PMID- 19886855
OWN - NLM
STAT- MEDLINE
DCOM- 20100205
LR  - 20181201
IS  - 1525-6006 (Electronic)
IS  - 1064-1963 (Linking)
VI  - 31
IP  - 7
DP  - 2009 Oct
TI  - Safety and tolerability of fixed-dose irbesartan/hydrochlorothiazide for rapid 
      control of severe hypertension.
PG  - 572-84
LID - 10.3109/10641960902929420 [doi]
AB  - This prospective, double-blind, multicenter trial compared the safety and 
      tolerability of irbesartan/hydrochlorothiazide (HCTZ) fixed-dose combination 
      therapy with irbesartan monotherapy in patients with severe hypertension (seated 
      diastolic blood pressure (SeDBP) >or=110 mm Hg, mean BP 172/113 mm Hg at 
      baseline). Patients were randomized 2:1 to 7 weeks' irbesartan/HCTZ 150/12.5 mg 
      to 300/25 mg (n = 468) or irbesartan 150 mg to 300 mg (n = 227). The incidence of 
      treatment-related adverse events (AEs) was similar with combination and 
      monotherapy (11.3% and 10.1%), and most AEs were mild-to-moderate. The combined 
      incidence of prespecified AEs was lower with irbesartan/HCTZ than with irbesartan 
      (8.8% vs. 11.5%). There were no treatment-related serious AEs or deaths. At week 
      5, more patients achieved SeDBP < 90 mm Hg compared to irbesartan (47% vs. 33%; P 
      = 0.0005). Despite more rapid and aggressive BP lowering, initial fixed-dose 
      irbesartan/HCTZ demonstrated a comparable AE profile to irbesartan monotherapy in 
      patients with severe hypertension.
FAU - Neutel, Joel M
AU  - Neutel JM
AD  - Orange County Research Center, Tustin, CA 92780, USA. JMNeutel@aol.com
FAU - Franklin, Stanley S
AU  - Franklin SS
FAU - Bhaumik, Amitabha
AU  - Bhaumik A
FAU - Lapuerta, Pablo
AU  - Lapuerta P
FAU - Oparil, Suzanne
AU  - Oparil S
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Exp Hypertens
JT  - Clinical and experimental hypertension (New York, N.Y. : 1993)
JID - 9305929
RN  - 0 (Angiotensin II Type 1 Receptor Blockers)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Drug Combinations)
RN  - 0 (Sodium Chloride Symporter Inhibitors)
RN  - 0 (Tetrazoles)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - J0E2756Z7N (Irbesartan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiotensin II Type 1 Receptor Blockers/administration & dosage/adverse effects
MH  - Antihypertensive Agents/*administration & dosage/adverse effects
MH  - Biphenyl Compounds/*administration & dosage/adverse effects
MH  - Blood Pressure/drug effects
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/*administration & dosage/adverse effects
MH  - Hypertension/*drug therapy/physiopathology
MH  - Irbesartan
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Sodium Chloride Symporter Inhibitors/administration & dosage/adverse effects
MH  - Tetrazoles/*administration & dosage/adverse effects
MH  - Young Adult
EDAT- 2009/11/06 06:00
MHDA- 2010/02/06 06:00
CRDT- 2009/11/06 06:00
PHST- 2009/11/06 06:00 [entrez]
PHST- 2009/11/06 06:00 [pubmed]
PHST- 2010/02/06 06:00 [medline]
AID - 10.3109/10641960902929420 [pii]
AID - 10.3109/10641960902929420 [doi]
PST - ppublish
SO  - Clin Exp Hypertens. 2009 Oct;31(7):572-84. doi: 10.3109/10641960902929420.