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HOPE-2

HOPE-2. H eart O utcomes P revention E valuation-2 trial. HOPE-2: Rationale. Observational data suggest elevated homocysteine levels may be an independent CVD risk factor

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HOPE-2

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  1. HOPE-2 Heart Outcomes Prevention Evaluation-2 trial

  2. HOPE-2: Rationale • Observational data suggest elevated homocysteine levels may be an independent CVD risk factor • Folic acid, vitamins B6 and B12 have a role in homocysteine metabolism; deficiencies result in elevated homocysteine levels • HOPE-2 was designed to evaluate whether prolonged use of homocysteine-lowering agents (folic acid, vitamins B6 and B12 supplements) reduces risk of major vascular events in high-risk patients HOPE-2 Investigators. Can J Cardiol. 2006;22:47-53.

  3. HOPE-2: Study design Primary outcome: Composite CV death, MI, stroke Secondary outcomes:Total ischemic events, hospitalization for unstable angina or HF, revascularization, death, incidence or death from cancer Follow-up: Every 6 months for 5 years History of vascular disease or diabetesplus additional atherosclerotic risk factor(s) N = 5522 Folic acid 2.5 mg +vitamins B6 50 mg + B12 1 mg qdn = 2758 Placebon = 2764 RandomizedDouble-blind HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  4. HOPE-2: Baseline characteristics Folate food-fortification status % Patients Fortification program *2.5-mg folic acid/50-mg B6/1-mgB12 HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  5. HOPE-2: Baseline prevalence of CV risk factors N = 5522 Patients (%) Active* Placebo *2.5-mg folic acid/50-mg B6/1-mgB12 HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  6. HOPE-2: Baseline prevalence of CVD N = 5522 Active* Placebo *2.5-mg folic acid/50-mg B6/1-mgB12 Other CVD history <10% HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  7. HOPE-2: Baseline medication use N = 5522 ASA or antiplatelets ACE inhibitors ARBs β-Blockers CCBs Diuretics Lipid-lowering agents Oral hypoglycemics Insulin HRT† Multivitamins Active* Placebo *2.5-mg folic acid/50-mg B6/1-mgB12 †Results in women only HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  8. HOPE-2: Change in plasma homocysteine over time  20%  7% 24  3.3 M/L 18  3.2 M/L Homocysteine (μmol/L) • Both groups had ~90% compliance rate at 5 years 13.2 12 12.9 12.2 12.2 9.9 9.7 6 0 Baseline 2 5 Baseline 2 5 Years Years Active* Placebo *2.5-mg folic acid/50-mg B6/1-mgB12 P values not available HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  9. HOPE-2: Primary outcome shows no benefit of vitamin supplementation Composite CV death, MI, stroke 25 5% RRRHR = 0.95 (0.84–1.07)P = 0.41 20 Placebo 15 Proportion of patients (%) Active* 10 5 0 0 1 2 3 4 5 Time (years) *2.5-mg folic acid/50-mg B6/1-mgB12 HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  10. HOPE-2: Primary outcome and components * *P = 0.03 HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  11. HOPE-2: Secondary outcome and components * *P = 0.02UA = unstable angina HF = heart failure HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

  12. HOPE-2: Summary • Supplements combining folic acid and vitamins B6 and B12 did not reduce the risk of major cardiovascular events in a high-risk population with vascular disease • Homocysteine could be a marker, but not a cause of vascular disease • Ongoing studies in non-fortified regions will further explore the role of B vitamin supplements in CVD prevention HOPE-2 Investigators. N Engl J Med. 2006;354:1567-77.

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