open access

Vol 8, No 5 (2004)
Prace oryginalne
Published online: 2004-11-15
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Efficacy and tolerance of the indapamide (Tertensif SR) in patients with mild to moderate arterial hypertension

Jerzy Głuszek, Andrzej Tykarski, Renata Duda, Bernard Żołyniak
Nadciśnienie tętnicze 2004;8(5):327-337.

open access

Vol 8, No 5 (2004)
Prace oryginalne
Published online: 2004-11-15

Abstract

Background Multicentre randomized trials revealed high effectiveness of thiazide diuretics in decreasing blood pressure and reducing risk of cardiovascular complications of hypertension. The most common side effect of thiazides is hypokaliemia. Indapamide is well known for several years thiazide-like diuretic. Servier company worked up new technology of sustained-release indapamide with reduced dose 1.5 mg.
The aim of this study was to asses the effectiveness and tolerance of indapamide sustained release in treatment of patients with uncomplicated mild to moderate essential hypertension.
Material and methods This was a Polish, open multi-center trial. Patients were included to this program if systolic blood pressure (SBP) was in the range of 140–179 mm Hg and diastolic blood pressure (DBP) between 90–109 mm Hg.
We enrolled 1047 persons in the age range of 18–81 (the average age was 49.9 years). During the first 6 weeks patients received indapamid sustained release in dose 1.5 mg per day as the only antihypertensive treatment. Perindopril 4 mg daily was added after 6 weeks if the treatment with indapamid did not result in normalization or significant reduction of blood pressure (SBP decrease of at least 20 mm Hg and/or DBP decrease of at least 10 mm Hg).
Results Initial SBP was 157.6 ± 9.2 mm Hg and DBP 96.8 ± 5.5 mm Hg. The mean fall of SBP was 18.5 mm Hg after 6 weeks and 25.7 mm Hg after 12 weeks (p < 0,0001). The mean fall of DBP was 9.8 and 14.2 mm Hg (p < 0.0001) after 6 and 12 weeks respectively. Normalization of blood pressure after 12 weeks of treatment was noted in 772 patients (77.7% in subgroup ITT and 81.9% in subgroup PP) and additionally decrease of SBP by 20 mm Hg and DBP by 10 mm Hg in 175 persons (together 95.3% ITT and 96.6% PP). No serious adverse events were recorded during the study. Patients described indapamid SR tolerance as excellent for 80.1% of them. According to doctor’s opinion indapamide tolerance was even better — 92.3%.
Conclusions 1. Indapamid SR in dose 1.5 mg is an effective antihypertensive drug. Blood pressure was controlled or decreased significantly in 71.2% of hypertensive patients after 6 weeks of indapamide SR monotherapy. 2. After 12 weeks of therapy the decrease of blood pressure by 25.7/14.2 mm Hg was observed in the whole study population. Blood pressure was controlled or decreased significantly in 95.3% of hypertensive patients. 3. Indapamide SR in dose 1.5 mg was well tolerated in 99% of patients. Hypokaliemia was noted in 1.4% of patients after 12 weeks therapy.

Abstract

Background Multicentre randomized trials revealed high effectiveness of thiazide diuretics in decreasing blood pressure and reducing risk of cardiovascular complications of hypertension. The most common side effect of thiazides is hypokaliemia. Indapamide is well known for several years thiazide-like diuretic. Servier company worked up new technology of sustained-release indapamide with reduced dose 1.5 mg.
The aim of this study was to asses the effectiveness and tolerance of indapamide sustained release in treatment of patients with uncomplicated mild to moderate essential hypertension.
Material and methods This was a Polish, open multi-center trial. Patients were included to this program if systolic blood pressure (SBP) was in the range of 140–179 mm Hg and diastolic blood pressure (DBP) between 90–109 mm Hg.
We enrolled 1047 persons in the age range of 18–81 (the average age was 49.9 years). During the first 6 weeks patients received indapamid sustained release in dose 1.5 mg per day as the only antihypertensive treatment. Perindopril 4 mg daily was added after 6 weeks if the treatment with indapamid did not result in normalization or significant reduction of blood pressure (SBP decrease of at least 20 mm Hg and/or DBP decrease of at least 10 mm Hg).
Results Initial SBP was 157.6 ± 9.2 mm Hg and DBP 96.8 ± 5.5 mm Hg. The mean fall of SBP was 18.5 mm Hg after 6 weeks and 25.7 mm Hg after 12 weeks (p < 0,0001). The mean fall of DBP was 9.8 and 14.2 mm Hg (p < 0.0001) after 6 and 12 weeks respectively. Normalization of blood pressure after 12 weeks of treatment was noted in 772 patients (77.7% in subgroup ITT and 81.9% in subgroup PP) and additionally decrease of SBP by 20 mm Hg and DBP by 10 mm Hg in 175 persons (together 95.3% ITT and 96.6% PP). No serious adverse events were recorded during the study. Patients described indapamid SR tolerance as excellent for 80.1% of them. According to doctor’s opinion indapamide tolerance was even better — 92.3%.
Conclusions 1. Indapamid SR in dose 1.5 mg is an effective antihypertensive drug. Blood pressure was controlled or decreased significantly in 71.2% of hypertensive patients after 6 weeks of indapamide SR monotherapy. 2. After 12 weeks of therapy the decrease of blood pressure by 25.7/14.2 mm Hg was observed in the whole study population. Blood pressure was controlled or decreased significantly in 95.3% of hypertensive patients. 3. Indapamide SR in dose 1.5 mg was well tolerated in 99% of patients. Hypokaliemia was noted in 1.4% of patients after 12 weeks therapy.
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Keywords

hypotensive therapy; indapamide; thiazide diuretics

About this article
Title

Efficacy and tolerance of the indapamide (Tertensif SR) in patients with mild to moderate arterial hypertension

Journal

Arterial Hypertension

Issue

Vol 8, No 5 (2004)

Pages

327-337

Published online

2004-11-15

Bibliographic record

Nadciśnienie tętnicze 2004;8(5):327-337.

Keywords

hypotensive therapy
indapamide
thiazide diuretics

Authors

Jerzy Głuszek
Andrzej Tykarski
Renata Duda
Bernard Żołyniak

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