Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatinEvan Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio 45229, USA
Am Heart J 148:447-55. 2004
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- Safety of rosuvastatin
James Shepherd
Department of Vascular Biochemistry, University of Glasgow, Glasgow, Scotland
Am J Cardiol 94:882-8. 2004
..Rosuvastatin was well tolerated by a broad range of patients who had dyslipidemia, and its safety profile was similar to those of the comparator statins investigated in this extensive clinical program...
- Are LDL subclass measurements clinically relevant?
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45229, USA
Nat Clin Pract Endocrinol Metab 2:120-1. 2006
Effect of a monoclonal antibody to PCSK9 on LDL cholesterolEvan A Stein
Metabolic and Atherosclerosis Research Center, 4685 Forest Ave, Cincinnati, OH 45212, USA
N Engl J Med 366:1108-18. 2012
..We report three phase 1 studies of a monoclonal antibody to PCSK9 designated as REGN727/SAR236553 (REGN727)...
- Potential of proprotein convertase subtilisin/kexin type 9 based therapeutics
Evan A Stein
Metabolic and Atherosclerosis Research Center and Medpace Reference Laboratories, 5355 Medpace Way, Cincinnati, OH, USA
Curr Atheroscler Rep 15:310. 2013
..Larger and much longer phase 3 trials are now in progress to assess the long-term tolerability, safety, and impact on cardiovascular disease events of these very effective LDLc lowering compounds...
- Low-density lipoprotein cholesterol-lowering effects of AMG 145, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease in patients with heterozygous familial hypercholesterolemia: the Reduction of LDL-C with PCSK9 Inhibiti
Frederick Raal
Carbohydrate and Lipid Metabolism Research Unit, Division of Endocrinology and Metabolism, Department of Medicine, University of the Witwatersrand, Johannesburg, South Africa
Circulation 126:2408-17. 2012
..This phase 2, multicenter, double-blind, randomized, placebo-controlled, dose-ranging study evaluated the efficacy and safety of AMG 145 in heterozygous familial hypercholesterolemia patients...
- Apolipoprotein B synthesis inhibition with mipomersen in heterozygous familial hypercholesterolemia: results of a randomized, double-blind, placebo-controlled trial to assess efficacy and safety as add-on therapy in patients with coronary artery disease
Evan A Stein
Metabolic and Atherosclerosis Research Center, 5355 Medpace Way, Cincinnati, OH 45227, USA
Circulation 126:2283-92. 2012
..We evaluated mipomersen, an apolipoprotein B synthesis inhibitor, to further lower LDL-C in HeFH patients with coronary artery disease...
- Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlle
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA
Lancet 380:29-36. 2012
..We assessed the efficacy and safety of various doses and dosing intervals of REGN727, a monoclonal antibody to PCSK9, added to statins, to further lower LDL-C in patients with heterozygous familial hypercholesterolaemia...
- Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program
Evan A Stein
Medpace Reference Laboratories, Inc, 4620 Wesley Avenue, Cincinnati, OH 45212, USA
Atherosclerosis 221:471-7. 2012
..We assessed the effects of rosuvastatin on the risk of developing renal impairment or renal failure among participants in the rosuvastatin clinical development program...
- Fluvastatin treatment is not associated with an increased incidence of cancer
E A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45229, USA
Int J Clin Pract 60:1028-34. 2006
..995-1.000; p = 0.107). In conclusion, fluvastatin treatment is not associated with an increased risk of cancer compared with placebo in clinical trials, independent of patient age, treatment duration and baseline cholesterol levels...
- Assessment of reaching goal in patients with combined hyperlipidemia: low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, or apolipoprotein B
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio 41075, USA
Am J Cardiol 96:36K-43K; discussion 34K-35K. 2005
..This article reviews the use of these 3 biomarkers in assessing cardiovascular risk, and the strategies for managing combined hyperlipidemia...
- Safety and tolerability of dalcetrapib
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH, USA
Am J Cardiol 104:82-91. 2009
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- Comparison of rosuvastatin versus atorvastatin in patients with heterozygous familial hypercholesterolemia
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, USA
Am J Cardiol 92:1287-93. 2003
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- Long-term efficacy and safety of rosuvastatin 40 mg in patients with severe hypercholesterolemia
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH, USA
Am J Cardiol 100:1387-96. 2007
..In conclusion, long-term treatment with rosuvastatin 40 mg is safe and effective in patients with severe hypercholesterolemia...
- Efficacy and tolerability of fluvastatin XL 80 mg alone, ezetimibe alone, and the combination of fluvastatin XL 80 mg with ezetimibe in patients with a history of muscle-related side effects with other statins
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, USA
Am J Cardiol 101:490-6. 2008
..In conclusion, in patients with a history of statin-associated MRSEs, fluvastatin XL alone or in combination with ezetimibe offers an effective and well-tolerated lipid-lowering option...
- After ENHANCE: is more LDL cholesterol lowering even better?
Evan A Stein
Medpace Reference Labs, Cincinnati, OH 45212, USA
Clin Chem 54:940-2. 2008
- Other therapies for reducing low-density lipoprotein cholesterol: medications in development
Evan A Stein
Metabolic and Atherosclerosis Research Center, 4685 Forest Avenue, Cincinnati, OH, USA
Endocrinol Metab Clin North Am 38:99-119. 2009
..Although most of the effective lipid-lowering drugs, the statins, have become generic and inexpensive, there remains a need for effective and safe agents. Hopefully, some of those discussed in this article will fill that need...
- Future trends in the treatment of dyslipidemia. Introduction
Evan A Stein
University of Cincinnati, Highland Heights, KY 41076, USA
Postgrad Med 112:4-5. 2002
..In turn, of these sudden deaths, almost half died before they reached medical attention at a hospital, and of those who did reach a hospital, 16.5% either were dead on arrival or died in the emergency room...
- Adult treatment panel III and the management of dyslipidemia risk factors
Evan A Stein
University of Cincinnati, Highland Heights, KY 41076, USA
Postgrad Med 112:12-7. 2002
..As a result, many more individuals have been identified as requiring intervention, and others will require more aggressive modalities, including cholesterol lowering pharmacotherapy...
- Colesevelam hydrochloride: efficacy and safety in pediatric subjects with heterozygous familial hypercholesterolemia
Evan A Stein
Metabolic and Atherosclerosis Research Center, 4685 Forest Ave, Suite A, Cincinnati, OH 45212, USA
J Pediatr 156:231-6.e1-3. 2010
..Evaluate the efficacy and safety of colesevelam hydrochloride in children with heterozygous familial hypercholesterolemia (heFH)...
Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trialEvan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA
Eur Heart J 31:480-8. 2010
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- Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, OH 45212, USA
Circulation 123:1974-85. 2011
..Lapaquistat acetate is a squalene synthase inhibitor investigated for the treatment of hypercholesterolemia...
- The power of statins: aggressive lipid lowering
Evan A Stein
Medical Research Laboratories International, Cincinnati, Ohio, USA
Clin Cardiol 26:III25-31. 2003
..A novel class of agents, cholesterol transport inhibitors, have recently become available. These and other new agents hold promise to help achieve ATP III goals when used in combination regimens initiated with a statin...
- Statins in children. Why and when
E A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, USA
Nutr Metab Cardiovasc Dis 11:24-9. 2001
..While additional well-controlled studies are needed, especially those focusing on surrogates of atherosclerosis to determine clinical benefit, it is opportune for re-evaluation of current treatment guidelines...
- Management of dyslipidemia in the high-risk patient
Evan A Stein
Metabolic and Atherosclerosis Research Center and Medical Research Laboratories International, Cincinnati, Ohio 45229, USA
Am Heart J 144:S43-50. 2002
..It is anticipated that such new options will allow clinicians to optimize the management of dyslipidemia in high-risk patients, thereby reducing the morbidity and mortality of CHD...
- Lipoprotein changes with statins
Evan A Stein
Medical Research Laboratories International, 2 Tesseneer Avenue, Highland Heights, KY 41076, USA
Curr Atheroscler Rep 4:14-8. 2002
..In addition, some recent papers have focused on new parameters that may mediate cardiovascular risk, such as high-sensitivity C-reactive protein...
- Managing dyslipidemia in the high-risk patient
Evan A Stein
Medical Research Laboratories International, Highland Heights, Kentucky 41076, USA
Am J Cardiol 89:50C-57C. 2002
..It is anticipated that these new options will allow clinicians to optimize the management of dyslipidemia in high-risk patients, thereby further reducing the morbidity and mortality of CAD...
- The lower the better? Reviewing the evidence for more aggressive cholesterol reduction and goal attainment
Evan Stein
Metabolic and Atherosclerosis Research Center, Suite 201, Medical Office Building East, 3131 Harvey Avenue, Cincinnati, OH 45229, USA
Atheroscler Suppl 2:19-23; discussion 23-5. 2002
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- Laboratory surrogates for anti-atherosclerotic drug development
E Stein
Medical Research Laboratories, Highland Heights, Kentucky 41076, USA
Am J Cardiol 87:21A-26A. 2001
..All of these parameters are involved in either the causation or propagation of the atherothrombotic process...
- Aggressive treatment of dyslipidemia: a review of supporting evidence
E A Stein
Medical Research Laboratories, Highland Heights, Kentucky 41076, USA
Cleve Clin J Med 68:130-1, 135-6, 137-8, 141-2. 2001
..Of the available cholesterol-lowering agents, statins produce the greatest reductions in LDL-C levels and coronary events and are currently the best treatment option for most patients...
- Introduction: rosuvastatin--an efficacy assessment based on pooled trial data
Evan A Stein
MRL International, Highland Heights, Kentucky 41076, USA
Am J Cardiol 91:1C-2C. 2003
- New statins and new doses of older statins
E A Stein
Medical Research Laboratories, 2 Tesseneer, Highland Heights, KY 41076, USA
Curr Atheroscler Rep 3:14-8. 2001
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- Lipid modulation and atherosclerotic events: extending the clinical spectrum with fibrates and statins
E A Stein
Medical Research Laboratories, 2 Tesseneer Drive, Highland Heights, KY 41076, USA
Curr Atheroscler Rep 2:11-3. 2000
..These include primary and secondary prevention of CAD in the elderly, primary prevention of CAD in persons with diabetes, and primary prevention of stroke...
- Pharmacodynamics, safety, tolerability, and pharmacokinetics of the 0.8-mg dose of cerivastatin in patients with primary hypercholesterolemia
E Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio 45219, USA
Am J Cardiol 83:1433-6. 1999
..The increased efficacy and lack of clinically significant laboratory abnormalities or adverse events demonstrates a need for a large long-term study to confirm the safety and efficacy of this dose of cerivastatin...
- Efficacy and safety of lovastatin in adolescent males with heterozygous familial hypercholesterolemia: a randomized controlled trial
E A Stein
Medical Research Laboratories, Highland Heights, KY, USA
JAMA 281:137-44. 1999
..The age at which drug therapy should be started is still controversial, as is the use of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins)...
- Effects of simvastatin, an HMG-CoA reductase inhibitor, in patients with hypertriglyceridemia
Jonathan Isaacsohn
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, USA
Clin Cardiol 26:18-24. 2003
..05 - < 0.001). CONCLUSION: The results of this study demonstrate the beneficial effects of simvastatin in patients with hypertriglyceridemia...
- The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels
Harold E Bays
Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY 40213, USA
Postgrad Med 121:145-50. 2009
..Thus, the 4-g/day dose contributes approximately 44 Cal/day, with approximately 36 Cal/day derived from the oil...
- Long-term up to 24-month efficacy and safety of concomitant prescription omega-3-acid ethyl esters and simvastatin in hypertriglyceridemic patients
Harold E Bays
Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY 40213, USA
Curr Med Res Opin 26:907-15. 2010
..Assess the long-term efficacy and safety of prescription omega-3-acid ethyl esters (P-OM3) coadministered with simvastatin in an extension of the Combination of Prescription Omega-3 Plus Simvastatin (COMBOS) trial...
- Effects of prescription omega-3-acid ethyl esters on non--high-density lipoprotein cholesterol when coadministered with escalating doses of atorvastatin
Harold E Bays
Louisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Ave, Louisville, KY 40213, USA
Mayo Clin Proc 85:122-8. 2010
..To evaluate the effects of prescription omega-3-acid ethyl esters on non-high-density lipoprotein cholesterol (HDL-C) levels in atorvastatin-treated patients with elevated non-HDL-C and triglyceride levels...
- Long-term efficacy and safety of cerivastatin 0.8 mg in patients with primary hypercholesterolemia
J Isaacsohn
Medpace, Cincinnati, Ohio 45212, USA
Clin Cardiol 24:IV1-9. 2001
..Statins are the agents of choice in reducing elevated plasma low-density lipoprotein cholesterol (LDL-C)...
- Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia
Michael Davidson
Chicago Center for Clinical Research, Chicago, Illinois, USA
Am J Cardiol 89:268-75. 2002
..Both treatments were well tolerated...
- An investigative look: selective cholesterol absorption inhibitors--embarking on a new standard of care
Evan A Stein
Cholesterol Treatment Center, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, USA
Am J Manag Care 8:S36-9; discussion S45-7. 2002
..Larger, long-term phase 3 trials confirmed the efficacy and safety of the 10-mg dose and also demonstrated that ezetimibe monotherapy is an excellent alternative for patients who cannot tolerate statins...
- Effects of rosuvastatin versus atorvastatin, simvastatin, and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR trial
Peter H Jones
Section of Atherosclerosis and Lipid Research, Baylor College of Medicine, Houston, Texas 77030, USA
Clin Ther 26:1388-99. 2004
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- Simvastatin with or without ezetimibe in familial hypercholesterolemia
John J P Kastelein
Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands
N Engl J Med 358:1431-43. 2008
..Ezetimibe, a cholesterol-absorption inhibitor, reduces levels of low-density lipoprotein (LDL) cholesterol when added to statin treatment. However, the effect of ezetimibe on the progression of atherosclerosis remains unknown...
- Identification and treatment of individuals at high risk of coronary heart disease
Evan A Stein
Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio, USA
Am J Med 112:3S-9S. 2002
..Other options that may soon be available as additive agents to statins to achieve greater LDL cholesterol reductions include bile acid transport inhibitors and cholesterol absorption inhibitors...
- Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial)
Peter H Jones
Baylor College of Medicine, 6565 Fannin Avenue, A 601, Houston, TX 77030, USA
Am J Cardiol 92:152-60. 2003
..0 mmol/L was achieved by 79% to 92% in rosuvastatin groups compared with 52% to 81% in atorvastatin groups. Drug tolerability was similar across treatments...
- Pharmacotherapy for dyslipidaemia--current therapies and future agents
Harold Bays
L MARC Research Center, 3288 Illinois Avenue, Louisville, KY 40213, USA
Expert Opin Pharmacother 4:1901-38. 2003
..Finally, current and future lipid-altering drugs may include anti-obesity agents which could favourably affect lipid levels...
- Efficacy of rosuvastatin compared with other statins at selected starting doses in hypercholesterolemic patients and in special population groups
James W Blasetto
AstraZeneca LP, Wilmington, Delaware 19850, USA
Am J Cardiol 91:3C-10C; discussion 10C. 2003
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- Rosuvastatin improves the atherogenic and atheroprotective lipid profiles in patients with hypertriglyceridemia
Donald B Hunninghake
Heart Disease Prevention Clinic, University of Minnesota, Minneapolis, Minnesota 55455, USA
Coron Artery Dis 15:115-23. 2004
..We examined the effects of rosuvastatin treatment on triglyceride levels and lipid measures in a parallel-group multicenter trial (4522IL/0035) in patients with hypertriglyceridemia (Fredrickson Type IIb or IV)...
- Lipid-modifying effects of rosuvastatin in postmenopausal women with hypercholesterolemia who are receiving hormone replacement therapy
James Shepherd
Glasgow Royal Infirmary, Glasgow, Scotland, UK
Curr Med Res Opin 20:1571-8. 2004
..CONCLUSIONS: Rosuvastatin 5 mg or 10 mg once daily is a well-tolerated and highly efficacious lipid-lowering therapy in postmenopausal women receiving HRT...
- Risk for myopathy with statin therapy in high-risk patients
Christie M Ballantyne
Center for Cardiovascular Disease Prevention, Baylor College of Medicine, 6565 Fannin, Mail Station A601, Suite A656, Houston, TX 77030, USA
Arch Intern Med 163:553-64. 2003
..Clinicians should be alert to the potential for drug-drug interactions to minimize the risk of myopathy during long-term statin therapy in patients at high risk for coronary heart disease...
- Efficacy of rosuvastatin 10 mg in patients with the metabolic syndrome
Christie M Ballantyne
Methodist DeBakey Heart Center and Baylor College of Medicine, Houston, Texas, USA
Am J Cardiol 91:25C-27C; discussion 28C. 2003
..Among patients who met the metabolic syndrome criteria and who had triglycerides > or =200 mg/dL, 64% met their ATP III non-HDL goals...
- Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin therapY (MERCURY) II
Christie M Ballantyne
Methodist DeBakey Heart Center, Baylor College of Medicine, Houston, TX, USA
Am Heart J 151:975.e1-9. 2006
..This target can be difficult to attain with diet and current therapy...
- Effects of simvastatin on C-reactive protein in mixed hyperlipidemic and hypertriglyceridemic patients
Harold E Bays
L-MARC Research Center, Louisville, Kentucky, USA
Am J Cardiol 90:942-6. 2002
..Simvastatin had no effect on VCAM, SAA, or IL-6. In summary, simvastatin significantly reduced CRP in patients with mixed hyperlipidemia and hypertriglyceridemia...
- A dose-titration and comparative study of rosuvastatin and atorvastatin in patients with homozygous familial hypercholesterolaemia
A David Marais
Groote Schuur Hospital and University of Cape Town, Lipidology, Internal Medicine, 5th Floor C Barnard Building, UCT Health Science Faculty, Anzio Road, Cape Town 7925, South Africa
Atherosclerosis 197:400-6. 2008
..All treatments were well tolerated. Rosuvastatin may have therapeutic value in the management of hoFH...
- Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study
Michael H Davidson
Radiant Research, 515 North State Street, Suite 2700, Chicago, IL 60610, USA
Clin Ther 29:1354-67. 2007
..The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) has identified non-HDL-C as a secondary therapeutic target in these patients, but treatment goals may not be reached with statin monotherapy alone...
- Patients with acute coronary syndromes should received statins
Donald M Black
Department of Pediatric Cardiology, University of Michigan; The Cholesterol Treatment Center, Cincinnati, Ohio; Medical Research Laboratories, 2 Tesseneer, Highland Heights, KY 41076, USA
Curr Atheroscler Rep 4:11-3. 2002
- Are measurements of LDL particles ready for prime time?
Evan A Stein
Clin Chem 52:1643-4. 2006
- Role of the apolipoprotein B-apolipoprotein A-I ratio in cardiovascular risk assessment: a case-control analysis in EPIC-Norfolk
Wim A van der Steeg
Academic Medical Center, Amsterdam, The Netherlands
Ann Intern Med 146:640-8. 2007
..It is not known whether this ratio is better than traditional lipid values for risk assessment and prediction and whether it adds predictive value to the Framingham risk score...
- Statins and children: whom do we treat and when?
Evan A Stein
Circulation 116:594-5. 2007
- CDC/AHA Workshop on Markers of Inflammation and Cardiovascular Disease: Application to Clinical and Public Health Practice: report from the laboratory science discussion group
Gary L Myers
Circulation 110:e545-9. 2004
