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Eur Heart J Cardiovasc Pharmacother. 2018 Apr 1;4(2):119-127. doi: 10.1093/ehjcvp/pvx031.

New strategies for the development of lipid-lowering therapies to reduce cardiovascular risk.

Author information

1
Trinity College, Adelaide Health Foundation, Tallaght Hospital, Dublin 24, Ireland.
2
Global Product Development/Internal Medicine, Pfizer, Inc., 235 E. 42nd Street, New York, New York 10017, NY, USA.
3
Dutch Medicines Evaluation Board (CBG-MEB), Graadt Van Roggenweg 500, 3531 AH Utrecht, The Netherlands.
4
Department of Pharmacy and Clinical Pharmacology, University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands.
5
Novartis Pharma AG, Asklepios 8, 4056 Basel, Switzerland.
6
Department of Pharmacological and Biomolecular Sciences and Multimedica IRCCS, University of Milan, via Balzaretti 9, 20133 Milano, Italy.
7
Departments of Clinical Research and Pharmacy Practice, Campbell University College of Pharmacy and Health Sciences, 217 Main St., Buies Creek, NC 27506, USA.
8
Cardiovascular Pharmacology, AstraZeneca, Pepparredsleden 1, SE-431 83 Mölndal, Sweden.
9
Department of Public Health, Faculty of Medicine and Health Sciences, Ghent University, University Hospital, K3, 4th floor, De Pintelaan 185, B9000 Ghent, Belgium.
10
Université Paris-Descartes, Cochin-Hôtel Dieu Hospital, French National Agency for Medicines and Health Products Safety, 143/147, Boulevard, Anatole France 93285, Saint-Denis, France.
11
Regulatory Affairs, Daiichi-Sankyo, 211 Mt. Airy Road, Basking Ridge, NJ 07920, USA.
12
Internal Medicine Research Unit, Pfizer, Inc., 1 Portland St., 4th floor, Cambridge, MA 02139, USA.
13
Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
14
Sanofi, 55 Corporate Drive, Bridgewater, NJ, USA.
15
Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
16
Licensing Division, United Kingdom Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London SW1W 9SZ, UK.
17
Department of Primary Care and Public Health, Imperial College, 323 Reynolds Building, Room 320, Charing Cross Hospital, London W68RF, UK.
18
Department of Epidemiology, College of Public Health, University of Iowa, 145 N. Riverside Dr S455 CPHB, Iowa City, IA 52242, USA.
19
Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
20
Oslo University Hospital, Ullevål, Medical Department, Postboks 4956 Nydalen, 0424 Oslo, Norway.
21
Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
22
Laboratory of Experimental Medicine and Endocrinology, University of Leuven, Herestraat 49, 3000 Leuven, Belgium.
23
Amgen, One Amgen Center Drive, MS 38.2.C, Thousand Oaks, CA 91320, USA.
24
Wallenberg Laboratory, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden.

Abstract

The very high occurrence of cardiovascular events presents a major public health issue, because treatment remains suboptimal. Lowering LDL cholesterol (LDL-C) with statins or ezetimibe in combination with a statin reduces major adverse cardiovascular events. The cardiovascular risk reduction in relation to the absolute LDL-C reduction is linear for most interventions without evidence of attenuation or increase in risk at low LDL-C levels. Opportunities for innovation in dyslipidaemia treatment should address the substantial risk of lipid-associated cardiovascular events among patients optimally treated per guidelines but who cannot achieve LDL-C goals and who could benefit from additional LDL-C-lowering therapy or experience side effects of statins. Fresh approaches are needed to identify promising drug targets early and develop them efficiently. The Cardiovascular Round Table of the European Society of Cardiology (ESC) convened a workshop to discuss new lipid-lowering strategies for cardiovascular risk reduction. Opportunities to improve treatment approaches and the efficient study of new therapies were explored. Circulating biomarkers may not be fully reliable proxy indicators of the relationship between treatment effect and clinical outcome. Mendelian randomization studies may better inform development strategies and refine treatment targets before Phase 3. Trials should match the drug to appropriate lipid and patient profile, and guidelines may move towards a precision-based approach to individual patient management. Stakeholder collaboration is needed to ensure continued innovation and better international coordination of both regulatory aspects and guidelines. It should be noted that risk may also be addressed through increased attention to other risk factors such as smoking, hypertension, overweight, and inactivity.

PMID:
29194462
DOI:
10.1093/ehjcvp/pvx031
[Indexed for MEDLINE]

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