Compliance with antihypertensive treatment Ortega KC et al. The ASCOT study15 (Anglo-Scandinavian Cardiac Outcomes Trial) has indicated a significant reduction in all causes of mortality with the use of current medications for treating hypertension: calcium channel antagonists and angiotensin- converting enzyme inhibitors. It has also been demonstrated that a high incidence of adverse events may decrease treatment compliance. However, in the LIFE16 study, angiotensin receptor antagonists proved to be better at reducing the risks related to cardiovascular events and they resulted in a lower rate of treatment discontinuation when compared to a beta-blocker. In view of these data, we evaluated the importance of providing guidelines to patients via active telephone calls for blood pressure management and preventing treatment discontinuation in hypertensive patients. We used two treatment regimens with low-dose medications that were offered for free to avoid the influence of financial factors. We opted for one regimen called ‘‘traditional’’ based on diuretics and beta-blockers and another called ‘‘current’’ based on angiotensin II antagonists and calcium channel blockers. METHODS The study participants were selected at the Hypertension Unit, University of Sa˜o Paulo General Hospital, Nephrology Division, University of Sa˜o Paulo School of Medicine. The patients had essential hypertension and were able to receive telephone calls to be reminded of their medical appoint- ments and be given guidance about hypertension. Patients were of both genders, from diverse ethnic backgrounds, over 18 years of age, and had body mass indices below 2 40 kg/m . The patients were enrolled in the study after signing a free and informed consent form. The study was approved by the Ethics Committee of the Board of Directors of the University of Sa˜o Paulo School of Medicine. Patients were excluded on several bases, including blood pressure ,140/90 mmHg without antihypertensive medi- cation, secondary hypertension, white-coat hypertension with systolic pressures $140 mmHg and/or diastolic pressures $90 mmHg at the doctor’s office and awake mean systolic pressures ,135 mmHg or awake mean diastolic pressures ,85 mmHg without antihypertensive medication, malignant hypertension and patients with a previous history of hypersensitivity reaction to the study medications. Other exclusion criteria were as follows: pregnant women or nursing mothers, the presence of liver dysfunction evidenced by the patient’s clinical history or by one of the liver function tests (levels twice the normal values for alkaline phosphatase, total bilirubin, aspartate amino- transferase), patients with clinical conditions that might interfere with the total conformity with the study or those who might have an increased risk for participating in the study, patients with a history of alcoholism, drug abuse or mental disorders that might invalidate the free and informed consent or limit the patient’s ability to meet the protocol rules and patients who had participated in any other studies involving investigational drugs or drugs already marketed within the previous month before enroll- ment in this study or concomitantly with this study. Blood Pressure Measurement Blood pressure and heart rate measurements were performed on the right upper limb on sitting patients five 858 CLINICS 2010;65(9):857-863 times by the nursing staff using an appropriately sized cuff with a validated automatic oscillometric device (Dixtal, DX2710, Sa˜o Paulo, Brazil).17 The mean of the last two measurements was calculated and recorded if the difference between these measurements was less than 4 mmHg. If after the five measurements the difference between the last two was greater than 4 mmHg, the measurement was repeated until the difference between the two measurements was less than 4 mmHg. During the study, blood pressure measure- ments were always performed in the afternoon by the same nursing staff using the same device. The diagnosis of hypertension was made when the mean values of the last two measurements were as follows: systolic pressure $140 mmHg and/or diastolic pressure $90 mmHg with or without medication at the initial visit (Visit 0). Patients who were receiving antihypertensive medication at the initial visit and had a systolic pressure ,140 mmHg or a diastolic pressure ,90 mmHg were re- evaluated eight weeks after discontinuation of their medica- tion and introduction of placebo; these patients were included in the study when the mean values included a systolic pressure $140 mmHg and/or a diastolic pressure $90 mmHg. Controlled blood pressure was defined in two levels as (with the patient in the seated position) a systolic/diastolic pressure less than 140/90 or 120/80 mmHg. All of the patients underwent Ambulatory Blood Pressure Monitoring (ABPM), which was performed with a validated oscillometric device (SpaceLabs 90207, SpaceLabs Inc, Richmond, WA, USA),18,19 five weeks after the start of the placebo to eliminate cases of patients with white-coat hypertension and, in patients who did not receive placebo, to identify the white-coat effect. According to clinical characteristics, the patients were assigned to two groups: a) ‘‘uncomplicated’’– hypertensive patients without complications and without other concur- rent diseases and b) ‘‘complicated’’- patients with severe hypertension (mean diastolic pressure $110 mmHg with or without medication) or comorbidities such as diabetes mellitus, renal failure (serum creatinine .1.4 mg/dL), coronary insufficiency, congestive heart failure or prior history of cerebrovascular accident. Patient Randomization All patients, from both the complicated and the uncom- plicated groups, were open-block randomized to receive active telephone calls (‘‘phone calls’’ group) or not to receive telephone calls (‘‘no phone calls’’ group) and to follow two treatment regimens, ‘‘traditional’’ or ‘‘current’’. Thus, after the first visit and randomization, patients from the ‘‘phone calls’’ group were invited to enroll by telephone in a program called ‘‘Biosinte´tica Assistance’’, supported by Biosinte´tica Laboratory. The patients who subscribed started receiving active telephone calls from appropriately trained operators and also started receiving magazines with health-related information, which were sent periodically by mail. There were six contacts by telephone during the study. During phone calls, the patient was reminded to attend the next visit, and he/she was educated about hypertension and any necessary clarifications about his/her treatment. All patients randomized to the ‘‘phone calls’’ group were invited to attend occasional informative lectures with the participation of a multidisciplinary team.