Amlodipine/Valsartan Single-Pill Combination: A Prospective, Observational Evaluation of the Real-Life Safety and Effectiveness in the Routine Treatment of Hypertension

Abstract

As several international guidelines on hypertension have now recommended, single-pill/fixed-dose combination antihypertensive therapies may be particularly beneficial as first-line therapy in high-risk patients, in whom more rapid and pronounced blood pressure (BP) control is desired. Upon the single-pill combination of amlodipine and valsartan becoming available, the authors conducted this international, observational study to evaluate its efficacy and safety in a real-life practice setting. This prospective, open-label, postmarketing surveillance study enrolled adults with arterial hypertension (systolic BP >140 mmHg and/or diastolic BP >90 mmHg) who were prescribed antihypertensive therapy with single-pill combination amlodipine/valsartan 5/80, 5/160, or 10/160 mg once daily. Patients were observed over a 3-month period (12 weeks) with approximately monthly intervals between clinic visits. A total of 8336 patients completed all study visits and were included in the efficacy analysis. Mean age was 54.7 years and 83.4% of patients had received prior antihypertensive therapy. BP reductions were dose related. Overall, mean BP was reduced from 165.0/99.3 mmHg at baseline to 128.7/80.4 mmHg at 12 weeks (36.3/18.9 mmHg; P<0.0001). The magnitude of BP reduction rose with increasing severity of baseline BP. Control of BP (<140/90 mmHg) was achieved in 77.7% of patients. Efficacy was consistent in subgroups of patients with comorbidities and regardless of whether patients were previously treated with monotherapy or combination therapy. Adverse events were reported in 5.3% of patients. The incidence of edema declined from 10.4% at baseline to 8.5% at study end. Single-pill combination amlodipine/valsartan safely and effectively reduced BP across all hypertension grades and allowed the vast majority of patients to achieve BP goals.