Primary prevention of cardiovascular disease with a Mediterranean diet (PREDIMED; corrected republication)
Revised intention-to-treat analysis of PREDIMED (n=7447; median follow-up 4.8 years) after randomisation issues at some sites: Mediterranean diets supplemented with extra-virgin olive oil or nuts showed lower hazard of the primary major cardiovascular event composite than a low-fat control advice arm (HR 0.69 and 0.72 respectively vs control).
Why this PubMed row exists
The 2013 primary PREDIMED report was retracted and republished with revised models—this wiki links the 2018 republication (PMID 29897866) as the citable abstract with adjusted effect estimates.
Event counts & HRs (published abstract)
- Primary endpoint: MI, stroke, or CV death
- Events: 288 total — 96 (3.8%) MedDiet + EVOO, 83 (3.4%) MedDiet + nuts, 109 (4.4%) control
- ITT + propensity-adjusted HRs vs control: 0.69 (95% CI 0.53–0.91) EVOO arm; 0.72 (0.54–0.95) nuts arm
- Sensitivity: authors report similar estimates after omitting 1588 participants with known/suspected non-protocol assignments
Evidence hygiene
Spanish high-risk primary prevention cohort with behavioural support and free foods—effect sizes are not automatic proof for every Mediterranean label in grocery aisles.
Publication
Estruch R, Ros E, Salas-Salvadó J, et al.; PREDIMED Study Investigators. N Engl J Med. 2018 Jun 21;378(25):e34 (corrected/republished article). PMID 29897866.
Outcomes
- ITT + propensity-adjusted HR vs control for primary composite (CV death, nonfatal MI, nonfatal stroke): 0.69 (95% CI 0.53–0.91) Mediterranean diet + extra-virgin olive oil; 0.72 (0.54–0.95) Mediterranean diet + mixed nuts (2018 republication).
- Events: 288 total — 96 (3.8%) EVOO arm, 83 (3.4%) nuts arm, 109 (4.4%) control; median follow-up 4.8 years (per abstract).