PMID- 22920048
OWN - NLM
STAT- MEDLINE
DCOM- 20130117
LR  - 20191112
IS  - 1179-187X (Electronic)
IS  - 1175-3277 (Linking)
VI  - 12
IP  - 5
DP  - 2012 Oct 1
TI  - Efficacy of olmesartan medoxomil and hydrochlorothiazide fixed-dose combination 
      therapy in patients aged 65 years and older with stage 1 and 2 hypertension or 
      isolated systolic hypertension.
PG  - 325-33
AB  - BACKGROUND: The incidence of hypertension, particularly isolated systolic 
      hypertension, increases with increasing age, as does the risk of fatal 
      cardiovascular disease. A combination antihypertensive therapy regimen may be 
      required to reach recommended BP goals in older patients. OBJECTIVES: This study 
      set out to report blood pressure (BP) data in elderly patients across the 
      subgroups of stage 1 and stage 2 hypertension (prespecified subgroup) and 
      isolated systolic hypertension (ISH) [post hoc]. DESIGN AND SETTING: This was a 
      subgroup analysis of a prospective, open-label study carried out in a 
      multicenter, outpatient setting (e.g. the BeniSILVER [Benicar Efficacy: New 
      Investigation Shows OM Treatment Increasingly Leads to Various Elderly 
      Populations to Safe BP Reductions; ClinicalTrials.gov identifier: NCT00412932] 
      study). The study included 176 patients with a mean age of approximately 72 
      years; stage 1 hypertension, 60, stage 2 hypertension, 116, and ISH, 98. 
      INTERVENTION: After a 2- to 3-week placebo run-in period, patients were 
      uptitrated every 3 weeks from olmesartan medoxomil (OM) 20 mg daily to OM 40 mg, 
      OM/hydrochlorothiazide (HCTZ) 40 mg/12.5 mg, and OM/HCTZ 40 mg/25 mg, if seated 
      cuff BP (SeBP) was >/=120/70 mmHg. MEASUREMENTS: Measurements included change from 
      baseline in mean 24-hour ambulatory BP and SeBP after 12 weeks of treatment, 
      percentage of patients achieving a cumulative SeBP goal of <140/90 mmHg (stage 1 
      and stage 2 cohorts) or seated cuff systolic BP (SeSBP) goal of <140 mmHg (ISH 
      cohort), and the incidence of adverse events (AEs). RESULTS: Combination therapy 
      was required by 159 patients. Changes from baseline in mean 24-hour ambulatory BP 
      (+/- standard deviation [SD]) were -24.2 (+/- 11.8)/-11.8 (+/- 6.9) mmHg, -26.5 (+/- 
      11.8)/-12.6 (+/- 6.7) mmHg, and -24.7 (+/- 12.5)/-11.2 (+/- 6.4) mmHg in the stage 1, 
      stage 2, and ISH cohorts, respectively (all p < 0.001 vs baseline). Mean SeBP 
      changes (+/- SD) from baseline in patients titrated to OM/HCTZ 40 mg/25 mg were 
      -24.6 (+/- 11.4)/-10.5 (+/- 7.3) mmHg in the stage 1 cohort, -26.4 (+/- 17.2)/-11.3 (+/- 
      9.7) mmHg in the stage 2 cohort, and -21.5 (+/- 15.6)/-6.8 (+/- 7.8) mmHg in the ISH 
      cohort (all p < 0.001). The cumulative proportions of patients achieving an SeBP 
      goal of <140/90 mmHg by week 12 were 88.3%, 56.0%, and 72.4% in the stage 1, 
      stage 2, and ISH cohorts, respectively, while 72.4% of patients achieved an SeSBP 
      of <140 mmHg in the ISH cohort. Treatment-emergent AEs ranged from 32.3% to 
      32.8%, with <3% of patients reporting drug-related hypotension. CONCLUSION: An 
      OM/HCTZ-based titration regimen enabled elderly patients with hypertension to 
      safely reduce BP throughout the 24-hour dosing interval and allowed the majority 
      of these patients to achieve a BP target of <140/90 mmHg or <140 mmHg.
FAU - Germino, F Wilford
AU  - Germino FW
AD  - Department of Internal Medicine, Orland Primary Care Specialists, Orland Park, IL 
      60467, USA. wgermino@hotmail.com
FAU - Neutel, Joel M
AU  - Neutel JM
FAU - Dubiel, Robert
AU  - Dubiel R
FAU - Maa, Jen-Fue
AU  - Maa JF
FAU - Chavanu, Kathleen J
AU  - Chavanu KJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00412932
PT  - Comparative Study
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Am J Cardiovasc Drugs
JT  - American journal of cardiovascular drugs : drugs, devices, and other 
      interventions
JID - 100967755
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Imidazoles)
RN  - 0 (Tetrazoles)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - 6M97XTV3HD (Olmesartan Medoxomil)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Ambulatory Care
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Blood Pressure Monitoring, Ambulatory
MH  - Dose-Response Relationship, Drug
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/administration & dosage/adverse effects/*therapeutic use
MH  - Hypertension/*drug therapy
MH  - Imidazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Olmesartan Medoxomil
MH  - Prospective Studies
MH  - Tetrazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2012/08/28 06:00
MHDA- 2013/01/18 06:00
CRDT- 2012/08/28 06:00
PHST- 2012/08/28 06:00 [entrez]
PHST- 2012/08/28 06:00 [pubmed]
PHST- 2013/01/18 06:00 [medline]
AID - 10.1007/BF03261841 [doi]
PST - ppublish
SO  - Am J Cardiovasc Drugs. 2012 Oct 1;12(5):325-33. doi: 10.1007/BF03261841.