title: Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice.
abstract: BACKGROUND
  Clinical trials indicate that the use of fixed-dose combinations (FDCs) is associated with a higher level of treatment adherence and prolonged blood pressure (BP) control. The aim of this study was to document the safety and effectiveness of the FDC olmesartan/amlodipine/hydrochlorothiazide in patients with essential hypertension in clinical practice.
  
  
  METHODS
  This multicenter, prospective, 24-week, noninterventional study enrolled 5,831 patients from primary care offices in Germany and Austria. Inclusion criteria were a diagnosis of essential hypertension and newly initiated treatment with the FDC.
  
  
  RESULTS
  The mean age of patients was 63.5 years, almost 50% of patients had a time since diagnosis of essential hypertension of over 5 years, and approximately 70% of patients had at least one cardiovascular risk factor, including 29.4% of patients with diabetes mellitus. Following approximately 24 weeks of treatment, the mean reduction in systolic/diastolic BP was 29.0/14.0 mmHg, a BP response was observed by 94.2% of patients, and a target BP of <140/90 mmHg was attained in 67.5% of patients. At least one adverse drug reaction (ADR) was experienced by 1.2% of patients, with the most common being peripheral edema. Subanalyses demonstrated that the following factors did not have a significant influence on the ADR rate: age (<65 years versus ≥65 years), diabetes mellitus (no/yes), cardiovascular risk (low/high), and concomitant medication (no/yes).
  
  
  CONCLUSIONS
  This study demonstrates that in clinical practice, treatment with the three-drug combination as an FDC tablet resulted in a very high proportion of patients with a BP response and control, accompanied by a very low rate of ADRs.
authors.affiliation: Institut für Pharmakologie und präventive Medizin, Mahlow, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
authors.affiliation: Daiichi Sankyo Europe GmbH, Munich, Germany.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Fronk
authors.affiliation: Daiichi Sankyo Deutschland GmbH, Munich, Germany.
authors.forename: Wolf-Peter
authors.initials: WP
authors.lastname: Wolf
authors.affiliation: Daiichi Sankyo Deutschland GmbH, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Smolnik
authors.affiliation: Institut für Pharmakologie und präventive Medizin, Mahlow, Germany.
authors.forename: Gemma
authors.initials: G
authors.lastname: Sutton
authors.affiliation: Abteilung für Nephrologie und Hypertensiologie, Universitätsklinikum Erlangen, Erlangen, Germany.
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001317:Austria; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004232:Diuretics / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005858:Germany; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D011446:Prospective Studies; D012307:Risk Factors; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; C437965:olmesartan
keywords: adverse drug reactions; blood pressure; clinical practice; fixed-dose combination; hypertension