Background: Chronic cough (CC) is a common reason for a physicians visit1. Since 2020 refractory chronic cough (RCC - specific underlying condition, refractory to therapy) and unexplained chronic cough (UCC – without any detectable cause) are defined as separate entities2. Due to the absence of an ICD-10 code, the prevalence of CC, RCC/UCC in Germany is unknown Objectives: To evaluate the prevalence of CC, RCC/UCC Methods: VICHAS was a prospective observational study conducted from 01.01.-31.12.2020 in 16 outpatient respiratory care offices (RCO) in Germany. We included all patients (pts) with CC/RCC/UCC to calculate prevalence data. A stepwise extrapolation was performed: 1. Collected data from the participating sites were extrapolated to the number of CC, RCC/UCC pts in all RCOs in Germany. With the help of prescription data (asthma) conversion to absolute numbers was obtained. 2. Two different assumptions were made regarding the frequency of referral of CC pts to RCOs (14% and 43%). They provided the framework for the upper & lower limits for prevalence. 3. Prevalence calculation and estimation was performed in relation to German adult population Results: Overall 2,937 CC pts were documented, RCC/UCC: 421. Extrapolations resulted in national prevalence estimates (depending on referral assumption) for RCC/UCC: 0.49% and 1.50%; CC: 0.83% and 2.32% Limitations: COVID-19, small number of sites & pts Conclusion: The survey provides solid estimates on the prevalence of CC, RCC/UCC pts in the German adult population in clinical practice, which is lower compared to studies in other countries 1. Schappert SM, Vital Health Stat 2006,1-66 2. Kardos P, Respir Med. 2020,170:10593

To document utilization of lipid-lowering therapy, attainment of low-density lipoprotein cholesterol target values, and cardiovascular outcomes in patients hospitalized for acute coronary syndrome in Germany.

The use of atorvastatin is rapidly increasing among statins since the introduction of generics. However, only limited data are available on its current use and the effectiveness outside of randomised trials. The aim of the study was to assess low-density lipoprotein (LDL-C) levels in ambulatory patients at very high cardiovascular risk on atorvastatin therapy in physician’s offices. A total of 2625 high-risk patients on atorvastatin were included into this cross-sectional study by 539 office-based physicians between June and December 2014. 47.0 % of the patients had documented coronary heart disease (CHD), 25.1 % type 2 diabetes mellitus (DM), and 27.9 % CHD plus concomitant DM. The mean age was 66.1 ± 10.8 years, 62.1 % were male. Atorvastatin at the dose of 10, 20, 40 and 80 mg/day was administered in 15.6, 45.7, 33.9, and 4.8 % of the patients, respectively. The treatment duration was 92.6 ± 109.6 weeks. The mean atorvastatin dose at therapy start was 24.8 ± 15.2 mg/day and at time of documentation 27.9 ± 15.8 mg/day. Low-density lipoprotein cholesterol (LDL-C) <70 mg/dL was achieved by 10.5 % of the total cohort (7.5 % in DM, 9.3 % in CHD, and 15.2 % in CHD + DM). In contrast, according to physicians’ subjective assessment, 62.7 % of patients (with small differences between groups) had reached their individual LDL-C target. In summary, higher doses of atorvastatin are not frequently used in clinical practice. The LDL-C target level <70 mg/dL as recommended by current guidelines is achieved only in a minority of atorvastatin treated patients at very high cardiovascular risk.

Aims:Disease management programs (DMP) for diabetes mellitus (DM) or coronary heart disease (CHD) address the treatment of lipid disorders. The current registry aimed to compare drug utilization, lipid lowering effects and further outcomes of outpatients at high cardiovascular risk in DMP for DM or CHD compared to patients in routine care (no-DMP).Methods:This was a prospective non-interventional registry with a 1 year follow-up which enrolled consecutive patients with known DM and/or any vascular disease on simvastatin 40 mg monotherapy, to document lipid target achievement in clinical practice in Germany according to existing guidelines. Drug use (maintenance, add-on, switch, discontinuation) and other components of care were upon the discretion of the treating physician.Results:Of a total of 12,154 patients (mean age 65.8 years, 61.2% males), 3273 were in DMP CHD, 3265 in DMP DM and 1760 in DMP CHD + DM. In DMP patients compared to no-DMP patients, comorbidities/risk factors were more frequent. More patients in the DMP groups attained the target level of low density lipoprotein (LDL-C) <70 mg/dl (1.8 mmol/l) at baseline (8.5% DMP vs. 5.7% no-DMP), at 6 month (10.3% vs. 7.4%) and 12 month follow-up (10.1% vs. 7.1%). Cholesterol absorption inhibitors were added in 16% of the patients at the end of the baseline or at the follow-up visits, while statin treatment (including mean dose) remained largely unchanged. Target achievement rates were highest for all time points in the DMP CHD + DM group. With respect to limitations, this study was restricted to lipid disorders as qualifying diagnosis and simvastatin as qualifying treatment, which is a potential cause of selection bias. Information on non-pharmacological measures was not collected, and the 12-month follow-up period was relatively short.Conclusion:Patients in DMP compared to those not in DMP achieved better LDL-C lowering and higher control rates, but overall lipid target achievement rates need to be improved. Longer-term observations are needed to corroborate these findings.

Background: Chronic kidney disease (CKD) is a frequent comorbidity among elderly patients and those with cardiovascular disease. CKD carries prognostic relevance. We aimed to describe patient characteristics, risk factor management and control status of patients in cardiac rehabilitation (CR), differentiated by presence or absence of CKD.Design and methods: Data from 92,071 inpatients with adequate information to calculate glomerular filtration rate (GFR) based on the Cockcroft-Gault formula were analyzed at the beginning and the end of a 3-week CR stay. CKD was defined as estimated GFR <60 ml/min/1.73 m(2).Results: Compared with non-CKD patients, CKD patients were significantly older (72.0 versus 58.0 years) and more often had diabetes mellitus, arterial hypertension, and atherothrombotic manifestations (previous stroke, peripheral arterial disease), but fewer were current or previous smokers had a CHD family history. Exercise capacity was much lower in CKD (59 vs. 92Watts). Fewer patients with CKD were treated with percutaneous coronary intervention (PCI), but more had coronary artery bypass graft (CABG) surgery. Patients with CKD compared with non-CKD less frequently received statins, acetylsalicylic acid (ASA), clopidogrel, beta blockers, and angiotensin converting enzyme (ACE) inhibitors, and more frequently received angiotensin receptor blockers, insulin and oral anticoagulants. In CKD, mean low density lipoprotein cholesterol (LDL-C), total cholesterol, and high density lipoprotein cholesterol (HDL-C) were slightly higher at baseline, while triglycerides were substantially lower. This lipid pattern did not change at the discharge visit, but overall control rates for all described parameters (with the exception of HDL-C) were improved substantially. At discharge, systolic blood pressure (BP) was higher in CKD (124 versus 121 mmHg) and diastolic BP was lower (72 versus 74 mmHg). At discharge, 68.7% of CKD versus 71.9% of non-CKD patients had LDL-C <100 mg/dl. Physical fitness on exercise testing improved substantially in both groups. When the Modification of Diet in Renal Disease (MDRD) formula was used for CKD classification, there was no clinically relevant change in these results.Conclusion: Within a short period of 3-4 weeks, CR led to substantial improvements in key risk factors such as lipid profile, blood pressure, and physical fitness for all patients, even if CKD was present.

AIMS:We aimed to document the drug management of patients at high cardiovascular risk in daily practice, with the special focus on lipid-lowering treatment. METHODS AND RESULTS:In this prospective noninterventional study in 2387 outpatient centers throughout Germany, a total of 13,942 high-risk patients (mean age 65.7 years, 61.6% males) were treated with simvastatin 40 mg/day at entry as monotherapy. All patients were followed up for 12 months in terms of drug utilization, laboratory values, target attainment, and clinical events (including death, hospitalization, vascular events, and dialysis). Patients had coronary heart disease in 35.0%, diabetes mellitus in 24.4%, and the combination of coronary heart disease plus diabetes mellitus in 25.7%. In 21% of patients, a cholesterol absorption inhibitor was added to statin therapy at the entry visit, and in 23%, this was added at the follow up visit 6 months later. The target values for low-density lipoprotein-cholesterol (<2.6 mmol/L) were reached by 31.8% of patients at entry and by 50.0% at the end of this registry after 12 months. Mean blood pressure decreased (from 135.9/80.5 mmHg at baseline) by 3.1/1.9 mmHg after 12 months. In patients with documented diabetes, the targeted glycated hemoglobin (HbA1c <6.5%) was reached by 33.5% at baseline and by 40.0% after 12 months. Clinical events occurred in 11.7% of patients between baseline and month 6, and in 12.0% between months 6 and 12. CONCLUSION:In patients at high risk for cardiovascular events, comprehensive management under daily practice conditions leads to improvement of lipid, glucose, and blood pressure parameters. There is a need to improve secondary prevention among high-risk patients.

AIM:Metabolic syndrome (MetS) is a clustering of factors that are associated with increased cardiovascular risk. We aimed to investigate the proportion of patients with MetS in patients undergoing cardiac rehabilitation (CR), and to describe differences between patients with MetS compared to those without MetS with regard to (1) patient characteristics including demographics, risk factors, and comorbidities, (2) risk factor management including drug treatment, and (3) control status of risk factors at entry to CR and discharge from CR.METHODS:Post-hoc analysis of data from 27,904 inpatients (Transparency Registry to Objectify Guideline-Oriented Risk Factor Management registry) that underwent a CR period of about 3 weeks were analyzed descriptively in total and compared by their MetS status.RESULTS:In the total cohort, mean age was 64.3 years, (71.7% male), with no major differences between groups. Patients had been referred after a ST elevation of myocardial infarction event in 41.1% of cases, non-ST elevation of myocardial infarction in 21.8%, or angina pectoris in 16.7%. They had received a percutaneous coronary intervention in 55.1% and bypass surgery (coronary artery bypass graft) in 39.5%. Patients with MetS (n = 15,819) compared to those without MetS (n = 12,085) were less frequently males, and in terms of cardiac interventions, more often received coronary artery bypass surgery. Overall, statin use increased from 79.9% at entry to 95.0% at discharge (MetS: 79.7% to 95.2%). Patients with MetS compared to those without MetS received angiotensin converting enzyme inhibitors, angiotensin receptor blockers, oral antidiabetics, and insulin at entry and discharge more frequently, and less frequently clopidogrel and aspirin/clopidogrel combinations. Mean blood pressure was within the normal range at discharge, and did not differ substantially between groups (124/73 versus 120/72 mmHg). Overall, between entry and discharge, levels of total cholesterol, low density lipoprotein cholesterol, and triglycerides were substantially lowered, in particular in MetS patients. Thus, control rates of lipid parameters improved substantially, with the exception of high density lipoprotein cholesterol. Low density lipoprotein cholesterol rates <100 mg/dL increased from 38.7% at entry to 73.8% at discharge (MetS: from 39.4% to 74.6%) and triglycerides control rates (<150 mg/dL) from 58.1% to 70.4% (MetS: 43.7% to 62.2%). Physical fitness on exercise testing improved substantially in both groups.CONCLUSION:Patients with and without MetS benefited substantially from the participation in CR, as their lipid profile, blood pressure, and physical fitness improved. Treatment effects were similar in the two groups.

Background There are few data available regarding the specificity and modifiability of major cardiovascular (CV) risk factors in patients with premature versus (vs) late-onset coronary artery disease (CAD). This study was designed to analyze and compare these risk factors. Patients and methods Data from 15,381 consecutive patients (mean age, 62.3 ± 11.7 years; female, 33.8%) hospitalized with CAD were collected from a large-scale registry (Transparency Registry to Objectify Guideline-Oriented Risk Factor Management) and analyzed. The patients were divided into two groups, depending on age at inclusion: group 1 patients (n = 5725; mean age, 50.5 ± 7.2 years) were males aged < 55 years and females aged < 65 years; group 2 patients (n = 9656; mean age, 69.4 ± 7.4 years) were males aged > 55 years and females aged > 65 years and had a low-density lipoprotein cholesterol level of >100 mg/dL on admission to cardiac rehabilitation. Besides the conventional risk factors, lipoprotein(a) concentrations and glucose tolerance were measured facultatively. Univariate (chi-square test) and multivariate logistic regression models were used. Results Cigarette smoking (group 1 at 31.5% vs group 2 at 9.4%; P < 0.001), family history of CAD (group 1 at 43.6% vs group 2 at 26.5%; P < 0.001), and dyslipidemia (group 1 at 92.7% vs group 2 at 91.8%; P < 0.001) were dominant risk factors in the younger group. Arterial hypertension (group 1 at 71.4% vs group 2 at 87.0%; P < 0.001) and diabetes (group 1 at 23.5% vs group 2 at 30.1%; P < 0.001) were dominant risk factors in the older group. Impaired glucose tolerance and diabetes were less frequent in the younger group (Ptrend = 0.038), and identical lipoprotein(a) concentration levels of >30 mg/dL were found in both groups (8.0%; P = 0.810). Modification of lipid profile and blood pressure was more effective in the younger group (low-density lipoprotein cholesterol < 100 mg/dL: group 1 at 66.3% vs group 2 at 61.1%; systolic blood pressure < 140 mmHg: group 1 at 91.7% vs group 2 at 83.0%; P < 0.001). Conclusion CV risk factors differ markedly between premature and non-premature CAD. Cardiac rehabilitation provides an opportunity to reinforce secondary prevention after acute coronary syndrome.

Patienten mit einem erhöhten kardiovaskulären Risiko sind in der klinischen Praxis häufig. Eine umfassende Behandlung der modifizierbaren Risikofaktoren, insbesondere der Dyslipidämie, ist erforderlich. Zahlreiche Studien in der hausärztlichen Praxis haben die Diskrepanz zwischen den Empfehlungen der einschlägigen Leitlinien und der tatsächlich erreichten Therapieeinstellung herausgearbeitet. Aktuelle Daten zur Behandlungssituation von Patienten mit hohem kardiovaskulären Risiko liefert das prospektive Register LIMA, in das niedergelassene Ärzte in 2387 Praxen in Deutschland insgesamt 13942 Patienten mit koronarer Herzkrankheit (KHK), Diabetes mellitus oder peripherer arterieller Verschlusskrankheit (PAVK) einschlossen. Die Vorbehandlung mit Simvastatin 40 mg/d war ein Einschlusskriterium. Die Ärzte dokumentierten die Arzneimittelanwendung, Laborwerte (Lipide, Blutzucker), Blutdruck und klinische Ereignisse über 1 Jahr, und erhielten nach Dateneingabe Informationen über die Zielwerterreichung ihrer Patienten. Im Mittel waren die Patienten 65,7 Jahre alt, und in 61,6 % Männer. KHK wurde in 70,6 % berichtet, Diabetes mellitus in 58,2 % und PAVK bei 14,9 %. Die meisten Patienten (68 %) erhielten auch nach der Eingangsdokumentation weiterhin Simvastatin als Monotherapie; 20,6 % der Patienten erhielten zusätzlich den Cholesterinabsorptionshemmer Ezetimib in den ersten 6 Monaten, und 23.3 % der Patienten in den zweiten 6 Monaten. Die Patienten erreichten den LDL-Cholesterin-Zielwert in 31,8 % zu Beginn und in 50,0 % nach einem Jahr. Den Blutdruckzielwert < 140 /90 mmHg erreichten 65,8 % nach 1 Jahr. Von den Patienten mit Diabetes mellitus erreichten 40,0 % einen HbA1c-Wert unter 6,5 %. Klinische Ereignisse (Tod, Krankenhauseinweisung, (kardio-)vaskuläre Ereignisse, Dialyse) traten in 11,7 % der Patienten zwischen Beginn und Monat 6, und in 12,0 % zwischen Monat 7 und 12 auf. In der täglichen Praxis bleibt die umfassende Einstellung der Risikofaktoren von Patienten mit hohem kardiovaskulären Risiko eine Herausforderung. Zur Normalisierung erhöhter LDL- Cholesterinwerte wird Ezetimib zu einer bestehenden Statintherapie hinzugefügt, was die Aussichten der Patienten für die Erreichung der Zielwerte verbessert.

According to various national and international guidelines, the target LDL-C level is <100 mg/dl for patients with established coronary heart disease (CHD) or CHD risk equivalent (CE). We aimed to investigate aspects of the lipid-lowering management of patients at high cardiovascular risk in-hospital care and the achievement of target values.

Background: After the acute hospital stay, most cardiac patients in Germany are transferred for a 3-4-week period of inpatient cardiac rehabilitation. We aim to describe patient characteristics and risk factor management of cardiac rehabilitation patients with a focus on drug treatment and control status, differentiated by education level (low level, elementary school; intermediate level, secondary modern school; high level, grammar school/university).Methods: Data covering a time period between 2003 and 2008 from 68,191-hospitalized patients in cardiac rehabilitation from a large-scale registry (Transparency Registry to-Objectify-Guideline-Oriented Risk Factor Management) were analyzed descriptively. Further, a-multivariate model was applied to assess factors associated with good control of risk factors.Results: In the total cohort, patients with a manifestation of coronary artery disease (mean age 63.7 years, males 71.7%) were referred to cardiac rehabilitation after having received percutaneous coronary intervention (51.6%) or coronary bypass surgery (39.5%). Statin therapy increased from 76.3% at entry to 88.9% at discharge, and low density lipoprotein cholesterol, 100 mg/dL rates increased from 31.1% to 69.6%. Mean fasting blood glucose decreased from 108 mg/dL to 104 mg/dL, and mean exercise capacity increased from 78 W to 95 W. Age and gender did not differ by education. In contrast with patients having high education, those with low education had more diabetes, hypertension, and peripheral arterial disease, had lower exercise capacity, and received less treatment with statins and guideline-orientated therapy in general. In the multivariate model, good control was significantly more likely in men (odds ratio 1.38; 95% confidence interval 1.30-1.46), less likely in patients of higher age (0.99; 0.99-0.99), with diabetes (0.90; 0.85-0.95), or peripheral arterial disease (0.88; 0.82-0.95). Compared with a low level education, a mid level education was associated with poor control (0.94; 0.89-0.99), while high education did not have a significant effect (1.08; 0.99-1.17).Conclusion: Patients with different levels of education treated in cardiac rehabilitation did not differ relevantly in terms of demographics, but did differ in some clinical aspects. With respect to the ultimate goal of cardiac rehabilitation, ie, optimal control of risk factors, education level does not play an important role.

Background: Since 2002 the sick funds in Germany have widely implemented disease management programs (DMPs) for patients with type 2 diabetes mellitus (DM) and coronary heart disease (CHD). Little is known about the characteristics, treatment and target attainment lipid levels of these patients enrolled in DMPs compared to patients in routine care (non-DMP).Methods: In an open, non-interventional registry (LUTZ) in Germany, 6551 physicians documented 15,211 patients with DM (10,110 in DMP, 5101 in routine care) and 14,222 (6259 in DMP, 7963 in routine care) over a follow-up period of 4 months. They received the NCEP ATP III guidelines as a reminder on lipid level targets.Results: While demographic characteristics of DMP patients were similar to routine care patients, the former had higher rates of almost all cardiovascular comorbidities. Patients in DMPs received pharmacological treatment (in almost all drug classes) more often than non-DMP patients (e. g. antiplatelets: in DM 27.0% vs 23.8%; in CHD 63.0% vs. 53.6%). The same applied for educational measures (on life style changes and diet etc.). The rate of target level attainment for low density lipoprotein cholesterol (LDL-C) < 100 mg/dl was somewhat higher in DMP patients at inclusion compared to non-DMP patients (DM: 23.9% vs. 21.3%; CHD: 30.6% vs. 23.8%) and increased after 4 months (DM: 38.3% vs. 36.9%; CHD: 49.8% vs. 43.3%). Individual LDL-C target level attainment rates as assessed by the treating physicians were higher (at 4 months in DM: 59.6% vs. 56.5%; CHD: 49.8% vs 43.3%). Mean blood pressure (BP) and HbA(1c) values were slightly lowered during follow-up, without substantial differences between DMP and non-DMP patients.Conclusion: Patients with DM, and (to a greater extent) with CHD in DMPs compared to non-DMP patients in routine care have a higher burden of comorbidities, but also receive more intensive pharmacological treatment and educational measures. The present data support that the substantial additional efforts in DMPs aimed at improving outcomes resulted in quality gains for achieving target LDL-C levels, but not for BP or HbA(1c). Longer-term follow-up is needed to substantiate these results.

Background Lipid-lowering treatment has been proven to decrease the rate of cardiovascular events in high-risk patients with manifest coronary artery disease (CAD) or CAD equivalent risk profile. Current treatment guidelines recommend low-density lipoprotein-cholesterol (LDL-C) less than 100 mg/dl (optional < 70 mg/dl) as the target level for this high-risk population. Little is known about the ambulatory treatment of high-risk patients in clinical practice and the achievement of guideline recommended target values. Methods and results In the ‘2L cardio’ registry in Germany, 295 cardiologists enrolled 6711 consecutive patients with known CAD, and/or diabetes mellitus, peripheral arterial disease (summarized as ‘coronary risk equivalent’, CE), on chronic statin treatment. They recorded actual LDL-C values at entry, probable changes in therapy, and the expected LDL-C values using a lipid calculator based on an earlier observational study in a similar setting. The three groups comprised 2618 patients with CAD plus CE (39.0%; median LDL-C 112 mg/dl), 3436 patients with CAD only (51.2%; median LDL-C 108 mg/dl), and 657 with CE only (9.8%; median LDL-C 124 mg/dl). They had LDL-C levels less than 100 mg/dl in 36.2% [95% confidence intervals (CI): 34.3–38.1], 39.7% (CI: 38.0–41.4), and 27.2% (CI: 23.7–30.7), respectively. Statin doses at entry were usually in the lower to intermediate range (e.g. simvastatin median 25 mg/day). Cardiologists switched to another statin in 10.1% (9.4–10.8), increased the dose of statins (if same drug) in 22.2% (CI: 21.1–23.2) and/or added a cholesterol absorption inhibitor in 23.7% (CI: 22.7–24.7) of the patients. The cardiologists’ intervention improved expected LDL-C levels in the total cohort by a mean of 9.0 mg/dl, but the 100 mg/dl LDL-C target was only reached in 51.3% (CI: 50.0–52.5) of the total cohort. CE patients appeared undertreated in terms of antiplatelet drugs. Discussion Through infrequent increases in statin doses and mainly through add-on of a cholesterol absorption inhibitor, cardiologists improved target level attainment. Compared with earlier studies in the outpatient setting, the treatment to target for LDL-C of high-risk CAD patients has improved, but is not satisfactory.

INTRODUCTION:Diabetic patients who have suffered from an acute coronary syndrome (ACS) or have had coronary artery bypass graft (CABG) surgery are at very high risk of recurrent cardiovascular events. Their prognosis, however, can be improved if the target values for blood pressure (BP < 130/80 mmHg) or low density lipoprotein cholesterol [LDL-C < 2.6 mmol/L (100 mg/dl), optionally < 1.8 mmol/L (70 mg/dl)] are achieved. It is not known what proportion of diabetic patients receives such stringent secondary prevention measures and achieves target level attainment for BP, lipids and glucose in cardiac rehabilitation (CR).METHODS:During 2003 to 2005, 11 973 diabetic (29.7%) and 28 370 non-diabetic patients (70.3%), predominantly after ACS (74 and 80%), were included in a nationwide registry. At entry and at discharge, patient characteristics, pharmacotherapy and blood pressure, lipids and blood glucose were recorded. In a mixed model approach, temporal changes between centres and within centres, respectively, were analysed.RESULTS:At discharge, a lower proportion of diabetic patients achieved normalisation of BP (in 2005: <140/90 mmHg: 78.4 vs. 82.9% in non-diabetic patients, p < 0.001) or <130/80 mmHg (45.5 vs. 49.8%), respectively. LDL-C < 2.6 mmol/L was more frequently attained in diabetic patients (68.2 vs. 66.5%), as was LDL-C < 1.8 mmol/L (28.8 vs. 23.0%). Fasting blood glucose was not changed during the observation period, as at discharge almost a quarter of all diabetic patients exceeded the threshold value of 7.0 mmol/L (126 mg/dl). In 2005 at discharge, statin therapy was administered in 93% in both diabetics and non-diabetics, acetylic salicylic acid in 79% in diabetics vs. 80% in non-diabetic patients (clopidogrel: 41 vs. 45%).CONCLUSION:Generally there is room for improvement in the management of cardiac risk factors for both patients groups. In diabetic patients in CR at high risk for recurrent cardiac events, in recent years an improvement of the lipid profile has been observed. Hypertension and glycaemia are still not optimally addressed.

BACKGROUND:In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combination of simvastatin (SIM 10, 20, 40 or 80 mg) plus ezetimibe (EZ 10 mg).METHODS:A prospective, observational study in 512 general practices throughout Germany. From a sample of patients at moderate or high cardiovascular risk who had previously taken part in a half-year study of an SIM/EZ combination, 5485 patients were documented after 1 year of treatment (mean 58 +/- 16 weeks) with regard to lipid parameters, adverse drug reactions (ADRs) and adverse events.RESULTS:At the start of follow-up, 78.6% of patients were still on the SIM/EZ combination. At the end of follow-up, mean low density lipoprotein cholesterol (LDL-C) in patients on the combination versus those on other lipid-lowering therapy was reduced by 29.3 vs. 17.6% compared with baseline, total cholesterol by 23.1 vs. 14.5%, mean high density lipoprotein cholesterol (HDL-C) was increased by 15.9 vs. 13.4%, and mean triglycerides were reduced by 16.1 vs. 7.9%. Individual LDL-C targets were achieved by 56.6% on the SIM/EZ combination versus 35.9% on other therapy. In the long term (but not the short term), low acceptance of nutrition counselling as rated by the physician was associated with poor lipid levels. ADRs during follow-up occurred in 18 patients (0.3%; all cases non-serious), with seven cases of myalgia, and three cases each of nausea or arthralgia.CONCLUSIONS:This observational study showed that long-term therapy with the SIM/EZ combination resulted in sustained beneficial effects on serum lipids and was well-tolerated. Compared to patients with therapy discontinuations or switches, those remaining on the combination had better outcomes regarding lipid status.

OBJECTIVE:To determine (a) the proportion of patients at high risk of cardiovascular events who achieve low-density lipoprotein cholesterol (LDL-C) goals as recommended by the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, and (b) the predictors of poor LDL-C control.METHODS:Two open-label, prospective, non-randomised, observational studies (study 1 with n=19 194 patients, predominantly with coronary artery disease (CHD); study 2 with n=19 484 patients, pre-dominantly with diabetes mellitus (DM)). Patients received, usually after statin pretreatment, ezetimibe 10 mg plus simvastatin as fixed-dose combinations over 3 months. Bivariate and multivariate regression analysis was performed to identify factors associated with poor LDL-C control.RESULTS:At study end, 38% (up from 4.7% at baseline) of CHD and 35% (up from 3.3% at baseline) of diabetic patients achieved the target LDL value <100 mg/dl (2.6 mmol/l) after treatment with a fixed-dose ezetimibe-simvastatin combination. In both studies, concomitant atherosclerotic disease was associated with good control. Conversely, factors associated with poor control were, among others, high baseline LDL-C values, pretreatment with certain statins, and (in the DM study) high HbA(1c), and high body mass index.CONCLUSION:Under real world, general practice conditions, a substantial proportion of high-risk patients with CHD and/or DM met LDL-C target levels on dual cholesterol inhibition with ezetimibe/simvastatin. A limited number of easily recognisable factors allow physicians to identify high risk patients whose LDL-C is likely to be difficult to control. Early identification of this patient group may have profound clinical benefits in general practice by enabling specific early interventions such as counselling on physical activity, dietary support and/or follow up visits to the GP.