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Effect of two antihypertensive combinations on metabolic control in type-2 diabetic hypertensive patients with albuminuria: a randomised, double-blind study

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.

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Acknowledgements

This study was conducted with the help of a grant facilitated by Laboratorios Knoll. R Fernández and J Garrido are employees of Laboratorios Knoll SA, the supplier of the study medication. There is no financial or any other kind of relations that could lead to a conflict of interest.

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Correspondence to R Fernández.

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This study is not under consideration by another journal and no part of the material has been published elsewhere. It was in part presented at the 32nd Annual Meeting of the American Society of Nephrology (November 1-8, 1999): [J Am Soc Neprhol 1999 (abstract); 10: 131A]

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Fernández, R., Puig, J., Rodríguez-Pérez, J. et al. Effect of two antihypertensive combinations on metabolic control in type-2 diabetic hypertensive patients with albuminuria: a randomised, double-blind study. J Hum Hypertens 15, 849–856 (2001). https://doi.org/10.1038/sj.jhh.1001279

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