van Ree J W, van der Pol G A
Department of General Practice, Maastricht University, The Netherlands.
J Hum Hypertens. 1996 Sep;10(9):613-8.
To establish the efficacy of 24-h ambulatory and casual blood pressure (BP) reduction, and the tolerability of once daily felodipine extended release (ER) 2.5 mg and felodipine ER 5 mg as monotherapy.
Randomised, double-blind placebo controlled 6 weeks parallel study.
From 15 general practices centres (with 19 GPs) in the region of the University of Maastricht, The Netherlands.
A total of 129 subjects aged 50-80 years with primary hypertension were screened; 27 men and 61 women with a casual diastolic BP of 100-115 mm Hg and/or a systolic BP of less than 200 mm Hg entered the study.
Casual and 24-h ambulatory BP and a subjective symptom assessment (SSA) questionnaire after 6 weeks of therapy.
After correlation for placebo response the mean casual systolic/diastolic BP (SBP/DBP) reduction was 10/5 mm Hg (NS) and 12/10 mm Hg (P < 0.05) for felodipine ER 2.5 and 5 mg, respectively. By using 24-h ambulatory BP measurements these reduction were 6/4 mm Hg (NS) and 13/8 mm Hg (P < 0.05), respectively. No significant difference for SBP and DBP was found during the night time between felodipine 2.5 and placebo (-1/0). Felodipine ER 5 mg lowered the BP load significantly during both daytime and night time but felodipine ER 2.5 mg only for DBP during the daytime. There was a significant difference for the number of responders between placebo (28%) vs felodipine ER 2.5 mg (55%) and ER 5.0 mg (59%). Both felodipine dosages and placebo were comparable in (a low) number of adverse events and results of the SSA.
During daytime felodipine ER 2.5 mg and 5 mg are effective in BP lowering in elderly hypertensive patients. However, only felodipine ER mg is effective in reducing BP during night time (22.00-7.00). Only felodipine ER 5 mg has a significant reducing effect on BP load during day and night time. Both felodipine ER 2.5 and ER 5.0 have a significant effect on the responder rate. It appeared from this study that compared to placebo, and in contrast with felodipine ER 5 mg, the ER form of felodipine 2.5 mg has no BP lowering effect during night time in elderly patients. To assess the effectivity during night time of felodipine ER 2.5 mg in an individual patient it is recommendable to measure the BP at the end of the dose interval.
确定24小时动态血压和偶测血压降低的疗效，以及每日一次服用2.5毫克非洛地平缓释片（ER）和5毫克非洛地平ER作为单一疗法的耐受性。
随机、双盲、安慰剂对照的6周平行研究。
来自荷兰马斯特里赫特大学地区的15个全科医疗中心（有19名全科医生）。
共筛选了129名年龄在50 - 80岁的原发性高血压患者；27名男性和61名女性，其偶测舒张压为100 - 115毫米汞柱和/或收缩压低于200毫米汞柱，进入研究。
治疗6周后的偶测和24小时动态血压以及主观症状评估（SSA）问卷。
校正安慰剂反应后，2.5毫克和5毫克非洛地平ER的偶测收缩压/舒张压（SBP/DBP）平均降低分别为10/5毫米汞柱（无统计学意义）和12/10毫米汞柱（P < 0.05）。通过24小时动态血压测量，这些降低分别为6/4毫米汞柱（无统计学意义）和13/8毫米汞柱（P < 0.05）。非洛地平2.5毫克与安慰剂在夜间SBP和DBP方面无显著差异（-1/0）。非洛地平ER 5毫克在白天和夜间均显著降低血压负荷，但非洛地平ER 2.5毫克仅在白天降低DBP。安慰剂（28%）与非洛地平ER 2.5毫克（55%）和ER 5.0毫克（59%）之间的有效应答者数量存在显著差异。两种非洛地平剂量组和安慰剂组在不良事件数量和SSA结果方面具有可比性（均较低）。
白天，2.5毫克和5毫克非洛地平ER对老年高血压患者降低血压有效。然而，仅非洛地平ER 5毫克在夜间（22:00 - 7:00）降低血压有效。仅非洛地平ER 5毫克在白天和夜间对血压负荷有显著降低作用。非洛地平ER 2.5和ER 5.0对有效应答率均有显著影响。从本研究来看，与安慰剂相比，且与非洛地平ER 5毫克不同，2.5毫克非洛地平ER剂型对老年患者夜间无降压作用。为评估个体患者中非洛地平ER 2.5毫克在夜间的有效性，建议在剂量间隔结束时测量血压。
