Low-density lipoprotein cholesterol in a global cohort of 57,885 statin-treated patients
Introduction
The importance of lowering low-density lipoprotein cholesterol (LDL-C) is undisputed, with research demonstrating that a decrease of 1 mmol/l (39 mg/dl) could reduce the 5-year risk of major coronary events, need for revascularization, and stroke by approximately a fifth, with additional decreases able to further improve the outlook [1], [2]. Studies on genetic polymorphisms have shown that lifelong exposure to lower LDL-C levels reduces the risk of coronary heart disease (CHD) [3], [4]. Furthermore, the data indicate that lowering LDL-C with a statin, ezetimibe, or combination therapy should provide similar risk reduction per unit decrease in LDL-C, and that the magnitude of the clinical benefit should be proportional to the reduction in LDL-C [5]. This rationale is reflected by the current European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines [6], which advocate pursuing LDL-C treatment targets that are defined based on a patient's risk. The American College of Cardiology (ACC) [7], [8] advocates risk-based treatment intensity in which low-intensity treatment should lower LDL-C by less than 30%, moderate-intensity treatment by 30 to <50% and high-intensity treatment by at least 50% and also refers to treatment targets in high risk patient groups in their recent expert consensus on non-statin lipid lowering treatment [7], [8].
Given this background, it appeared relevant to assess how many patients would truly be able to achieve treatment targets and, especially in the light of the consensus on non-statin LLT, how many patients would be eligible for further escalation of treatment. We based these analyses on the multinational cross-sectional Dyslipidaemia International Study (DYSIS) of >57,000 patients, which had a structured, centralized data collection and was conducted globally in multiple countries across Europe, the Middle East, Canada, Africa, and Asia, with a large number of patients from China.
Section snippets
Study design
DYSIS is a cross-sectional, observational, multicenter study with the original purpose of investigating the prevalence and types of persistent lipid abnormalities in statin-treated (mono/combination therapy) outpatients on a global scale. Between the years 2006 and 2013, a total of 6–10 patients were enrolled consecutively per center from within 30 countries around the world. The respective institutional ethical review bodies approved the study, and it adhered to all local laws in place. Each
Patient characteristics
We enrolled a total of 61,805 patients, of which 3920 (6.3%) were excluded because details regarding statin therapy and/or risk status were unavailable (Fig. 1). The characteristics of these patients were not hugely different from those of the remaining 57,885 that were analyzed (see Supplementary Table 1). Of the latter patients, 43.79% were enrolled prior to 2011, with the largest proportion enrolled during 2012 (46.63%) (Supplementary Table 2). The majority of centers at which patients were
Discussion
DYSIS is a large data set containing information on patients from 30 countries across Europe, the Middle East, Canada, Africa, and Asia who were at risk for cardiovascular events and on chronic statin therapy. Median LDL-C values were high throughout and LDL-C target levels for patients at different levels of risk were commonly not met. The results call for the optimization of existing effective treatment strategies and a collaborative effort to improve the consensus between treatment guidance
Conflict of interest
Dr. Gitt reports to have received consultancy fees and lecture fees by MSD, Pfizer, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Novonordisk, Regeneron, Roche, Sanofi.
Dr. Ferrieres reports to have received grants and fees from Amgen, AstraZeneca, Merck and Sanofi.
Dr. Kastelein declares that he has acted as a consultant to and received honoraria from the following companies: Amgen, AstraZeneca, Boehringer Ingelheim, Catabasis, Cerenis, CSL Behring, Dezima Pharmaceuticals, Eli
Financial support
The work was supported by Merck & Co., Inc., NJ, Whitehouse Station, USA.
Author contributions
Authors' contributions were as follows: (a) substantial contributions to the conception and design (AKG, DL, JF, JK, HD, MH, PBru, BV, FC, VS and BA); or the acquisition, analysis, or interpretation of the data (AKG, DL, JF, JK, HD, MH, PBra, BA), (b) the drafting of the article (AKG, DL, MH, PBra and BA) or critical revision for important intellectual content (JF, JK, HD, PBru, BV, FC, VS), (c) final approval of the version to be published (all), and (d) agreement to be accountable for all
Acknowledgements
Authors of the present study would like to thank all DYSIS investigators for their contribution to the successful completion of this study.
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