Heartfelt with Dr Melissa Walton-ShirleyView all posts »
Space---the final frontier? Likely just the beginning with JUPITERNov 9, 2008 18:50 EST
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.