Thulin T, Almkvist H, Berglund L, Björnsson T, Fagher B, Henningsen N, Honkavaara M, Naukkarinen V, Nordenström P, Sillanpää J
Department of Medicine, University Hospital, Lund, Sweden.
Cardiovasc Drugs Ther. 1994 Dec;8(6):845-9. doi: 10.1007/BF00877403.
Efficacy, tolerability, and optimal doses of felodipine ER (FER) and diltiazem SR (DSR), given as monotherapy, were evaluated in patients with mild or moderate primary hypertension.
This was a multicenter, double-blind, parallel-group study of 98 hypertensive patients. Following a 4 weeks placebo run-in period, patients were randomized to either FER 5 mg once daily (qd) or DSR 90 mg twice daily (bid). If supine DBP was > 90 mmHg after 2 and 4 weeks treatment, the dose was increased to 10 mg FER qd or 120 mg DSR bid plus 20 mg FER qd or 180 mg DSR bid, respectively. The double-blind treatment lasted 8 weeks.
After 8 weeks FER treatment 70% of the patients responded (DBP < or = 90 mmHg or DBP decrease > or = 10 mmHg) and 50% became normotensive (DBP < or = 90 mmHg); the corresponding figures for DSR were 63% and 37%, respectively. No statistical significant differences in BP reduction and HR were found between the two compounds. HR did not change during the study. Seven patients discontinued due to adverse events (AEs). Five patients received FER and two patients received DSR. The AEs were similar in the two groups and generally mild.
At the highest dose levels of FER and DSR, no further BP reduction was observed, but there was a tendency to report more AEs. Both FER and DSR can be used as first-line therapy in hypertension.
评估缓释非洛地平（FER）和缓释地尔硫䓬（DSR）单药治疗轻度或中度原发性高血压患者的疗效、耐受性及最佳剂量。
这是一项针对98例高血压患者的多中心、双盲、平行组研究。经过4周的安慰剂导入期后，患者被随机分为每日一次服用5 mg FER或每日两次服用90 mg DSR。如果治疗2周和4周后仰卧位舒张压>90 mmHg，则剂量分别增加至每日一次10 mg FER或每日两次120 mg DSR加每日一次20 mg FER或每日两次180 mg DSR。双盲治疗持续8周。
FER治疗8周后，70%的患者有反应（舒张压≤90 mmHg或舒张压下降≥10 mmHg），50%的患者血压恢复正常（舒张压≤90 mmHg）；DSR的相应数字分别为63%和37%。两种药物在血压降低和心率方面未发现统计学显著差异。研究期间心率未发生变化。7例患者因不良事件停药。5例患者服用FER，2例患者服用DSR。两组不良事件相似，且一般较轻。
在FER和DSR的最高剂量水平下，未观察到血压进一步降低，但报告的不良事件有增多趋势。FER和DSR均可作为高血压的一线治疗药物。
