Low incidence of paradoxical reductions in HDL-C levels in dyslipidemic patients treated with fenofibrate alone or in combination with ezetimibe or ezetimibe/simvastatin

<p>Abstract</p> <p>Background</p> <p>Fibrates have been reported to cause paradoxical decreases in HDL-C in certain patients.</p> <p>Design and methods</p> <p>This post-hoc analysis explored the frequency/magnitude of HDL-C reductions in a pooled database of mixed dyslipidemic patients (LDL-C:3.4-5.7 mmol/L;TG:1.7-5.7 mmol/L) receiving placebo (PBO), fenofibrate (FENO), ezetimibe plus FENO (EZE+FENO), or EZE/simvastatin plus FENO (EZE/SIMVA+FENO) for 12 weeks.</p> <p>Results</p> <p>PBO-treated patients had the highest incidence of HDL-C reductions from baseline (45%) compared with patients taking FENO (14%), EZE+FENO (9%), or EZE/SIMVA+FENO (9%). Reductions <30% reflected natural variability since the largest reduction in HDL-C approached 30% in the PBO group. Only 3 patients exhibited HDL-C reductions ≥30% (i.e., 2 patients in the FENO group and 1 in the EZE+FENO group). There were no differences in demographic/biochemical characteristics between patients with and without HDL-C reductions.</p> <p>Conclusions</p> <p>The incidence of paradoxical HDL-C reductions was low in mixed dyslipidemic patients receiving FENO alone or combined with EZE or EZE/SIMVA.</p> <p>Trial registrations</p> <p>Clinicaltrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00092560">NCT00092560</a> and <a href="http://www.clinicaltrials.gov/ct2/show/NCT00092573">NCT00092573</a></p

0188: Suboptimal control of low-density lipoprotein cholesterol in French patients after an acute coronary syndrome. Contemporary data from DYSIS IIACS study

AimTo document low-density lipoprotein cholesterol (LDL-C) values during hospitalization of ACS patients with/without lipid-lowering therapy (LLT) at admission, and achievement of the ESC LDL-C target (LDL-C≤70mg/dL) at 4 months following the acute event using data from the French cohort of the DYSIS IIACS study.MethodsDYSIS IIACS was a multicentre prospective observational cohort study (recruitment: Oct 2013 to Oct 2014) conducted in 24 coronary care units in France. Adults hospitalized for an ACS event and who had a lipid panel measured within 24 hours of admission were consecutively enrolled. Eligible patients had to be on LLT for≥3 months or taking no LLT. A telephone follow-up interview was carried out with patients (or their next of kin) 120±15 days after the index event.ResultsOf the 468 patients enrolled, 50.6% had ST-elevation myocardial infarction/left bundle branch block, 40.8% had non-ST-elevation myocardial infarction, and 8.5% had unstable angina. Of the 277 (59.2%) patients on LLT at admission, 25.3% had an LDL-C<70mg/dl (Table). Most patients (96.4%) were on statin therapy at discharge (mean+SD dose calculated in atorvastatin 49±28mg/day). Non-statin LLT was used in 5.6% patients at discharge (61.5% with a cholesterol-absorption inhibitor). At 120 days after admission, 50.9% of ACS patients with follow-up data had achieved the LDL-C target.ConclusionsThese observational data from contemporary French clinical practice in coronary care units indicate suboptimal LDL-C control, with a substantial proportion of very high cardiovascular risk patients presenting with elevated LDL-C despite taking LLT. Four months after the acute event, half of the patients (with data) failed to achieve the target, with a large difference between mean value and target LDL-C.Abstract 0188 – Table: Characteristics of and lipid values in ACS patients: during hospitalization and at 120 daysAll patients (n=468)LLT at admission (n=277)No LLT at admission (n=191)Age (years)65±1267±1261±12***Men80.178.083.2Diabetes type 221.827.413.6**Chronic kidney disease3.84.03.7Lipid variables (within 24 h of admission)LDL-C (mg/dL)110.6±43.493.6±36.4135.3±40.9***LDL<70mg/dL (%)16.925.34.7***Difference between mean and target values (mg/dL)52.1±38.337.0±32.169.3±37.5***Statin at hospital discharge96.497.594.8Lipid variables (120 days after admission)(n=159)(n=86)(n=73)LDL-C (mg/dL)76.1±31.179.7±31.171.9±30.7*LDL-C<70mg/dL50.941.961.6*Difference between mean and target values (mg/dL)29.7±25.828.0±26.532.6±24.7Data are mean±SD or %.*P<0.05**P?0.001**P?0.0001 (LLT vs no LLT

0191: Poor achievement of low-density lipoprotein cholesterol targets in French patients with stable coronary heart disease. Contemporary data from DYSIS II CHD study

AimWe sought to determine achievement of lipid targets according to current European guidelines (low-density lipoprotein cholesterol [LDL-C]≤70mg/dL) in patients with stable coronary heart disease (CHD) with or without lipid-lowering therapy (LLT), in the French cohort of the Dyslipidemia International Study IICHD (DYSIS IICHD).MethodsDYSIS IICHD was a multicentre observational cross-sectional study conducted from July 2013 to October 2014 in 27 centres in France. Adults with stable CHD (defined as≥1 of the following:>50% stenosis on coronary angiography or computed tomography, prior percutaneous coronary intervention, prior coronary bypass graft, history of ACS>3 months previously) and a fasting lipid profile done within the previous 12 months were consecutively enrolled. Eligible patients had to be on LLT for≥3 months or taking no LLT.ResultsA total of 436 CHD patients were enrolled. Of the 424 patients (97.2%) on LLT, 91.5% were on statin treatment at the moment of inclusion (mean±SD dose calculated in atorvastatin 27±23mg/day). Non-statin LLT was used in 17.7% patients (79.2% were on a cholesterol-absorption inhibitor). Mean±SD LDL-C was 87.4±30.5mg/dL, 28.4% achieved LDL-C<70mg/dL, and 67.7% had an LDL-C<100mg/dL (Table).Abstract 0191 – Table: Characteristics of lipid values in patients with stable CHDAll patients (n=436)LLT (n=424)No LLT (n=12)Age (years)69±1269±1274±12Men80.079.791.7ACS>3 months previously70.070.066.7Diabetes type 227.027.316.7Chronic kidney disease5.05.20Lipid variablesLDL-C (mg/dL)87.4±30.586.0±29.6135.3±24.5**LDL<70mg/dL28.429.20*Distance to target of<70mg/dL (mg/dL)31.1±24.229.7±23.265.3±24.5**LDL<100mg/dL67.769.38.3**Data are mean±SD or %.*P<0.05**P?0.0001 (LLT vs no LLT)ConclusionsThese observational data from contemporary clinical practice in France indicate suboptimal lipid control, with over two-thirds of high-risk CHD patients failing to achieve the LDL-C target despite taking LLT, and a large difference between mean value and target LDL-C. More-intensive treatment is required to optimize achievement of lipid goals in CHD

Ezetimibe/Simvastatin 10/20 mg versus Rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency

<p>Abstract</p> <p>Objective</p> <p>This <it>post-hoc </it>analysis compared the lipid-altering efficacy of Ezetimibe/Simvastatin 10/20 mg (EZ/Simva) versus Rosuvastatin 10 mg (Rosuva) in patients stratified by statin potency/dose prior to randomization.</p> <p>Methods</p> <p>Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite prior statin treatment (n = 618) were randomized 1:1 to EZ/Simva 10/20 mg or Rosuva 10 mg for 6 weeks. Percent change from baseline in lipids and attainment of lipid targets were assessed within each subgroup (low potency n = 369, high potency n = 249). Consistency of the treatment effect across subgroups was evaluated by testing for treatment-by-subgroup interaction. No multiplicity adjustments were made.</p> <p>Results</p> <p>Significant treatment-by-subgroup interaction occurred for LDL-C (p = 0.013), total cholesterol (p = 0.025), non-HDL-C (p = 0.032), and apolipoprotein B (p = 0.016) with greater between-treatment differences in favor of EZ/Simva observed in patients from the high potency stratum vs low potency stratum. Individual and triple target attainment was higher for Eze/Simva compared with Rosuva in both strata.</p> <p>Conclusions</p> <p>Compared with Rosuva, switching to EZ/Simva provided greater reductions in LDL-C, total cholesterol, non-HDL-C and apolipoprotein B and higher target attainment in patients on prior statin treatment, regardless of potency, although patients treated with higher potency statins prior to randomization experienced greater between treatment differences in favor of EZ/Simva.</p> <p>Trial Registration</p> <p>Registered at ClinicalTrials.gov: NCT00479713</p

Subgroup Evaluation of Ezetimibe/Simvastatin Versus Rosuvastatin

SUMMARY Aims: This post hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) or rosuvastatin 10 mg (ROSUVA) in uncontrolled high-risk hypercholesterolemic patients with/without type 2 diabetes mellitus (T2DM) despite statin monotherapy. Methods: Patients (n = 618) at high risk for coronary vascular disease with elevated LDL-C ≥100 and ≤190 mg/dL despite use of statins were randomized 1:1 to double-blind EZE/SIMVA 10/20 mg or ROSUVA 10 mg for 6 weeks. Patients were classified as having T2DM based on ≥1 of the following: diagnosis of T2DM, antidiabetic medication, or FPG ≥126 mg/dL. This analysis evaluated percent changes from baseline in lipids among patients with (n = 182) and without T2DM (n = 434). Results: EZE/SIMVA was more effective than ROSUVA at lowering LDL-C, TC, non-HDL-C, and apo B in the overall study population and within both subgroups. Numerically, greater between-treatment reductions in LDL-C, TC, non-HDL-C, and apo B were seen in patients with T2DM versus those without T2DM. A significant interaction (P= 0.015) was seen for LDL-C indicating that patients with T2DM achieved larger between-group reductions versus those without T2DM. Conclusions: Switching to EZE/SIMVA 10/20 mg versus ROSUVA 10 mg provided superior lipid reductions in patients with/without T2DM

Do Acute Coronary Events Affect Lipid Management and Cholesterol Goal Attainment in Germany?

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) lowdensity 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 followup (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

Efficacy of Ezetimibe/Simvastatin 10/20 mg Versus Rosuvastatin 10 mg in High-Risk Patients With or Without Obesity

Introduction: This post-hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) or rosuvastatin 10 mg (ROSUVA) in high-risk hypercholesterolemic patients with/without obesity. Methods: Patients (n=618) at high-risk for coronary heart disease with elevated low-density lipoprotein cholesterol (LDL-C) ≥2.59 and ≤4.92 mmol/L, while on a statin, entered a 6-week open-label stabilization/screening period during which they continued on the same statin. Patients were then randomized 1:1 to double-blind EZE/SIMVA 10/20 mg or ROSUVA 10 mg for 6 weeks. Patients were classified as non-obese (n=437) or obese (n=180) based on body mass index 0.050 for all). Conclusions: In this post-hoc analysis of high-risk patients with elevated LDL-C, despite prior use of statin therapy, switching to EZE/SIMVA 10/20 mg versus ROSUVA 10 mg provided superior reductions in LDL-C, TC, and non-HDL-C in obese and non-obese patients

Prevalence Of Potential Familial Hypercholesteremia (Fh) In 54,811 Statin-Treated Patients In Clinical Practice

Background and aims: Familial hypercholesterolemia (FH) is a life-threatening disease, characterized by elevated LDL-C levels and a premature, increased risk of coronary heart disease (CHD) that is globally underdiagnosed. The percentage of patients with possible or probable FH in various countries was examined in the Dyslipidemia International Study (DYSIS). Methods: DYSIS is a multinational, cross-sectional observational study of 54,811 adult outpatients treated with statin therapy. The percentages of patients with high levels of LDL-C, and with possible or probable FH, were assessed using the Dutch scoring method for FH across 29 countries, in age subgroups for the analysis population and among diabetes patients. Results: Despite statin therapy, 16.1% (range 4.4-27.6%) of patients had LDL-C > 3.6 mmol/L (140 mg/dL) across countries and the prevalence of possible FH was 15.0% (range 5.5-27.8%) and 1.1% (range 0.0-5.4%) for probable FH. The highest percentages of probable FH occurred in Egypt (5.4%), the Baltic states (4.2%), Russia (3.2%), and Slovenia (3.1%), with the lowest rates in Israel (0.0%), Canada (0.2%), and Sweden (0.3%). Rates of FH were the highest in younger patients (45-54 years) for secondary prevention, regardless of the presence/absence of diabetes. Conclusions: Despite statin therapy, high LDL-C levels and rates of possible and probable FH were observed in some countries. The prevalence of FH was the highest in younger age patients, and > 60% of patients with probable FH displayed CHD. Earlier diagnosis and treatment of patients with FH are needed to reduce CHD risk in these patients. (C) 2016 The Authors. Published by Elsevier Ireland Ltd

Prevalence of Lipid Abnormalities and Cholesterol Target Value Attainment in Patients with Stable and Acute Coronary Heart Disease in the United Arab Emirates

Background: Careful management of lipid abnormalities in patients with coronary heart disease (CHD) or an acute coronary syndrome (ACS) can reduce the risk of recurrent cardiovascular events. The extent of hyperlipidemia in these very high-risk patients in the United Arab Emirates (UAE), along with the treatment strategies employed, is not clear. Methods: The Dyslipidemia International Study II was a multinational observational analysis carried out from 2012 to 2014. Patients were enrolled if they had either stable CHD or an ACS. Patient characteristics, lipid levels, and use of lipid-lowering therapy (LLT) were recorded at enrollment. For the ACS patients, the LLT used during the 4 months\u27 follow-up period was documented, as were any cardiovascular events. Results: A total of 416 patients were recruited from two centers in the UAE, 216 with stable CHD and 200 hospitalized with an ACS. Comorbidities and cardiovascular risk factors were extremely common. A low-density lipoprotein cholesterol level of \u3c70 mg/dl, recommended for patients at very high cardiovascular risk, was attained by 39.3% of the LLT-treated CHD patients and 33.3% of the LLT-treated ACS patients at enrollment. The mean atorvastatin-equivalent daily statin dose was 29 ± 15 mg for the CHD patients, with 13.7% additionally using ezetimibe. For the ACS patients, the daily dosage was 23 ± 13 mg at admission, rising to 39 ± 12 mg by the end of the 4-month follow-up. The use of nonstatin agents was extremely low in this group. Conclusions: Despite LLT being widely used, hyperlipidemia was found to be prevalent in ACS and CHD patients in the UAE. Treatment strategies need to be significantly improved to reduce the rate of cardiovascular events in these very high-risk patients