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著者: Mario Castro, Tonya S King, Susan J Kunselman, Michael D Cabana, Loren Denlinger, Fernando Holguin, Shamsah D Kazani, Wendy C Moore, James Moy, Christine A Sorkness, Pedro Avila, Leonard B Bacharier, Eugene Bleecker, Homer A Boushey, James Chmiel, Anne M Fitzpatrick, Deborah Gentile, Mandeep Hundal, Elliot Israel, Monica Kraft, Jerry A Krishnan, Craig LaForce, Stephen C Lazarus, Robert Lemanske, Njira Lugogo, Richard J Martin, David T Mauger, Edward Naureckas, Stephen P Peters, Wanda Phipatanakul, Loretta G Que, Ajay Sheshadri, Lewis Smith, Julian Solway, Lisa Sullivan-Vedder, Kaharu Sumino, Michael E Wechsler, Sally Wenzel, Steven R White, E Rand Sutherland, National Heart, Lung, and Blood Institute’s AsthmaNet
雑誌名: JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
Abstract/Text
IMPORTANCE: In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency.
OBJECTIVE: To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.
DESIGN, SETTING, AND PARTICIPANTS: The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized.
INTERVENTIONS: Oral vitamin D3 (100,000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained.
MAIN OUTCOMES AND MEASURES: The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care).
RESULTS: Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]).
CONCLUSIONS AND RELEVANCE: Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01248065.
PMID 24838406 JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
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