Evaluation of effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide single-pill combination therapy in hypertensive patients: an observational study

OBJECTIVE: This study evaluated the effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide (A + V + H) single-pill combination therapy in the treatment of hypertensive patients in daily practice. DESIGN AND METHODS: This prospective, open-label, observational study, enroled adults for whom their physician considered treatment with the single pill combination as indicated. The observational period per patient was ∼3 months. Results were evaluated using basic descriptive statistical methods. MAIN OUTCOME: Data of 7132 patients were analyzed. At baseline, the mean blood pressure (BP) was 158.8 ± 17.7 mmHg (systolic, sBP) and 91.5 ± 10.7 mmHg (diastolic, dBP). The most common cardiovascular risk factors were positive family history, dyslipidemia, and diabetes mellitus. The most commonly used daily doses of A + V + H at study end were 5/160/12.5 mg (30.5%) or 10/160/12.5 mg (33.1%). At the last visit mean BP was 135.0 ± 11.8 mmHg (sBP) and 80.2 ± 7.3 mmHg (dBP). The mean BP reduction at last visit compared with baseline was -23.7 ± 17.5 mmHg (sBP) and -11.3 ± 10.6 mmHg (dBP); 43.5% of the patients reached normalization (BP <140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics) and 71.3% reached therapeutic response (sBP <140 or ≥20 mmHg decrease vs baseline and dBP <90 or ≥10 mmHg decrease vs baseline in non-diabetic patients and sBP <130 mmHg or ≥20 mmHg decrease vs baseline and dBP <80 mmHg or ≥10 mmHg decrease vs baseline in patients with diabetes). Adverse events (AEs) were recorded in 2.3% of the patients, the most frequent being peripheral edema (0.6%) and dizziness (0.2%). CONCLUSIONS: In daily practice, A + V + H single-pill treatment effectively lowered the average BP in patients with essential hypertension and was well tolerated.