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.
| Parameter | Analysis excluding the one week titration phase | Analysis including the one week titration phase | Estimate | SE | 95% confid. limits | | | Estimate | SE | 95% confid. limits | | |
| Systolic blood pressure | Intercept | 123.68 | 1.94 | 119.87–127.48 | 63.66 |
<0.0001 | 124.80 | 1.74 | 121.38–128.21 | 71.66 | <0.0001 | Medication | −2.22 | 2.39 | −6.91–2.47 | −0.93 | 0.35 | −3.54 | 2.24 | −7.94–0.86 | −1.58 | 0.11 | Week | 0.17 | 0.14 | −0.11–0.45 | 1.22 | 0.22 | 0.01 | 0.13 | −0.26–0.27 | 0.01 | 0.99 | Med. by Week | −0.14 | 0.21 | −0.54–0.26 | −0.69 | 0.49 | 0.02 | 0.19 | −0.36–0.40 | 0.09 | 0.93 |
| Diastolic blood pressure | Intercept | 78.48 | 1.51 | 75.52–81.45 | 51.82 | <0.0001 | 79.33 | 1.28 | 76.82–81.84 | 61.84 | <0.0001 | Medication | −2.38 | 1.99 | −6.27–1.52 | −1.20 | 0.23 | −2.91 | 1.66 | −6.16–0.34 | −1.75 | 0.08 | Week | 0.09 | 0.13 | −0.17–0.35 | 0.67 | 0.51 | −0.04 | 0.11 | −0.25–0.17 | −0.38 | 0.70 | Med. by Week | −0.11 | 0.20 | −0.50–0.28 | −0.54 | 0.59 | −0.03 | 0.16 | −0.35–0.28 | −0.18 | 0.85 |
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