CLINICS 2010;65(9):857-863 At the initial stage of treatment (following eight weeks of treatment with placebo), the ‘‘uncomplicated’’ group received one of the following treatment regimens: a) ‘‘traditional’’ treatment with 6.25 mg 2x/day hydrochlor- othiazide and 25 mg 2x/day atenolol; b) ‘‘current’’ treat- ment with 25 mg 2x/day losartan and 2.5 mg 2x/day amlodipine. If the blood pressure could not be controlled during the visits, the medication doses were doubled or another antihypertensive was added. The ‘‘complicated’’ group did not undergo the treatment period with placebo and was randomized to receive either ‘‘traditional’’ or ‘‘current’’ drug regimens similar to the ones administered to the ‘‘uncomplicated’’ group, though the specifics of each condition were carefully considered. The addition of other antihypertensive agents in the ‘‘uncomplicated’’ group and the specificities of the patient regimens in the ‘‘complicated’’ group were performed according to the guidelines from the V Brazilian Guidelines on Arterial Hypertension.3 All patients were instructed to take their medication every day at 7:00 AM and 7:00 PM, with a variation of up to one hour. A 12-month supply of the necessary medication was supplied to the patients by the physician at the end of the visit at no cost to eliminate the financial factor in this analysis; patients were given enough medication to last between visits. Patients were instructed to bring the remaining pills to their subsequent visits, at which time they were counted by the nursing staff without the patients’ knowledge of this procedure. Doctors’ visits, preceded by the nursing staff visit, took place every eight weeks for 56 weeks and included measurements of blood pressure, heart rate and weight. The weight was checked with the patient wearing light clothes standing barefoot on a scale (model 2096PP, Toledo do Brasil, Sa˜o Paulo, Brazil). Study withdrawal was characterized by non-attendance to appointments for up to three months after the scheduled date. Patients who returned to the medical clinic within three months after the scheduled date were allowed to continue in the study and be evaluated in an unscheduled visit. The tests performed during the placebo treatment and after 40 weeks of active treatments included the following: fasting glucose, urea, creatinine, total cholesterol, fractions of cholesterol, triglycerides, uric acid, total bilirubin, creatine phosphokinase (CPK), sodium (Na+), potassium Table 1 - Study groups demographics. Age (years) 53¡11 Gender (%) Male 27 Female 73 Skin color (%) Whites 62 Non-whites 38 BMI (kg/m2) 29¡4 Blood Pressure at Randomization (mmHg) Systolic 155¡12 Diastolic 91¡10 Heart rate 80¡13 53¡11 41 59 52 48 29¡4 163¡24 102¡20 83¡13 54¡11 33 67 60 40 29¡4 159¡19 96¡17 81¡13 859 Compliance with antihypertensive treatment Ortega KC et al. (K+), hemoglobin, thyroid-stimulating hormone (TSH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotranferase (ALT) and urinary excretion of sodium in 24 h. Statistical Analysis Data were analyzed using an analysis of variance (ANOVA) according to the factor of controlled or uncon- trolled hypertension. P,0.05 was considered statistically significant. RESULTS The study included 398 patients. Of those, 44 were excluded for the following reasons: a) lack of enrollment in the Biosinte´tica Assistance program (n = 17); b) body mass index .40 kg/m2 (n = 6); c) secondary hypertension (n = 4); d) white-coat hypertension (n = 3); e) white-coat normoten- sion (‘‘masked hypertension’’) (n = 3); f) alcohol use (n = 2); g) classification error (n = 4); h) refusal to do ABPM (n = 2); i) loss of blood pressure measurements from the first visit (n = 1); j) pregnancy (n = 1); k) death (n = 1). A total of 354 patients were evaluated. There were no statistically significant differences in age, gender, skin color, body mass index, blood pressure or heart rate between the groups classified as: ‘‘complicated’’ (n = 175) and ‘‘uncomplicated’’ (n = 179); ‘‘traditional’’ (n = 176) and ‘‘current’’ (n = 178); ‘‘phone calls’’ (n = 108) and ‘‘no phone calls’’ (n = 246) (Table 1). In addition, no differences were seen in marital status, education or occupation. a) Control of Blood Pressure A marked reduction in blood pressure was seen in patients from both the ‘‘complicated’’ and ‘‘uncomplicated’’ groups (Table 2). The blood pressure was reduced by 19¡10/20¡14 mmHg in the ‘‘uncomplicated’’ group and by 18¡14/22¡17 mmHg (systolic/diastolic) in the ‘‘com- plicated’’ group (p.0.05; n = 354). The ‘‘phone calls’’ and ‘‘no phone calls’’ groups showed significantly lower blood pressures at the end of treatment (p, 0.00001). The ‘‘traditional’’ and ‘‘current’’ groups showed significantly lower blood pressures at the end of treatment (Figure 1). 52¡11 34 66 54 46 29¡4 158¡19 97¡16 82¡13 54¡11 33 67 56 44 29¡4 159¡19 97¡16 82¡13 52¡11 34 66 60 40 29¡4 158¡19 97¡17 82¡13 Uncomplicated n = 179 Complicated n = 175 Traditional n = 176 Current n = 178 No Phone Calls n = 246 Phone Calls n = 108 Data are shown as mean¡s.d.; BMI = Body Mass Index; p.0.05: ‘‘complicated’’ vs. ‘‘uncomplicated’’, ‘‘traditional’’ vs. ‘‘current’’, ‘‘phone calls’’ vs. ‘‘no phone calls’’ for age, gender, skin color and BMI. Blood pressure at randomization: uncomplicated vs. complicated groups: systolic – t = 3.78, p = 0.0002; diastolic – t = 6.44, p,0.000001; FC – t = 2.41, p = 0.016