Fanaroff Alexander C, James Stefan K, Weisz Giora, Prather Kristi, Anstrom Kevin J, Mark Daniel B, Ben-Yehuda Ori, Alexander Karen P, Stone Gregg W, Ohman E Magnus
Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
J Am Coll Cardiol. 2017 May 9;69(18):2304-2313. doi: 10.1016/j.jacc.2017.02.056.
Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control.
This study sought to examine ranolazine's antianginal effect in relation to glucose control.
The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA) at 6- and 12-month follow-up. Interaction between baseline HbA and ranolazine's effect on Seattle Angina Questionnaire angina frequency at 6 and 12 months was tested.
Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA by 0.42 ± 0.08% (adjusted mean difference ± SE) and 0.44 ± 0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19 ± 0.02% and 0.20 ± 0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced Seattle Angina Questionnaire angina frequency at 6 months among DM patients but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA ≥7.5% than those with HbA <7.5% (interaction p = 0.07).
In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA, but the effect on angina dissipated by 12 months.
慢性心绞痛在血糖控制不佳的糖尿病（DM）患者中更为常见。雷诺嗪既能治疗慢性心绞痛，又能改善血糖控制。
本研究旨在探讨雷诺嗪与血糖控制相关的抗心绞痛作用。
作者对RIVER-PCI（经皮冠状动脉介入治疗后不完全血运重建患者的雷诺嗪治疗）试验进行了二次分析，该临床试验将2604例经皮冠状动脉介入治疗后患有慢性心绞痛且血运重建不完全的患者随机分为雷诺嗪组和安慰剂组。采用混合效应模型比较雷诺嗪与安慰剂在6个月和12个月随访时对糖化血红蛋白（HbA）的影响。测试了基线HbA与雷诺嗪在6个月和12个月时对西雅图心绞痛问卷心绞痛发作频率的影响之间的相互作用。
总体而言，961例患者（36.9%）基线时患有DM。与安慰剂相比，雷诺嗪在DM患者中从基线到6个月和12个月时分别使HbA显著降低0.42±0.08%（调整后平均差异±标准误）和0.44±0.08%，在非DM患者中6个月和12个月时分别降低0.19±0.02%和0.20±0.02%。与安慰剂相比，雷诺嗪在DM患者中6个月时显著降低了西雅图心绞痛问卷心绞痛发作频率，但在12个月时未降低。基线HbA≥7.5%的患者心绞痛发作频率的降低在数值上大于HbA<7.5%的患者（相互作用p=0.07）。
在经皮冠状动脉介入治疗后患有DM和慢性心绞痛且血运重建不完全的患者中，雷诺嗪在6个月时对血糖控制和心绞痛的作用与基线HbA成比例，但对心绞痛的作用在12个月时消失。
