Comparison of switch to the highest dose of rosuvastatin vs. add-on nicotinic acid vs. add-on fenofibrate for mixed dyslipidaemia

Authors


  • Disclosures Dr Evangelos Liberopoulos, Dimitri Mikhalidis and Moses Elisaf have given talks, attended conferences and participated in trials and advisory boards sponsored by various pharmaceutical companies, including Astra-Zeneca, Abbott and Merck Sharpe and Dohme (MSD). No conflict of interest declared.
  • Clinical Trials gov: NCT 01010516.
  • Linked Comment: Wierzbicki. Int J Clin Pract 2013; 67: 391–3.

  • Linked Comment: www.youtube.com/IJCPeditorial

Correspondence to:

Dr Evangelos N Liberopoulos MD FASA FRSH, Assistant Professor of Internal Medicine, University of Ioannina Medical School, 45 110 Ioannina, Greece

Tel.: +302651007502

Fax: +302651007016

Email: vaglimp@yahoo.com

Summary

Background

Use of a statin at a standard dose may be insufficient for the treatment of mixed dyslipidaemia. Whether switch to the highest dose of rosuvastatin (40 mg) or add-on nicotinic acid (NA) or fenofibrate is more efficacious remains unknown.

Patients and methods

This was a prospective, randomised, open-label, blinded end-point (PROBE) study. We recruited 100 patients with mixed dyslipidaemia who were treated with a statin at a standard dose but had not achieved lipid targets. Patients were randomised to switch to the highest approved dose of rosuvastatin (40 mg), add-on extended release nicotinic acid (ER-NA)/l-aropiprant (LRPT) or to add-on micronised fenofibrate for 3 months. The primary end-point was the change in non-high-density lipoprotein cholesterol (non-HDL-C) levels.

Results

Ninety patients completed the study. Non-HDL-C decreased in all groups (by 23, 24 and 7% in the rosuvastatin, ER-NA/LRPT and fenofibrate group, respectively, p < 0.01 for all compared with baseline and p < 0.01 for all compared with fenofibrate group). Low-density lipoprotein cholesterol (LDL-C) decreased by 23 and 19% in the rosuvastatin and ER-NA/LRPT group, respectively (p < 0.01 compared with baseline), but not in the add-on fenofibrate group. Add-on ER-NA/LRPT was associated with the greatest HDL-C increase, while add-on ER-NA/LRPT and add-on fenofibrate were associated with the greatest triglyceride decrease. Twenty-four per cent of patients initially randomised to add-on ER-NA/LRPT dropped out because of side effects.

Conclusions

In conclusion, switch to the highest dose of rosuvastatin and add-on ER-NA/LRPT may be better options compared with add-on fenofibrate for the management of patients with mixed dyslipidaemia not on treatment goals with a statin at a standard dose.

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