Table 1.
Summary of Large‐Scale Clinical Trials for Vitamin Supplementation and CVD Prevention
| Study | Intervention | No. of Patients | Characteristics | Follow‐up, y | Outcomes | HR (95% CI) |
|---|---|---|---|---|---|---|
| Armitage et al, 20107 | Folate, 2 mg/d; vitamin B12, 1 mg/d | 12 064 | Mean age 64 years, history of MI | 6.7 | Composite: coronary death, MI, coronary revascularization | 1.04 (0.97‐1.12) |
| Hankey 20109 | Folate, 2 mg/d; vitamin B6, 25 mg/d; vitamin B12, 0.5 mg/d | 8164 | Mean age 63 years, recent TIA/CVA | 3.4 | Composite: stroke, MI, vascular death | 0.91 (0.8‐1.0) |
| Albert et al, 20088 | Folate, 2.5 mg/d; vitamin B6, 50 mg/d; vitamin B12, 1 mg/d | 5442 | Mean age 63 years, all F, known history of CVD or ≥3 CVD risk factors | 7.3 | Composite: MI, stroke, coronary revascularization, cardiovascular death | 1.03 (0.9‐1.19) |
| Hsia et al, 200724 | Calcium carbonate, 500 mg/d; vitamin D, 200 IU/d | 36 282 | Mean age 62 years, all F | 7.0 | Composite: MI, cardiovascular death | 1.04 (0.92‐1.18) |
| Törnwall et al, 200432 | Vitamin A, 20 mg/d; vitamin E, 50 mg/d (=111 IU/d); vitamin A + E | 5768, 5794, 5741 | Finnish M only, smokers, mean age 52 years | 6.0 | Composite: nonfatal MI, cardiovascular death | Vitamin A, 1.13 (1–1.28); vitamin E, 0.94 (0.83‐1.07); A + E, 1.08 (0.95‐1.22) |
| Cook et al, 200733 | Vitamin A, 50 mg every other day; vitamin C, 500 mg/d; vitamin E, 600 IU every other day | 8171 total | Mean age 61 years, all F | 9.4 | Composite: cardiovascular death, MI, stroke, coronary revascularization, total mortality | Vitamin A, 1.02 (0.92‐1.13); vitamin C, 1.02 (0.92‐1.13); vitamin E, 0.94 (0.85‐1.04) |
| Sesso et al, 200840 | Vitamin C, 500 mg/d; vitamin E, 400 IU every other day | 14 641 total | Mean age 64 years, all M | 8.0 | Composite: nonfatal MI or stroke, cardiovascular death | Vitamin C, 0.99 (0.89‐1.11); vitamin E, 1.01 (0.9‐1.13) |
| Lee et al, 200554 | Vitamin E, 600 IU every other day (vitamin A arm stopped) | 39 876 | Mean age 55 years, all F, no known CVD | 10.1 | Composite: nonfatal MI/stroke, cardiovascular death | 0.93 (0.82‐1.05) |
| Vardi et al, 2012,48 meta‐analysis of post hoc data from 3 select vitamin E trials reporting Hp genotype | Vitamin E, 400–600 IU/d (intervention trials); Hp 2–2 gene; non–Hp 2–2 gene | Pooled: 2110, 2656 | WHS study data34: age ≥40 years, F, DM; Milman et al, 200849: age 69–70 years, DM; HOPE study data50: mean age 66 years, DM | 8.0, 1.5, 4.5 | Composite: total MI, total stroke, cardiovascular death | Hp 2–2, OR: 0.66 (0.48‐0.9); non–Hp 2–2, OR: 1.11 (0.80‐1.53)a |
| Sesso et al, 20121 | Daily multivitamin | 14 641 | Mean age 64 years, all M | 11.2 | Composite: nonfatal MI, nonfatal stroke, cardiovascular death | 1.01 (0.91‐1.1) |
| Lamas et al, 201351 | Daily compound multivitamin | 1708 | Median age 65 years, recent MI (within 6 wks of trial) | 2.6 | Composite: total mortality, recurrent MI, stroke, coronary revascularization, hospitalization for angina | 0.89 (0.75‐1.07) |
| Hercberg et al, 20102 | Multivitamin: vitamins A (6 mg), C (120 mg), E (30 mg), selenium (100 µg), zinc (20 mg) | 12 741 | Mean age 49 years | 7.5 | Ischemic CVD, overall mortality | 0.95 (0.75‐1.2); 0.77 (0.57‐1.04) |
Abbreviations: CI, confidence interval; CVA, cerebrovascular accident; CVD, cardiovascular disease; DM, diabetes mellitus; F, female; HOPE, Heart Outcomes Prevention Evaluation; Hp, haptoglobin; HR, hazard ratio; IU, international units; M, male; MI, myocardial infarction; OR, odds ratio; TIA, transient ischemic attack; WHS, Women's Health Study.
a
For the entry for Vardi et al 2012, ORs and 95% CIs are listed instead of HRs.