December 16th, 2009
FDA Advisers Recommend Expanded Use of Rosuvastatin
JoAnne M. Foody, MD
The Associated Press reports that, based on the JUPITER study, an FDA panel of advisers has recommended expansion of rosuvastatin. The FDA is expected to decide whether to act on this recommendation in 2010. According to the report, Astra Zeneca will develop an approach to use rosuvastatin in all patients at risk for heart disease based on hypertension and family history. This is beyond the group of patients that were studied in JUPITER which only assessed older patients with hsCRP above 2mg/dL. Do you agree with this approach, should rosuvastatin use be expanded to all at risk without hsCRP testing? How will you implement in your practice?
5 Responses to “FDA Advisers Recommend Expanded Use of Rosuvastatin”
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It seems like a rather large leap, both for the novel indication, as well as the choice of rosuvastatin in particular. I am concerned about cost-effectiveness among many other things, especially here in the US, where our health care spending is already high. With just JUPITER, which does not seem to provide direct evidence for this indication anyway, I am still not convinced it will really be worth the resources. The number needed to treat for Jupiter was already high (~100 if I can remember correctly), and I am wary of what it may be for these other indications. We should put such resources towards promoting lifestyle change instead.
NNT at 5 years is very favorable
Dr. Krumholz’s brother-in-law, Dr. Paul Ridker, published a very influential study this fall in one of the Circulation journals (editor-in-chief is Dr. Krumholz) that the number needed to treat (NNT) is better than the prior primary prevention trials. Dr. Christy Ballantyne just published an article in JACC (in press) that the event rate in ARIC was higher for those with a high hsCRP and low LDL-C as compared to a high LDL-C and normal hsCRP. Keep in mind that the average age of the JUPITER population was 64. Most of us will start with a generic statin in a JUPTER like patient and reserve the rosuva for someone who doesn’t get to LDL-C and non-HDL-C targets. -Roger S. Blumenthal
Competing interests pertaining specifically to this post, comment, or both:
I like tennis and golf and lacrosse and I have played golf with friends of Tiger.
A Large Leap
I’m confused as to why the JUPITER study is used as the pretext to justify rosuvastatin therapy for patients with hypertension and family history of heart disease (i.e., the JUPITER patients had elevated hsCRP). This appears to be a “large leap” of faith.
Is anyone besides me bothered by the fact that 84% of the JUPITER patients (mean age 66 yrs and all with evidence systemic inflammation) were not taking aspirin? In other words, if the patients were treated with aspirin, would the addition of rosuvastatin been helpful, and if so, what would be the NNT?
Leap of Faith?
Great comments. These echo my concerns about extending JUPITER beyond those studied in clinical trials. As most have stated, it isn’t time just yet to put rosuvastatin in the water!
Many questions remain, particularly in low risk individuals.
Competing Interests As Dr. Blumenthal will attest, I am a Yankees fan trapped in Boston.
Why limit treatment based on CRP levels?
I believe by excluding those with CRP<2 mg/L in the JUPITER trial, an opportunity was lost to gauge whether the effect of treatment would have been same , less or more in this group as compared to those with elevated CRP . This would have provided us with invaluable information on the true value of CRP screening for identfiying candidates who would benefit from aggressive pharmacotherapy among those with LDL<130 mg/dl.
To date, no data is presented by the JUPITER group on the relative risk of events with rosuvastatin vs. placebo based on specified baseline CRP levels, which would have otherwise provided us with some indication of the efficacy of treatment among those with CRP<2 mg/L by studying the trend across CRP levels.
However all is not lost. This information can at least be extrapolated from the second study published by the group in Lancet earlier this year. In this study a greater benefit was seen in those achieving post treatment CRP levels <2 mg/L compared to those whom CRP levels remained > 2 mg/L. Interestingly, the baseline levels (median, interquartile range) of CRP achieving the greatest benefit was lower, i.e 3.2 (2.4-3.1) compared to those with who did not achieve post treatment levels of <2 mg/L with median (IQR) baseline levels of 5.4 (3.6-8.6).
Based on this findings, one would conservatively assume atleast same, if not more, beneficial effect of rosuvastatin therapy among those with baseline CRP<2, a group not studied by JUPITER.
In my opinion there is no reason for limiting treatment based on CRP levels, and the indication should be expanded to all irrespective of baseline CRP, especially those with a family history of heart disease who appeared to derive the greatest benefit as shown in the original NEJM publication.