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

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

Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey

Abstract Background Goal attainment of guideline-recommended low-density lipoprotein cholesterol (LDL-C) is suboptimal. Little is known about how patient factors influence physicians’ treatment decision-making in hypercholesterolemia. We examined physicians’ treatment recommendations in high-risk patients whose LDL-C remained uncontrolled despite statin monotherapy. Methods Physicians completed a questionnaire prior to randomization into period I of a two-period randomized controlled trial evaluating LDL-C goal attainment in patients whose LDL-C remained ≥100 mg/dL after 5 weeks’ treatment with atorvastatin 10 mg/day (NCT01154036). Physicians’ treatment recommendations were surveyed for two hypothetical and one real scenario: (1) LDL-C presumed near goal (between 100–105 mg/dL), (2) LDL-C presumed far from goal (~120 mg/dL), and (3) observed baseline LDL-C of enrolled patients. Prognostic factors considered during decision-making were identified by regression analysis. Observed lipid outcomes at the end of period I (following 6 weeks’ treatment with ezetimibe 10 mg plus atorvastatin 10 mg, atorvastatin 20 mg, or rosuvastatin 10 mg) were compared with estimated LDL-C outcomes for physicians’ treatment recommendations after 6 weeks (based on individual patients’ pre-randomization LDL-C and expected incremental change). Results Questionnaires were completed for 1,534 patients. No change in therapy, or double atorvastatin dose, were frequently recommended, even when LDL-C was far from goal (6.5% and 52.2% of patients, respectively). Double atorvastatin dose was commonly recommended in all scenarios (43–52% of patients). More intensive LDL-C-lowering regimens were recommended infrequently e.g. double atorvastatin dose and add ezetimibe only <12% in all scenarios. Overall, cardiovascular risk factors and desire to achieve a more aggressive LDL-C goal were prominent factors in decision-making for treatment. Comparison of observed and estimated LDL-C levels showed that physicians tended to overestimate the effectiveness of their recommendations. Conclusions This study provides insight into physicians’ perspectives on clinical management of hypercholesterolemia and highlights a gap in knowledge translation from guidelines to clinical practice. The need for lower LDL-C and cardiovascular risk were key drivers in clinical decision-making, but physicians’ treatment choices were more conservative than guideline recommendations, potentially resulting in poorer LDL-C reduction. When compared with actual outcomes, projected LDL-C control was better if physicians used more comprehensive strategies rather than simply doubling the statin dose. Trial registration Clinicaltrials.gov: NCT0115403

Attainment of cholesterol target values in Greece: Results from the Dyslipidemia International Study II

Introduction: Current European guidelines recommend treatment with lipid-lowering therapy (LLT) to a low-density lipoprotein cholesterol (LDL-C) target of &lt; 70 mg/dl for patients at very high risk. LDL-C target attainment and use of LLTs in these patients in Greece is not known. Material and methods: The Dyslipidemia International Study (DYSIS) II was a multicenter observational study. The coronary heart disease (CHD) cohort was divided into two groups based on treatment status (on LLT for ≥ 3 months or not on LLT). The acute coronary syndrome (ACS) cohort was evaluated at the time of admission and again 120 ±15 days after admission. Results: In the CHD cohort (n = 499), 457 (91.6%) patients were on LLT. The LDL-C target value was attained by 26.5% of LLT users. Statin monotherapy was used by 77.5% of treated patients, with a mean ± SD atorvastatin dose equivalent of 24 ±16 mg/day. In the ACS cohort (n = 200), 159 (79.5%) patients were on LLT at admission. Mean ± SD LDL-C levels were 108 ±40 mg/dl at admission and 86 ±25 mg/dl at follow-up. LDL-C target value attainment rates were 16.2% at admission and 25.0% at follow-up. At admission, statin monotherapy was used by 86.8% of treated patients. The mean ± SD atorvastatin dose equivalent increased from 20 ±14 mg/day at admission to 29 ±15 mg/day at follow-up. The statin dose was associated with higher odds of LDL-C target value attainment (OR = 1.05, 95% CI: 1.02–1.08). Conclusions: The LDL-C target attainment by very high risk patients in Greece is suboptimal. Increasing the statin dose or combining it with non-statins may improve target value attainment. Copyright © 2018 Termedia &amp; Banac

Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey

Background Goal attainment of guideline-recommended low-density lipoprotein cholesterol (LDL-C) is suboptimal. Little is known about how patient factors influence physicians’ treatment decision-making in hypercholesterolemia. We examined physicians’ treatment recommendations in high-risk patients whose LDL-C remained uncontrolled despite statin monotherapy. Methods Physicians completed a questionnaire prior to randomization into period I of a two-period randomized controlled trial evaluating LDL-C goal attainment in patients whose LDL-C remained ≥100 mg/dL after 5 weeks’ treatment with atorvastatin 10 mg/day NCT01154036. Physicians’ treatment recommendations were surveyed for two hypothetical and one real scenario: (1) LDL-C presumed near goal (between 100–105 mg/dL), (2) LDL-C presumed far from goal (~120 mg/dL), and (3) observed baseline LDL-C of enrolled patients. Prognostic factors considered during decision-making were identified by regression analysis. Observed lipid outcomes at the end of period I (following 6 weeks’ treatment with ezetimibe 10 mg plus atorvastatin 10 mg, atorvastatin 20 mg, or rosuvastatin 10 mg) were compared with estimated LDL-C outcomes for physicians’ treatment recommendations after 6 weeks (based on individual patients’ pre-randomization LDL-C and expected incremental change). Results Questionnaires were completed for 1,534 patients. No change in therapy, or double atorvastatin dose, were frequently recommended, even when LDL-C was far from goal (6.5% and 52.2% of patients, respectively). Double atorvastatin dose was commonly recommended in all scenarios (43–52% of patients). More intensive LDL-C-lowering regimens were recommended infrequently e.g. double atorvastatin dose and add ezetimibe only <12% in all scenarios. Overall, cardiovascular risk factors and desire to achieve a more aggressive LDL-C goal were prominent factors in decision-making for treatment. Comparison of observed and estimated LDL-C levels showed that physicians tended to overestimate the effectiveness of their recommendations. Conclusions This study provides insight into physicians’ perspectives on clinical management of hypercholesterolemia and highlights a gap in knowledge translation from guidelines to clinical practice. The need for lower LDL-C and cardiovascular risk were key drivers in clinical decision-making, but physicians’ treatment choices were more conservative than guideline recommendations, potentially resulting in poorer LDL-C reduction. When compared with actual outcomes, projected LDL-C control was better if physicians used more comprehensive strategies rather than simply doubling the statin dose