[Efficacy and safety of indapamide 1.5 mg sustained release coated tablets in the therapy of arterial 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 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.