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April 28, 2008
GlaxoSmithKline and Protherics reported mixed results from a phase IIb trial of Digibind for the treatment of pre-eclampsia. This parallel-group, double-blind, placebo-controlled, randomized study was dubbed DEEP (Digoxin Immune Fab (DIF) Efficacy Evaluation in Pre-eclampsia). It enrolled fifty-one women with severe pre-eclampsia who were in the twenty-fourth through thirty-fourth week of pregnancy, and for whom delivery of the baby was considered necessary within seventy-two hours. The subjects received either Digibind or placebo every six hours for up to forty-eight hours. The two primary endpoints were creatinine clearance, a measure of kidney function, and the use of antihypertensive medication to lower blood pressure. The DEEP study met the first endpoint; the deterioration in kidney function during the 24-48 hours period of treatment was significantly less (p<0.05) in subjects receiving Digibind compared to subjects receiving placebo. However, there was no significant difference for the other primary endpoint, the use of antihypertensive drugs. Based on the results the companies planned to conduct a full analysis of the data in order to determine the future course of action.