LONG-TERM SAFETY AND EFFICACY OF MOEXIPRIL ALONE AND IN COMBINATION WITH HYDROCHLOROTHIAZIDE IN ELDERLY PATIENTS WITH HYPERTENSION

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 Nineteen patients (11%) were prematurely withdrawn f rom the study because of inadequate therapeutic response and 28 (16%) because of adverse experiences.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.