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3 results on '"Kastelein, John J.P."'

1. LOWER, a registry of lomitapide-treated patients with homozygous familial hypercholesterolemia: Rationale and design

Author

Blom, Dirk, Fayad, Zahi, Kastelein, John J.P., Larrey, Dominique, Makris, Lukas, Schwamlein, Charles, Bloeden, LeAnne, Underberg, James, investigators, LOWER, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules souches normales et cancéreuses, Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), ACS - Amsterdam Cardiovascular Sciences, and Vascular Medicine

Subjects
Adult, Registry, medicine.medical_specialty, Time Factors, Endocrinology, Diabetes and Metabolism, Effectiveness, Homozygous familial hypercholesterolemia, Familial hypercholesterolemia, 030204 cardiovascular system & hematology, Hyperlipoproteinemia Type II, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pregnancy, Internal medicine, Internal Medicine, Coagulopathy, Humans, Medicine, Medical history, Registries, 030212 general & internal medicine, Dosing, Nutrition and Dietetics, medicine.diagnostic_test, business.industry, Anticholesteremic Agents, Patient Selection, Homozygote, medicine.disease, Plaque, Atherosclerotic, Lomitapide, 3. Good health, Surgery, Cardiovascular imaging, chemistry, Concomitant, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Benzimidazoles, Female, Observational study, Safety, Cardiology and Cardiovascular Medicine, business, Lipid profile
Abstract

International audience; BACKGROUND:Lomitapide is an orally active selective inhibitor of microsomal triglyceride transfer protein approved as adjunctive therapy for homozygous familial hypercholesterolemia (HoFH). The Lomitapide Observational Worldwide Evaluation Registry (LOWER) is a global, long-term, prospective, observational treatment registry established as a regulatory requirement.OBJECTIVES:LOWER will evaluate the long-term safety and effectiveness of lomitapide in clinical practice. The objectives include evaluation of the occurrence of events of special interest and assessment of the long-term effectiveness of lomitapide in maintaining reduced serum lipid levels.METHODS:LOWER is a noninterventional study open to eligible lomitapide-treated patients. At least 300 patients will be enrolled and followed for at least 10 years. Data will be collected in conjunction with usual care visits and analyzed annually. LOWER includes a cardiovascular imaging substudy; an independent pregnancy exposure registry is also open.RESULTS:Events of special interest include hepatic abnormalities, gastrointestinal events, certain gastrointestinal tumors, major adverse cardiovascular events, and events associated with coagulopathy. Data will be collected on demographics, diagnosis, patient history, lomitapide dosing, concomitant treatment, lipid profile, and other laboratory results.CONCLUSION:LOWER will assess the long-term safety, efficacy, and patterns of use of lomitapide, increase understanding of the benefit-to-risk profile, and add to knowledge of HoFH.

Published
2016

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

Author

Marie T. Baccara-Dinet, Michel Farnier, Dirk J. Blom, Richard Ceska, Robert Dufour, Robert Pordy, John J.P. Kastelein, Jian Zhao, Henry N. Ginsberg, Michel Krempf, Daniel A. Gipe, Mary Jane Geiger, Fernando Civeira, Christelle Lorenzato, Gisle Langslet, G. Kees Hovingh, University of Amsterdam [Amsterdam] (UvA), Columbia University [New York], Oslo University Hospital [Oslo], Charles University in Prague, Partenaires INRAE, Institut de recherches cliniques de Montréal, University of Cape Town, Hospital Universitario Miguel Servet, Centre hospitalier universitaire de Nantes (CHU Nantes), Sanofi, Regeneron Pharmaceuticals Inc., Le point, Kastelein, John J.P., ACS - Amsterdam Cardiovascular Sciences, and Vascular Medicine

Subjects
Male, medicine.medical_specialty, Heterozygote, Statin, medicine.drug_class, Heterozygous familial hypercholesterolaemia, Placebo, Antibodies, Monoclonal, Humanized, Gastroenterology, Drug Administration Schedule, PCSK9, Hyperlipoproteinemia Type II, Double-Blind Method, Alirocumab, Cardiovascular risk, LDL-C, Risk Factors, Internal medicine, medicine, Clinical endpoint, Food and Nutrition, Humans, Adverse effect, FASTTrack Esc Clinical Trial Update, Dose-Response Relationship, Drug, business.industry, Communication, Anticholesteremic Agents, Antibodies, Monoclonal, Cholesterol, LDL, Middle Aged, Lipids, 3. Good health, Discontinuation, Santé publique et épidémiologie, Endocrinology, Treatment Outcome, Alimentation et Nutrition, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Cardiology and Cardiovascular Medicine, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, Algorithms
Abstract

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

Published
2015

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