Hansson L, Forslund T, Höglund C, Istad H, Lederballe-Pedersen O, Kristinsson A, Segaard E, Svensson A, Aärynen M, Wahrenberg H, Wennersten G, Kjellström T
Department of Geriatrics, University of Uppsala, Sweden.
J Cardiovasc Pharmacol. 1996 Jul;28(1):1-5. doi: 10.1097/00005344-199607000-00001.
The new angiotensin-converting enzyme (ACE) inhibitor fosinopril was compared with the ACE inhibitor enalapril in a multicenter (n = 11), multinational (Denmark, Finland, Iceland, Norway, and Sweden), double-blind, randomized, parallel-group 24-week study in 195 patients with mild to moderate essential hypertension [supine diastolic blood pressure, (SDBP) > or = 95 to < or = 110 mm Hg]. After discontinuing all previous antihypertensive medication, patients were entered into a placebo lead-in period of 4-6 weeks, followed by 24 weeks of randomized treatment with the active compounds administered with a double-dummy technique. The dose of fosinopril was 20 mg, which could be increased to 40 mg after 8 weeks (average 25.6 mg); that of enalapril was 10 mg, which could be increased to 20 mg after 8 weeks (average 12.9 mg). Hydrochlorothiazide 12.5 mg could be added after 16 weeks and was administered to 27% of the patients in the fosinopril group and to 30% in the enalapril group. All drugs were administered once daily. Supine systolic BP (SSBP) decreased from 157 to 143 mm Hg in the fosinopril group (p < 0.01), and from 159 to 147 mm Hg in the enalapril group (p < 0.01). SSDP decreased from 100 to 89 mm Hg in the fosinopril group (p < 0.01) and from 100 to 92 mm Hg in the enalapril group (p < 0.01). Throughout the study period, fosinopril reduced SSBP and SDBP numerically more than did enalapril, by 0-3 mm Hg. Adverse events (AE) caused withdrawal of study medication in 8 patients in the fosinopril group and in 14 patients in the enalapril group (NS). The number of reported AE was not statistically different in the two groups. Inhibition of the ACE was assessed in a subgroup of patients (n = 26, 13 in each group). Fosinopril caused a greater inhibition of ACE at the doses used in the present study, which was statistically significant. Both fosinopril and enalapril caused statistically significant reductions in BP of a similar magnitude, and both agents were well tolerated. However, fosinopril was consistently numerically slightly more effective than enalapril in reducing BP. There were fewer withdrawals due to AE (NS) in the fosinopril group, and the overall recorded AE were fewer in the fosinopril group (NS).
在一项多中心（n = 11）、跨国（丹麦、芬兰、冰岛、挪威和瑞典）、双盲、随机、平行组的24周研究中，将新型血管紧张素转换酶（ACE）抑制剂福辛普利与ACE抑制剂依那普利进行了比较，研究对象为195例轻度至中度原发性高血压患者[仰卧位舒张压，（SDBP）≥95至≤110 mmHg]。在停用所有先前的抗高血压药物后，患者进入4 - 6周的安慰剂导入期，随后采用双模拟技术对活性化合物进行24周的随机治疗。福辛普利的剂量为20 mg，8周后可增至40 mg（平均25.6 mg）；依那普利的剂量为10 mg，8周后可增至20 mg（平均12.9 mg）。16周后可加用12.5 mg氢氯噻嗪，福辛普利组27%的患者和依那普利组30%的患者使用了该药物。所有药物均每日服用一次。福辛普利组仰卧位收缩压（SSBP）从157 mmHg降至143 mmHg（p < 0.01），依那普利组从159 mmHg降至147 mmHg（p < 0.01）。福辛普利组仰卧位舒张压（SSDP）从100 mmHg降至89 mmHg（p < 0.01），依那普利组从100 mmHg降至92 mmHg（p < 0.01）。在整个研究期间，福辛普利在数值上降低SSBP和SDBP的幅度比依那普利略大，相差0 - 3 mmHg。不良事件（AE）导致福辛普利组8例患者和依那普利组14例患者停用研究药物（无统计学差异）。两组报告的AE数量无统计学差异。在一组患者（n = 26，每组13例）中评估了ACE抑制情况。在本研究使用的剂量下，福辛普利对ACE的抑制作用更强，具有统计学意义。福辛普利和依那普利均使血压在统计学上显著降低，且降低幅度相似，两种药物耐受性均良好。然而，在降低血压方面，福辛普利在数值上始终比依那普利略有效。福辛普利组因AE导致的停药较少（无统计学差异），且福辛普利组总体记录的AE较少（无统计学差异）。
