Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease The PRIMO Randomized Controlled Trial
Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease The PRIMO Randomized Controlled Trial
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DOI：
10.1001/jama.2012.120
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发表时间：
2012-02-15
影响因子：
120.7
通讯作者：
Solomon, Scott D.
中科院分区：
文献类型：
--
作者：
Thadhani, Ravi;Appelbaum, Evan;Solomon, Scott D.
维生素D与降低心血管相关的发病率和死亡率有关，可能是通过改变心脏结构和功能，但这两者都缺乏确凿的证据。目的研究活性维生素D化合物paricalcitol对肾小球滤过率为15 - 60ml /min/1.73 m患者48周左心室质量的影响。设计、环境和参与者：2008年7月至2010年9月，在11个国家进行了一项跨国、双盲、随机安慰剂对照试验，纳入227例慢性肾病、轻中度左心室肥厚和保留左心室射血分数的患者。干预措施参与者被随机分配接受口服paricalcitol， 2 μ g/d (n=115)，或匹配安慰剂（n=112）。主要观察指标通过心血管磁共振成像观察48周左心室质量指数的变化。次要终点包括超声心动图左室舒张功能改变。结果：paricalcitol治疗4周内降低甲状旁腺激素水平，并在整个研究期间维持在正常范围内。在48周时，治疗组之间左心室质量指数的变化没有差异(paricalcitol组，0.34 g/m(2.7) [95% CI, -0.14至0.83 g/m(2.7)]与安慰剂组，-0.07 g/m（2.7) [95% CI, -0.55至0.42 g/m(2.7)]）。多普勒测量的舒张功能包括舒张早期峰值二尖瓣外侧组织速度（特立醇组，-0.01 cm/s [95% CI, -0.63至0.60 cm/s] vs安慰剂组，-0.30 cm/s [95% CI, -0.93至0.34 cm/s]）也无差异。与安慰剂组相比，特立西醇组出现高钙血症的频率更高。结论对慢性肾病患者48周的帕立克醇治疗并不能改变左心室质量指数或改善某些舒张功能障碍指标。
Context Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking.Objective To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m(2).Design, Setting, and Participants Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010.Intervention Participants were randomly assigned to receive oral paricalcitol, 2 mu g/d (n=115), or matching placebo (n=112).Main Outcome Measures Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echo-cardiographic changes in left ventricular diastolic function.Results Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m(2.7) [95% CI, -0.14 to 0.83 g/m(2.7)] vs placebo group, -0.07 g/m(2.7) [95% CI, -0.55 to 0.42 g/m(2.7)]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, -0.01 cm/s [95% CI, -0.63 to 0.60 cm/s] vs placebo group, -0.30 cm/s [95% CI, -0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group.Conclusion Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease.