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Title: Effect of two antihypertensive combinations on metabolic control in type-2 diabetic hypertensive patients with albuminuria: A randomised, double-blind study
Authors: Fernández, Raul
Puig, J. G.
Rodríguez-Pérez, J. C. 
Garrido, J.
Redon, J.
Fernández, R.
Puig, J. García
Pérez, J. C.Rodríguez
Redón, J.
Mercado, M. R.Lázaro De
Bueno, J.
Tisaire, J.
Universitario, H.
Calvo, C.
Xeral, H.
Paz, H. La
Castillo, F. Martín
General, H.
Campdera, F. Gómez
Vinuesa, S. García De
Marañoín, H. G.
Nieto, J.
Vozmeniano, C.
Alarcos, H. Ntra Sra
Plaza, C.
Hortal, L.
Negrín, H. Doctor
Hidalgo, A. Martín
Piedecausa, M.
Masia, M.
Robles, R.
Cristina, H. Infanta
Solís, J.
Ochoa, H. Severo
Fernández, C.
Nieves, H. V.
UNESCO Clasification: 32 Ciencias médicas
3205 Medicina interna
Keywords: Hypertension
Type 2 diabetes mellitus
Combination therapy
Issue Date: 2001
Journal: Journal of Human Hypertension 
Abstract: The objective of this study was to compare, at equal blood pressure (BP) reduction, the effect of two different combinations on metabolic control and albuminuria in type 2 diabetic hypertensive patients with albuminuria. This was a prospective, randomised, double-blind, parallel, controlled trial carried out in 11 Spanish hospitals. A total of 103 type 2 diabetic patients with stable albuminuria and BP not controlled on monotherapy were randomised of which 93 finished the study. After a 4-week single-blind placebo period, patients were randomised to verapamil SR/trandolapril 180/2 mg (VT) or to enalapril/hydroclorothiazide 20/12.5 mg (EH). Treatment duration was 6 months. The main outcome measures were changes in BP, 24-h albuminuria, blood glucose and glycated haemoglobin. Overall BP was significantly reduced from 157.3 ± 12.0/98.3 ± 6.4 mm Hg to 140.5 ± 14.5/86.1 ± 8.2 mm Hg (P < 0.001) and albuminuria significantly decreased from 508.6 ± 693.8 mg/24 h to 253.4 ± 517.2 mg/24 h (P < 0.001), both without significant differences between treatments. Glycated haemoglobin was not modified on VT: baseline, 5.91 ± 1.43%; end of treatment, 5.94 ± 1.62%, but increased on EH: baseline, 5.96 ± 1.25%; final, 6.41 ± 1.51%, (ANOVA interaction P = 0.040). At the end of the study, a blood glucose <126 mg/dL was attained in 72.7% of the VT group—improving in 29.5% and worsening in 6.8% of patients (P = 0.021)—and in 50% of the EH group, 13.6% of patients improved and 11.4% worsened (P = 1.000). There were no changes in body weight, serum creatinine, uric acid, potassium, cholesterol, tryglicerides and serum albumin. In hypertensive type 2 diabetic patients not controlled on monotherapy, both treatments similarly reduced albuminuria. The combination verapamil/ trandolapril seems to allow a better metabolic control than enalapril/hydroclorothiazide.
ISSN: 0950-9240
DOI: 10.1038/sj.jhh.1001279
Source: Journal of Human Hypertension[ISSN 0950-9240],v. 15, p. 849-856 (Diciembre 2001)
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