Long-term efficacy of a new, fixed, very-low-dose angiotensin-converting enzyme-inhibitor/diuretic combination as first-line therapy in elderly hypertensive patients

objective To determine the long-term efficacy and safety of a fixed, very-t ow-dose tablet combining one-half the standard dose of perindopril with one -quarter the standard dose of indapamide as first-line treatment in elderly patients. Design Double-blind, randomized, placebo-controlled study in an outpatient setting. Patients and interventions Following a single-blind, placebo run-in period of 4 weeks, patients [65-85 years, with mild-to-moderate essential hyperten sion or isolated systolic hypertension (ISH)] were randomized to receive on e tablet of perindopril 2 mg/indapamide 0.625 mg (Per/ind) (n = 193) or pla cebo (n = 190), daily for 12 weeks. After this first 12-week period, all pa tients on Per/Ind (n = 138) and patients responding to placebo (n = 61) wer e maintained on their previous regimen for a further 48 weeks. Patients in the placebo group whose blood pressure was not normalized, were switched to Per/Ind (n = 60). Main outcome measure The primary endpoint was the proportion of patients wi th blood pressure that normalized between weeks 0 and 60. Results After 1 year of treatment (intention-to-treat) supine systolic and diastolic blood pressure decreased by 23.0 +/- 15.3 mmHg and 13.3 +/- 9.4 m mHg with Per/Ind (n = 253: 193 from randomized Per/Ind group and 60 from th e placebo group switched at week 12), The mean decreases in systolic blood pressure were similar in essential hypertension and ISH (systolic blood pre ssure 23.2 versus 22.7 mmHg, respectively). Per/Ind treatment (n = 253) ach ieved an initial normalization of brood pressure in 96.2% [95% confidence i nterval (CI) 93.6-98.9%; Kaplan-Meier estimate] of Per/Ind-treated patients ; 79.8% (95% CI 74.1-85.5%) of these maintained a normalized blood pressure throughout the 1-year follow-up. The incidence of adverse events was simil arly low in the placebo and active therapy groups. Efficacy and safety resu lts for the over 75 years subgroup were similar to those for the younger el derly subjects. Conclusions The fixed, very low-dose combination of perindopril 2 mg/indapa mide 0.625 mg results in sustained blood pressure control when used as firs t line treatment of elderly hypertensive patients over 1-year, and is well- tolerated. J Hypertens 2000, 18:327-337 (C) Lippincott Williams & Wilkins.