**6.2 Results of the Lyon Diet Heart study**

Despite the small decreases in LDL-cholesterol (usually <5%) with the Mediterranean diet food, in meta-analysis of many cohort studies, the magnitude of decreases in CV events was to the same extent or even larger than in statin studies [192–194]. Effects on CV events beyond LDL-cholesterol reduction with the Mediterranean diet has been demonstrated in two RCTs, the Lyon Diet Heart study and the PREDIMED study [6]. The Lyon Diet Heart study [82, 195], which was the first RCT of the Mediterranean diet before the statin era, randomized 605 patients with history of myocardial infarction to compare that diet with a French style diet. The Mediterranean diet reduced the primary endpoint by 73% (CI: 0.12–0.59, *P* = 0.001). The overall mortality was also reduced by 70% (CI: 0.11–0.82, *P* = 0.02). Although the study was originally planned to follow CV events for 5 years, it was terminated early, 2 years and 3 months after the study initiation, due to the high mortality rate in the control group. There were no significant differences in body weight, blood pressure, LDL and HDL cholesterol, and blood glucose levels between the two diet groups at the end of the study. Therefore, the marked differences in rates of CV events were not due to improvement of these classical surrogate risk markers. The investigators presented results of an extended follow-up, and the striking reduction of CV evens was maintained for up to 4 years [195].
