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6744820 
Journal Article 
Amlodipine/valsartan single-pill combination: a prospective, observational evaluation of the real-life safety and effectiveness in the routine treatment of hypertension 
Karpov, Y; Dongre, N; Vigdorchik, A; Sastravaha, K 
2012 
Yes 
Advances in Therapy
ISSN: 0741-238X
EISSN: 1865-8652 
29 
2 
134-147 
English 
22271158 
WOS:000303446300004 
INTRODUCTION: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.