Characterization and cholesterol management in patients with cardiovascular events and/or type 2 diabetes in the Netherlands

Abstract

Objective: To describe clinical characteristics and cholesterol management of patients with cardiovascular events (CVEs) and/or type 2 diabetes mellitus (T2DM) with high low-density lipoprotein cholesterol (LDL-C) > 1.8 mmol/L in the Netherlands.

Research design and methods: From the PHARMO Database Network a cross-sectional cohort was constructed. The descriptive study included patients on lipid modifying therapy (LMT) in 2009, classified as high cardiovascular risk based on a history of T2DM or CVE, with 2010 LDL-C levels above 1.8 mmol/L (2011 European Society of Cardiology [ESC] target). Sub-cohorts were created: T2DM + CVE from the T2DM cohort and multiple CVE from the CVE only cohort.

Main outcome measures: Clinical characteristics and drug treatment were determined at the time of the last LDL-C measurement in 2010.

Results: Of 10,864 very high risk patients, 66% had T2DM, 37% of whom also had CVE. In the CVE only cohort (34%), 18% had multiple events. More regular check-ups skewed inclusion towards diabetes patients. T2DM vs. CVE cohort characteristics were: 53% vs. 63% male, 42% vs. 27% obese, 19% vs. 24% current smoker, 54% vs. 51% systolic blood pressure <140 mmHg, with similar proportions in the sub-cohorts. Proportions reaching the Dutch guideline LDL-C target of <2.5 mmol/L were 56% (T2DM), 57% (T2DM + CVE), 48% (CVE only) and 53% (multiple CVE only). Frequencies of high intensity dose statin (simvastatin ≥80 mg, atorvastatin ≥40 mg or rosuvastatin ≥20 mg) were 6% (T2DM), 9% (T2DM + CVE, CVE only) and 14% (multiple CVE only); 1–2% received additional ezetimibe and 3–5% received non-statin LMT only, including ezetimibe.

Conclusion: Despite LMT, >40% of the patients above ESC target also failed to reach the less stringent Dutch target, even in the higher risk groups. Therefore, management of hypercholesterolemia after CVE or T2DM should be optimized to improve cardiovascular outcomes. There is substantial room for improving other cardiovascular risk factors.

Keywords:

• Cardiovascular diseases
• Diabetes mellitus type 2
• Hyperlipidemia
• Lipid modifying therapy

Transparency

Declaration of funding

This study was sponsored by Amgen and performed by the PHARMO Institute. Amgen was involved in the design of the study and the writing of the manuscript. A.L. has provided critical review from a clinical perspective.

Declaration of financial/other relationships

E.H., J.K., F.P. and R.H. have disclosed that they are employed by PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies. B.L. has disclosed that she is an employee of Amgen BV Breda, The Netherlands and owns stock options. L.K. has disclosed that she is an employee of Amgen (Europe) GmbH, Zug and owns stock options. A.L. has disclosed that he is employed by Sint Franciscus Gasthuis and has served as a consultant to Amgen, Sanofi, MSD, AstraZeneca, Daiichi Sankyo, Lilly and Pfizer.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work. Peer reviewer 1 has disclosed that he has received personal fees from AstraZeneca and Pfizer; personal fees and grants from MSD; personal fees and non-financial support from Abbott and Boehringer Ingelheim; and non-financial support from Eli Lilly and GSK. Peer reviewer 2 has given talks, attended conferences and participated in trials sponsored by MSD, Novartis, Amgen, Sanofi, Novo Nordisk and Libytec.

Acknowledgments

The authors acknowledge Elsa van den Berg (PHARMO Institute) for analytical support, and Charles van Haaster and Jacques Renes (Amgen BV) for discussions on clinical context during the study design and execution.

Previous presentation: An abstract of this work has been presented as a poster at the European Atherosclerosis Society congress in Innsbruck, 29 May–1 June 2016.

The codes used to identify CVE, T2DM and clinical characteristics are available from the corresponding author upon request.

Notice of Correction

Please note that the legend has been added to Figure 2 since the article was first published online (29 September 2016)