PMID- 11549097
OWN - NLM
STAT- MEDLINE
DCOM- 20020219
LR  - 20190826
IS  - 0091-2700 (Print)
IS  - 0091-2700 (Linking)
VI  - 41
IP  - 9
DP  - 2001 Sep
TI  - The pharmacokinetics and pharmacodynamics of irbesartan in heart failure.
PG  - 935-42
AB  - Alterations in the pharmacokinetic parameters of a number of medications have 
      been observed in patients with heart failure. Because the angiotensin II receptor 
      antagonist irbesartan has beneficial effects in patients with heart failure, the 
      pharmacokinetics and pharmacodynamics of irbesartan in 10 patients with New York 
      Heart Association (NYHA) class II or III heart failure compared with 10 control 
      subjects matched with respect to race, age, weight, and sex were studied. In a 
      crossover study, participants were randomized to receive open-label irbesartan 75 
      mg as either an oral capsule or an intravenous (i.v.) infusion in the first 
      treatment period. After a 7- to 10-day washout period, participants were crossed 
      over to the other treatment arm. Single-dose noncompartmental pharmacokinetic 
      parameters, angiotensin II levels, and plasma renin activity (PRA) of irbesartan 
      were determined for each participant. Following oral and i.v. administration, the 
      pharmacokinetics of irbesartan in patients with heart failure was not 
      significantly different from those of matched controls, indicating that there is 
      little influence of potential changes in organ/tissue perfusion and gut edema on 
      the absorption, distribution, and elimination of irbesartan. After dosing with 
      irbesartan, mean increases in angiotensin II and PRA concentrations were higher 
      in patients with heart failure than in the matched controls, but there was more 
      interpatient variability in the patients with heart failure. Given the 
      variability of the data, no definitive conclusions can be made with regard to 
      these pharmacodynamic parameters. The results of this study indicate that the 
      pharmacokinetics of irbesartan following oral and i.v. administration is not 
      altered in patients with heart failure. Therefore, this indicates that no dosage 
      adjustment is needed when prescribing irbesartan in heart failure patients.
FAU - Kostis, J B
AU  - Kostis JB
AD  - University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical 
      School, New Brunswick, USA.
FAU - Vachharajani, N N
AU  - Vachharajani NN
FAU - Hadjilambris, O W
AU  - Hadjilambris OW
FAU - Kollia, G D
AU  - Kollia GD
FAU - Palmisano, M
AU  - Palmisano M
FAU - Marino, M R
AU  - Marino MR
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - J Clin Pharmacol
JT  - Journal of clinical pharmacology
JID - 0366372
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Receptor, Angiotensin, Type 1)
RN  - 0 (Tetrazoles)
RN  - J0E2756Z7N (Irbesartan)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Angiotensin Receptor Antagonists
MH  - Antihypertensive Agents/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Area Under Curve
MH  - Biphenyl Compounds/adverse effects/*pharmacokinetics/*therapeutic use
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Half-Life
MH  - Heart Failure/*drug therapy
MH  - Humans
MH  - Injections, Intravenous
MH  - Irbesartan
MH  - Male
MH  - Middle Aged
MH  - Receptor, Angiotensin, Type 1
MH  - Tetrazoles/adverse effects/*pharmacokinetics/*therapeutic use
EDAT- 2001/09/11 10:00
MHDA- 2002/02/20 10:01
CRDT- 2001/09/11 10:00
PHST- 2001/09/11 10:00 [pubmed]
PHST- 2002/02/20 10:01 [medline]
PHST- 2001/09/11 10:00 [entrez]
AID - 10.1177/00912700122010906 [doi]
PST - ppublish
SO  - J Clin Pharmacol. 2001 Sep;41(9):935-42. doi: 10.1177/00912700122010906.