Would appreciate your take Prazi and Stavi

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StewardshipDude

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10+ Year Member
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I know you dudes hate me since I talk to select industry reps and because I still believe that their are serious questions with generic pip-tazo safety but I appreciate yalls take on antibiotics. So, I am interested in your ideas on how I should balance 2 recent conflicting studies.

First, the recent Kalil article in Critical Care Medicine seemed to indicate that there was, based on retrospective looks at published RCTs, no significant difference between vanc and linezolid. Pretty darn good review although I realize that it was not a prospective look in and of itself. I like the fact that the authors were not funded by industry.


Having just returned from IDSA, I was interested in the Pfizer funded study that showed linezolid to be statistically superior to vanc in nosocomial pneumonia. http://www.prnewswire.com/news-rele...n-in-mrsa-nosocomial-pneumonia-105422943.html
Of course it is industry funded, but their data looks robust.

We are a data driven account. What is your take on how this might affect future guidelines? My experience is that our critical care pulmonary staff already believes linezolid to be superior, while my colleagues in pharmacy and in ID believe the two agents to be equivalent.

Thanks in advance.

I also would appreciate it if the WVU dude would refrain from insulting me because I talk to industry MSLs. thanks.
 
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I know you dudes hate me since I talk to select industry reps and because I still believe that their are serious questions with generic pip-tazo safety but I appreciate yalls take on antibiotics. So, I am interested in your ideas on how I should balance 2 recent conflicting studies.

First, the recent Kalil article in Critical Care Medicine seemed to indicate that there was, based on retrospective looks at published RCTs, no significant difference between vanc and linezolid. Pretty darn good review although I realize that it was not a prospective look in and of itself. I like the fact that the authors were not funded by industry.


Having just returned from IDSA, I was interested in the Pfizer funded study that showed linezolid to be statistically superior to vanc in nosocomial pneumonia. http://www.prnewswire.com/news-rele...n-in-mrsa-nosocomial-pneumonia-105422943.html
Of course it is industry funded, but their data looks robust.

We are a data driven account. What is your take on how this might affect future guidelines? My experience is that our critical care pulmonary staff already believes linezolid to be superior, while my colleagues in pharmacy and in ID believe the two agents to be equivalent.

Thanks in advance.

I also would appreciate it if the WVU dude would refrain from insulting me because I talk to industry MSLs. thanks.

To me, the entire issue is kind of muddled. The meta-analysis didn't take into account the vancomycin concentrations, nor could it have. The main results weren't really surprising at all, but I thought the adverse event analyses were (no nephrotoxicity difference). It looks like a similar issue exists with the IDSA study, but I can't be certain without the abstract/poster/presentation (do you have a copy? I'd be interested to see it)...how was vancomycin dosed? It says 15mg/kg, but then adjusted per clinician judgment. Before I can pass a judgment, I'd need to see proportion of time above 15, prior vancomycin exposure/failure, etc.

As far as guidelines go, I don't think you can make a change based off of either of these two studies. Some of the data coming out on treatment failures in patients previously exposed to vancomycin may lead towards a suggestion that linezolid be used in that subset of patients, but not for the overall population.

Anyways, who knows. Still a good topic for discussion.
 
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im drivin so i will reply later but if memory serves me right, the recent linezolid superiority presentation compared zyvox 600mg vs. vanc 15mg per kg q12h....while we are out here dosing 25-30mg per kg load and 20mg per kg maintenance dose. both with failure rates near 50 percent is nothing to write home about while the mortality shows no difference between 2 tx groups. even the author concluded if vanc was properly dosed, outcome may have been different.

that being said, i believe that pharmacists who speak on behalf of pharma who use skewed data to rip off our healthcare system are one of the lowest forms of our profession.
 
$20 says they ****ed up the dosing and/or monitoring for patients on Vanc.

Any takers?

....

Kinda like that study back in the day where 40mg of Nexium was, amazingly, superior to 20mg of omeprazole. My favoritist study in the history of laughable drug company studies.

....
 
thanks prazi, I don't have the study. all they gave out was the abstract. I doubt it is published yet. I don't recall the mortality data, but I don't think it was different.
 
im drivin so i will reply later but if memory serves me right, the recent linezolid superiority presentation compared zyvox 600mg vs. vanc 15mg per kg q12h....while we are out here dosing 25-30mg per kg load and 20mg per kg maintenance dose. both with failure rates near 50 percent is nothing to write home about while the mortality shows no difference between 2 tx groups. even the author concluded if vanc was properly dosed, outcome may have been different.

that being said, i believe that pharmacists who speak on behalf of pharma who use skewed data to rip off our healthcare system are one of the lowest forms of our profession.

perhaps a different study then, because this guy presenting the poster certainly did not conclude that vanc was not dosed properly. he did criticize previous studies that had a fixed dose of vanc, but said this study they were going for troughs of 20 but that it was ultimately up to the clinician. Also, not sure if he was correct but and he was hard to understand because he had a thick accent but he suggested this was the largest culture confirmed mrsa pneumonia trial ever. I'll have to check that out.
 
perhaps a different study then, because this guy presenting the poster certainly did not conclude that vanc was not dosed properly. he did criticize previous studies that had a fixed dose of vanc, but said this study they were going for troughs of 20 but that it was ultimately up to the clinician. Also, not sure if he was correct but and he was hard to understand because he had a thick accent but he suggested this was the largest culture confirmed mrsa pneumonia trial ever. I'll have to check that out.


It's the same study. Here

Right...they were really going for 20mcg/ml trough with 15mg/kg q12h. Good luck with that. It's the same ole study Kollef and Wunderink ran 10 years ago.. $2.3 billion penalty to the FDA wasn't enough...Pfizer is really is trying hard. This study is not published yet...but I can't wait. It's full of holes.

I would like to see the inclusion criteria and how hard Pfizer is going to try to fudge the ITT population.

The Kalil et al Meta Analysis did look at all randomized "prospective" trials comparing linezolid to comparators. I like how they used Q & I stat method for statistical heterogeneity and variation magnitude due to 2ndary heterogeneity. The large study sample size failed to show superiority of Zyvox over Vanco yet showed higher rates of ADR with Linezolid.

Who are you going to believe... homers who are getting paid to show linezolid is superior or people just running a meta analysis because it's the right thing to do??

As far as your Zosyn question goes... we didn't see issues with it 17 years ago when we used the old formulation and we certainly aren't seeing it today.