PMID- 17157119
OWN - NLM
STAT- MEDLINE
DCOM- 20070213
LR  - 20131121
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 10
DP  - 2006 Oct
TI  - A multicenter, randomized, double-blind, parallel-group trial of the 
      antihypertensive efficacy and tolerability of a combination of once-daily 
      losartan 100 mg/hydrochlorothiazide 12.5 mg compared with losartan 100-mg 
      monotherapy in the treatment of mild to severe essential hypertension.
PG  - 1639-48
AB  - BACKGROUND: Because patients with hypertension may require >1 antihypertensive 
      agent to control blood pressure (BP), physicians often prescribe a fixed 
      combination of antihypertensive medications. OBJECTIVE: This study evaluated the 
      effect of adding low-dose hydrochlorothiazide 12.5 mg (HCTZ12.5) to high-dose 
      losartan 100 mg (L100) in patients with hypertension whose BP was inadequately 
      controlled with L100 monotherapy. METHODS: Enrolled in this multicenter, 
      randomized, double-blind, parallel-group, filter study were patients aged > or 
      =18 years with a mean trough sitting diastolic BP (SiDBP) of 95 to 120 mm Hg. 
      Patients were treated with L100 QD for 4 weeks. Patients who did not achieve 
      adequate BP control were randomly assigned to receive L100/HCTZ12.5 or L100 QD 
      for 6 weeks. The primary efficacy measure was the mean change in trough SiDBP 
      from baseline in the 2 groups. Responders were defined as patients with a mean 
      trough SiDBP of <90 mm Hg or patients who had a > or =10-mm Hg decrease in mean 
      trough SiDBP. RESULTS: Demographic characteristics were similar between treatment 
      groups. The patients randomized to the double-blind treatment period were mostly 
      white (65.1%) and male (57.5%), with a mean age of 53.8 years. The mean (SD) 
      duration of hypertension at baseline was 9.7 (8.5) years. The proportion of 
      patients previously treated with antihypertensive therapy was 76.7%. Of the 367 
      patients enrolled in the L100 filter period, 292 patients had BP inadequately 
      controlled with L100 monotherapy and were randomized to receive L100 (n = 145) or 
      L100/HCTZ12.5 (n = 147). At week 6 after randomization, mean trough SiDBP was 
      significantly lower in the L100/HCTZ12.5 group than in the L100 group (-8.3 vs 
      -5.2, respectively; P < 0.001). The between-group difference was -3.0 mm Hg (95 % 
      CI, -4.6 to -1.40; P < 0.001), and the proportion of responders was significantly 
      greater in the L100/HCTZ12.5 group than in the L100 group (63.0% vs 44.4%; P < 
      0.001). The incidence of adverse events (AEs) occurring in >2% of patients during 
      the double-blind period was similar for both groups. AEs occurring in the L100 
      group and the L100/HCTZ12.5 group included respiratory tract infection (6.2% vs 
      3.4%, respectively), dizziness (2.1% vs 0.7%), and headache (0.7% vs 3.4%). 
      CONCLUSIONS: After 6 weeks of therapy, L100/HCTZ12.5 was associated with greater 
      antihypertensive efficacy than L100, as measured by the change in mean trough 
      SiDBP The percentage of responders was significantly greater in the L100/HCTZ12.5 
      group than in the L100 group.
FAU - Gleim, Gilbert W
AU  - Gleim GW
AD  - Merck Research Laboratories, Merck & Co., Inc., Blue Bell, Pennsylvania, USA. 
      gilbert_gleim@merck.com
FAU - Rubino, Joseph
AU  - Rubino J
FAU - Zhang, Hongyan
AU  - Zhang H
FAU - Shahinfar, Shahnaz
AU  - Shahinfar S
FAU - Soffer, Beth A
AU  - Soffer BA
FAU - Lyle, Paulette A
AU  - Lyle PA
FAU - Littlejohn, Thomas W 3rd
AU  - Littlejohn TW 3rd
FAU - Feig, Peter U
AU  - Feig PU
LA  - eng
SI  - ClinicalTrials.gov/NCT00307060
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antihypertensive Agents)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - JMS50MPO89 (Losartan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antihypertensive Agents/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/administration & dosage/*therapeutic use
MH  - Losartan/administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2006/12/13 09:00
MHDA- 2007/02/14 09:00
CRDT- 2006/12/13 09:00
PHST- 2006/07/18 00:00 [accepted]
PHST- 2006/12/13 09:00 [pubmed]
PHST- 2007/02/14 09:00 [medline]
PHST- 2006/12/13 09:00 [entrez]
AID - S0149-2918(06)00254-2 [pii]
AID - 10.1016/j.clinthera.2006.10.014 [doi]
PST - ppublish
SO  - Clin Ther. 2006 Oct;28(10):1639-48. doi: 10.1016/j.clinthera.2006.10.014.