On the way to achieve hypertension treatment goals: results of the open observational program AESCULAP (Exforge - Clinical safety and efficiency of using a double combination of antihypertensive drugs in patients with uncontrolled blood pressure)

Aim. To collect information on the efficiency and safety of a fixed-dose combination of amlodipine/valsartan in patients who failed to achieve blood pressure (BP) control in the use of the combination of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and a thiazide/thiazide-like diuretic. Subjects and methods. During routine clinical practice, the 12-week observation program covered 8594 hypertensive patients receiving a fixed-dose combination of amlodipine/valsartan 5/160, 10/160 mg (exforge, Novartis Pharma) with/without a diuretic. The inclusion criteria were 18 years of age or older; systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg) at the first visit; failure to achieve BP (≥140/90 mm Hg) control in the use of the combination of an ACE inhibitor or an ARB and a thiazide/thiazide-like diuretic; a patient's consent to participate in the program. The exclusion criteria were, besides the contraindications given in the drug use instruction, absent. Amlodipine/valsartan 5/160 or 10/160 mg were used after the previous ineffective therapy was discontinued. The patients visited their physician's office every 4 weeks. Results. The patients' baseline BP was 169.3/99.9 mm Hg. The risk of cardiovascular events was assessed as high in 38% of the patients and as very high in 43.1%. The previous therapy included thiazide or thiazide-like diuretics (92%), an ACE inhibitor (78.5%), an ARB (23.2%), Β-adrenoblockers (38.6%), calcium antagonists (23.1%), and other medications (25.5%). In the entire group, BP decreased from 169.3±15.6/99.9±9.3 to 129.1±9.1/80.3±6.4 mm Hg at the fourth visit. BP reductions at 12 weeks were 40.1±14.9/19.6±9.5 mm Hg. The therapy was effective in different treatment subgroups. At baseline, the majority of patients had grades 2 (53.1%) and 3 (35.4%) hypertension. At 12 weeks, 74% of the patients were found to have normal or high normal BP. Grade 3 hypertension was preserved only in 0.2% of the patients by the end of the program. BP goals were achieved in 79.5% of the patients. The therapy was well tolerated by the patients. Adverse reactions were observed in 3.1% of the patients and required treatment discontinuation in 0.5%. The most common side effect was peripheral edemas (1.4%). Conclusion. In the observation program AESCULAP using the fixed-dose combination of amlodipine/valsartan as different dosage regimens (5/160 and 10/160 mg) and/or a diuretic, there was a marked antihypertensive effect in different subgroups of patients with previously uncontrolled hypertension and the BP goals being achieved in 79.5% of cases. Most patients tolerated amlodipine/valsartan well and showed high compliance with the prescribed therapy. The rate of side effects in the AECULAP program was not greater than that (3.1%) in the earlier trials.

uncontrolled hypertension, antihypertensive drugs, angiotensin II receptor blockers, calcium antagonists, valsartan, amlodipine, exforge, AESCULAP.