Clinical experience with ezetimibe/simvastatin in a Mediterranean population

ABSTRACT

Objectives: This study aimed to describe the clinical experience of the ezetimibe (EZE)/simvastatin (SIMVA) combination in a hypercholesterolaemic Greek population who did not attain the cholesterol goals on statin treatment alone.

Methods: Patients already treated with a statin, at any dose, for at least 8 weeks, with LDL-C levels above the goal, (>100, >130 or >160 mg/dl according to their risk category), where the physician chose EZE/SIMVA as appropriate treatment, entered the study. Medical history, demographics and laboratory values were recorded at baseline and 2 months later.

Results: The study included 1514 patients (male 53.4%) of mean age 60.1 ± 10.5 years. Diabetes mellitus was reported in 29.9% of the patients, 61.2% had hypertension, 39% were obese, 10.5% had a history of myocardial infarction and 6.8% had a history of stroke or peripheral arterial disease. Current and ex-smoking was reported in 46.8%. Atorvastatin (33%) and SIMVA (27.2%) were the most frequently used statins prior to using the EZE/SIMVA regimen. After 2 months of EZE/SIMVA therapy mean LDL-C was reduced by 33%, mean total cholesterol by 26%, mean triglycerides by 15%, while HDL-C was increased by 10%. The percentage of patients who achieved the LDL-C goal with EZE/SIMVA was 73.8%. One serious adverse event, not related to study treatment and 23 adverse events in total were recorded. There was a significant decrease in serum creatinine levels in patients with baseline values greater than 1.0 mg/dl (88 μmol/L).

Conclusions: Treatment with the EZE/SIMVA combination appears an effective and safe therapeutic option for patients who do not achieve the LDL-C goals on statin therapy alone.

Keywords: :

• Cholesterol absorption inhibitor
• Combination therapy
• Coronary heart disease
• Creatinine
• Ezetimibe
• Hypercholesterolaemia
• Simvastatin

Transparency

Declaration of funding

This study was supported by Merck and Schering-Plough Pharmaceuticals.

Declaration of relevant financial relationships

F.V. has disclosed that she is an employee of VIANEX SA Pharmaceuticals, representing MERCK & Co. Inc., Greece. I.M. has disclosed that he has carried out clinical trials on behalf of Eli-Lilly, Novartis and Merck Sharpe and Dohme (MSD) and that he is on the speakers bureau for MSD and Novartis. A.E. has disclosed that he is on the speakers bureau for MSD, Menarini and Astra-Zeneca. St.P. has disclosed that he has carried out clinical trials on behalf of Eli-Lilly and MSD and that he is on the speakers bureau for MSD, GlaxoSmithKline, Pfizer and Novartis. D.A. has disclosed that he has carried out clinical trials on behalf of sanofi-aventis. D.P.M. has disclosed that he is an advisory board member for MSD and that he is on the speakers bureau for MSD, Solvay and Astra-Zeneca.

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 and Peer Reviewer 2 have disclosed that they have no relevant financial relationships.

Acknowledgement

Data management and statistical analyses were performed by CORONIS, Athens, Greece. CORONIS is an independent contract research organization that received funding for these analyses from VIANEX SA Pharmaceuticals, representing MERCK & Co. Inc., Greece.