Mion Júnior D, Lima Júnior E, Almeida F A, Chaves H, Rocha J C, Nicolau J C, Saragoça M, Spritzer N, Kohlmann Júnior O, Luna R L
Hospital das Clínicas da USP, SP.
Arq Bras Cardiol. 1993 Mar;60(3):203-8.
To evaluate during 12 weeks the effectiveness and safety of once-a-day fosinopril (10 or 20 mg/day comparative to placebo) in mild to moderate hypertensives according to an open design comparative to placebo.
One hundred and nineteen patients were studied; 52 +/- 11 years (mean +/- sd) range 18 a 76 years, 86 women and 33 men, 57% whites, 26% blacks and 17% mulattos, 71 mild hypertensives (95 < or = diastolic pressure < or = 104mmHg) e 48 moderate hypertensives (101 < diastolic pressure < or = 115mmHg).
There was a significant reduction in systolic/diastolic pressure on the 6th week of treatment (from 161 +/- 16/103 +/- 7 before to 148 +/- 16/94 +/- 9mmHg on the 6th week). On the 12th week of treatment there was an additional significant reduction in systolic/diastolic pressure (from 148 +/- 16/94 +/- 9 on the 6th week to 145 +/- 17/89 +/- 8mmHg on the 12th week). There was a "favorable" response in 71% of the patients on the 12th week; 62% showed diastolic pressure < or = 90mmHg and 9% presented diastolic reduction > or = 10mmHg. There was no difference in the normalization rates between whites and non-whites, mild and moderate hypertensive, obese and non-obese patients, under or above 50 years of age and those patients from no drug-treatment to those on 3 drug before the study. There was no clinically relevant changes in laboratory evaluations before and at the end of the study. The number of adverse reactions was reduced in comparison with previous treatment.
Fosinopril, according to our and others data, is effective and safe for the treatment of mild to moderate hypertensives, in whites or non-whites, obese or non-obese, younger or older than 50 years and receiving 0 or 3 drugs before the study.
按照开放设计,对比安慰剂,评估在12周内每日一次服用福辛普利(10毫克/天或20毫克/天)对轻度至中度高血压患者的有效性和安全性。
研究了119名患者;年龄52±11岁(均值±标准差),范围为18至76岁,女性86名,男性33名,57%为白人,26%为黑人,17%为混血儿,71名轻度高血压患者(舒张压95≤或=104mmHg)和48名中度高血压患者(舒张压101<或=115mmHg)。
治疗第6周时收缩压/舒张压显著降低(从治疗前的161±16/103±7降至第6周时的148±16/94±9mmHg)。治疗第12周时收缩压/舒张压进一步显著降低(从第6周时的148±16/94±9降至第12周时的145±17/89±8mmHg)。第12周时71%的患者有“良好”反应;62%的患者舒张压≤或=90mmHg,9%的患者舒张压降低≥或=10mmHg。白人与非白人、轻度与中度高血压患者、肥胖与非肥胖患者、50岁以下与50岁以上患者以及研究前未接受药物治疗与接受3种药物治疗的患者之间的血压正常化率无差异。研究前和研究结束时实验室评估无临床相关变化。与先前治疗相比,不良反应数量减少。
根据我们和其他研究数据,福辛普利对治疗轻度至中度高血压患者有效且安全,无论患者是白人或非白人、肥胖或非肥胖、年龄小于或大于50岁,以及在研究前接受0种或3种药物治疗。