Communicating the Value of Pharmacodynamic Modelling in Drug ...
Communicating the Value of Pharmacodynamic Modelling in Drug ...
Communicating the Value of Pharmacodynamic Modelling in Drug ...
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Q3: Given <strong>the</strong> magnitude <strong>of</strong> LDL-C lower<strong>in</strong>g across <strong>the</strong><br />
gemcabene + stat<strong>in</strong> dose range should cl<strong>in</strong>ical<br />
development cont<strong>in</strong>ue?<br />
Data<br />
Analysis<br />
Method<br />
Data Base<br />
Assumpt<br />
ions<br />
Mean (95% CI)<br />
Comments<br />
Gemcabene<br />
Combo - mono<br />
ANCOVA Phase IIA trial Few -4.8<br />
Traditional analysis<br />
only (n=255)<br />
(-12.3 to 2.7)<br />
Meta-Dose- Phase IIA trial Many<br />
Width <strong>of</strong> CI decreased ½<br />
Response The gemcabene pooled with CI from <strong>the</strong> -2.5 meta-analysis compared to does traditional<br />
Development relevant <strong>of</strong> gemcabene (-5.8 to was 1.2) discont<strong>in</strong>ued.<br />
analysis<br />
not overlap historic ezetimibe data CI, clearly suggest<strong>in</strong>g that<br />
gemcabene is unlikely to<br />
Ezetimibe<br />
lower LDL-C to <strong>the</strong><br />
Combo - mono<br />
Meta-Dose- extent Phase necessary IIA trial Many to compete with Gemcabene ezetimibe. comb<strong>in</strong>ation<br />
Response pooled with<br />
relevant<br />
historic data<br />
-8.6<br />
(-9.1 to -8.3)<br />
has very low probability<br />
<strong>of</strong> reach<strong>in</strong>g target<br />
competitor level <strong>of</strong> LDL-<br />
C lower<strong>in</strong>g<br />
slide 42<br />
30 May 2008, ARCS<br />
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