Table 2

ClopidogrelAM Pharmacokinetics With and Without PPIs

VariableClopidogrel With PPIClopidogrel AloneRatio90% CI
Lansoprazole 30 mg
 Tmax (h)0.50 ± 0.50/4.00 (38)0.50 ± 0.50/1.50 (38)
 Cmax (ng/ml)30.01 ± 15.26 (38)39.14 ± 12.55 (38)0.700.611–0.803
 AUCt (ng · h/ml)36.42 ± 10.82 (38)41.69 ± 10.02 (38)0.860.802–0.916
Dexlansoprazole 60 mg
 Tmax (h)0.50 ± 0.50/1.50 (36)0.50 ± 0.50/1.50 (36)
 Cmax (ng/ml)29.33 ± 12.4 (36)38.85 ± 15.7 (36)0.730.652–0.827
 AUCt (ng · h/ml)37.75 ± 13.13 (36)41.25 ± 14.69 (36)0.910.857–0.967
Esomeprazole 40 mg
 Tmax (h)0.50 ± 0.50/1.50 (38)0.50 ± 0.50/1.50 (38)
 Cmax (ng/ml)24.69 ± 10.64 (38)40.97 ± 22.91 (38)0.680.506–0.909
 AUCt (ng · h/ml)31.23 ± 9.94 (38)42.35 ± 18.79 (38)0.840.644–1.093
Omeprazole 80 mg
 Tmax (h)0.50 ± 0.50/3.00 (38)0.50 ± 0.50/1.00 (38)
 Cmax (ng/ml)22.55 ± 10.68 (38)38.25 ± 12.46 (38)0.560.488–0.635
 AUCt (ng · h/ml)26.28 ± 8.80 (38)37.78 ± 12.04 (38)0.690.644–0.749

Values are median ± minimum/maximum (n) for Tmax and mean ± SD (n) for Cmax and AUCt.

AUCt = area under the plasma concentration–time curve; CI = confidence interval; clopidogrelAM = clopidogrel active metabolite; Cmax = peak plasma concentration; PPI = proton pump inhibitor; Tmax = time to reach peak concentration.

  • Point estimates for ratios of the central values for the natural logarithms of Cmax and AUCt. The pre-specified lower no-effect boundary limit for the 90% CI of the ratio was 0.80, and the upper no-effect boundary limit was 1.25.