Long-term safety and efficacy of moexipril alone and in combination with hydrochlorothiazide in elderly patients with hypertension

Abstract

The purpose of this study was to evaluate the long-term safety and efficacy of moexipril, a non-sulphydryl angiotensin converting enzyme inhibitor, alone or in combination with hydrochlorothiazide in older patients with hypertension. One hundred and seventy two hypertensive men and women, 65-80 years old, with seated DBP between 95 and 114 mm Hg were studied. The study was a 2 year, multicentre (12 centres), open-label protocol of moexipril monotherapy or combination therapy (with hydrochlorothiazide). 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 hydrochlorothiazide if the seated DBP remained > or = 90 mm Hg on moexipril monotherapy. The primary measure of efficacy was a change from baseline in seated DBP. Secondary outcome measures included changes in seated DBP, pulse rate, laboratory parameters and adverse side-effects. Following 1 year of therapy in 135 patients, the BP fell 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 Nineteen patients (11%) were prematurely withdrawn from the study because of inadequate therapeutic response and 28 (16%) because of adverse experiences. There were no significant changes in pulse rate or postural reductions in BP on either moexipril monotherapy or combination treatment. Three adverse side-effects occurred at a frequency exceeding 2% that were possibly or probably attributable to moexipril or combination therapy: hypotension (2%), dizziness (6%) and increased cough (12%). There were no clinically relevant mean group changes from baseline laboratory values in the treatment groups. In conclusion, these long-term data demonstrate that moexipril, either alone or in combination with hydrochlorothiazide, has long-term anti-hypertensive efficacy and is generally well tolerated in elderly patients with hypertension.