A comparison of fosinopril and hydrochlorothiazide with hydrochlorothiazide in non-insulin-dependent diabetes mellitus patients with mild to moderate hypertension.

A multicentre, randomised, double-blind, parallel-group study of the tolerability and antihypertensive efficacy of once-daily fosinopril 20 mg/hydrochlorothiazide 12.5mg (FOS/HCTZ) compared with once-daily hydrochlorothiazide 25mg (HCTZ) was conducted in 142 patients with non-insulin-dependent diabetes mellitus (NIDDM) and mild to moderate essential hypertension. After 12 weeks of treatment, both groups had statistically significant mean changes from baseline in seated diastolic and systolic blood pressures (FOS/HCTZ, -15.0mm Hg; HCTZ, -11.9mm Hg for seated diastolic blood pressure). The difference between treatment groups was statistically significant (p < 0.001). In addition, normalisation of seated diastolic blood pressure was achieved in 85% of FOS/HCTZ patients compared with 71% of HCTZ patients. A statistically significant difference (p < 0.05) in favour of FOS/HCTZ was observed for the total number of favourable responses (normalisation or >/=10mm Hg reduction in seated diastolic blood pressure) at week 12 and for the end-point analysis. One FOS/HCTZ patient and 5 HCTZ patients discontinued treatment because of adverse events. No clinically significant changes in serum glucose, potassium or cholesterol were observed. A slight but statistically significant increase in fasting triglycerides occurred with FOS/HCTZ compared with HCTZ (+26.1 vs +13.5 mg/dl, respectively; p < 0.05). These results show that the combination of fosinopril and hydrochlorothiazide has considerable potential as an effective antihypertensive regimen that does not significantly alter glucose or lipid metabolism in patients with NIDDM.

RCT Entities:   Population Interventions Outcomes