Heller G V, Sridharan M, Morse J, Glasser S, Beach C L
Division of Cardiology, Hartford Hospital, Connecticut 06102, USA.
Pharmacotherapy. 1997 Jul-Aug;17(4):760-6.
To determine the safety and efficacy of diltiazem CD 180 mg administered once/day in patients with chronic stable angina inadequately controlled with P-blockers, long-acting nitrates, or both.
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.
Medical clinics in the private and academic sectors.
Of 172 patients, 170 completed the 2-week double-blind treatment period.
. Patients received either diltiazem CD 180 mg or placebo once/day in combination with existing antianginal therapy.
The time to termination of exercise tolerance testing, 24 hours after the dose increased significantly in the diltiazem CD group (37.2 sec) compared with the placebo group (21.3 sec, p=0.0438). Time to onset of angina during exercise testing also increased (57.6 vs 35.0 sec, respectively, p=0.0324), as did time to moderate angina (37.5 vs 20.6 sec, respectively, p=0.0354). The rates of total angina attacks and of angina attacks on exertion were significantly reduced in the diltiazem CD group versus placebo (p<0.05). Significant reductions in systolic and diastolic blood pressures and heart rate-blood pressure product measured at rest, submaximum exercise, and exercise termination were observed in diltiazem CD-treated patients compared with placebo (p<0.05). The frequency of treatment-related adverse events was identical in the two groups, 15.1%.
Diltiazem CD 180 mg once/day is an effective, safe, and beneficial initial dosage when added to existing antianginal therapy.
确定对于使用β受体阻滞剂、长效硝酸盐类药物或两者联合治疗后仍控制不佳的慢性稳定性心绞痛患者,每日一次服用180毫克缓释地尔硫䓬的安全性和有效性。
多中心、随机、双盲、安慰剂对照、平行组试验。
私立和学术机构的医疗诊所。
172例患者中,170例完成了为期2周的双盲治疗期。
患者每日一次服用180毫克缓释地尔硫䓬或安慰剂,并联合现有的抗心绞痛治疗。
与安慰剂组(21.3秒,p = 0.0438)相比,缓释地尔硫䓬组在剂量增加24小时后运动耐量测试终止时间显著延长(37.2秒)。运动测试期间心绞痛发作时间也有所增加(分别为57.6秒和35.0秒,p = 0.0324),中度心绞痛发作时间同样增加(分别为37.5秒和20.6秒,p = 0.0354)。与安慰剂组相比,缓释地尔硫䓬组的总心绞痛发作率和运动时心绞痛发作率显著降低(p < 0.05)。与安慰剂组相比,服用缓释地尔硫䓬的患者在静息、次极量运动和运动终止时测量的收缩压、舒张压和心率 - 血压乘积显著降低(p < 0.05)。两组治疗相关不良事件的发生率相同,均为15.1%。
对于现有的抗心绞痛治疗,每日一次服用180毫克缓释地尔硫䓬是一种有效、安全且有益的初始剂量。