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

Abstract

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.

Keywords::

• Hypertension
• Amlodipine
• Combination
• Hydrochlorothiazide
• Observational study
• Triple therapy
• Valsartan

Transparency

Declaration of funding

This study and the article publication charges were funded by Novartis Pharma GmbH. Financial support for medical editorial assistance was provided by Novartis Pharma GmbH.

Declaration of financial/other relationships

Andreas Hagendorff has received funding from GE Healthcare and Novartis and lecture fees from GE Healthcare, Philips, Siemens, Toshiba, Servier, and Novartis. Ira Kurz is employed by Kantar Health GmbH, which conducted the study and the analysis on behalf of Novartis Pharma GmbH. Sven Klebs is an employee of Novartis Pharma GmbH. Alfons Müller is an employee of Novartis Pharma GmbH.

Acknowledgments

The authors acknowledge the co-operation of the patients, investigators, and staff at all participating sites of this study. The authors thank Sarah Hemer, PhD, for her medical editorial assistance with this manuscript on behalf of Kantar Health GmbH.