Clinical Study

Pharmacodynamics Must Inform Statistics: An Example from a Cocaine Dependence Pharmacotherapy Trial

Table 1

Systolic and diastolic blood pressure results as a function of titration data inclusion in the statistical model.

ParameterAnalysis excluding the one week titration phaseAnalysis including the one week titration phase
EstimateSE95% confid. limits EstimateSE95% confid. limits

Systolic blood pressure
Intercept123.681.94119.87–127.4863.66 <0.0001124.801.74121.38–128.2171.66<0.0001
Medication−2.222.39−6.91–2.47−0.930.35−3.542.24−7.94–0.86−1.580.11
Week0.170.14−0.11–0.451.220.220.010.13−0.26–0.270.010.99
Med. by Week−0.140.21−0.54–0.26−0.690.490.020.19−0.36–0.400.090.93

Diastolic blood pressure
Intercept78.481.5175.52–81.4551.82<0.000179.331.2876.82–81.8461.84<0.0001
Medication−2.381.99−6.27–1.52−1.200.23−2.911.66−6.16–0.34−1.750.08
Week0.090.13−0.17–0.350.670.51−0.040.11−0.25–0.17−0.380.70
Med. by Week−0.110.20−0.50–0.28−0.540.59−0.030.16−0.35–0.28−0.180.85