Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: Design and rationale of ODYSSEY ALTERNATIVE, a randomized.

Slides:

Advertisements

Similar presentations

Corn oil improves the plasma lipoprotein lipid profile compared with extra-virgin olive oil consumption in men and women with elevated cholesterol: Results.

Advertisements

J Am Coll Cardiol. 2015;65(24): doi: /j.jacc Figure Legend:

Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated.

Patient and Physician Perspectives on Administration of the PCSK9 Monoclonal Antibody Alirocumab, an Injectable Medication to Lower LDL-C Levels† Eli.

Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: Results of a 24week, double-blind, randomized.

A Summary and Critical Assessment of the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease.

A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT) Kwang Kon Koh, MD, PhD, FACC, Chang Wook Nam,

LDL Established Target for Cardiovascular Risk

Charles R. Harper, MD, Terry A. Jacobson, MD Mayo Clinic Proceedings

A Summary and Critical Assessment of the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease.

Patient Presentation. Patient Presentation PRIMO Study Incidence of Muscle Adverse Effects.

Corn oil improves the plasma lipoprotein lipid profile compared with extra-virgin olive oil consumption in men and women with elevated cholesterol: Results.

Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial.

An assessment by the Statin Muscle Safety Task Force: 2014 update

An assessment by the Statin Liver Safety Task Force: 2014 update

Efficacy of alirocumab in high cardiovascular risk populations with or without heterozygous familial hypercholesterolemia: Pooled analysis of eight ODYSSEY.

Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: A double-blinded, randomized, placebo controlled.

Beyond Statin Therapy.

Martin W. Schoen, MD, MPH, Joanne Salas, MPH, Jeffrey F

Charles R. Harper, MD, Terry A. Jacobson, MD Mayo Clinic Proceedings

Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients Evan Stein, MD, Harold Bays, MD, Michael Koren,

A review of PCSK9 inhibition and its effects beyond LDL receptors

Emerging LDL therapies: Mipomersen—antisense oligonucleotide therapy in the management of hypercholesterolemia Peter P. Toth, MD, PhD, FAAFP, FICA, FNLA,

Glucagon-like peptide-1 receptor agonists reduced the low-density lipoprotein cholesterol in Japanese patients with type 2 diabetes mellitus treated with.

A nutraceutical approach (Armolipid Plus) to reduce total and LDL cholesterol in individuals with mild to moderate dyslipidemia: Review of the clinical.

Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia Joep C. Defesche, PhD,

New LDL-C Lipid Targets

Radical New Concepts in Lipid Management

Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study)

Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance

Effects of Xuezhikang in patients with dyslipidemia: A multicenter, randomized, placebo- controlled study Patrick M. Moriarty, MD, Eli M. Roth, MD, Adam.

Jonathan C. Cohen, PhD Journal of Clinical Lipidology

J. W. Balder, MD, PhD, P. J. Lansberg, MD, PhD, M. H. Hof, MSc, A

Meredith Kilgore, PhD, Paul Muntner, PhD, J

Carmelo V. Venero, MD, Paul D. Thompson, MD, Antonio B. Fernandez, MD

Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial

Charles J. Glueck, MD, Alan Brown, MD, Anne C. Goldberg, MD, James M

National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary Terry A. Jacobson, MD, Matthew.

Paul D. Thompson, MD, John Rubino, MD, Matthew J. Janik, MD, Diane E

Relations of GlycA and lipoprotein particle subspecies with cardiovascular events and mortality: A post hoc analysis of the AIM-HIGH trial James D. Otvos,

Increased prevalence of clinical and subclinical atherosclerosis in patients with damaging mutations in ABCA1 or APOA1 Omar Abdel-Razek, MD, Singh N.

Barriers to PCSK9 inhibitor prescriptions for patients with high cardiovascular risk: Results of a healthcare provider survey conducted by the National.

An assessment by the Statin Intolerance Panel: 2014 update

Assessment of statin therapy, LDL-C levels, and cardiovascular events among high-risk patients in the United States Sudhir K. Unni, PhD, MBA, Ruben G.W.

Long-term treatment adherence to the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in 6 ODYSSEY Phase III clinical studies with treatment.

Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: Results of a 24week, double-blind, randomized.

Corn oil improves the plasma lipoprotein lipid profile compared with extra-virgin olive oil consumption in men and women with elevated cholesterol: Results.

Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia G. Kees Hovingh, MD,

Approximate Dose Equivalency of Statin LDL-C Efficacy.

Recommendations for the management of patients with homozygous familial hypercholesterolaemia: Overview of a new European Atherosclerosis Society consensus.

Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis: Rationale and design of the ODYSSEY ESCAPE trial

Alirocumab efficacy in patients with double heterozygous, compound heterozygous, or homozygous familial hypercholesterolemia Merel L. Hartgers, MD, Joep.

Mipomersen preferentially reduces small low-density lipoprotein particle number in patients with hypercholesterolemia Raul D. Santos, Frederick J. Raal,

Sokunthea Peou, PharmD, Brittany Milliard-Hasting, MD, Sachin A

Patterns of statin use and cholesterol goal attainment in a high-risk cardiovascular population: A retrospective study of primary care electronic medical.

Influence of low-glucose peritoneal dialysis on serum lipids and apolipoproteins in the IMPENDIA/EDEN trials Allan D. Sniderman, MD, James A. Sloand,

Efficacy, safety, and tolerability of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia: Rationale and design of the HAUSER-RCT.

Diabetes is associated with an increased risk of cardiovascular disease in patients with familial hypercholesterolemia Martine Paquette, MSc, Sophie.

Achieving Lipid Targets With PCSK9 Inhibition

Efficacy and safety of lipoprotein apheresis in children with homozygous familial hypercholesterolemia: A systematic review Ilse K. Luirink, MD, Jim.

Alirocumab efficacy in patients with double heterozygous, compound heterozygous, or homozygous familial hypercholesterolemia Merel L. Hartgers, MD, Joep.

Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results.

Can Low-Radiation Coronary Computed Tomography Angiography Improve Upon Clinical Risk Assessment in Patients with Familial Hypercholesterolemia?* Anna.

A Clinical Pharmacist Patient-Safety Initiative to Reduce Against-Label Prescribing of Statins with Cyclosporine Donald G. Lamprecht, PharmD, Anne M.

III. Treating dyslipidemias

Pediatric experience with mipomersen as adjunctive therapy for homozygous familial hypercholesterolemia Frederick J. Raal, PhD, Marjet J. Braamskamp,

PCSK9 inhibition in patients with and without prior myocardial infarction or ischemic stroke: A pooled analysis of nine randomized-controlled studies.

Emerging low-density lipoprotein (LDL) therapies: Management of severely elevated LDL cholesterol—The role of LDL-apheresis Mary P. McGowan, MD, FNLA

Long-term clinical results of microsomal triglyceride transfer protein inhibitor use in a patient with homozygous familial hypercholesterolemia Anna.

National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary Terry A. Jacobson, MD, Matthew.

Presentation transcript:

Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: Design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial Patrick M. Moriarty, MD, Terry A. Jacobson, MD, Eric Bruckert, MD, Paul D. Thompson, MD, John R. Guyton, MD, Marie T. Baccara- Dinet, MD, Daniel Gipe, MD Journal of Clinical Lipidology Volume 8, Issue 6, Pages 554-561 (November 2014) DOI: 10.1016/j.jacl.2014.09.007 Copyright © 2014 National Lipid Association Terms and Conditions

Figure 1 Study design of (A) the main part of the ODYSSEY ALTERNATIVE study and (B) the open-label extension. Time points for lipid assessments are indicated by vertical arrows under the schematics. *Eligible patients can opt to participate in a 196-week open-label treatment period. ATV, atorvastatin; CV, cardiovascular; EZE, ezetimibe; LDL-C, low-density lipoprotein cholesterol; NCEP-ATP III TLC, National Cholesterol Education Program Adult Treatment Panel III Therapeutic Lifestyle Changes; OLE, open-label extension; PO, orally; Q2W, every 2 weeks; QD, daily; R, randomization; RYR, red yeast rice; SC, subcutaneously; W, week. Journal of Clinical Lipidology 2014 8, 554-561DOI: (10.1016/j.jacl.2014.09.007) Copyright © 2014 National Lipid Association Terms and Conditions