Is moderate dose rosuvastatin in combination with fenofibrate more effective than high dose rosuvastatin in patients with stable coronary artery disease with mixed dyslipidemia. A PROBE study

[Speaker] Rupendra K Bharti:1
[Co-author] Prakash C Negi:1,2, Purssotam K Kaundal:2
1:Pharmacology, NIMS University, India, 2:AIIMS, IGMC, India

Background: Large body of data has demonstrated consistently that reduction in cardiovascular events with statins is a function of level of reduction in Low-Density Lipoprotein Cholesterol (LDL-C) both in primary and secondary prevention trials irrespective of baseline LDL-C Level. High dose statins are more effective than low dose statins in reducing CV events. Doubling of standard dose of statin achieves only additional reduction of LDL-C by 6%. Thus increasing rosuvastatin to 40 mg from 10 mg will reduce LDL-C by additional 12 percent only. Fenofibrate decrease LDL-C by 5-20%, thus the combination of fenofibrate will achieve additional 25-30% LDL-C reduction apart from more effective lowering of TG, VLDL atherogenic lipoproteins and increase in high-density-lipoprotein cholesterol (HDL-C). Thus the combination of moderate dose statins with fenofibrate is likely to be more effective in reducing LDL-C and non HDL-C levels.

Methods: 165 patients with stable CAD with mixed dyslipidemia were randomly assigned to Group- A (n-79, Rosuvastatin 40 mg) and Group- B (n-86, Rosuvastatin 20 mg with Fenofibrate 145 mg). These two groups were compared at baseline and after 12 weeks of treatment.

Result: After 12-week intervention, the change in percentage of total cholesterol was (-32.01±17.92 vs -38.33±13.51); p<0.02, HDL-C (-3.85±17.27 vs +11.01±24.37); p<0.0001, Non HDL-C (-38.80±32.46 vs -48.94±15.89); p<0.003, LDL-C (-38.34±24.44 vs -49.38±18.90); p<0.001, and triglyceride (-28.5±24.60 vs -47.0±57.57); p<0.009 observed from the baseline in Group A versus Group B, respectively. While 38.0% of Group A and 52.3% of Group B achieved their LDL-C goal (< 70 mg/dl) p >0.09, 55.70% of group A and 62.80% of group B achieved their non-HDL goal (<100 mg/dl) p >0.44, respectively. There was also increase incidence of loss of appetite (44.3% vs. 16.3%) p<0.0001 & CPK Level (24.1% vs. 10.5%); p<0.03 in Group A versus Group B, respectively.

Conclusion: The combination of moderate dose Rosuvastatin and Fenofibrate is more effective in reducing atherogenic lipid fractions and increasing the HDL-C level compared to rosuvastatin monotherapy and it was well tolerated and tolerability of combination was better than rosuvastatin monotherapy.

keywords: Combination, Mixed Dyslipidemia, Rosuvastatin, Fenofibrate, Randomization

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