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  • Title: [Efficacy and safety of indapamide 1.5 mg sustained release coated tablets in the therapy of arterial hypertension].
    Author: Asmar R.
    Journal: Ann Cardiol Angeiol (Paris); 1998 Feb; 47(2):94-104. PubMed ID: 9772936.
    Abstract:
    OBJECTIVE: In line with international recommendations concerning the need to decrease the doses of antihypertensives, a low dose form (1.5 mg) of indapamide, sustained release coated tablet (SR), has been developed in order to optimize the efficacy-safety ratio while maintaining a once daily dosage. The objective of this study was to evaluate the benefit obtained by reviewing the results of two clinical trials conducted according to a similar methodology. PATIENTS AND METHODS: European randomized double-blind trials were conducted in a total of 690 hypertensive patients. The first trial was conducted in 285 patients treated for 2 months and the second trial was conducted in 405 patients treated for 3 months. The second study was extended to 9 months under open-label conditions in order to obtain a follow-up of one year with clinical and ambulatory blood pressure monitoring. The average patient characteristics on inclusion were, in the two studies: age: 53 and 57 years, 44% and 57% of men, diastolic blood pressure (DRP): 100.6 and 102.5 mmHg, systolic blood pressure (SBP): 161.0 and 164.5 mmHg. RESULTS: The first dose-ranging study demonstrated the antihypertensive efficacy of indapamide 1.5 mg SR; the study second confirmed the equivalent efficacy with the 2.5 mg immediate release form of indapamide and a greater than 50% reduction of the number of patients presenting a serum potassium less than 3.4 mmol/l. The long-term study verified the absence of therapeutic escape. Clinical safety data assessed the absence of effects of indapamide on carbohydrate and lipid metabolism. CONCLUSION: Indapamide 1.5 mg sustained release coated tablet presents an optimized antihypertensive efficacy/safety ratio in line with international recommendations concerning the use of low-dose antihypertensives and diuretics as first-line treatment for hypertension.
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