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Efficacy of Indapamide 1.5 Mg, Sustained Release, in the Lowering of Systolic Blood Pressure

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Efficacy of Indapamide 1.5 Mg, Sustained Release, in the Lowering of Systolic Blood Pressure Journal of Human Hypertension (2004) 18, S9–S14 & 2004 Nature Publishing Group All rights reserved 0950-9240/04 $30.00 www.nature.com/jhh ORIGINAL ARTICLE Efficacy of indapamide 1.5 mg, sustained release, in the lowering of systolic blood pressure GM London Service de ne´phrologie, Hoˆpital Manhe`s, Ste Genevie`ve des Bois, France The relationship between the increase in blood pressure indapamide SR resulted in a better or equivalent control and the incidence of cardiovascular disease is well of SBP than treatment with a standard dose of a true recognized today. Studies have shown that more thiazide diuretic (hydrochlorothiazide), a calcium chan- attention should be paid to systolic blood pressure nel blocker (amlodipine), and an angiotensin-converting (SBP) in relation to cardiovascular risk and that enzyme inhibitor (enalapril). No therapeutic escape was therapeutic interventions should preferably focus on observed. All treatments showed good acceptability reducing SBP. The antihypertensive efficacy of indapa- with no unexpected adverse event. In conclusion, mide 1.5 mg sustained release (indapamide SR), a low- indapamide SR is very effective in lowering SBP—a dose thiazide-type diuretic, was assessed on SBP. Three major independent cardiovascular risk factor—notably randomized, double-blind, controlled studies were con- in hypertensive high-risk patients with LVH, the elderly ducted with indapamide SR, over a period of 3 to 12 and diabetics, when compared to major antihyperten- months. Elderly patients or patients with target-organ sive treatments. This SBP-lowering effect is maintained damage, hypertension and left ventricular hypertrophy over the long term. (LVH) (LIVE study) or with type II diabetes with micro- Journal of Human Hypertension (2004) 18, S9–S14. albuminuria (NESTOR study) showed a decrease in SBP doi:10.1038/sj.jhh.1001799 varying from 22.7 to 31.8 mmHg. The treatment with Keywords: systolic blood pressure; cardiovascular risk; indapamide 1.5 mg sustained release Introduction to the haemodynamic characteristics of the disease, which was attributed to a reduction in the calibre or The aim of this review is to assess the efficacy number of small arteries, with a resulting increase in of indapamide 1.5 mg sustained release (indapamide peripheral vascular resistance and the fact that SR; brand names: Natrilix SR, Natrilix LP, Natrilix increases in peripheral resistance was the principal Retard, Natrilix AP, Fludex LP, Fludex retard, haemodynamic cause of high BP. Peripheral resis- Fludex SR, Fludex 1.5 mg, Tertensif SR, Tertensif tance is a determinant of mean blood pressure retard, Arifon retard, Pretanix) on the reduction in (MBP) close to the level of DBP. Nevertheless, many systolic blood pressure (SBP) and to highlight its cross-sectional studies have shown that end-organ effect in hypertensive patients with diabetes, the damage in hypertensive people is more strongly elderly and patients with target-organ damage. associated to SBP. Furthermore, recent prospective epidemiological studies3,4 have directed attention to SBP as a better guide than DBP to evaluate Increasing importance of SBP cardiovascular and all-cause mortality. A meta- analysis of outcome trials has confirmed the over- Epidemiological studies have emphasized the close whelming importance of SBP as a determinant of relationship existing between the increase in blood risk.5 Studies have shown that drug treatment of pressure (BP) and the incidence and prevalence of hypertension frequently results in an adequate cardiovascular disease.1 In the past, the severity of control of DBP (p90 mmHg), whereas the ability to hypertension was classified principally on the basis control SBP (p140 mmHg) is achieved to a signifi- of diastolic blood pressure (DBP).2 This was related cantly smaller extent.4–7 Such studies have focused attention on the factors that determine the level of Correspondence: Dr GM London, Service de ne´phrologie, hoˆpital SBP and cardiovascular risk in hypertensive indivi- Manhe`s, 8 rue Roger Clavier, Fleury Merogis, 91712 Ste duals, and on therapeutic interventions preferably Genevie`ve des Bois, France. reducing SBP. Several therapeutic trials have SBP and indapamide 1.5 mg sustained release GM London S10 confirmed that SBP increases markedly with age SBP lowering in elderly patients while DBP8–10 becomes stable and even tends to fall spontaneously after the age of 50–60 years. In the After a 4-week, single-blind, placebo run-in period, Systolic Hypertension in the Elderly Program 524 patients with a mean age of 72.4 years and a study11 involving elderly subjects with isolated mean supine SBP/DBP of 174.5/97.9 mmHg (hyper- systolic hypertension (ISH), the reduction in cardio- tension criteria defined as 161 to 209 mmHg and vascular risk was associated with a decrease in below 110 mmHg for supine SBP and DBP, respec- SBP, whereas, in contrast, a decrease in DBP was tively) were included in this study. Of these, 128 associated with an increase in cardiovascular risk.12 patients had an ISH defined as 160oSBPo In the past few years, several authors13–15 have 210 mmHg and DBP o95 mmHg. All patients were clearly shown that brachial pulse pressure was also randomized for a 12-week treatment period with one a strong cardiovascular risk factor for myocardial of the three following active drugs: indapamide SR, infarction in populations of individuals with hyper- the calcium channel blocker amlodipine 5 mg or a 16 standard dose of the true thiazide diuretic hydro- tension. Furthermore, some studies have clearly 22 indicated that cardiovascular risk is related not only chlorothiazide 25 mg. An additional 12 months follow-up open period with indapamide SR was to an increase in SBP but also to a decrease in DBP. 23 Cardiovascular mortality was indeed substantially performed in the responder patients. reduced but, at the end of the trial, the population Results showed an equivalent antihypertensive was still characterized by a low DBP contrasting effect for the three treatment arms (equivalence with an elevated SBP. Taken together, these findings Po0.001); the mean decreases in SBP/DBP were indicate that, in elderly subjects treated for hyper- À22.7/À11.8 mmHg with indapamide SR; À22.2/ tension, the classic haemodynamic pattern of ISH is À10.7 mmHg with amlodipine 5 mg and À19.4/ still present despite adequate drug treatment.11 À10.8 mmHg with hydrochlorothiazide 25 mg, Figure 1. During the follow-up period, the efficacy of indapamide SR was maintained for a year. A Pathophysiological approach to reduction decrease in SBP/DBP of À26.3/À14.3 mmHg was in SBP observed in the 356 patients treated with indapa- mide SR, Figure 1. In the ISH subgroup, indapamide Medical treatment of hypertension usually results in SR is significantly more effective than hydro- parallel decline of SBP as well as DBP. Nevertheless, chlorothiazide 25 mg at reducing SBP (À24.7 vs as already stated previously, an adequate control is À18.5 mmHg, respectively; equivalence P ¼ 0.117), frequently achieved on DBP and to a significantly while similar results were obtained with amlodipine smaller extent on SBP.4–7 In the case of ISH, the 5mg (À23 mmHg, equivalence Po0.001). The nor- therapeutic goal is to obtain a preferential decrease malization rate was relatively high for indapamide in SBP while maintaining unchanged DBP. In SR (75.3%), when compared with amlodipine patients with essential hypertension, the Interna- (66.9%) and hydrochlorothiazide (67.3%). More- tional guidelines recommend the use of thiazide- over, in the subgroup of ISH patients, the normal- type diuretics in monotherapy or in combination; ization rate was as high as 84.2% in the indapamide they also highlight the need to select the lowest SR groups vs 80.0% for amlodipine and 71.4% for dosages.17,18 Other recommended pharmacological hydrochlorothiazide. classes of antihypertensive agents include beta- The most frequently reported clinical adverse blockers, diuretics, angiotensin converting enzyme effect was peripheral oedema with amlodipine (ACE) inhibitors, angiotensin II receptor antagonists (7.4%) and back pain with either hydrochlorothia- and calcium antagonists.19 zide (5.8%) or indapamide SR (1.5%). While diuretics are still regarded as the treatment of choice in elderly patients and those with systolic hypertension, not all drugs in this class have the SBP lowering in hypertensive patients with type II same efficacy.19 Indapamide SR, a thiazide-type diabetes—the NESTOR study diuretic, has shown activity in the elderly, as well Following a 4-week placebo run-in period, 570 type as in patients with left ventricular hypertrophy II diabetic hypertensive patients with microalbumi- (LVH) or type II diabetes mellitus.20,21 nuria were randomly allocated to receive either indapamide SR (n ¼ 284) or enalapril 10 mg Indapamide SR and SBP (n ¼ 286) once a day for a 1-year treatment period. An additional label treatment by amlodipine 5–10 mg Three large double-blind clinical trials assessing the (first step) and atenolol 50–100 mg (second step)/day effect of indapamide SR on SBP are reviewed. These was allowed after 6 weeks of treatment.24 studies have all been published and their methodol- Results showed that the decrease in SBP was ogy has already been thoroughly detailed. This significantly (P ¼ 0.02) more important with inda- review, therefore, mainly focuses on the results pamide SR (À23.8 mmHg) than with enalapril reported in various groups of hypertensive patients (À21.0 mmHg), Figure 2. The noninferiority of with major cardiovascular risk factors. indapamide SR vs enalapril was achieved for Journal of Human Hypertension SBP and indapamide 1.5 mg sustained release GM London S11 ∆ SBP INDAPAMIDE SR HCTZ AMLODIPINE INDAPAMIDE SR mm Hg n=178n=171 n=175 n=356 0 -19.4 -19 (15. 5) -20 -22.7 -22.2 -26.3 -21 (15 .4) (14 .4) (14 .9) -22 -23 -24 3 MONTHS -25 -26 -27 1 YEAR Figure 1 SBP lowering in the elderly hypertensive patients.
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