Key result
Doxazosin shows similar elimination half-life in renal failure versus healthy controls despite prolonged blood pressure recovery.
Why the study?
The antihypertensive efficacy and pharmacokinetics of doxazosin in patients with renal failure compared to healthy subjects were not well characterized.
Does a single 1 mg oral dose of doxazosin have different pharmacokinetics and blood pressure effects in patients with renal failure compared to healthy volunteers?
Does a single 1 mg oral dose of doxazosin have different pharmacokinetics and blood pressure effects in patients with renal failure compared to healthy volunteers?
Absolute Event Rate: 13.3% vs 12.6%
p-value: p=not significant
While doxazosin pharmacokinetics are similar between healthy subjects and those with renal failure, the blood pressure lowering effect is significantly prolonged in patients with renal failure.
May warrant dosing caution in renal failure due to prolonged BP effects; leaves open optimal regimens for prospective study.
The antihypertensive efficacy and pharmacokinetics of a single 1 mg oral dose of doxazosin were investigated in five healthy male volunteers, six patients with renal failure not on hemodialysis, and four patients with end-stage renal failure studied between two hemodialyses. The dialyzability of doxazosin was studied in five patients. The maximum fall in blood pressure of both volunteers and patients occurred between 4 and 8 hours. In four of five volunteers the blood pressure had returned to baseline within 10 to 12 hours, whereas in the patients with renal failure it took as long as 72 hours. Maximum plasma concentrations were reached in 2.6 to 3.6 hours. The mean AUC did not differ significantly between the groups. The mean (SE) elimination t1/2 was 12.6 hours (3.3) in the volunteers and 13.3 hours (1.8) in the patients with renal insufficiency (not significant). Doxazosin was not appreciably dialyzable.
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Carlson et al. (1986) studied renal failure (n=15). Doxazosin vs. Healthy volunteers was evaluated on elimination t1/2 (hours) (p=not significant). A single 1 mg dose of doxazosin showed similar elimination half-life in patients with renal failure and healthy volunteers (13.3 vs 12.6 hours), though blood pressure recovery took up to 72 hours.
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