Ruddy T D, Wright J M, Savard D, Handa S P, Chockalingam A, Fischer L, Boulet A P
University of Ottawa Heart Institute, Ontario, Canada.
Cardiovasc Drugs Ther. 1995 Dec;9(6):799-807. doi: 10.1007/BF00879874.
The antihypertensive effects of once-daily diltiazem CD over a 24 hour period were compared with twice-daily diltiazem SR in 95 patients with mild to moderate hypertension using ambulatory blood pressure monitoring. This trial was designed as a multicenter, double-blind, parallel-group study. Following a 2 to 4 week placebo run-in period, diltiazem was administered as once-daily CD or twice-daily SR, starting with 180 mg daily and increasing to a maximum of 360 mg daily, to achieve a seated diastolic blood pressure goal of < or = 90 mmHg as measured by cuff between 08:00 and 10:00 in the morning. Following drug titration, patients received a maintenance dose of diltiazem for an additional 6 week follow-up phase. Twenty-four hour ambulatory blood pressure monitoring recordings were obtained at the end of the placebo, titration, and maintenance phases. Both diltiazem CD and diltiazem SR significantly reduced both systolic and diastolic blood pressure over the 24 hour day and maintained a normal circadian pattern. As well, treatment with once-a-day diltiazem CD significantly decreased the slope of the early morning rise of diastolic and mean blood pressure. Thus, diltiazem CD is as effective as diltiazem SR in lowering diastolic blood pressure over a 24 hour period and has the advantage of a once-daily formulation.
采用动态血压监测,对95例轻至中度高血压患者比较了一日一次的缓释地尔硫䓬(diltiazem CD)与一日两次的缓释地尔硫䓬(diltiazem SR)在24小时期间的降压效果。该试验设计为多中心、双盲、平行组研究。在2至4周的安慰剂导入期后,给予地尔硫䓬一日一次的CD制剂或一日两次的SR制剂,起始剂量为每日180毫克,最大增至每日360毫克,以实现上午8点至10点通过袖带测量的坐位舒张压目标≤90毫米汞柱。药物滴定后,患者接受地尔硫䓬维持剂量,再进行6周的随访阶段。在安慰剂期、滴定期和维持期结束时获取24小时动态血压监测记录。缓释地尔硫䓬CD和缓释地尔硫䓬SR在24小时内均显著降低收缩压和舒张压,并维持正常的昼夜模式。此外,一日一次的缓释地尔硫䓬CD治疗显著降低了舒张压和平均血压清晨上升的斜率。因此,缓释地尔硫䓬CD在24小时期间降低舒张压方面与缓释地尔硫䓬SR同样有效,且具有一日一次给药的优势。