Prevención con Dieta Mediterránea - PREDIMED

Description:

The goal of the trial was to evaluate treatment with a Mediterranean diet compared with a control diet among patients at high cardiovascular risk.

Hypothesis:

A Mediterranean diet will prevent adverse cardiovascular events.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients were eligible to participate if they had diabetes, or at least three of the following risk factors: hypertension, smoking, elevated low-density lipoprotein cholesterol, low high-density lipoprotein cholesterol, overweight or obesity, or a family history of premature coronary heart disease

    Number of screened applicants: 8,713
    Number of enrollees: 7,447
    Duration of follow-up: Median 4.8 years
    Mean patient age: 67 years
    Percentage female: 59 years

Exclusions:

  • Cardiovascular disease

Primary Endpoints:

  • Cardiovascular death, myocardial infarction, or stroke

Secondary Endpoints:

  • Cardiovascular death
  • Myocardial infarction
  • Stroke
  • All-cause death

Drug/Procedures Used:

Patients at high cardiovascular risk, but no cardiovascular disease were randomized to a Mediterranean diet supplemented with extra-virgin olive oil (n = 2,543) versus a Mediterranean diet supplemented with mixed nuts (n = 2,454) versus a control diet with advice to reduce dietary fat (n = 2,450).

A Mediterranean diet is characterized by high intake of olive oil, fruits, vegetables, and cereals, a moderate intake of fish and poultry, and a low intake of dairy products, red meat, processed meats, and sweets.

Concomitant Medications:

At baseline, 49% of participants were taking an angiotensin-converting enzyme inhibitor, 21% a diuretic, 41% a statin, 30% an oral hypoglycemic, and 19% an antiplatelet agent.

Principal Findings:

Overall 7,447 patients were randomized. The mean age was 67 years, 59% were women, 82% had hypertension, 50% had diabetes, 14% were current smokers, mean body mass index was 30 kg/m2, and mean waist circumference was 100 cm.

The primary outcome of cardiovascular death, myocardial infarction, or stroke occurred at a frequency of 8.1 events/1,000 person-years in the Mediterranean diet plus olive oil group (adjusted hazard ratio [HR] vs. control = 0.69, p = 0.008), 8.0 events/1,000 person-years in the Mediterranean diet plus nuts group (adjusted HR vs. control = 0.72, p = 0.03), and 11.2 events/1,000 person-years in the control diet. Obese patients appeared to derive more benefit from a Mediterranean diet than nonobese patients (p for interaction = 0.05).

Event rates (per 1,000 person-years) for the following outcomes are provided for Mediterranean diet plus olive oil, Mediterranean diet plus nuts, and control diet, respectively:

- Stroke: 4.1, 3.1, 5.9
- Myocardial infarction: 3.1, 3.0, and 3.9
- Cardiovascular death: 2.2, 3.0, and 3.1
- All-cause death: 10.0, 11.2, and 11.7

Interpretation:

Among patients at elevated risk of cardiovascular disease, a Mediterranean diet was effective at reducing the composite endpoint of cardiovascular death, myocardial infarction, or stroke at a median follow-up of 4.8 years. A Mediterranean diet was also effective at reducing the incidence of stroke compared with a control diet. Mediterranean diet supplemented with extra-virgin olive oil or nuts seemed to be equally effective at reducing adverse events. This study complements the Lyon Heart Study, which documented the benefits of a Mediterranean diet when used for secondary prevention of cardiovascular disease events.

References:

Estruch R, Ros E, Salas-Salvado J, et al. Primary Prevention of Cardiovascular Disease With a Mediterranean Diet. N Engl J Med 2013;368:1279-90.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Diet, Hypertension, Smoking

Keywords: Follow-Up Studies, Dietary Fats, Unsaturated, Coronary Disease, Risk Factors, Poultry, Diet, Mediterranean, Cholesterol, Waist Circumference, Complement System Proteins, Fruit, Plant Oils, Vegetables, Obesity, Hypertension, Stroke, Myocardial Infarction, Dietary Fats, Smoking, Lipoproteins, LDL, Body Mass Index, Secondary Prevention, Dairy Products, Cereals, Nuts, Lipoproteins, HDL, Diabetes Mellitus, Meat


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