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      European Society of Cardiology/European Atherosclerosis Society Task Force consensus statement on proprotein convertase subtilisin/kexin type 9 inhibitors: practical guidance for use in patients at very high cardiovascular risk.

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          The Agenda for Familial Hypercholesterolemia: A Scientific Statement From the American Heart Association.

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            ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia

            Aims To assess long-term (78 weeks) alirocumab treatment in patients with heterozygous familial hypercholesterolaemia (HeFH) and inadequate LDL-C control on maximally tolerated lipid-lowering therapy (LLT). Methods and results In two randomized, double-blind studies (ODYSSEY FH I, n = 486; FH II, n = 249), patients were randomized 2 : 1 to alirocumab 75 mg or placebo every 2 weeks (Q2W). Alirocumab dose was increased at Week 12 to 150 mg Q2W if Week 8 LDL-C was ≥1.8 mmol/L (70 mg/dL). Primary endpoint (both studies) was percentage change in calculated LDL-C from baseline to Week 24. Mean LDL-C levels decreased from 3.7 mmol/L (144.7 mg/dL) at baseline to 1.8 mmol/L (71.3 mg/dL; −57.9% vs. placebo) at Week 24 in patients randomized to alirocumab in FH I and from 3.5 mmol/L (134.6 mg/dL) to 1.8 mmol/L (67.7 mg/dL; −51.4% vs. placebo) in FH II (P < 0.0001). These reductions were maintained through Week 78. LDL-C <1.8 mmol/L (regardless of cardiovascular risk) was achieved at Week 24 by 59.8 and 68.2% of alirocumab-treated patients in FH I and FH II, respectively. Adverse events resulted in discontinuation in 3.4% of alirocumab-treated patients in FH I (vs. 6.1% placebo) and 3.6% (vs. 1.2%) in FH II. Rate of injection site reactions in alirocumab-treated patients was 12.4% in FH I and 11.4% in FH II (vs. 11.0 and 7.4% with placebo). Conclusion In patients with HeFH and inadequate LDL-C control at baseline despite maximally tolerated statin ± other LLT, alirocumab treatment resulted in significant LDL-C lowering and greater achievement of LDL-C target levels and was well tolerated. Clinical trial registration Cinicaltrials.gov (identifiers: NCT01623115; NCT01709500).
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              Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.

              This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses. Statin intolerance, which is predominantly due to muscle-related side effects, is reported in up to 10% to 20% of patients. Evolocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), demonstrated marked reductions in plasma low-density lipoprotein cholesterol (LDL-C) in a phase 2 study in statin-intolerant patients. The GAUSS-2 (Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) trial was a 12-week, double-blind study of randomized patients (2:2:1:1) to evolocumab 140 mg every two weeks (Q2W) or evolocumab 420 mg once monthly (QM) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg. Co-primary endpoints were percent change from baseline in LDL-C at the mean of weeks 10 and 12, and at week 12. Three hundred seven patients (age 62 ± 10 years; LDL-C 193 ± 59 mg/dl) were randomized. Evolocumab reduced LDL-C from baseline by 53% to 56%, corresponding to treatment differences versus ezetimibe of 37% to 39% (p <0.001). Muscle adverse events occurred in 12% of evolocumab-treated patients and 23% of ezetimibe-treated patients. Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups. Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing the largely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant. (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2; NCT01763905). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Eur. Heart J.
                European heart journal
                Oxford University Press (OUP)
                1522-9645
                0195-668X
                Oct 27 2016
                Affiliations
                [1 ] Department of Cardiology, Charité-Universitätsmedizin Berlin (CBF), Hindenburgdamm 30, 12203 Berlin, Berlin Institute of Health (BIH), and Deutsches Zentrum für Herz-Kreislaufforschung (DZHK), Germany ulf.landmesser@charite.de.
                [2 ] National Institute for Health and Medical Research (INSERM), University of Pierre and Marie Curie, Pitié-Salpêtrière Hospital, 47 Hôpital boulevard, Paris, 75013 France.
                [3 ] Lipid Clinic, Point Medical, Dijon, France.
                [4 ] Cardiology Division, Department of Specialties in Medicine, Geneva University Hospitals, 4, rue Gabrielle-Perret-GentilCH - 1211 Geneva, Switzerland.
                [5 ] Department of Internal Medicine III, Martin-Luther-University Halle/Wittenberg, University Hospital, Dept. of Int. Medicine III, Universitätsring 19/2006108, Halle/Saale, Germany.
                [6 ] Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
                [7 ] University Heart Center, Cardiology Clinic, University Hospital Zurich, Rämistrasse 100, 8091 Zurich and Center for Integrative Human Physiology, University of Zurich, Zurich, Switzerland.
                [8 ] Department of Cardiology, Charité-Universitätsmedizin Berlin (CBF), Hindenburgdamm 30, 12203 Berlin, Berlin Institute of Health (BIH), and Deutsches Zentrum für Herz-Kreislaufforschung (DZHK), Germany.
                [9 ] Hacettepe University, Faculty of Medicine, Sihhiye, Ankara, Turkey.
                [10 ] Sahlgrenska University Hospital, SE-413 45 Gothenburg, Sweden.
                [11 ] Department of Cardiology, University Hospital Ramón y Cajal, Colmenar Viejo Road, Km. 9.1, Madrid, Spain.
                [12 ] Cardiology Department, CCUL, CAML, Faculdade de Medicina, Universidade de Lisboa, Alameda da Universidade, Lisboa, Portugal.
                [13 ] Department of Pharmacological and Biomolecular Sciences, University of Milan, Via Balzaretti 9, 20133 Milan and Multimedica IRCSS Milano, Milan, Italy.
                Article
                ehw480
                10.1093/eurheartj/ehw480
                27789571
                c11776c7-a5d6-4878-8a61-981f65ab6c11

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