Do acute coronary events affect lipid management and cholesterol goal attainment in Germany? : Results from the Dyslipidemia International study II.

OBJECTIVE: 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. METHODS: The Dyslipidemia International Study II was a multicenter, observational study of the prevalence of dyslipidemia and lipid target value attainment in patients surviving any acute coronary syndrome event. Among patients on lipid-lowering therapy for ≥3 months, use of lipid-lowering therapy and lipid profiles were assessed at admission and again at 120 ± 15 days after admission (the follow-up time point). Multivariate logistic regression was used to identify variables predictive of low-density lipoprotein cholesterol target value attainment in patients using lipid-lowering therapy. RESULTS: A total of 461 patients hospitalized for acute coronary syndrome were identified, 270 (58.6%) of whom were on lipid-lowering therapy at admission. Among patients on lipid-lowering therapy, 90.7% and 85.9% were receiving statin monotherapy at admission and follow-up, respectively. Mean (SD) low-density lipoprotein cholesterol levels in patients on lipid-lowering therapy were 101 (40) mg/dl and 95 (30) mg/dl at admission and follow-up, respectively. In patients with data at both admission and follow-up (n = 61), low-density lipoprotein cholesterol target value attainment rates were the same (19.7%) at both time points. Smoking was associated with a 77% lower likelihood of attaining the low-density lipoprotein cholesterol target value. CONCLUSION: Hospitalization for an acute event does not greatly alter lipid management in acute coronary syndrome patients in Germany. Both lipid-lowering therapy doses and rates of low-density lipoprotein cholesterol target value attainment remained essentially the same several months after the event.

Atorvastatin treatment and LDL cholesterol target attainment in patients at very high cardiovascular risk.

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.

Better lipid target achievement for secondary prevention through disease management programs for diabetes mellitus and coronary heart disease in clinical practice in Germany.

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.

Treatment patterns, risk factor control and functional capacity in patients with cardiovascular and chronic kidney disease in the cardiac rehabilitation setting.

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. 92 Watts). 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.

Lipid management in 13,000 high risk cardiovascular patients treated under daily practice conditions: LIMA Registry.

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.

Disparity in risk factor pattern in premature versus late-onset coronary artery disease: a survey of 15,381 patients.

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 (P(trend) = 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.

Treatment patterns and risk factor control in patients with and without metabolic syndrome in cardiac rehabilitation.

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.

Current state of cardiac rehabilitation in Germany: patient characteristics, risk factor management and control status, by education level.

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.

Adherence of hospital-based cardiologists to lipid guidelines in patients at high risk for cardiovascular events (2L registry).

OBJECTIVES: 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. METHODS: In the internet-based 2L registry in Germany (2005-2006), cardiologists in 42 hospitals documented at a single visit 3,131 consecutive patients with known CHD, and/or diabetes mellitus, peripheral arterial disease, or a 10-year CHD risk >20% (summarized as CE), who were on chronic statin treatment. They received instructions on the guidelines and instant feedback on the effect of their treatment decisions (educational study component). RESULTS: The three groups comprised 1,458 patients with CHD + CE (46.6%; median LDL-C 107 mg/dl), 1,104 patients with CHD only (35.3%; median LDL-C 104 mg/dl), and 569 with CE only (18.2%; median LDL-C 111 mg/dl). At admission, LDL-C levels <100 mg/dl were observed in 43.1, 44.8 and 37.9% of patients in the three groups, respectively. Statin doses at admission were usually in the low to intermediate range (e.g., simvastatin 10-20 mg/day). Cardiologists switched to another statin in 14.6%, increased the dose of statins (if same drug) in 22.9% (mean increase from 26.8 mg/day at baseline to 31.6 mg/day) and/or added a cholesterol absorption inhibitor (CAI) in 11.6%. The cardiologists' intervention improved estimated LDL-C levels (using a lipid calculator); however, the 100 mg/dl LDL-C target was only reached in 49.0, 48.5, and 42.9%. CONCLUSIONS: When compared with earlier studies in the outpatient setting, the treatment to target for LDL-C of high-risk CHD patients has improved, but is not satisfactory.

Characteristics, management and attainment of lipid target levels in diabetic and cardiac patients enrolled in Disease Management Program versus those in routine care: LUTZ registry.

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 HbA1c 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 HbA1c. Longer-term follow-up is needed to substantiate these results.

Guideline-oriented ambulatory lipid-lowering therapy of patients at high risk for cardiovascular events by cardiologists in clinical practice: the 2L cardio registry.

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.

Sustained effects in hypercholesterolaemic patients on combined simvastatin/ezetimibe treatment: observational cohort study in clinical practice.

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.

Predictors of uncontrolled hyperlipidaemia in high-risk ambulatory patients in primary care.

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.

Dual cholesterol inhibition with ezetimibe/simvastatin in pre-treated hypercholesterolaemic patients with coronary heart disease or diabetes mellitus: prospective observational cohort studies in clinical practice.

OBJECTIVE: Patients with primary hypercholesterolaemia and concomitant coronary heart disease (CHD) and/or diabetes mellitus (DM), who are at particularly high risk of cardiovascular events such as stroke or myocardial infarction, benefit from aggressive lipid lowering strategies. The present studies investigated the incremental efficacy and safety of dual cholesterol inhibition with ezetimibe/simvastatin in such high-risk patients pre-treated with statins but not reaching the 100 mg/dL (2.6 mmol/L) low density cholesterol (LDL-C) cholesterol threshold in the primary care setting. METHODS: Two open-label, prospective, non-randomised, observational studies (study 1 with n = 19 194 patients, predominantly with CHD; study 2 with n = 19 484 patients, predominantly with DM). Patients received--almost all after statin pre-treatment--ezetimibe 10 mg plus simvastatin 10 mg (study 1: 15%, study 2: 16%), 20 mg (in 68% each), 40 mg (12%/10%) or 80 mg (1%/1%) as fixed dose combinations over 3 months (dosage at investigator's discretion). RESULTS: Mean LDL-C was reduced by 28%/27% (study 1/ study 2) compared with baseline values (on statin monotherapy). Mean total cholesterol was decreased by 22% in each study, mean triglycerides by 16/17%, and mean high density cholesterol (HDL-C) was increased by 9/10%. Adverse events were reported in 0.3% and 0.2% of patients, respectively. CONCLUSION: Dual cholesterol inhibition with ezetimibe/simvastatin was effective and well tolerated under real practice conditions in high-risk patients with CHD and/or DM.

Drug utilization of ezetimibe in rehabilitation centres: registry analysis of factors influencing prescription and effectiveness of treatment.

BACKGROUND: While randomized controlled trials (RCTs) generate informative data about clinical outcomes, by their nature they cannot provide information about drug utilization and factors influencing prescribing decisions. In the secondary prevention of patients with cardiac events, lipid lowering therapy with statins and other agents, such as cholesterol absorption inhibitors (CAI, e.g. ezetimibe) plays a pivotal role and is often initiated or modified in rehabilitation centres. The aims of the present study were to analyse factors that influence the prescribing decisions of physicians, and to investigate success rates of lipid lowering therapy with ezetimibe after adjustment for covariates. METHODS: Ninety-three rehabilitation centres throughout Germany documented a total of 17029 patients in cardiac rehabilitation, of which 6976 (41.6%) were prescribed a CAI. A logistic regression model with forward selection based on 31 potential regressors for ezetimibe prescription (demographics, diagnosis, risk factors etc.) was used to construct a propensity score, which reflects the inclination of physicians to prescribe CAI. This score was subsequently used for bias reduction in the comparison of co-medications and success rates. RESULTS: Nineteen variables were associated with ezetimibe prescriptions, the most important ones being total cholesterol, level of education, unstable angina pectoris and arterial hypertension. Ezetimibe was more frequently prescribed together with simvastatin and pravastatin than with other statins, and frequently together with aspirin or beta blockers, respectively. After adjustment for baseline lipid values and covariates, the probability of target level achievement appears to be substantially higher for patients on ezetimibe than for those without ezetimibe. CONCLUSIONS: Other factors than conventional risk factors contribute to the CAI prescription habits of physicians. Additional lipid level reductions due to ezetimibe are seen in routine health care corresponding to findings from randomized studies.