal and liver function and precautions in those with heart failure for the use of metformin (NYHA III-IV) and glitazones. On the other hand, GLP-1 analogs, DPP-4 inhibitors and acarbose are generally less critical and can be used in the majority of patients. We identified the following gaps with respect to the selection of antidiabetic drug treatment in patients with co-morbid disease conditions: 1) Guidelines fail to give advice on the use of specific antidiabetic drugs in patients with co-morbidity. 2) The literature is deficient in studies documenting antidiabetic drug use in patients with severely impaired renal function, diabetic retinopathy, cerebrovascular disease and systolic heart failure. 3) Further there are no specific data on patients with multiple of these co-morbid disease conditions. We postulate that differential use of antidiabetic drugs in patients with co-morbid disease constellations will help to reduce treatment related complications and might improve prognosis.

EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy--rationale and design of the EARLY hypertension registry.

BACKGROUND: Arterial hypertension is highly prevalent but poorly controlled. Blood pressure (BP) reduction substantially reduces cardiovascular morbidity and mortality. Recent randomized, double-blind clinical trials demonstrated that azilsartan medoxomil (AZM) is more effective in reducing BP than the ubiquitary ACE inhibitor ramipril. Therefore, we aimed to test whether these can be verified under clinical practice conditions. METHODS/DESIGN: The "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry is a prospective, observational, national, multicenter registry with a follow-up of up to 12 months. It will include up to 5000 patients on AZM or ACE-inhibitor monotherapy in a ratio of 7 to 3. A subgroup of patients will undergo 24-hour BP monitoring. EARLY has two co-primary objectives: 1) Description of the safety profile of azilsartan and 2) achievement of BP targets based on recent national and international guidelines for patients treated with azilsartan in comparison to those treated with ACE-inhibitors. The most important secondary endpoints are the determination of persistence with treatment and the documentation of cardiovascular and renal events. Recruitment commenced in January 2012 and will be completed by February 2013. CONCLUSIONS: The data obtained will supplement previous results from randomized controlled trials to document the potential value of utilizing azilsartan medoxomil in comparison to ACE-inhibitor treatment for target BP achievement in clinical practice.

Hypercholesterolemia diagnosis, treatment patterns and target achievement in patients with acute coronary syndromes in Germany.

BACKGROUND: Patients who experience an acute coronary syndrome (ACS) are at high risk of further cardiovascular events. Long-term treatment of cardiovascular risk factors, such as hyperlipidemia, is critical to prevent progression of coronary heart disease. However, many patients do not reach recommended target levels for low-density lipoprotein (LDL) cholesterol, despite receiving lipid-lowering therapy. OBJECTIVE: To obtain an insight into the current treatment situation for very high-risk patients after an initial ACS in Germany. METHODS: The multicenter HYDRA-ACS registry study was initiated to document the clinical characteristics of very high-risk patients with ACS and hyperlipidemia in clinical practice. In addition, lipid profiles, lipid-lowering therapy, and lipid target achievement during treatment were documented over 1 year. RESULTS: 353 patients who were documented had a mean age of 57.3 years, mean body mass index was 28.6 kg/m2, and 73.4% were male; 52.4% had a family history of myocardial infarction (MI) and 32.6% a family history of coronary heart disease (CHD). Patients' medical histories commonly included CHD (32.9%), percutaneous coronary intervention (PCI; 25.5%), and previous ACS (23.0%). Common comorbidities included hypertension (68.6%), diabetes (17.3%), heart failure (16.7%), and stable angina pectoris (15.9%). The proportion of patients receiving lipid-lowering therapy increased from 65.7% at baseline to 100% at the 12-month follow-up (p < 0.0001). Substantial increases in use were seen for statins (85.0% vs. 36.5%, p = 0.0002) and cholesterol resorption inhibitors (32.9% vs. 8.6%, p = 0.0003). Use of combination therapy increased. The proportion of patients undertaking physical exercise increased (p < 0.0001), as did consumption of fruit and vegetables (p = 0.0222) and fish (p = 0.0162), while alcohol consumption decreased (p = 0.0019). Median LDL cholesterol level decreased significantly from baseline (87 vs. 166 mg/dL, p < 0.0001), and the proportion of patients with a level < 70 mg/dL increased (50.0% vs. 5.7%, p < 0.0001). Median HDL cholesterol increased (47 vs. 45 mg/dL, p = 0.0235) and median triglyceride level decreased (119 vs. 148 mg/dL, p = 0.0080). The proportion of patients receiving antihypertensive drugs and platelet aggregation inhibitors increased. The most frequent cardiovascular events during the 12-month follow-up were PCI (25.9%) and cardiac catheterization without PCI (12.9%); MI occurred in 2.4% of patients; no deaths were reported. CONCLUSIONS: This study provides a contemporary picture of the treatment of hyperlipidemia after ACS in patients in Germany. Despite treatment with lipid-lowering therapy, many patients did not achieve recommended lipid targets by 12 months after an ACS event.

Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice - study rationale and protocol of DIALOGUE.

BACKGROUND: Patients with type 2 diabetes have 2-4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD. METHODS: DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1) individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2) individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE) and the rate of hospitalizations are the most important. CONCLUSION: The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti-diabetic and anti-hypertensive drugs in clinical trials and their real world balance of effectiveness and safety.

Oral antidiabetic treatment in type-2 diabetes in the elderly: balancing the need for glucose control and the risk of hypoglycemia.

BACKGROUND: We aimed at identifying variables predicting hypoglycemia in elderly type 2 diabetic patients and the relation to HbA1c values achieved. DESIGN: Prospective, observational registry in 3810 patients in primary care. Comparison of patients in different age tertiles: with an age < 60 (young, n=1,253), age 60 to < 70 (middle aged, n=1,184) to those ≥ 70 years (elderly, n=1,373). Odds Ratios (OR) with 95% confidence intervals (CI) were determined from univariable and multivariable regression analyses. RESULTS: Elderly patients had a later diabetes diagnosis, a longer diabetes duration, better glucose control and more frequent co-morbid disease conditions. Overall 10.7% of patients experienced any severity hypoglycemia within the last 12 months prior to inclusion. Higher rates of hypoglycemia were observed in the elderly than in the young after adjusting for differences in HbA1c, fasting and post-prandial blood glucose (OR 1.68; 95%CI 1.16-2.45). This was particularly true for hypoglycemic episodes without specific symptoms (OR 1.74; 95%CI 1.05-2.89). In a multivariate model stroke / transitory ischemic attack, the presence of heart failure, clinically relevant depression, sulfonylurea use and blood glucose self-measurement were associated with hypoglycemic events. CONCLUSION: Elderly patients are at an increased risk of hypoglycemia even at comparable glycemic control. Therefore identified variables associated with hypoglycemia in the elderly such as heart failure, clinically relevant depression, the use of sulfonylurea help to optimize the balance between glucose control and low levels of hypoglycemia. Asymptomatic hypoglycemia should not be disregarded as irrelevant but considered as a sign of possible hypoglycemia associated autonomic failure.

Incidence and predictors of hypoglycaemia in type 2 diabetes - an analysis of the prospective DiaRegis registry.

BACKGROUND: Hypoglycaemia is a serious adverse effect of antidiabetic drug therapy. We aimed to determine incidence rates of hypoglycaemia in type-2 diabetic patients and identify predictors of hypoglycaemia when treatment is intensified. METHODS: DiaRegis is a prospective German registry that follows 3810 patients with type-2 diabetes referred for treatment intensification because of insufficient glycaemic control on one or two oral antidiabetic drugs. RESULTS: Out of a total of 3347 patients with data available for the present analysis 473 (14.1%) presented any severity hypoglycaemia over a follow-up of 12 months. 0.4% were hospitalized (mean of 1.3±0.6 episodes), 0.1% needed medical assistance (1.0±0.0), 0.8% needed any help (1.1±0.5) and 10.1% no help (3.4±3.7), and 8.0% had no specific symptoms (3.6±3.5). Patients with incident hypoglycaemia had longer diabetes duration, higher HbA1c and a more frequent smoking history; more had co-morbid disease conditions such as coronary artery disease, peripheral arterial disease, amputation, heart failure, peripheral neuropathy, diabetic retinopathy and clinically relevant depression at baseline. Multivariable adjusted positive predictors of incident hypoglycaemia over the follow-up were prior anamnestic hypoglycaemia, retinopathy, depression, insulin use and blood glucose self-measurement, but not sulfonylurea use as previously reported for anamnestic or recalled hypogylcaemia. On the contrary, glitazones, DPP-4 inhibitors and GLP-1 analogues were associated with a reduced risk of hypoglycaemia. CONCLUSIONS: Hypoglycaemia is a frequent adverse effect in ambulatory patients when antidiabetic treatment is intensified. Particular attention is warranted in patients with prior episodes of hypoglycaemia, microvascular disease such as retinopathy and in patients receiving insulin. On the other hand glitazones, DPP-4 inhibitors and GLP-1 analogues are associated with a reduced risk.