Clinical Drug Investigation

, Volume 20, Issue 5, pp 371–384


A Review of the Evidence of its Benefits in Hypertension and Acute Myocardial Infarction
  • Claudio Borghi
  • Ettore Ambrosioni
Clinical Review

DOI: 10.2165/00044011-200020050-00008

Cite this article as:
Borghi, C. & Ambrosioni, E. Clin. Drug Investig. (2000) 20: 371. doi:10.2165/00044011-200020050-00008


The efficacy and tolerability of zofenopril in the treatment of essential hypertension have been evaluated in four well-designed trials. In a dose-finding study (zofenopril 7.5 to 60 mg/day) dosages >7.5 mg/day were significantly more effective than placebo in reducing 24-hour ambulatory blood pressure (BP). In three comparative studies, zofenopril 30 to 60 mg/day once daily was as effective as atenolol 50 to 100 mg/day, amlodipine 5 to 10 mg/day and enalapril 20 to 40 mg/day when assessed by reductions in diastolic BP. In general, adverse effects reported for zofenopril were class specific, mild and transient, and rarely required drug withdrawal.

Two major controlled trials evaluated the efficacy and tolerability of zofenopril in the treatment of myocardial infarction (MI). The Survival of Myocardial Infarction Long term Evaluation (SMILE) trial assessed 6 weeks’ zofenopril treatment in 1556 patients with anterior acute (<24 hours from symptoms) MI not receiving thrombolytic therapy. Zofenopril significantly reduced the relative risk for the incidence of death or severe congestive heart failure (CHF) at 6 weeks by 32.7% (95% CI = 6.8 to 51.4%) compared with placebo. Mortality at 12 months was also significantly reduced in zofenopril versus placebo recipients, indicating that the benefits of zofenopril therapy extended beyond treatment end. Hypotension was more frequent in zofenopril than in placebo recipients (17.1 vs 8.9%; p < 0.001). In the SMILE-II trial, the tolerability and efficacy of zofenopril versus lisinopril for 6 weeks were compared in patients with MI receiving thrombolytic therapy (n = 1024). The incidence of severe hypotension was similar between zofenopril and lisinopril recipients (10.9 vs 11.7%), but this event was considered by the investigators to be related to the study medication in a significantly lower percentage of zofenopril versus lisinopril recipients (6.7 vs 9.8%; p< 0.05).

In conclusion, these findings indicate that zofenopril is at least as effective and well tolerated as many other antihypertensive drugs in the treatment of essential hypertension. On the strength of its anti-ischaemic properties (as shown by its efficacy in acute MI), it should be particularly suitable for the treatment of patients with myocardial ischaemia

Copyright information

© Adis International Limited 2000

Authors and Affiliations

  • Claudio Borghi
    • 1
  • Ettore Ambrosioni
    • 1
  1. 1.Department of Internal MedicineUniversity of BolognaBolognaItaly
  2. 2.Clinica Medica 3rd, Policlinico S. OrsolaBolognaItaly