Space---the final frontier? Likely just the beginning with JUPITER

 JUPITER - With the potential to reduce the number of myocardial infarctions by "250,000 world-wide" this study is perhaps the most widely anticipated and discussed study of this meeting and certainly the one with the greatest potential to impact what goes on behind exam room doors.     17,802 patients from 26 countries  are now our template for treating patients with normal LDL but elevated hsCRP.  With 38% of the study population being women ( a total of 7000 in all)  and 25% black or hispanic, we get a real world experience with this study, rather than the usual white male cohort.  A 47% reduction in the  grouped components of the primary endpoint of MI, stroke or CV death was to say the least, incredible.     The safety data  was  also reassuring  with only one reported patient suffering rhabdo which was a 90 - year -old with trauma and pneumonia. Only  Nineteen myopathic events wre reported in 10 subjects receiving therapy and in 9  in the placebo arm. 

The only unexplained rings around the JUPITER trial were the slightly increased Hba1c's which included a small but possibly significant number of patients, a signal we've seen before in other trials.  Also, post menopausal women on hormone replacement therapy were excluded. Additionally, this study as any other "primary prevention trial" begs the question "what exactly is primary prevention".  Are we preventing events by preventing the development of atheroma, or are we stabilizing atheroma and preventing  events or both?  Finally, real world practice never yields a compliance rate of 75% with any directed activity except perhaps breathing or sex , so this final frontier is still  insurmountable as of today in most clinics and private physicians' offices. 

 When asked the invariable "cancer signal" question in regard to statin use the reply was that "we have a modest  area under the exposure curve" as it was stopped at 1.9 years and that "it takes 5-20 years for solid organ cancers" to show up, however, we have a "large amount of exposure data for the safety of statins as a class" pointing to overall safety. 

The youngest female enrolled in this trial was "60 years and one day" which reconfirms our lack of data for women who are premenopausal with normal LDL's and high hsCRP's.  I asked the presenter regarding his recommendation with this type of patient, a question which seemed to annoy more than stimulate.   Rather, I thought he should be flattered that we would be interested in his opinion on the subject, after all, he must have one with his level of experience and expertise.  Alas, he merely replied "you are asking me to comment on a patient who was not enrolled in this study". ---- I know. That is why I asked it and still would like to know the answer.

So what I know today is that when  a post menopausal female over the age of 60 or a male 50 years old or older with a normal LDL asks me whether they will benefit from statin therapy, I can reach  for an answer ....with a simple hsCRP.   With a 47% reduction in events, the sky and even outerspace are no longer the limit thanks to  JUPITER.   

Melissa

Your comments

	Space---the final frontier? Likely just the beginning with JUPITER
	# 1 of 1	November 12, 2008 11:32 (EST)
	JD	sorry....I posted this comment in another one of your blogs by mistake................ If we look deep down at this study and several of Crestors previous studies...these are "Marketing" driven studies and not true "Scientifically" driven studies...screen 90000 patients so you can get exactly the type of patient that you can show benefit, then compare your statin to placebo...the 44% reduction in the Crestor arm was 142 patients versus 251 in the placebo arm...yes, a reduction of 44%...out of 17000 patients!!!...then end the study at 1.9 years before cancers and AE start showing up to tarnish the study...what about the higher incidence of diabets in the active arm versus the placebo arm...knowing full well Crestor's past with Proteinuria, Hematuria and kidney toxcity when using the higher doses of 40mg and the banned dose of 80mg?...once again...a "marketing" driven study...which the media beautifully picked up and most people are touting as extraordinary...but why?...why?...because Crestor has to create a bigger Cholesterol market pie in order to grow more market share...why?...when Lipitor goes generic in 2011...the Cholesterol pie will take a big hit...unless you are Crestor and you have prepared some clever marketing studies over the past years to show that you are different than Lipitor and you are worth the cost beyond generics!...once again..."Marketing" driven study taken right out of the Pfizer playbook!!!...what this study does support is the LDL Hypothesis...that using statins to lower LDL-C below 70, even for patients with no pre-existing cardio risks...it provides benefits......but the itch that can't be scratched is...what would the results be if they used another active comparator and let the trial run its course?

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