TOLERABILITY AND EFFICACY OF FOSINOPRIL AND HYDROCHLOROTHIAZIDE COMPARED WITH AMILORIDE AND HYDROCHLOROTHIAZIDE IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

This 6-month multicentre, randomised, double-blind, parallel group cli nical trial compared the tolerability and antihypertensive efficacy of a once-daily combination of fosinopril 20mg/hydrochlorothiazide 12.5m g (FOS/HCTZ) with a combination of amiloride 5mg/hydrochlorothiazide 5 0mg (AMI/HCTZ) in 217 patients with mild to moderate essential hyperte nsion. Adverse events related to hypotension or to specifically target ed clinical laboratory values were observed infrequently with FOS/HCTZ compared with AMI/HCTZ: with FOS/HCTZ, only 4 of 104 patients (3.9%) experienced such events, compared with 16 of 113 (14.1%) in the AMI/HC TZ group (p < 0.001). While statistically significant differences were found between the two treatment groups for changes from baseline in s erum potassium, cholesterol, triglyceride and glucose values, the meta bolic profile was uniformly unfavourable towards the AMI/HCTZ group; f or example, reductions in potassium and elevations in cholesterol, tri glyceride and glucose were more pronounced with the AMI/HCTZ group tha n with the FOS/HCTZ group. Both antihypertensive regimens produced sta tistically significant reductions from baseline in seated diastolic bl ood pressure that were equivalent at most points of measurement during double-blind treatment. Therapeutic response rates were high (greater than or equal to 95%) and were similar for both regimens throughout t he study. Because the relative risk for adverse events was markedly le ss over the long term with FOS/HCTZ than with AMI/HCTZ, the combinatio n of fosinopril and hydrochlorothiazide may offer significant tolerabi lity advantages over amiloride plus hydrochlorothiazide for such patie nts.