title: Equivalence of indapamide SR and enalapril on microalbuminuria reduction in hypertensive patients with type 2 diabetes: the NESTOR Study.
abstract: 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.
authors.affiliation: Hôpital Bichat, Service de Diabétologie et d'Endocrinologie, Paris, France. michel.marre@bch.ap-hop-paris.fr
authors.forename: Michel
authors.initials: M
authors.lastname: Marre
authors.forename: Juan Garcia
authors.initials: JG
authors.lastname: Puig
authors.forename: Franciszek
authors.initials: F
authors.lastname: Kokot
authors.forename: Margarita
authors.initials: M
authors.lastname: Fernandez
authors.forename: György
authors.initials: G
authors.lastname: Jermendy
authors.forename: Lionel
authors.initials: L
authors.lastname: Opie
authors.forename: Valentin
authors.initials: V
authors.lastname: Moyseev
authors.forename: André
authors.initials: A
authors.lastname: Scheen
authors.forename: Constantin
authors.initials: C
authors.lastname: Ionescu-Tirgoviste
authors.forename: M Helena
authors.initials: MH
authors.lastname: Saldanha
authors.forename: Aaron
authors.initials: A
authors.lastname: Halabe
authors.forename: Bryan
authors.initials: B
authors.lastname: Williams
authors.forename: Decio
authors.initials: D
authors.lastname: Mion Júnior
authors.forename: Maximino
authors.initials: M
authors.lastname: Ruiz
authors.forename: Kjeld
authors.initials: K
authors.lastname: Hermansen
authors.forename: Jaakko
authors.initials: J
authors.lastname: Tuomilehto
authors.forename: Bartolomé
authors.initials: B
authors.lastname: Finizola
authors.forename: Yves
authors.initials: Y
authors.lastname: Gallois
authors.forename: Philippe
authors.initials: P
authors.lastname: Amouyel
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Ollivier
authors.forename: Roland
authors.initials: R
authors.lastname: Asmar
mesh_terms: 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
chemical_list: D000959:Antihypertensive Agents; D004656:Enalapril; D007190:Indapamide