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Lipid profile could be modified by Mediterranean diet (MD) and by red yeast rice (RYR).We assessed the lipid-lowering effects of MD alone or in combination with RYR on dyslipidemic statin-intolerant subjects, with or without type 2 diabetes, for 24 weeks. We evaluated the low-density lipoprotein (LDL) cholesterol level, total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, triglyceride, liver enzyme, and creatinine phosphokinase (CPK) levels. We studied 171 patients: 46 type 2 diabetic patients treated with MD alone (Group 1), 44 type 2 diabetic patients treated with MD associated with RYR (Group 2), 38 dyslipidemic patients treated with MD alone (Group 3), and 43 dyslipidemic patients treated with MD plus RYR (Group 4).The mean percentage changes in LDL cholesterol from the baseline were -7.34 ± 3.14% (P < 0.05) for Group 1; -21.02 ± 1.63% (P < 0.001) for Group 2; -12.47 ± 1.75% (P < 0.001) for Group 3; and -22 ± 2.19% (P < 0.001) for Group 4 with significant intergroup difference (Group 1 versus Group 2, P < 0.001; Group 3 versus Group 4, P > 0.05). No significant increase in AST, ALT, and CPK levels was observed in all groups. Our results indicate that MD alone is effective in reducing LDL cholesterol levels in statin-intolerant patients with a presumably low cardiovascular risk, but associating MD with the administration of RYR improves patients' LDL cholesterol levels more, and in patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]