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Brahmajee K. Nallamothu, MD, MPH; A. Mark Fendrick, MD; Melvyn Rubenfire, MD; Sanjay Saint, MD, MPH; Rajesh R. Bandekar, PhD; Gilbert S. Omenn, MD, PhD

Arch Intern Med. 2000;160:3406-3412.

Background  Elevated total homocyst(e)ine levels (11 µmol/L) have been identified as a potential risk factor for coronary heart disease. However, the benefits expected from lowering homocyst(e)ine levels with folic acid and vitamin B₁₂ supplementation have yet to be demonstrated in clinical trials.

Subjects and Methods  We constructed a decision analytic model to estimate the clinical benefits and economic costs of 2 homocyst(e)ine-lowering strategies: (1) "treat all"—no screening, daily supplementation with folic acid (400 µg) and vitamin B₁₂ (cyanocobalamin; 500 µg) for all; (2) "screen and treat"—screening, followed by daily supplementation with folic acid and vitamin B₁₂ for individuals with elevated homocyst(e)ine levels. Simulated cohorts of 40-year-old men and 50-year-old women in the general population were evaluated. In the base-case analysis, we assumed that lowering elevated levels would reduce excess coronary heart disease risk by 40%; however, this assumption and others were evaluated across a broad range of potential values using sensitivity analysis. Primary outcomes were discounted costs per life-year saved.

Results  Although the treat-all strategy was slightly more effective overall, the screen and treat strategy resulted in a much lower cost per life-year saved ($13 600 in men and $27 500 in women) when compared with no intervention. Incremental cost-effectiveness ratios for the treat-all strategy compared with the screen and treat strategy were more than $500 000 per life-year saved in both cohorts. Sensitivity analysis showed that cost-effectiveness ratios for the screen and treat strategy remained less than $50 000 per life-year saved under several unfavorable scenarios, such as when effective homocyst(e)ine lowering was assumed to reduce the relative risk of coronary heart disease–related death by only 11% in men or 23% in women.

Conclusions  Homocyst(e)ine lowering with folic acid and vitamin B₁₂ supplementation could result in substantial clinical benefits at reasonable costs. If homocyst-(e)ine lowering is considered, a screen and treat strategy is likely to be more cost-effective than universal supplementation.

From the Department of Internal Medicine (Drs Nallamothu, Fendrick, Rubenfire, Saint, and Omenn), Consortium for Health Outcomes, Innovation, and Cost-Effectiveness Studies (Dr Fendrick), and Department of Human Genetics (Dr Omenn), University of Michigan Medical School, Ann Arbor; and Department of Biostatistics, University of Michigan School of Public Health (Dr Bandekar).

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