Centralized Pan-European survey on the under-treatment of hypercholesterolaemia (CEPHEUS): overall findings from eight countries

Abstract

Background:

Surveys evaluating plasma lipid goal attainment in patients with coronary heart disease have shown that hypercholesterolaemia is inadequately treated. Limited data account for the reasons behind this. The aim of the CEntralized Pan-European survey on tHE Under-treatment of hypercholeSterolaemia (CEPHEUS) survey was to evaluate the current use and efficacy of lipid-lowering drugs (LLD), and to identify possible patient/physician characteristics associated with failure to achieve low-density lipoprotein cholesterol (LDL-C) targets recommended by the 2003 European guidelines (Third Joint Task Force).

Methods:

CEPHEUS was a European, multi-centre, cross-sectional survey conducted in eight countries and involved patients on LLD for >3 months (stable medication >6 weeks). One visit was scheduled for data collection, including fasting lipids. In all but one country, physicians and patients filled in a questionnaire about aspects of hypercholesterolaemia and treatment.

Clinical trial registration:

Trial registration: ClinicalTrials.gov identifier: NCT00542867.

Results:

Of the 15 199 patients recruited, 14 478 were included in the final analyses. The mean age was 63.2 years, and 45% of patients were female. Overall, 55.3% of the patients achieved their LDL-C target. In multivariate analyses, the factors identified as positive predictors for achieving LDL-C goals included normal body mass index, not smoking, not having metabolic syndrome, being on statin therapy and good treatment adherence.

Limitations:

The population was a selected group of subjects treated with LLD, and the results cannot be extrapolated to the general population. Patient consent was obtained, which may have selected more motivated patients and induced a positive bias. The physician and patient questionnaires were not validated, but were only used for exploratory purposes.

Conclusion:

Only 55.3% of patients using LLD achieved the LDL-C target recommended in the 2003 European guidelines.

Keywords::

• Hypercholesterolaemia
• LDL-C
• Lipid lowering drugs
• Statins
• Undertreatment

Transparency

Declaration of funding

AstraZeneca sponsored the trial, coordinated the writing of the manuscript and provided funding for editorial support.

Declaration of financial relationships

M.P.H has disclosed receiving research grants from Solvay Pharma, LifeScan and Menarini, and acting as a consultant/advisor for AstraZeneca, Bayer, Eli Lilly, Solvay Pharma, GlaxoSmithKline, LifeScan, Menarini, Merck Sharp & Dohme, NovoNordisk, Pfizer, Roche and Sanofi-Aventis. M.C.C. has disclosed acting as a consultant/advisor for AstraZeneca, and has received speaker’s fees from most companies in the cardiovascular field. T.S. has disclosed acting as a consultant/advisor for, and serving on the speakers’ bureau of several pharmaceutical companies, including AstraZeneca; he also holds stock in Orion Pharma. J.F. has disclosed receiving research grants from Bristol Myers Squibb, Sanofi-Aventis, Pfizer, Boehringer Ingelheim and AstraZeneca. M.E. has disclosed receiving research grants from AstraZeneca, Merck, Sanofi-Synthelabo, Solvay and Fournier; and acting as a consultant/advisor for, and serving on the Speakers’ Bureau of AstraZeneca, Merck, Schering-Plough, Pfizer, Solvay and Fournier. G.M. has disclosed receiving research grants for participation in clinical trials from AstraZeneca, Pfizer and NovoNordisk; he also serves as a member of the advisory boards of several pharmaceutical companies. V.S. has disclosed serving as a consultant/advisor for Pfizer, AstraZeneca, Boehringer Ingelheim and GlaxoSmithKline, and serving on the Speakers’ Bureau of AstraZeneca, GlaxoSmithKline, Merck Sharp & Dohme, and Boehringer Ingelheim. John Feely (1947–2009) sadly passed away during the preparation of this manuscript.

Peer revieers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed no relevant financial relationships; Peer Reviewer 2 has disclosed that he is the recipient of sponsorship funding to attend meetings on behalf of MSD and Astra-Zeneca; is a consultant for MSD; and is a member of the speakers bureaux for MSD, Solvay and Astra-Zeneca.

Acknowledgements

The authors would like to thank Michel Maes of General Biomedical and Statistical Consulting for medical writing support, with funding support from AstraZeneca.

Data reported here was previously presented at the following meetings:

• DALM (Drugs Affecting Lipid Metabolism), New York, USA, 4–7 October 2007

• ISPOR (International Society of Pharmacoeconomics and Outcome Research), Dublin, Ireland, 20–23 October 2007

• BSC (Belgian Society of Cardiology), Brussels, Belgium, 31 January–2 February 2008

• ALFEDIAM (Association de langue française pour l’étude du diabète et des maladies métaboliques), Brussels, Belgium, 25–28 March 2008

Three country-specific publications from the CEPHEUS study have been previously published: Belgium: Ref 21; France: Ref 22; Luxembourg (article in French): Ref 23.