Resistant hypertension optimal treatment trial: a randomized controlled trial.

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen.

Office blood pressure and 24-hour ambulatory blood pressure measurements: high proportion of disagreement in resistant hypertension.

OBJECTIVE: To evaluate the accuracy and quantify the agreement between office blood pressure (BP) and daytime ambulatory BP monitoring in the assessment of BP control of patients with a clinical diagnosis of resistant hypertension. STUDY DESIGN AND SETTING: Office BP measurements were done in a cohort of 228 true resistant (TR) or white-coat resistant (WCR) hypertensives classified by ambulatory BP in a hypertension clinic in Rio de Janeiro in this validity study. The agreement between the daytime ambulatory BP and office BP was analyzed using the graphic methods of Altman -- Bland and survival -- agreement plots. RESULTS: The likelihood ratio of a positive test result of office BP was 1.99 for the assessment of uncontrolled BP in TR patients and 1.05 for the WCR hypertensive patients. The Altman and Bland plot showed a significant difference between the two methods, and the presence of a fixed and a proportional bias. The survival-agreement plot showed that a tolerance limit of 20 mm Hg of difference between systolic office BP and systolic daytime ambulatory BP would generate a proportion of disagreement equal to 57.5%. CONCLUSION: The office BP is still an important tool to monitor BP control of patients with TR hypertension, whereas the monitoring of patients with WCR hypertension requires ambulatory BP.

Orlistat in hypertensive overweight/obese patients: results of a randomized clinical trial.

OBJECTIVE: To assess the effect of orlistat plus diet compared with diet alone in promoting weight loss and blood pressure reduction in hypertensive, overweight/obese patients. DESIGN: A pragmatic randomized, controlled trial. SETTING: Hypertension clinic of a university hospital. PATIENTS: Hypertensive patients aged 18-75 years with a body mass index greater than 25 kg/m(2). INTERVENTIONS: Orlistat 360 mg/day combined with a hypocaloric diet (treatment group), or a calorie-restricted diet alone (control group). MAIN OUTCOME MEASURES: Primary outcomes were reductions in weight and blood pressure. Secondary outcomes were decreases in lipid and glucose concentrations. A subgroup analysis of the main outcomes among diabetic and non-diabetic patients was also performed. RESULTS: A total of 204 patients were included in the intention-to-treat analysis. After 12 weeks the orlistat group lost, on average, 3.7 kg and the control group lost 2.0 kg in weight (P < 0.001). Systolic (SBP) and diastolic (DBP) blood pressures decreased by 15.3 and 11.4 mmHg, respectively, in the group given orlistat plus a hypocaloric diet and by 11.6 and 5.2 mmHg, respectively, in the control group given the calorie-restricted diet alone (P = 0.25 and P = 0.0004, respectively). Fasting glucose (0.82 and 0.17 mmol/l, P = 0.01) and total cholesterol (0.85 and 0.56 mmol/l, P = 0.05) were reduced to a greater extent with orlistat than with diet alone. The mean reduction in triglycerides with orlistat plus the hypocaloric diet was 0.75 mmol/l and that in the control group was 0.30 mmol/l (P = 0.28); the increases in high-density lipoprotein cholesterol were 0.05 and 0.00 mmol/l, respectively, in the two groups (P = 0.17). Treatment improved blood pressure and glucose control in the individuals with diabetes, but not in those without diabetes. CONCLUSION: In both groups there was a reduction in weight, blood pressure and metabolic parameters. The orlistat group performed better in reducing weight, DBP, glucose and cholesterol. Results show that even a small reduction in weight helps to control blood pressure and glucose. The cost-benefit of the use of orlistat should be evaluated for hypertensive obese patients.