RESUMEN
OBJECTIVES: This double-blind randomized controlled trial investigated raising serum 25-hydroxyvitamin D (25D) with extended-release calcifediol (ERC) on time to symptom resolution in patients with mild to moderate COVID-19. METHODS: COVID-19 outpatients received oral ERC (300 mcg on days 1-3 and 60 mcg on days 4-27) or placebo (NCT04551911). Symptoms were self-reported daily. Primary end points were raising 25D to ≥50 ng/mL and decreasing resolution time for five aggregated symptoms (three respiratory). RESULTS: In all, 171 patients were randomized, 160 treated and 134 (65 ERC, 69 placebo) retained. The average age was 43 y (range 18-71), 59% were women. The mean baseline 25D was 37 ± 1 (SE) ng/mL. In the full analysis set (FAS), 81% of patients in the ERC group achieved 25D levels of ≥50 ng/mL versus 15% in the placebo group (P < 0.0001). In the per-protocol (PP) population, mean 25D increased with ERC to 82 ± 4 (SE) ng/mL (P < 0.0001) by day 7; the placebo group trended lower. Symptom resolution time was unchanged in the FAS by ERC (hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.695-1.390; P = 0.922). In the PP population, respiratory symptoms resolved 4 d faster when 25D was elevated above baseline level at both days 7 and 14 (median 6.5 versus 10.5 d; HR, 1.372; 95% CI, 0.945-1.991; P = 0.0962; Wilcoxon P = 0.0386). Symptoms resolved in both treatment groups to a similar extent by study end. Safety concerns including hypercalcemia were absent with ERC treatment. CONCLUSION: ERC safely raised serum 25D to ≥50 ng/mL in outpatients with COVID-19, possibly accelerating resolution of respiratory symptoms and mitigating the risk for pneumonia. These findings warrant further study.
Asunto(s)
COVID-19 , Deficiencia de Vitamina D , Humanos , Femenino , Adulto , Masculino , Calcifediol , Pacientes Ambulatorios , Método Doble Ciego , Resultado del TratamientoRESUMEN
This review evaluates the cost-effectiveness of using coronary artery calcium (CAC) to guide long-term statin therapy compared with treating all patients eligible for statins according to 2013 American College of Cardiology/American Heart Association cholesterol management guidelines for atherosclerotic cardiovascular disease. The authors used a microsimulation model to compare costs and effectiveness from a societal perspective over a lifetime horizon. Both strategies resulted in similar costs and quality-adjusted life years (QALYs). CAC resulted in increased costs (+$81) and near-equal QALY (+0.01) for an incremental cost-effectiveness ratio of $8,100/QALY compared with the treat-all strategy. For 10,000 patients, the treat-all strategy would theoretically avert 21 atherosclerotic cardiovascular disease events, but would add 47,294 person-years of statins. With CAC costs <$100, and higher cost and/or disutility associated with statin therapy, CAC strategy was favored. These findings suggest the economic value of both approaches were similar. Clinicians should account for individual preferences in context of shared decision making when choosing the most appropriate strategy to guide statin decisions.