Clinical Positioning of Indapamide Sustained Release 1.5mg in Management Protocols for Hypertension
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Drugs 2000; 59 Suppl. 2: 27-38 0012-6667/00/0002-0027/$25.00/0 © Adis International Limited. All rights reserved.
Clinical Positioning of Indapamide Sustained Release 1.5mg in Management Protocols for Hypertension Gastone Leonetti Medical University of Milano and Cardiovascular Rehabilitation and Cardiac Disease Unit, S. Luca Hospital IRCCS, Milano, Italy
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.
Diuretics have been the most popular drugs for the treatment of hypertension for more than 30 years, from soon after their introduction in 1957[1] until very recently, when they were surpassed by calcium antagonists and ACE inhibitors. The modern era of antihypertensive therapy began in the 1950s with the introduction of orally effective and reasonably well tolerated agents, in-
cluding reserpine, hydralazine and, soon after, methyldopa and guanidine. However, when these drugs were used alone and particularly at high dosages, pseudo-resistance, sometimes erroneously referred to as tachyphylaxis, was often observed, with the initial fall in blood pressure largely ablated. It was soon recognised that the problem arose from reactive renal sodium retention with expansion
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of plasma volume that blunted the antihypertensive efficacy of the adrenergic inhibitor or direct vasodilator.[2] The pseudo-resistance could easily be overcome by the addition of a diuretic.[3] Thereafter, diuretics as monotherapy were shown to have antihypertensive efficacy equal to that of the other drug
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