§Four double-blind, placebo-controlled studies
–MARISA,
CARISA and 2 IR studies
–1397 patients
(1073 men, 324 women)
–10,998
ETT-plasma concentration pairs
§No influence on concentration-response
–Demographic
factors: age, weight, and race
–Concurrent
diseases: CHF class, diabetes
–Background
anti-anginal therapy
§Men and women respond differently
–Women: 6.4
sec/1000 ng/mL, 95% CI (3.1, 9.7)
–Men: 16.8
sec/1000 ng/mL, 95% CI (14.6, 19.0)