Fenofibrate, simvastatin and their combination in the management of dyslipidaemia in type 2 diabetic patients

ABSTRACT

Objective: To evaluate the efficacy of fenofibrate, simvastatin or their combination in type 2 diabetic patients with combined dyslipidaemia.

Research design and methods: 241 patients, who had never previously taken lipid-lowering medications, received fenofibrate 145 mg/day, or simvastatin 40 mg/day, or fenofibrate 145 mg/day + simvastatin 40 mg/day combination for 12 months. We evaluated lipids, glycaemic, haemostatic, and inflammatory variables at baseline, and after 6 and 12 months.

Results: After 12 months total cholesterol (TC), LDL cholesterol (LDL-C) and triglycerides (Tg) decreased while HDL cholesterol (HDL-C) increased in all groups, even if the values obtained with fenofibrate + simvastatin were the best. At the end of the study apolipoprotein A-1 (Apo A-1) increased with fenofibrate + simvastatin, while apolipoprotein B (Apo B) decreased in all groups compared to baseline. Plasminogen activator inhibitor-1 (PAI-1) and high-sensitivity C reactive protein (hs-CRP) decreased after 12 months compared to baseline with simvastatin, and with fenofibrate + simvastatin even if the value obtained with fenofibrate–simvastatin was the lowest. After 12 months, fibrinogen (Fg) decreased compared to baseline with fenofibrate + simvastatin.

Limitations: This study has some limitations. The first one is the relatively small sample of studied patients. The second one is the lack of an advanced lipid proteins evaluation, such as lipoprotein subfraction changes in the different treatment regimen. Finally, we have not selected patients that could show the best response to fibrate (i.e.: hypertriglyceridemics) or statins (i.e.: hypercholesterolemics) monotherapy, so the effect of these drugs administered alone may have been partly attenuated.

Conclusions: Fenofibrate + simvastatin association improved lipid parameters, prothrombotic and inflammatory factors, and appeared to have a good tolerability profile over 12 months of therapy.

Key words: :

• Combination
• Fenofibrate
• Simvastatin
• Target
• Type 2 diabetes mellitus

Transparency

Declaration of funding

The publication of this article was sponsored by Solvay Pharma (Italy). The sponsors did not have any role in funding, designing or conducting the study. They had no role in drafting, writing or reviewing this article. The authors take full responsibility for the views expressed in this article which may not be shared by the sponsors.

Declaration of financial/other relationships

All authors (G.D., P.M., S.A.T.S., I.F., A.G., R.M., I.P., A.D'a. A.F.G.C.) have disclosed that they are recipients of research sponsorship from Solvay Pharma (Italy).

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she has received research grants from Merck-Schering-Plough; that he/she has acted as a consultant and/or advisor to AstraZeneca, LifeCycle Pharma, SurfaceLogix, Gilead, GlaxoSmithKline, Genzyme, Merck Sharpe & Dohme and Merck-Schering-Plough and that he/she is on the Speaker's Bureau for AstraZeneca, Gilead, GlaxoSmithKline, Genzyme, Merck Sharpe & Dohme and Merck-Schering-Plough. Peer Reviewer 2 has disclosed that he/she has received honoraria for attending international meetings on behalf of AstraZeneca and Merck Sharp & Dohme, and that he is on the Speaker's Bureau for AstraZeneca, Merck Sharp & Dohme and Solvay.

Acknowledgements

None.