Mediterranean diet and antihypertensive drug use: a randomized controlled trial.

Objective: To examine in older individuals at high cardiovascular risk whether following a Mediterranean diet decreased the necessity of antihypertensive drugs and modulated their associated cardiovascular risk.

Methods: In the PREvención con DIeta MEDiterránea study, we assessed whether volunteers randomly allocated to an intervention with a Mediterranean diet enriched with extra-virgin olive oil or nuts (relative to a low-fat control diet) disclosed differences in the risk of: initiating antihypertensive medication in nonusers at baseline (n = 2188); and escalating therapy in participants using one, two, or three drugs at baseline (n = 2361, n = 1579, and n = 554, respectively). We also assessed whether allocation to Mediterranean diet modified the association between antihypertensive drug use and incident cardiovascular events.

Results: Participants allocated to Mediterranean diet interventions were associated with lower risk of initiating antihypertensive therapy [5-year incidence rates: 47.1% in the control diet, 43.0% in MedDiets; hazard ratio = 0.84, 95% CI (0.74--0.97), in a model adjusted for age, sex, and recruitment site]. Volunteers using two drugs at baseline in the Mediterranean diet intervention enriched with extra-virgin olive oil decreased their risk of therapy escalation [5-year incidence rates: 22.9% in the control diet, 20.1% in the MedDiet; hazard ratio = 0.77, 95% CI (0.60--0.99)]. Allocation to Mediterranean diet interventions attenuated the association between antihypertensive therapy at baseline and incidence of major adverse cardiovascular events (P interaction = 0.003).

Conclusion: In an older population at high cardiovascular risk, following a Mediterranean diet reduced the risk of initiating or escalating antihypertensive medication and attenuated cardiovascular risk in antihypertensive drug users.