A COMPARISON OF FOSINOPRIL AND HYDROCHLOROTHIAZIDE WITH HYDROCHLOROTHIAZIDE IN NON-INSULIN-DEPENDENT DIABETES-MELLITUS PATIENTS WITH MILD-TO-MODERATE HYPERTENSION
R. Saini et al., A COMPARISON OF FOSINOPRIL AND HYDROCHLOROTHIAZIDE WITH HYDROCHLOROTHIAZIDE IN NON-INSULIN-DEPENDENT DIABETES-MELLITUS PATIENTS WITH MILD-TO-MODERATE HYPERTENSION, Clinical drug investigation, 15(1), 1998, pp. 21-28
A multicentre, randomised, double-blind, parallel-group study of the t
olerability and antihypertensive efficacy of once-daily fosinopril 20
mg/hydrochlorothiazide 12.5mg (FOS/HCTZ) compared with once-daily hydr
ochlorothiazide 25mg (HCTZ) was conducted in 142 patients with non-ins
ulin-dependent diabetes mellitus (NIDDM) and mild to moderate essentia
l hypertension. After 12 weeks of treatment, both groups had statistic
ally significant mean changes from baseline in seated diastolic and sy
stolic blood pressures (FOS/HCTZ, -15.0mm Hg; HCTZ, -11.9mm Hg for sea
ted 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 pa
tients compared with 71% of HCTZ patients. A statistically significant
difference (p < 0.05) in favour of FOS/HCTZ was observed for the tota
l number of favourable responses (normalisation or greater than or equ
al to 10mm Hg reduction in seated diastolic blood pressure) at week 12
and for the end-point analysis. One FOS/HCTZ patient and 5 HCTZ patie
nts discontinued treatment because of adverse events. No clinically si
gnificant changes in serum glucose, potassium or cholesterol were obse
rved. A slight but statistically significant increase in fasting trigl
ycerides occurred with FOS/HCTZ compared with HCTZ (+26.1 vs +13.5 mg/
dl, respectively; p < 0.05). These results show that the combination o
f fosinopril and hydrochlorothiazide has considerable potential as an
effective antihypertensive regimen that does not significantly alter g
lucose or lipid metabolism in patients with NIDDM.