伊伐布雷定(一种选择性 I(f)抑制剂)在慢性稳定型心绞痛伴糖尿病患者中的疗效。

Efficacy of ivabradine, a selective I(f) inhibitor, in patients with chronic stable angina pectoris and diabetes mellitus.

机构信息

Howard Gilman Institute for Heart Valve Diseases, State University of New York Downstate Medical Center, Brooklyn, NY, USA.

出版信息

Am J Cardiol. 2010 Jan 1;105(1):29-35. doi: 10.1016/j.amjcard.2009.08.642. Epub 2009 Nov 10.

Abstract

Ivabradine is a specific heart rate-lowering antianginal agent that was evaluated in a clinical development program involving approximately 3,000 patients with stable coronary artery disease, most with angina pectoris. We analyzed the pharmacokinetics, efficacy (evaluated by exercise tolerance testing), safety, and effects on glucose metabolism of ivabradine in patients with diabetes mellitus (DM) in this program. Most analyses included data from 535 patients with DM, approximately 18% of the overall patient sample. Patients with DM were older, more likely to be women, and more likely to have more severe angina pectoris than patients without DM. The pharmacokinetics of ivabradine did not differ in patients with DM versus those without DM. A reduction in the heart rate at rest with ivabradine was similar in those with (15.2%) and without (15.7%) DM. At baseline, the exercise capacity tended to be lower in the patients with DM, but the improvements in most exercise tolerance measures with ivabradine treatment were similar in patients with and without DM. No special safety concerns were associated with ivabradine in those with DM. The rates of sinus bradycardia and visual disturbances, known to be related to the action of ivabradine, showed no relative increase in the patients with DM. Ivabradine treatment was not associated with adverse effects on glucose metabolism. In conclusion, ivabradine was effective in preventing angina in patients with DM and was not associated with particular safety concerns or adverse effects on glucose metabolism. Ivabradine represents an attractive alternative to beta blockers in patients with stable angina pectoris and DM.

摘要

异搏定是一种特异性的降心率抗心绞痛药物,曾在一项涉及约 3000 例稳定性冠心病患者(多数为心绞痛患者)的临床开发项目中进行评估。我们分析了该项目中糖尿病(DM)患者的异搏定药代动力学、疗效(通过运动耐量试验评估)、安全性和对葡萄糖代谢的影响。大多数分析包括 535 例 DM 患者的数据,约占总患者样本的 18%。与非 DM 患者相比,DM 患者年龄更大,女性更多,且更可能患有严重的心绞痛。DM 患者与非 DM 患者的异搏定药代动力学无差异。DM 患者和非 DM 患者应用异搏定后静息心率均有下降(分别为 15.2%和 15.7%)。在基线时,DM 患者的运动能力往往较低,但应用异搏定治疗后大多数运动耐量指标的改善在 DM 患者和非 DM 患者中相似。DM 患者应用异搏定并未出现特殊的安全性问题。已知与异搏定作用相关的窦性心动过缓和视觉障碍的发生率在 DM 患者中并未增加。异搏定治疗与葡萄糖代谢不良事件无关。总之,异搏定可有效预防 DM 患者的心绞痛,且与特殊安全性问题或对葡萄糖代谢的不良影响无关。对于稳定性心绞痛和 DM 患者,异搏定代表了一种有吸引力的β受体阻滞剂替代药物。

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