Wb. White et M. Stimpel, LONG-TERM SAFETY AND EFFICACY OF MOEXIPRIL ALONE AND IN COMBINATION WITH HYDROCHLOROTHIAZIDE IN ELDERLY PATIENTS WITH HYPERTENSION, Journal of human hypertension, 9(11), 1995, pp. 879-884
The purpose of this study was to evaluate the long-term safety and eff
icacy of moexipril, a non-sulphydryl angiotensin converting enzyme inh
ibitor, alone or in combination with hydrochlorothiazide in older pati
ents with hypertension. One hundred and seventy two hypertensive men a
nd women, 65-80 years old, with seated DBP between 95 and 114 mm Hg we
re studied. The study was a 2 year, multicentre (12 centres), open-lab
el protocol of moexipril monotherapy or combination therapy (with hydr
ochlorothiazide). Blood pressure, pulse rate, weight, adverse effects
and laboratory studies were assessed following moexipril at 7.5 or 15
mg once daily or 7.5 or 15 mg daily in combination with 25 mg of hydro
chlorothiazide if the seated DBP remained greater than or equal to 90
mm Hg on moexipril monotherapy. The primary measure of efficacy was a
change from baseline in seated DBP. Secondary outcome measures include
d changes in seated DBP, pulse rate, laboratory parameters and adverse
side-effects. Following 1 year of therapy in 135 patients, the BP fel
l 16/14 mm Hg among patients receiving moexipril monotherapy and 27/17
mm Hg for those receiving combined therapy compared with baseline (P
< 0.001 for both). After 2 years of treatment, reductions were similar
in 120 patients. Nineteen patients (11%) were prematurely withdrawn f
rom the study because of inadequate therapeutic response and 28 (16%)
because of adverse experiences. There were no significant changes in p
ulse rate or postural reductions in BP on either moexipril monotherapy
or combination treatment. Three adverse side-effects occurred at a fr
equency exceeding 2% that were possibly or probably attributable to mo
exipril or combination therapy: hypotension (2%), dizziness (6%) and i
ncreased cough (12%). There were no clinically relevant mean group cha
nges from baseline laboratory values in the treatment groups. In concl
usion, these long-term data demonstrate that moexipril, either alone o
r in combination with hydrochlorothiazide, has long-term anti-hyperten
sive efficacy and is generally well tolerated in elderly patients with
hypertension.