title: Amlodipine/valsartan single-pill combination: a prospective, observational evaluation of the real-life safety and effectiveness in the routine treatment of hypertension.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Russian Cardiology Scientific-Industrial Complex, Moscow, Russia.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Karpov
authors.forename: Neelesh
authors.initials: N
authors.lastname: Dongre
authors.forename: Alexey
authors.initials: A
authors.lastname: Vigdorchik
authors.forename: Krisada
authors.initials: K
authors.lastname: Sastravaha
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000627:therapeutic use*; D000068838:Amlodipine, Valsartan Drug Combination; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D004338:Drug Combinations; D004487:Edema / Q000139:chemically induced; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013777:Tetrazoles / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000068838:Amlodipine, Valsartan Drug Combination; D000959:Antihypertensive Agents; D004338:Drug Combinations; D013777:Tetrazoles; D017311:Amlodipine