Seabra-Gomes R, Aleixo A M, Adao M, Machado F P, Mendes M, Bruges G, Palos J L
Hospital de Santa Cruz, Carnaxide, Linda-A-Velha, Portugal.
Am J Cardiol. 1990 Jun 1;65(20):1308-12. doi: 10.1016/0002-9149(90)91318-z.
Thirty-three men with stable exercise-induced angina pectoris entered a randomized, double-blind, crossover study in which controlled-release isosorbide-5-mononitrate 60 mg once daily was compared with conventional isosorbide dinitrate 20 mg 3 times daily. Each drug was given for 2 weeks. Twenty-eight patients completed the study and data on exercise variables are available in 23 patients. Treatment with either drug resulted in significant antianginal effects, when measured 6 hours after a single dose and after 2 weeks of therapy compared with baseline placebo; however, there were significantly fewer signs of myocardial ischemia during treatment with isosorbide-5-mononitrate. There was no evidence of tolerance to either drug treatment but a significant attenuation of resting blood pressure (but not of exercise blood pressure) was observed with both drugs. Headache was the only clinically significant adverse event during therapy and it occurred more frequently in the isosorbide dinitrate treatment group (p less than 0.05 vs placebo); 3 such patients had to withdraw from the study because of headache. Thus, once-daily, controlled-release isosorbide-5-mononitrate appears as effective as conventional isosorbide dinitrate 3 times daily in patients with stable angina pectoris. The once-daily administration is convenient and improves patient compliance.
33名患有稳定型运动诱发型心绞痛的男性患者进入了一项随机、双盲、交叉研究，该研究将每日一次服用60毫克控释单硝酸异山梨酯与每日三次服用20毫克常规硝酸异山梨酯进行了比较。每种药物服用2周。28名患者完成了研究，23名患者有运动变量的数据。与基线安慰剂相比，在单剂量给药6小时后以及治疗2周后测量时，两种药物治疗均产生了显著的抗心绞痛作用；然而，在单硝酸异山梨酯治疗期间，心肌缺血的迹象明显较少。没有证据表明对两种药物治疗产生耐受性，但两种药物均观察到静息血压（而非运动血压）显著下降。头痛是治疗期间唯一具有临床意义的不良事件，且在硝酸异山梨酯治疗组中更频繁发生（与安慰剂相比，p<0.05）；3名此类患者因头痛不得不退出研究。因此，对于稳定型心绞痛患者，每日一次的控释单硝酸异山梨酯似乎与每日三次的常规硝酸异山梨酯一样有效。每日一次给药方便且提高了患者的依从性。
