title: Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension.
abstract: BACKGROUND
  A post-hoc analysis was performed on the data from a 54 weeks phase III study (ClinicalTrials.gov identifier: NCT00923091) to measure changes in the health-related quality of life (HRQoL) of 2,690 patients aged ≥18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ), using the MINICHAL and EQ-5D instruments.
  
  
  METHODS
  Descriptive statistics were used to assess blood pressure and HRQoL scores over the study period. Analysis of covariance (ANCOVA) was used to identify those factors that could possibly have influenced HRQoL. Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores.
  
  
  RESULTS
  Patients' baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6. Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33%. Patients' baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively, increasing by 6% and 12% over the study period. Patients' QALY gain over the 54 weeks study period was estimated to be 0.029 QALYs. The ANCOVA showed that changes in patients' HRQoL was likely to have been influenced by patients' achievement of blood pressure control, the amount of concomitant medication and patients' last used dosage strength of antihypertensive. Linear regression showed that blood pressure improvement may have been associated with improved HRQoL.
  
  
  CONCLUSIONS
  This study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients' HRQoL. Achieving blood pressure control, amount of concomitant medication and dosage strength of antihypertensive impacted on patients' HRQoL.
authors: Arterial Investigation Unit, Medicine 4, Santa Marta's Hospital, CHLC, Lisbon, Portugal. pmarques.silva@sapo.pt.
authors: Pedro
authors: P
authors: Marques da Silva
authors: HaaPACS GmbH, Schriesheim, Germany. uwe.haag@haapacs.com.
authors: Uwe
authors: U
authors: Haag
authors: Catalyst Health Economics Consultants, Northwood, UK. julian.guest@catalyst-health.com.|Faculty of Life Sciences and Medicine, King's College, London, UK. julian.guest@catalyst-health.com.
authors: Julian F
authors: JF
authors: Guest
authors: Health Economics and Decision Science (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. j.e.brazier@sheffield.ac.uk.
authors: John E
authors: JE
authors: Brazier
authors: Health Economics & Outcomes Research Department, Daiichi-Sankyo Europe, Munich, Germany. marco_soro@virgilio.it.
authors: Marco
authors: M
authors: Soro
mesh_terms: D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage; D006973:Hypertension / Q000188:drug therapy* / Q000523:psychology*; D007093:Imidazoles / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil; D011788:Quality of Life / Q000523:psychology*; D013777:Tetrazoles / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068557:Olmesartan Medoxomil; C437965:olmesartan