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Erschienen in: Drugs 2/2000

01.04.2000 | Review Article

Clinical Positioning of Indapamide Sustained Release 1.5mg in Management Protocols for Hypertension

verfasst von: Professor Gastone Leonetti

Erschienen in: Drugs | Sonderheft 2/2000

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Abstract

Indapamide sustained release (SR) 1.5mg is a new galenic formulation that is characterised by a relatively constant plasma concentration at steady state, with only minor fluctuations during the 24-hour period.
A dose-titration study of 3 doses of indapamide SR (1.5, 2 and 2.5mg) given once daily has shown that the 3 dosages are equipotent in lowering blood pressure, and have an effect similar to that of indapamide immediate-release (IR) 2.5mg; all were statistically more effective than placebo. The percentage of hypertensive patients whose serum potassium was less than 3.4 mmol/L was significantly lower after indapamide SR 1.5mg than after indapamide IR 2.5mg. Neither indapamide formulation had any significant effects on lipid profile, glucose, urea and serum creatinine; only uric acid was slightly raised during the 2-month study.
In an equivalence study, indapamide SR 1.5mg and IR 2.5mg produced similar blood pressure reductions (within the equivalence limit of ±5mm Hg), whereas the percentage of patients whose serum potassium fell to less than 3.4 mmol/L was lower in the IR 1.5mg group than in the SR 2.5mg group.
Antihypertensive treatment with indapamide SR 1.5mg once daily produced reductions in blood pressure in elderly patients with systolic/diastolic or isolated systolic hypertension that were similar to reductions with amlodipine 5 mg/day.
The incidence of adverse effects was very low in all studies with indapamide SR 1.5mg and very similar to that in the placebo group, confirming thereby the improvement in the efficacy : tolerance ratio with the new indapamide compound.
Literatur
1.
Zurück zum Zitat Hollander W, Wilkins RW. Chlorothiazide: a new type of drug for the treatment of hypertension. BMQ 1957; 8: 68–75 Hollander W, Wilkins RW. Chlorothiazide: a new type of drug for the treatment of hypertension. BMQ 1957; 8: 68–75
2.
Zurück zum Zitat Weil JV, Chidsey CA. Plasma volume expansion resulting from interference with adrenergic function in normal man. Circulation 1968; 37: 54–61PubMedCrossRef Weil JV, Chidsey CA. Plasma volume expansion resulting from interference with adrenergic function in normal man. Circulation 1968; 37: 54–61PubMedCrossRef
3.
Zurück zum Zitat Finnerty Jr FA, Davidov M, Mroczek WJ, et al. Influence of extracellular fluid volume on response to antihypertensive drugs. Circ Res 1970; 26 Suppl. 1: 71–80CrossRef Finnerty Jr FA, Davidov M, Mroczek WJ, et al. Influence of extracellular fluid volume on response to antihypertensive drugs. Circ Res 1970; 26 Suppl. 1: 71–80CrossRef
4.
Zurück zum Zitat Veterans Administration Cooperative Study Group on Anti-hypertensive Agents. Effects of treatment on morbidity in hypertension. Results in patients with diastolic averaging 115 through 129 mmHg. JAMA 1967; 202: 1028–34 Veterans Administration Cooperative Study Group on Anti-hypertensive Agents. Effects of treatment on morbidity in hypertension. Results in patients with diastolic averaging 115 through 129 mmHg. JAMA 1967; 202: 1028–34
5.
Zurück zum Zitat MacMahon S, Rodgers A. The effects of blood pressure reduction in older patients: an overview of five randomized controlled trials in elderly hypertensives. Clin Exp Hypertens 1993; 15: 967–78PubMedCrossRef MacMahon S, Rodgers A. The effects of blood pressure reduction in older patients: an overview of five randomized controlled trials in elderly hypertensives. Clin Exp Hypertens 1993; 15: 967–78PubMedCrossRef
6.
Zurück zum Zitat The fifth report of the Joint National Committee on detection, evaluation and treatment of high blood pressure (JNC V). Arch Intern Med 1993; 153(2): 154–83CrossRef The fifth report of the Joint National Committee on detection, evaluation and treatment of high blood pressure (JNC V). Arch Intern Med 1993; 153(2): 154–83CrossRef
7.
Zurück zum Zitat The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure (JNC VI). Arch Intern Med 1997; 157(21): 2413–46CrossRef The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure (JNC VI). Arch Intern Med 1997; 157(21): 2413–46CrossRef
8.
Zurück zum Zitat MacMahon S, Peto R, Cutler J, et al. Blood pressure, stroke, and coronary heart disease. Part 1, Prolonged differences in blood pressure: prospective observational studies corrected for regression dilution bias. Lancet 1990; 335: 765–74 MacMahon S, Peto R, Cutler J, et al. Blood pressure, stroke, and coronary heart disease. Part 1, Prolonged differences in blood pressure: prospective observational studies corrected for regression dilution bias. Lancet 1990; 335: 765–74
9.
Zurück zum Zitat Kaplan NM. Treatment of hypertension: rationale and goals. In: Kaplan NM, editor. Clinical hypertension. 6th ed. Baltimore: Williams & Wilkins, 1994: 145–70 Kaplan NM. Treatment of hypertension: rationale and goals. In: Kaplan NM, editor. Clinical hypertension. 6th ed. Baltimore: Williams & Wilkins, 1994: 145–70
10.
Zurück zum Zitat McVeigh G, Galloway D, Johnston D. The case for low dose diuretics in hypertension: comparison of low and conventional doses of cyclopenthiazide. BMJ 1988; 297: 95–8PubMedCrossRef McVeigh G, Galloway D, Johnston D. The case for low dose diuretics in hypertension: comparison of low and conventional doses of cyclopenthiazide. BMJ 1988; 297: 95–8PubMedCrossRef
11.
Zurück zum Zitat Carlsen JE, Kober L, Torp-Pederson C, et al. Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects. BMJ 1990; 300: 975–8PubMedCrossRef Carlsen JE, Kober L, Torp-Pederson C, et al. Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects. BMJ 1990; 300: 975–8PubMedCrossRef
12.
Zurück zum Zitat Johnston GD, Wilson R, McDermott BJ, et al. Low-dose cyclopenthiazide in the treatment of hypertension: a one-year community-based study. Q JMed 1991; 78: 135–43 Johnston GD, Wilson R, McDermott BJ, et al. Low-dose cyclopenthiazide in the treatment of hypertension: a one-year community-based study. Q JMed 1991; 78: 135–43
13.
Zurück zum Zitat Harper R, Ennis CN, Sheridan B, et al. Effects of low dose versus conventional dose thiazide diuretic on insulin action in essential hypertension. BMJ 1994; 309: 226–30PubMedCrossRef Harper R, Ennis CN, Sheridan B, et al. Effects of low dose versus conventional dose thiazide diuretic on insulin action in essential hypertension. BMJ 1994; 309: 226–30PubMedCrossRef
14.
Zurück zum Zitat Hall WD, Weber MA, Ferdinand K, et al. Lower dose diuretic therapy in the treatment of patients with mild to moderate hypertension. J Hum Hypertens 1994; 8: 571–5PubMed Hall WD, Weber MA, Ferdinand K, et al. Lower dose diuretic therapy in the treatment of patients with mild to moderate hypertension. J Hum Hypertens 1994; 8: 571–5PubMed
15.
Zurück zum Zitat Andren L, Weiner L, Svensson A, et al. Enalapril with either a ‘very low’ or ‘low’ dose of hydrochlorothiazide is equally effective in essential hypertension. A double-blind trial in 100 hypertensive patients. J Hypertens 1983; 1 Suppl. 2: 384–6 Andren L, Weiner L, Svensson A, et al. Enalapril with either a ‘very low’ or ‘low’ dose of hydrochlorothiazide is equally effective in essential hypertension. A double-blind trial in 100 hypertensive patients. J Hypertens 1983; 1 Suppl. 2: 384–6
16.
Zurück zum Zitat Frishman WH, Bryzinski BS, Coulson LR, et al. A multifactorial trial design to assess combination therapy in hypertension. Arch Intern Med 1994; 154: 1461–8PubMedCrossRef Frishman WH, Bryzinski BS, Coulson LR, et al. A multifactorial trial design to assess combination therapy in hypertension. Arch Intern Med 1994; 154: 1461–8PubMedCrossRef
17.
Zurück zum Zitat Yakovlevitch M, Black HR. Resistant hypertension in tertiary care clinic. Arch Intern Med 1991; 151: 1786–92PubMedCrossRef Yakovlevitch M, Black HR. Resistant hypertension in tertiary care clinic. Arch Intern Med 1991; 151: 1786–92PubMedCrossRef
18.
Zurück zum Zitat 1993 guidelines for the management of mild hypertension. Memorandum from a World Health Organization/International Society of Hypertension Meeting. Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. Hypertension 1993; 22(3): 392–403 1993 guidelines for the management of mild hypertension. Memorandum from a World Health Organization/International Society of Hypertension Meeting. Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. Hypertension 1993; 22(3): 392–403
19.
Zurück zum Zitat Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomized drug trials in their epidemiological context. Lancet 1990; 335: 827–38 Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomized drug trials in their epidemiological context. Lancet 1990; 335: 827–38
20.
Zurück zum Zitat SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug-treatment in older persons with isolated systolic hypertension. JAMA 1991; 265: 3255–64CrossRef SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug-treatment in older persons with isolated systolic hypertension. JAMA 1991; 265: 3255–64CrossRef
21.
Zurück zum Zitat Medical Research Council trial of treatment of hypertension in older adults: principal results. BMJ 1992; 304: 405–12CrossRef Medical Research Council trial of treatment of hypertension in older adults: principal results. BMJ 1992; 304: 405–12CrossRef
22.
Zurück zum Zitat Leonetti G, Rappelli A, Salvetti A, et al. Long-term effects of indapamide: final results of a 2-year Italian multicenter study in systemic hypertension. Am J Cardiol 1990; 65: 67H-71CrossRef Leonetti G, Rappelli A, Salvetti A, et al. Long-term effects of indapamide: final results of a 2-year Italian multicenter study in systemic hypertension. Am J Cardiol 1990; 65: 67H-71CrossRef
23.
Zurück zum Zitat Chaffman M, Heel RC, Brodgen RN, et al. Indapamide: a review of its pharmacodynamic properties and therapeutic efficacy in hypertension. Drugs 1988; 28: 121–249 Chaffman M, Heel RC, Brodgen RN, et al. Indapamide: a review of its pharmacodynamic properties and therapeutic efficacy in hypertension. Drugs 1988; 28: 121–249
24.
Zurück zum Zitat Senior R, Imbs JL, Bory M, et al. Indapamide reduces hypertensive left ventricular hypertrophy: an international multicenter study. J Cardiovasc Pharmacol 1993; 22 Suppl. 6: S106–10PubMed Senior R, Imbs JL, Bory M, et al. Indapamide reduces hypertensive left ventricular hypertrophy: an international multicenter study. J Cardiovasc Pharmacol 1993; 22 Suppl. 6: S106–10PubMed
25.
Zurück zum Zitat Carey PA, Sheridan DJ, de Cordoue A, et al. Effect of indapamide on left ventricular hypertrophy in hypertension: a meta-analysis. Am J Cardiol 1996; 17B–9 Carey PA, Sheridan DJ, de Cordoue A, et al. Effect of indapamide on left ventricular hypertrophy in hypertension: a meta-analysis. Am J Cardiol 1996; 17B–9
26.
Zurück zum Zitat Ames RP. A comparison of blood lipid and blood pressure responses during treatment of systemic hypertension with indapamide and with thiazides. Am J Cardiol 1996; 77: 12B-6CrossRef Ames RP. A comparison of blood lipid and blood pressure responses during treatment of systemic hypertension with indapamide and with thiazides. Am J Cardiol 1996; 77: 12B-6CrossRef
27.
Zurück zum Zitat Leonetti G, Rappelli A, Salvetti A, et al. Tolerability and well-being with indapamide in the treatment of mild-moderate hypertension. Am J Med 1988; 84 Suppl 1B: 59–64PubMed Leonetti G, Rappelli A, Salvetti A, et al. Tolerability and well-being with indapamide in the treatment of mild-moderate hypertension. Am J Med 1988; 84 Suppl 1B: 59–64PubMed
28.
Zurück zum Zitat Asmar R, Guez D, Malbezin M, et al. Therapeutic benefit of a low dose of indapamide: results of a double-blind against placebo European controlled study [in French]. Arch Mal Coeur Vaiss 1995; 88: 1083–7PubMed Asmar R, Guez D, Malbezin M, et al. Therapeutic benefit of a low dose of indapamide: results of a double-blind against placebo European controlled study [in French]. Arch Mal Coeur Vaiss 1995; 88: 1083–7PubMed
29.
Zurück zum Zitat Ambrosioni E, Safar M, Degaute JP, et al. Low-dose antihypertensive therapy with 1.5 mg sustained-release indapamide: results of randomized double-blind controlled studies. J Hypertens 1998; 16: 1677–84PubMedCrossRef Ambrosioni E, Safar M, Degaute JP, et al. Low-dose antihypertensive therapy with 1.5 mg sustained-release indapamide: results of randomized double-blind controlled studies. J Hypertens 1998; 16: 1677–84PubMedCrossRef
30.
Zurück zum Zitat Staessen JA, Fagard R, Thiys L, et al. A consensus view on the technique of ambulatory blood pressure monitoring. Hypertension 1995; 261: 912–8CrossRef Staessen JA, Fagard R, Thiys L, et al. A consensus view on the technique of ambulatory blood pressure monitoring. Hypertension 1995; 261: 912–8CrossRef
31.
Zurück zum Zitat Parati G, Pomidossi G, Albini F, et al. Relationship of 24-hour blood pressure mean and variability to severity of target organ damage in hypertension. J Hypertens 1987; 5: 93–8PubMedCrossRef Parati G, Pomidossi G, Albini F, et al. Relationship of 24-hour blood pressure mean and variability to severity of target organ damage in hypertension. J Hypertens 1987; 5: 93–8PubMedCrossRef
32.
Zurück zum Zitat Mallion JM, Asmar R, Ambrosioni E, et al. Evaluation of trough-to-peak ratio of indapamide 1.5 mg sustained-release form assessed by ambulatory blood pressure monitoring. Arch Mal Coeur Vaiss 1996; 89 Spec 4: 27–38 Mallion JM, Asmar R, Ambrosioni E, et al. Evaluation of trough-to-peak ratio of indapamide 1.5 mg sustained-release form assessed by ambulatory blood pressure monitoring. Arch Mal Coeur Vaiss 1996; 89 Spec 4: 27–38
33.
Zurück zum Zitat Mallion JM, Asmar R, Boutelant S, et al. Twenty-four hour antihypertensive efficacy of indapamide 1.5 mg sustained-release: results of two randomized double-blind controlled studies. J Cardiovasc Pharmacol 1998; 32: 673–8PubMedCrossRef Mallion JM, Asmar R, Boutelant S, et al. Twenty-four hour antihypertensive efficacy of indapamide 1.5 mg sustained-release: results of two randomized double-blind controlled studies. J Cardiovasc Pharmacol 1998; 32: 673–8PubMedCrossRef
34.
Zurück zum Zitat Meredith PA, Elliott HF. FDA guidelines on trough peak ratios in the evaluation of antihypertensive agents. J Cardiovasc Pharmacol 1994; 23: 526–30CrossRef Meredith PA, Elliott HF. FDA guidelines on trough peak ratios in the evaluation of antihypertensive agents. J Cardiovasc Pharmacol 1994; 23: 526–30CrossRef
35.
Zurück zum Zitat Emeriau JP, Bulpitt CJ, Abate G, et al. Equivalence de l’effet antihypertenseur d’indapamide 1.5 mg comprimé enrobé a libération prolongée (LP) versus hydroclorothiazide 25 mg et versus amlodipine 5 mg dans l’hypertension artérielle du sujet âgé [abstract P36]. Arch Mal Coeur Vaiss 1997; 90: 36 Emeriau JP, Bulpitt CJ, Abate G, et al. Equivalence de l’effet antihypertenseur d’indapamide 1.5 mg comprimé enrobé a libération prolongée (LP) versus hydroclorothiazide 25 mg et versus amlodipine 5 mg dans l’hypertension artérielle du sujet âgé [abstract P36]. Arch Mal Coeur Vaiss 1997; 90: 36
36.
Zurück zum Zitat Emeriau JP, Bulpitt CJ, Abate G, et al. Hypertension artérielle systolique isolée du sujet âgé: comparison de l’effet antihypertenseur d’indapamide 1.5 mg comprimé enrobé a libération prolongée (LP) versus hydroclorothiazide 25 mg et versus amlodipine 5 mg [abstract P38]. Arch Mal Coeur Vaiss 1997; 90: 37 Emeriau JP, Bulpitt CJ, Abate G, et al. Hypertension artérielle systolique isolée du sujet âgé: comparison de l’effet antihypertenseur d’indapamide 1.5 mg comprimé enrobé a libération prolongée (LP) versus hydroclorothiazide 25 mg et versus amlodipine 5 mg [abstract P38]. Arch Mal Coeur Vaiss 1997; 90: 37
37.
Zurück zum Zitat Guez D, Mallion JM, Malini PL, et al. Treatment of hypertension with indapamide 1.5mg sustained-release form: synthesis of results [in French]. Arch Mal Coeur Vaiss 1996; 89 (Spec. Issue): 17–25PubMed Guez D, Mallion JM, Malini PL, et al. Treatment of hypertension with indapamide 1.5mg sustained-release form: synthesis of results [in French]. Arch Mal Coeur Vaiss 1996; 89 (Spec. Issue): 17–25PubMed
38.
Zurück zum Zitat Schiavi P. Pharmacokinetics of slow and immediate release formulations of indapamide after repeated administration in healthy volunteers. Eur J Drug Metab Pharmacokinet 1996; Special Issue: 41 Schiavi P. Pharmacokinetics of slow and immediate release formulations of indapamide after repeated administration in healthy volunteers. Eur J Drug Metab Pharmacokinet 1996; Special Issue: 41
Metadaten
Titel
Clinical Positioning of Indapamide Sustained Release 1.5mg in Management Protocols for Hypertension
verfasst von
Professor Gastone Leonetti
Publikationsdatum
01.04.2000
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe Sonderheft 2/2000
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200059002-00004

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