D. Guez et al., TREATMENT OF HYPERTENSION WITH INDAPAMIDE 1.5 MG SUSTAINED-RELEASE FORM - SYNTHESIS OF RESULTS, Archives des maladies du coeur et des vaisseaux, 89, 1996, pp. 17-25
In accordance with international recommendations on the need to decrea
se doses of antihypertensive drugs, a low-dose (1.5 mg) sustained-rele
ase form of indapamide was developed so as to optimize the safety/effi
cacy ratio, while maintaining a once-daily administration. The new for
mulation ensures that the active ingredient release occurs in a sustai
ned manner over 24 hours, with mean concentrations close to the maxima
l concentration over a prolonged period, while avoiding peak plasma co
ncentrations. Clinical data were obtained mainly through two European
multicenter, randomized, double-blind trials, totalling 690 patients.
Firstly, the antihypertensive efficacy of the new indapamide 1.5 mg fo
rm was demonstrated by measuring blood pressure 24 hours after the las
t drug intake, using a mercury sphygmomanometer ; the equivalence of i
ts antihypertensive efficacy with the immediate-release form of indapa
mide 2.5 mg was then verified. Biochemical safety data showed better a
cceptability with indapamide 1.5 mg with in particular a reduction of
more than 50 % of the number of patients with kalemia <3.4 mmol/l; cli
nical safety data confirmed the good acceptability observed with the 2
.5 mg immediate-release form of indapamide since many years, especiall
y regarding glucose and lipid neutrality. In conclusion, the 1.5 mg su
stained-release form of indapamide has an improved antihypertensive ef
ficacy/safety ratio which is in accordance with international recommen
dations for the usage of low doses of antihypertensive drugs and diure
tics in the first-line treatment of hypertension.