Equivalence of indapamide SR and enalapril on microalbuminuria reduction in hypertensive patients with type 2 diabetes
Year: 2004
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVES: 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. DESIGN: 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.
Source: Journal of Hypertension
Authors: Michel Marre, Juan Garcia Puig, Franciszek Kokot, Margarita Fernandez, György Jermendy, Lionel Opie, Valentin Moyseev, André Scheen, Constantin Ionescu-Tirgoviste, M Helena Saldanha, Aaron Halabe, Bryan Williams, Decio Mion, Maximino Ruiz, Kjeld Hermansen, Jaakko Tuomilehto, Bartolomé Finizola, Yves Gallois, Philippe Amouyel, Jean-Pierre Ollivier, Roland Asmar
Institutions: Hôpital Bichat-Claude-Bernard, Hospital Universitario La Paz, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Bajcsy-Zsilinszky Kórház és Rendelőintézet, Groote Schuur Hospital, Unidade Local de Saúde de Coimbra, Wolfson Medical Center, University of Leicester, Centre Hospitalier Universitaire d'Angers, Inserm, Institut Pasteur de Lille, HIA du Val-de-Grâce à Paris
Language: English
Subfield: Nephrology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2152178651