This week an article titled Primary Prevention of Cardiovascular Disease with a Mediterranean Dietwas featured in the New England Journal of Medicine. The study received a considerable amount of attention, including an article in the NY Times.
Study design
The objective of this study, as its name suggests, was to study the impact of a Mediterranean Diet on the primary prevention of CVD. Primary prevention of X implies looking at patients (ideally those susceptible to X) who have not yet had X to see if your intervention prevents X. Such trials are more difficult (i.e., larger and more expensive) than secondary prevention trials because in secondary prevention trials you start with patients who have already had X and are therefore at much greater risk of having X again.
Let’s use a relevant example. A primary prevention trial for CVD would study subjects who have never had a heart attack or stroke, and look for which treatment (e.g., a drug like a statin) reduces the number of such events (sometimes called MACE – Major Adverse Cardiac Events). A secondary prevention trial would study subjects who have already suffered some MACE and look at interventions to prevent a recurrence.
This study, a primary prevention trial, enrolled about 7,500 patients who were at high risk for CVD, but who had not suffered any MACE, and randomized them to one of three diets – two variants of a Mediterranean Diet, and a low fat diet. Table 1 shows the dietary targets. The two variants of the Mediterranean Diet were (i) one that emphasized extra virgin olive oil (EVOO) and (ii) another that emphasized nuts.
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