de Vries R J, van den Heuvel A F, Lok D J, Claessens R J, Bernink P J, Pasteuning W H, Kingma J H, Dunselman P H
Department of Cardiology/Thoraxcenter, University Hospital Groningen, The Netherlands.
Int J Cardiol. 1996 Dec 6;57(2):143-50. doi: 10.1016/s0167-5273(96)02806-9.
The gastrointestinal therapeutic system formulation of nifedipine enables a once-daily dosing resulting in predictable, relatively constant plasma concentrations. To evaluate the efficacy and safety of this formulation and to compare this with the beta-blocker atenolol, we conducted a double-blind, randomised, multi-centre study in 129 male patients with documented exercise induced angina pectoris. After 4 weeks' treatment, nifedipine (60 mg), improved time to onset of 0.1 mV ST-segment depression from 536 s by 72 +/- 117s, time to onset of pain from 619 s by 56 +/- 120 s, and total exercise time from 685 s by 40 +/- 88 s. Atenolol 100 mg, had a comparable effect, time to onset of 0.1 mV ST-segment depression improved from 496 s by 53 +/- 129 s, time to onset of pain from 572 s by 57 +/- 118 s, and total exercise time from 653 s by 33 +/- 99 s. Between group analysis revealed no statistically significant differences for these exercise parameters. Atenolol, but not nifedipine, significantly reduced heart rate and systolic blood pressure at rest and during exercise (P < 0.001 between groups), indicating different modes of action of the drugs. With regard to safety, both drugs were generally well tolerated. There were significantly (P = 0.01) more vasodilation related side effects with nifedipine. These data demonstrate that gastrointestinal therapeutic system formulation of nifedipine and atenolol as once-daily monotherapy are equally effective and safe, but with different effects on exercise parameters.
硝苯地平的胃肠道治疗系统制剂能够每日给药一次,从而产生可预测的、相对稳定的血浆浓度。为了评估该制剂的疗效和安全性,并与β受体阻滞剂阿替洛尔进行比较,我们对129例有运动诱发型心绞痛记录的男性患者进行了一项双盲、随机、多中心研究。经过4周的治疗,硝苯地平(60毫克)使0.1毫伏ST段压低的发作时间从536秒缩短了72±117秒,疼痛发作时间从619秒缩短了56±120秒,总运动时间从685秒增加了40±88秒。阿替洛尔100毫克有类似效果,0.1毫伏ST段压低的发作时间从496秒缩短了53±129秒,疼痛发作时间从572秒缩短了57±118秒,总运动时间从653秒增加了33±99秒。组间分析显示这些运动参数无统计学显著差异。阿替洛尔而非硝苯地平在静息和运动时显著降低心率和收缩压(组间P<0.001),表明两种药物作用方式不同。关于安全性,两种药物一般耐受性良好。硝苯地平与血管舒张相关的副作用显著更多(P=0.01)。这些数据表明,硝苯地平的胃肠道治疗系统制剂和阿替洛尔作为每日一次的单一疗法同样有效且安全,但对运动参数有不同影响。