title: 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.
authors.affiliation: Medical Department, Laboratorios Knoll, S.A. 28050 Madrid, Spain. raul.fernandez@knoll.de
authors.forename: R
authors.initials: R
authors.lastname: Fernández
authors.forename: J G
authors.initials: JG
authors.lastname: Puig
authors.forename: J C
authors.initials: JC
authors.lastname: Rodríguez-Pérez
authors.forename: J
authors.initials: J
authors.lastname: Garrido
authors.forename: J
authors.initials: J
authors.lastname: Redon
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000150:complications / Q000188:drug therapy / Q000378:metabolism; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000008:administration & dosage; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004656:Enalapril / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage*; D006973:Hypertension / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D007211:Indoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011336:Probability; D011446:Prospective Studies; D013030:Spain; D016896:Treatment Outcome; D014700:Verapamil / Q000008:administration & dosage*
chemical_list: D000959:Antihypertensive Agents; D007211:Indoles; D006852:Hydrochlorothiazide; C052035:trandolapril; D004656:Enalapril; D014700:Verapamil