Very-low-dose perindopril 2 mg/indapamide 0.625 mg achieved sustained blood pressure normalization over 1 year in 79.8% (95% CI 74.1-85.5%) of elderly hypertensive patients.
RCT (n=383)
Double-blind
randomized
Does a fixed very-low-dose combination of perindopril and indapamide improve blood pressure normalization in elderly patients with mild-to-moderate hypertension?
A fixed, very-low-dose combination of perindopril and indapamide is effective and well-tolerated for long-term blood pressure control as first-line therapy in elderly hypertensive patients.
OBJECTIVE: To determine the long-term efficacy and safety of a fixed, very-low-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 hypertension or isolated systolic hypertension (ISH) were randomized to receive one tablet of perindopril 2 mg/indapamide 0.625 mg (Per/ Ind) (n=193) or placebo (n=190), daily for 12 weeks. After this first 12-week period, all patients on Per/Ind (n=138) and patients responding to placebo (n=61) were 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 with 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 +/- 94 mmHg with Per/Ind (n=253: 193 from randomized Per/Ind group and 60 from the placebo group switched at week 12). The mean decreases in systolic blood pressure were similar in essential hypertension and ISH (systolic blood pressure 23.2 versus 22.7 mmHg, respectively). Per/Ind treatment (n=253) achieved an initial normalization of blood pressure in 96.2% 95% confidence interval (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 similarly low in the placebo and active therapy groups. Efficacy and safety results for the over 75 years subgroup were similar to those for the younger elderly subjects CONCLUSIONS: The fixed, very low-dose combination of perindopril 2 mg/indapamide 0.625 mg results in sustained blood pressure control when used as first line treatment of elderly hypertensive patients over 1-year, and is well-tolerated.
Chalmers et al. (Wed,) conducted a rct in mild-to-moderate essential hypertension or isolated systolic hypertension (n=383). perindopril/indapamide vs. placebo was evaluated on proportion of patients with blood pressure that normalized between weeks 0 and 60 (95% CI 74.1-85.5). Very-low-dose perindopril 2 mg/indapamide 0.625 mg achieved sustained blood pressure normalization over 1 year in 79.8% (95% CI 74.1-85.5%) of elderly hypertensive patients.