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Clinical Trial
. 2000 Oct 7;356(9237):1213-8.
doi: 10.1016/s0140-6736(00)02783-5.

Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial

M Boaz  1 , S Smetana, T Weinstein, Z Matas, U Gafter, A Iaina, A Knecht, Y Weissgarten, D Brunner, M Fainaru, M S Green
Affiliations
Clinical Trial

Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial

M Boaz et al. Lancet. .

Abstract

Background: Excess cardiovascular mortality has been documented in chronic haemodialysis patients. Oxidative stress is greater in haemodialysis patients with prevalent cardiovascular disease than in those without, suggesting a role for oxidative stress in excess cardiovascular disease in haemodialysis. We investigated the effect of high-dose vitamin E supplementation on cardiovascular disease outcomes in haemodialysis patients with pre-existing cardiovascular disease.

Methods: Haemodialysis patients with pre-existing cardiovascular disease (n=196) aged 40-75 years at baseline from six dialysis centres were enrolled and randomised to receive 800 IU/day vitamin E or matching placebo. Patients were followed for a median 519 days. The primary endpoint was a composite variable consisting of: myocardial infarction (fatal and non-fatal), ischaemic stroke, peripheral vascular disease (excluding the arteriovenous fistula), and unstable angina. Secondary outcomes included each of the component outcomes, total mortality, and cardiovascular-disease mortality.

Findings: A total of 15 (16%) of the 97 patients assigned to vitamin E and 33 (33%) of the 99 patients assigned to placebo had a primary endpoint (relative risk 0.46 [95% CI 0.27-0.78], p=0.014). Five (5.1%) patients assigned to vitamin E and 17 (17.2%) patients assigned to placebo had myocardial infarction (0.3 [0.11-0.78], p=0.016). No significant differences in other secondary endpoints, cardiovascular disease, or total mortality were detected.

Interpretation: In haemodialysis patients with prevalent cardiovascular disease, supplementation with 800 IU/day vitamin E reduces composite cardiovascular disease endpoints and myocardial infarction.

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Comment in

  • ACP J Club. 2001 May-Jun;134(3):91
  • Antioxidant strategy for cardiovascular diseases.
    Hooper L, Ness AR, Smith GD. Hooper L, et al. Lancet. 2001 May 26;357(9269):1705-6. doi: 10.1016/s0140-6736(00)04876-5. Lancet. 2001. PMID: 11428363 No abstract available.
  • Vitamin E supplementation.
    Gazis A, Fogarty A. Gazis A, et al. Lancet. 2001 Feb 24;357(9256):631-2; author reply 632-3. doi: 10.1016/S0140-6736(05)71417-3. Lancet. 2001. PMID: 11558503 No abstract available.
  • Vitamin E supplementation.
    Nuttall SL, Kendall MJ, Townend JN, Wheeler DC. Nuttall SL, et al. Lancet. 2001 Feb 24;357(9256):631; author reply 632-3. doi: 10.1016/S0140-6736(00)04070-8. Lancet. 2001. PMID: 11558504 No abstract available.
  • Vitamin E supplementation.
    Violi F, Micheletta F, Iuliano L. Violi F, et al. Lancet. 2001 Feb 24;357(9256):632-3. doi: 10.1016/s0140-6736(05)71418-5. Lancet. 2001. PMID: 11558505 No abstract available.
  • Vitamin E supplementation.
    Fryer MJ. Fryer MJ. Lancet. 2001 Feb 24;357(9256):633. doi: 10.1016/S0140-6736(05)71420-3. Lancet. 2001. PMID: 11558506 No abstract available.

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