FOLIC ACID SUPPLEMENTATION
Study Design No. of Patient Interventions Outcomes Subgroup Analyses of Notes Patients Population Clinical Endpoints in Women
Liem RCT N overall: Secondary 1) Open-label folic Primary study outcome(s): None reported 2003 593 prevention acid 0.5 mg QD (n Composite of vascular = 300) events (death, MI, stroke, N women: Pts had “stable revascularization, vascular 72 treated, CAD” defined 2) Standard of care surgery) 59 control as at least one (n = 293) of following: Clinical endpoints of interest: Mean age: MI, lesions ≥ 1) Composite outcome(s): 64.9 treated, 60% on Folic acid: 37 (12.3%) 65.5 control angiography, events PCI, CABG Control: 33 (11.2%) events Age range: SD 9.9 Mean follow up 2) Heart attack/MI: treated, SD 24 months Folic acid: 3 9.7 control Control: 4
% Diabetics: 3) Stroke (hemorrhagic, 7% treated, non-hemorrhagic, TIA): 11% control Folic acid: 4 Control: 3 % Caucasian: 4) Revascularization NR procedure (PCI, bypass): Folic acid: 10 Control: 6
5) Death/mortality: Folic acid: 12 Control: 14
6) CHF: NR
Schnyder RCT N overall: Secondary 1) Folate 1 mg, Primary study outcome(s): None reported Primary 2001 205 patients prevention Vitamin B12 400 Presence or absence of endpoint of mcg, pyridoxine 10 restenosis by follow up restenosis N women: Status post mg tab QD (n = angiography reached in 18/92
Page 1 of 4 Study Design No. of Patient Interventions Outcomes Subgroup Analyses of Notes Patients Population Clinical Endpoints in Women 46 PTCA 105) treated pts Clinical endpoints of interest: (19.6%) vs. 32 Mean age: 2) Placebo (n = 1) Composite outcome(s): of 85 placebo 61 100) Treatment: 13 pts (37.6%), P = Placebo: 23 0.01 Age range: Followed for 6 SD 11.3 months 2) Heart attack/MI: Treatment: 5 % Diabetics: Placebo: 7 27 3) Stroke (hemorrhagic, % non-hemorrhagic, TIA): Caucasian: NR NR 4) Revascularization procedure (PCI, bypass): Treatment: 11 Placebo: 21
5) Death/mortality: Treatment: 1 Placebo: 2
6) CHF: NR
Schnyder RCT N overall: Secondary 1) Folic acid 1 mg Primary study outcome(s): 1) Composite outcome(s): 2002 553 prevention QD, Vitamin B12 Composite outcome of Data presented in figure, no 400 mcg QD, death, nonfatal MI, need for absolute numbers given, N women: Status post pyridoxine 10 mg repeat revascularization at 6 95% CI approx 0.45-1.3 108 PTCA QD (n = 272) months and 1 year 2) Heart attack/MI: NR Mean age: 2) Placebo QD (n = Clinical endpoints of interest: 63.4 treated, 281) 1) Composite outcome(s): 3) Stroke (hemorrhagic, 61.8 placebo 6 months: 11.4% treatment, non-hemorrhagic, TIA): NR For 6 months 18.9% placebo; RR, 0.60; Age range: 95%CI 0.40-0.91, P = 0.02 4) Revascularization SD 10.6 procedure (PCI, bypass): treated, 11.0 12 months: n = 42, 15.4% NR placebo treatment, n = 64, 22.8% placebo; RR, 0.68, 95% CI 5) Death/mortality: NR % Diabetics: 0.48-0.96, P = 0.03
Page 2 of 4 Study Design No. of Patient Interventions Outcomes Subgroup Analyses of Notes Patients Population Clinical Endpoints in Women 27-28 6) CHF: NR 2) Heart attack/MI: % 12 months: Caucasian: 7 treatment, 12 placebo, NR unadjusted p = .27, HR 0.60 (95%CI .24-1.51), adjusted p = .17, HR .57 (.27-1.42)
3) Stroke (hemorrhagic, non-hemorrhagic, TIA): NR
4) Revascularization procedure (PCI, bypass): Target lesion revascularization: Treatment n = 27, placebo n = 45, unadjusted p = 0.03, HR 0.62 (0.40-0.97), adjusted p = .02, HR 0.61 (0.41-0.95) Any revascularization: Treatment n = 38, placebo n = 56, unadjusted p = .06, HR 0.70 (0.49-1.01), adjusted p = .04, HR 0.69 (0.51-0.98)
5) Death/mortality: Cardiac death: Treatment n = 3, placebo = 6, unadjusted p = .34, HR 0.52 (0.13-2.04), adjusted p = .23, HR 0.51(0.15-2.00)
Any death: Treatment n = 4, placebo n = 8, unadjusted p = .27, HR 0.54(0.16-1.70), adjusted p = .17, HR 0.52 (0.21-1.56)
6) CHF: NR
Page 3 of 4 REFERENCES:
1. Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, et al. Secondary prevention with folic acid: effects on clinical outcomes. Journal of the American College of Cardiology 2003;41(12):2105-13.
2. Schnyder G, Roffi M, Pin R, et al. Decreased rate of coronary restenosis after lowering of plasma homocysteine levels. New England Journal of Medicine 2001;345(22):1593-600.
3. Schnyder G, Roffi M, Flammer Y, et al. Effect of homocysteine-lowering therapy with folic acid, vitamin B(12), and vitamin B(6) on clinical outcome after percutaneous coronary intervention: the Swiss Heart study: a randomized controlled trial. JAMA 2002;288(8):973-9.
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