R Asmar1. 1. Service de Médecine Interne, Hôpital Broussais, Paris, France.
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.
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 hypertensivepatients. 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.