Equivalence of indapamide SR and enalapril on microalbuminuria reduction in hypertensive patients with type 2 diabetes: the NESTOR Study.
OBJECTIVE
To test whether microalbuminuria in patients with type 2 diabetes and hypertension is primarily dependent on the severity of hypertension, and to compare the effectiveness of two antihypertensive drugs with opposite effects on the renin-angiotensin system [the diuretic, indapamide sustained release (SR), and an angiotensin-converting enzyme inhibitor, enalapril] in reducing microalbuminuria.


METHODS
A multinational, multicentre, controlled, double-blind, double-dummy, randomized, two-parallel-groups study over 1 year.


METHODS
After a 4-week placebo run-in period, 570 patients (ages 60.0 +/- 9.9 years, 64% men) with type 2 diabetes, essential hypertension [systolic blood pressure (SBP) 140-180 mmHg, and diastolic blood pressure (DBP) < 110 mmHg], and persistent microalbuminuria (20-200 microg/min) were allocated randomly to groups to receive indapamide SR 1.5 mg (n = 284) or enalapril 10 mg (n = 286) once a day. Amlodipine, atenolol, or both were added, if necessary, to achieve the target blood pressure of 140/85 mmHg.


RESULTS
There was a significant reduction in the urinary albumin : creatinine ratio. Mean reductions were 35% [95% confidence interval (CI) 24 to 43] and 39% (95% CI 30 to 47%) in the indapamide SR and enalapril groups, respectively. Equivalence was demonstrated between the two groups [1.08 (95% CI 0.89 to 1.31%); P = 0.01]. The reductions in mean arterial pressure (MAP) were 16.6 +/- 9.0 mmHg for the indapamide SR group and 15.0 +/- 9.1 mmHg for the enalapril group (NS); the reduction in SBP was significantly greater (P = 0.0245 ) with indapamide SR. More than 50% of patients in each group required additional antihypertensive therapy, with no differences between groups. Both treatments were well tolerated.


CONCLUSIONS
Indapamide-SR-based therapy is equivalent to enalapril-based therapy in reducing microalbuminuria with effective blood pressure reduction in patients with hypertension and type 2 diabetes.
Marre
Michel
M
Hôpital Bichat, Service de Diabétologie et d'Endocrinologie, Paris, France. michel.marre@bch.ap-hop-paris.fr
Puig
Juan Garcia
JG
Kokot
Franciszek
F
Fernandez
Margarita
M
Jermendy
György
G
Opie
Lionel
L
Moyseev
Valentin
V
Scheen
André
A
Ionescu-Tirgoviste
Constantin
C
Saldanha
M Helena
MH
Halabe
Aaron
A
Williams
Bryan
B
Mion Júnior
Decio
D
Ruiz
Maximino
M
Hermansen
Kjeld
K
Tuomilehto
Jaakko
J
Finizola
Bartolomé
B
Gallois
Yves
Y
Amouyel
Philippe
P
Ollivier
Jean-Pierre
JP
Asmar
Roland
R
D000368:Aged; D000419:Albuminuria / Q000150:complications / Q000188:drug therapy; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004656:Enalapril / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007190:Indapamide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D004656:Enalapril; D007190:Indapamide