Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2002
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September 2002 issues (click links below for full story)
Using Time-to-Progession as a Clinical Trial Endpoint
Summary: Uncertainty over the best endpoints for a clinical trial is not limited to researchers. Even the FDA has been holding internal meetings to discuss appropriate endpoints, particularly in oncology trials. The FDA has approved drugs based on trials with a time-to-progression (TTP) endpoint, but it is a high hurdle, and the agency has no immediate plans to issue guidelines on the use of TTP endpoints. TTP is less precise than survival, and it raises questions -- about patient selection, cherry-picking, bias, measurement interpretation, the comparator, etc. - that must be answered.
European Respiratory Society - Stockholm, Sweden
Summary:Intermune impressed doctors with the significant survival benefit in a subgroup analysis of its Phase III trial of Actimmune (interferon-g), even though that drug failed its primary and secondary endpoints. Pfizer and Boehringer-Ingelheim were aggressively and successfully marketing their new COPD treatment, Spiriva (tiotropium). New data was presented on the antimicrobials, telithromycin (Aventis's Ketek) and moxifloxacin (Bayer's Avelox), but there was little excitement about either of them.
European Society of Cardiology - Berlin, Germany
Summary: Nine-month safety data from the SIRIUS trial showed Johnson & Johnson's sirolimus-eluting Cypher stent is safe, and use is increasing in Europe Achieve, Guidant's paclitaxel-eluting stent, got CE Mark during the meeting, but there was little enthusiasm for it, mostly due to insufficient data. Biosensor is in human trials of its everolimus-eluting stent and may apply for CE mark in early 2003. AstraZeneca's Crestor beat out Pfizer's Lipitor across all dosage ranges, and doctors indicated it may do well - if it performs well clinically. Pharmacia announced that the EPHESUS trial of its anti-hypertensive, eplerenone ended, with data expected at ACC2003. The concern with hyperkalemia appears to be waning. Cardiologists are not convinced of the utility of Zetia, Schering Plough's new cholesterol absorber, and the problem is lack of outcomes data more than need to take two pills (Zetia plus a statin).