tag:blogger.com,1999:blog-4230162007222918868.post8814245250815294045..comments2023-09-19T05:50:03.130-04:00Comments on Renal Fellow Network: Bardoxolone - Part 2Gearoid McMahonhttp://www.blogger.com/profile/08049723797363526138noreply@blogger.comBlogger5125tag:blogger.com,1999:blog-4230162007222918868.post-44482828120802004322011-10-10T14:50:54.744-04:002011-10-10T14:50:54.744-04:00Where are the animal studies showing benefits of b...Where are the animal studies showing benefits of bardoxolone treatments on chronic renal insufficiency? If they are available no reference is made to them on PubMed.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4230162007222918868.post-13734988795718348352011-07-17T23:38:53.949-04:002011-07-17T23:38:53.949-04:00As Nephrologists, we have been badly burnt by not ...As Nephrologists, we have been badly burnt by not asking the right questions before rolling out treatments (like Epo) to patients. I think your skepticism is healthy and appropriate, and the issues raised have a sound pathophysiological basis. <br />I would take a very different position to the last poster... in a field with such a dismal track record, we must insist on the highest quality evidence before accepting a new treatment, lest we repeat the problems of the past.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4230162007222918868.post-497057809311627732011-07-17T18:17:16.257-04:002011-07-17T18:17:16.257-04:00Such cynicism! The reported changes in eGFR seem t...Such cynicism! The reported changes in eGFR seem too dramatic to just explain away as merely hemodynamic effect in absence of major concurrent (correlating) blood pressure changes, (and the earlier reports suggest statistical independence here.)<br /> <br />The ACR findings are the most problematic, but in a field with such a dismal track record--we could perhaps do better than to smugly deride a promising development--which will at least perhaps lead to some fundamental discoveries.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4230162007222918868.post-45424245186227930172011-07-17T14:23:30.677-04:002011-07-17T14:23:30.677-04:00Great post,
Amazing work, as usual by a nephrolog...Great post,<br /><br />Amazing work, as usual by a nephrologist. There is always tons of stuff hidden behind the abstract and the paper. <br /><br />The company was smart to report only eGFR and hence get another study and get "rapid" approval from FDA. You only need to market the abstract. <br /><br />Thanks for this gr8 post.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4230162007222918868.post-85183820160422393432011-07-16T18:39:33.894-04:002011-07-16T18:39:33.894-04:00If this is true then I agree that it would be a pr...If this is true then I agree that it would be a pretty big deal for our specialty. If however the MOA of eGFR increase is something that further hastens renal damage then well...that would be a foolish and expensive mistake. The phase 3 trial as I heard from some investigators participating in the trial is an an event driven composite endpoint study. If the MOA of improved eGFR is increased intraglomerular pressure that would be pretty evident in a renal endpoint study. If the MOA is repair then perhaps it may improve outcomes. <br /><br />Here is what I don't get. The company who owns it and that has been developing it, did they actually consult a nephrologist when designing the studies? It is puzzling to me that they did not think to measure GFR in their earlier studies. Seems a bit naive to think a nephrologist would accept changes in eGFR as a primary endpoint.BeanMDnoreply@blogger.com