FOSINOPRIL VERSUS ENALAPRIL IN THE TREATMENT OF HYPERTENSION - A DOUBLE-BLIND-STUDY IN 195 PATIENTS

The new angiotensin-converting enzyme (ACE) inhibitor fosinopril was c ompared with the ACE inhibitor enalapril in a multicenter (n = 11), mu ltinational (Denmark, Finland, Iceland, Norway, and Sweden), double-bl ind, randomized, parallel-group 24-week study in 195 patients with mil d to moderate essential hypertension [supine diastolic blood pressure, (SDBP) greater than or equal to 95 to less than or equal to 110 mm Hg ]. After discontinuing all previous antihypertensive medication, patie nts were entered into a placebo lead-in period of 4-6 weeks, followed by 24 weeks of randomized treatment with the active compounds administ ered 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); tha t of enalapril was 10 mg, which could be increased to 20 mg after 8 we eks (average 12.9 mg). Hydrochlorothiazide 12.5 mg could be added afte r 16 weeks and was administered to 27% of the patients in the fosinopr il group and to 30% in the enalapril group. All drugs were administere d once daily. Supine systolic BP (SSBP) decreased from 157 to 143 mm H g 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 th e fosinopril group (p < 0.01) and from 100 to 92 mm Hg in the enalapri l group (p < 0.01). Throughout the study period, fosinopril reduced SS BP and SDBP numerically more than did enalapril, by 0-3 mm Hg. Adverse events (AE) caused withdrawal of study medication in 8 patients in th e fosinopril group and in 14 patients in the enalapril group (NS). The number of reported AE was not statistically different in the two grou ps. Inhibition of the ACE was assessed in a subgroup of patients (n = 26, 13 in each group). Fosinopril caused a greater inhibition of ACE a t the doses used in the present study, which was statistically signifi cant. Both fosinopril and enalapril caused statistically significant r eductions in BP of a similar magnitude, and both agents were well tole rated. However, fosinopril was consistently numerically slightly more effective than enalapril in reducing EP. There were fewer withdrawals due to AE (NS) in the fosinopril group, and the overall recorded AE we re fewer in the fosinopril group (NS).