350 OLAS: Olmesartan/Amlodipine vs Olmesartan/Thiazide FJ Martinez-Martin et al significant. These differences between the two groups were significant. Figure 4a shows the percentage changes in albuminuria, fasting insulin, IRI and adiponectin; the percentage changes in adiponectin showed an inverse correlation with the percentage changes in the IRI (Pearson’s R test ¼ 0.54, Po0.001). Of the inflammation markers studied, only CRP was significantly reduced in both groups (by 16.7 and 14.1% in the OA and OH groups, respectively, both Po0.05; 95% confidence intervals for the difference was 2.1 to 7.2%), with no significant difference between the two groups. The other inflammation markers were significantly reduced in the OA group only (by 16.1% for TNF-a, 18.5% for IL-1b, 18.1% for IL-6, 12.8% for IL-8, 20.8% for ICAM-1 and 30.8% for VCAM-1); the between-group differences were significant for all of these inflam- mation markers. Figure 4b shows the percentage changes in all of the inflammation markers studied. A post hoc analysis was performed within each group in order to assess the effect of the addition of doxazosin (after week 26) on the studied variables. Figure 4 (a) Percentage change from baseline in urinary albumin/creatinine quotient, fasting plasma insulin, homeostasis model assessment index of insulin resistance and plasma adiponectin. (b) Percentage changes from baseline in inflamma- tory markers: tumour necrosis factor-a (TNF-a), C-reactive protein (CRP), interleukins-1b, -6 and -8 (IL-1b, IL-6 and IL-8); inter- cellular adhesion molecule-1 (ICAM-1) and vascular cell adhe- sion molecule-1 (VCAM-1). *Po0.05 vs baseline; wPo0.01 vs baseline; zPo0.05 between groups; yPo0.01 between groups. For simplicity, only the baseline and final values are shown, but no significant changes were observed after week 26. Journal of Human Hypertension With the exception of a significant reduction in SBP and diastolic BP (similar for both groups), no differences could be found between the patients taking doxazosin and those not receiving doxazosin. After week 26, the only variables that underwent significant changes were SBP and diastolic BP (Figure 3), and new-onset T2DM (Figure 5). During the study, three patients (5.0%) developed T2DM in the OA group, compared with 11 (18.3%) in the OH group (odds ratio 4.24 for OA vs OH; absolute risk reduction 13.3%). The Kaplan–Meier survival analysis is plotted in Figure 5. The log-rank test showed a significant difference between the groups (P ¼ 0.02). A logistic regression modelling analysis determined that the predictors of T2DM development (after adjustement for gender and baseline values of age, body mass index, waist circumference and fasting plasma glucose) were: the IRI (OR 1.27 per 0.5 AU increment, P ¼ 0.013), OH treatment (OR 3.98, P ¼ 0.023) and low adipo- nectin (OR 2.26 per 1 mg ml 1 decrement, P ¼ 0.043). The addition of doxazosin showed no correlation with new-onset T2DM. The compliance rate was high: 96.1% for the OA group up to week 26 and 92.7% at the end of the study; the respective figures were 94.1 and 91.8% for the OH group. Only one patient withdrew from the study because of side effects (malleolar oedema, in the OA group) but minor side effects were reported by low proportions of patients in the OA group (oedema (8.3%), headache (6.7%) and flush- ing or dizziness (1.7%)) and in the OH group (oedema (3.3%), headache (5.0%) and flushing or dizziness (5.0%)). Three patients (5.0%) in each group were withdrawn from the study because of poor BP control, with SBP 4160 mm Hg despite full treatment. There were no differences in the inci- dence of side effects between the groups (Fisher’s exact test). None of the patients had hypokalaemia during the study, and the correlation studies between potassium and insulin, glucose or IRI were negative (data not shown). Figure 5 Kaplan–Meier survival analysis for the incidence of type 2 diabetes mellitus. A, amlodipine; ARR, absolute risk reduction; H, hydrochlorothiazide; O, olmesartan; OR, odds ratio.