Subgroup analyses of the incidence of diabetic retinopathy by intervention group in the PREDIMED trial after a median 6.1 years of follow-up
Events/total | HR (95% CI) | P for interaction† | |||||
---|---|---|---|---|---|---|---|
MedDiet+EVOO | MedDiet+Nuts | Control group | MedDiet+EVOO | MedDiet+Nuts | EVOO | EVOO+Nuts | |
Sex | |||||||
Male | 9/574 | 10/593 | 8/540 | 0.76 (0.28–2.04) | 0.82 (0.31–2.16) | 0.38 | 0.33 |
Female | 13/708 | 10/549 | 24/650 | 0.46 (0.23–0.92) | 0.51 (0.24–1.08) | ||
Age, years* | |||||||
<70 | 18/790 | 14/729 | 17/709 | 0.84 (0.42–1.66) | 0.74 (0.36–1.54) | 0.20* | 0.38* |
≥70 | 4/492 | 6/413 | 15/481 | 0.24 (0.07–0.73) | 0.47 (0.17–1.26) | ||
BMI, kg/m2 | |||||||
<30 | 15/689 | 11/630 | 12/608 | 1.00 (0.46–2.18) | 0.80 (0.34–1.86) | 0.59* | 0.74* |
≥30 | 7/596 | 9/512 | 20/582 | 0.26 (0.10–0.62) | 0.50 (0.23–1.12) | ||
Hypertension | |||||||
No | 7/308 | 5/292 | 14/268 | 0.35 (0.14–0.89) | 0.31 (0.10–0.90) | 0.62 | 0.28 |
Yes | 15/974 | 15/850 | 18/922 | 0.70 (0.34–1.42) | 0.90 (0.45–1.82) | ||
Dyslipidemia | |||||||
No | 13/518 | 14/469 | 18/485 | 0.60 (0.28–1.23) | 0.78 (0.38–1.62) | 0.86 | 0.47 |
Yes | 9/764 | 6/673 | 14/705 | 0.50 (0.20–1.17) | 0.41 (0.16–1.10) | ||
MedDiet adherence at baseline (0 to 14 score) | |||||||
<10 | 11/841 | 15/735 | 24/878 | 0.47 (0.23–0.97) | 0.75 (0.38–1.48) | 0.10 | 0.18 |
≥10 | 11/441 | 5/407 | 8/312 | 0.68 (0.26–1.79) | 0.31 (0.09–1.09) |
All models are fully adjusted for the confounders shown in model 1 in Table 2 and stratified by center.
↵†Two interactions were assessed: only for the effect of MedDiet+EVOO (1 degree of freedom) and for both groups (2 degrees of freedom).
↵*The interactions with age and BMI were assessed using age and BMI as continuous variables.