Berdah J, Guest M, Salvador M
Unité Thérapeutique Cardio-vasculaire, Lipha-Santé, Lyon.
Ann Cardiol Angeiol (Paris). 1998 Mar;47(3):169-75.
The efficacy and good safety of fosinopril, an angiotensin converting enzyme inhibitor recently made available to the medical profession in France, has been demonstrated by several controlled studies versus placebo and reference antihypertensives. A phase IV multicentre clinical trial was conducted among general practitioners in order to assess, on a larger scale and under conditions of daily practice, the results obtained in terms of blood pressure control and quality of life as well as the clinical and laboratory safety of the drug. This analysis was based on 19,435 hypertensive patients, 989 of whom were over the age of 75 years, followed for 12 weeks after introduction of fosinopril either as monotherapy or in combination with the antihypertensive treatment(s) already prescribed. Under these conditions, after 12 weeks of treatment, blood pressure was controlled in 79.8% of patients, with improvement of all items of the quality of life scale. The very low incidence of clinical and laboratory adverse events, even among the oldest patients, confirms the safety of use of fosinopril, predictive of good long-term compliance with treatment.
福辛普利是一种血管紧张素转换酶抑制剂，最近已在法国投入医疗行业使用。多项对照研究将其与安慰剂及其他参考抗高血压药物进行比较，证实了福辛普利的疗效和良好安全性。开展了一项IV期多中心临床试验，受试者为全科医生，目的是在更大规模和日常医疗条件下，评估在血压控制、生活质量方面所取得的结果以及该药物的临床和实验室安全性。该分析基于19435例高血压患者，其中989例年龄超过75岁，在采用福辛普利单药治疗或与已开具的抗高血压治疗联合用药后，随访12周。在这些条件下，治疗12周后，79.8%的患者血压得到控制，生活质量量表的所有项目均有改善。临床和实验室不良事件的发生率极低，即使在年龄最大的患者中也是如此，这证实了使用福辛普利的安全性，预示着长期治疗依从性良好。
