Why the study?
Does extreme old age affect the pharmacokinetics and pharmacodynamics of a single 15 mg oral dose of oxazepam?
Does extreme old age affect the pharmacokinetics and pharmacodynamics of a single 15 mg oral dose of oxazepam?
Extreme old age significantly reduces the clearance of unbound oxazepam and increases sensitivity to its psychomotor effects.
May support lower oxazepam doses in the elderly; hypothesis-generating and requires confirmation in larger trials.
The effect of extreme old age on the pharmacokinetics and pharmacodynamics of orally administered oxazepam 15 mg was studied in 10 healthy elderly (age 80-94 years) institutionalised subjects and 10 healthy young controls (age 26-42 years). The total oxazepam clearance was 1.24 (0.91-1.80) ml min-1 kg-1 (median and range) and 1.44 (0.88-2.13) ml min-1 kg-1 in the elderly and young, respectively (NS), and the elimination half-lives were 8.1 (5.5-10.8) h and 5.7 (4.9-6.2) h. respectively (P less than 0.01). The percent of unbound oxazepam was greater in the elderly; 9.8 (8.1-13.3)% as opposed to 5.1 (3.7-5.9)% in the young (P less than 0.0001). Clearance of unbound oxazepam was lower in the elderly, median values being 13.8 (7.1-21.1) ml min-1 kg-1 compared with 30.3 (18.3-41.5) ml min-1 kg-1 in the young (P less than 0.0001). A single 15 mg dose oxazepam decreased the ability of the elderly to perform a finger tapping test at 3 h but not 8 h after drug administration, whereas placebo had no effect at either times. No effect was observed in the young subjects.
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Sonne et al. (1991) studied this question.
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