Department of Cardiology, Fu Wai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, PR China.
Clin Exp Hypertens. 2010;32(8):491-8. doi: 10.3109/10641961003686427.
Several previous trials from Western population studies have showed that statins may help reduce blood pressure (BP). However, randomized clinical data is limited. Xuezhikang, a partially extract of red yeast rice, contains a family of naturally occurring statins, and has a marked impact on lipids, but it is unknown whether Xuezhikang has any effect on BP during long-term follow-up in the Chinese population. This is a post-hoc subgroup analysis of a randomized, double-blinded, placebo-controlled, parallel group clinical trial, Chinese Coronary Secondary Prevention Study (CCSPS). A total of 2704 hypertensive patients with previous myocardial infarction (MI) were assigned either to placebo (n = 1341) or to Xuezhikang (n = 1363) daily for an average of 4.5 years. The primary outcome was the unadjusted changes in mean arterial pressure (MAP) from baseline to 6 months. We also assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure. Analysis of covariance was used to calculate the adjusted effects of treatment on changes in these outcomes at 6, 12, 24, and 48 months post-randomization, after controlling for potential confounders. This analysis included 2704/4870 (55.5%) hypertensive patients for whom BP was measured at baseline and at least one follow-up visit after randomization. Median duration of the follow-up was 4.5 years (54 months), and 25 patients (0.92%) were lost to the last follow-up because of adverse effects. The results showed that the unadjusted and adjusted changes in MAP, SBP, DBP, or pulse pressure from baseline were not significantly different for Xuezhikang or placebo recipients at 6, 12, 24, and 48 months after randomization. In this post-hoc subgroup analysis, we failed to demonstrate any significant reducing effects of Xuezhikang on BP in Chinese hypertensive patients with previous MI, suggesting that further prospective study on the effects of statins on BP would be needed, especially in high-risk patients.
几项来自西方人群研究的试验表明，他汀类药物可能有助于降低血压（BP）。然而，随机临床试验数据有限。血脂康是红曲的部分提取物，含有一组天然他汀类药物，对脂质有显著影响，但尚不清楚血脂康在长期随访中对中国人群的血压是否有影响。这是一项随机、双盲、安慰剂对照、平行分组临床试验——中国冠心病二级预防研究（CCSPS）的事后亚组分析。共有 2704 名患有既往心肌梗死（MI）的高血压患者被随机分为安慰剂组（n = 1341）或血脂康组（n = 1363），每日服用一次，平均随访 4.5 年。主要终点是从基线到 6 个月时平均动脉压（MAP）的未调整变化。我们还评估了收缩压（SBP）、舒张压（DBP）和脉压。采用协方差分析计算治疗对随机分组后 6、12、24 和 48 个月时这些结果的调整作用，同时控制潜在混杂因素。该分析包括 2704/4870（55.5%）名高血压患者，这些患者在基线和随机分组后至少一次随访时测量了血压。中位随访时间为 4.5 年（54 个月），有 25 名患者（0.92%）因不良反应而在最后一次随访时失访。结果显示，在随机分组后 6、12、24 和 48 个月时，血脂康或安慰剂组患者的 MAP、SBP、DBP 或脉压的未调整和调整变化无显著差异。在这项事后亚组分析中，我们未能证明血脂康对既往 MI 的中国高血压患者的血压有显著降低作用，提示需要进一步开展他汀类药物对血压影响的前瞻性研究，特别是在高危患者中。
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