Thursday, June 10, 2010

Jupiter - Rosuvastatin Study

JUPITER's old news but interesting as can be.  These kinds of studies are hard to do right, but this one gives you reason to wonder if that's what they are trying to do.  I will assume they are, but the main stream reporting was astonishingly uncritical.

http://junkfoodscience.blogspot.com/2008/11/when-news-sounds-too-good-statins-new.html
"Today, we learned that the actual (absolute) difference in mortality between the statin and control groups after nearly 2 years in the JUPITER trial was only 0.25% and incidences of heart attacks and strokes differed by a mere 0.35% a year."
"Adults were excluded from participating if they had any history or evidence of cardiovascular disease; if they had any inflammatory condition such as arthritis, lupus or inflammatory bowel disease; diabetes; hypothyroidism; high blood pressure; any evidence of liver or kidney dysfunction (including abnormal lab values); had a history of cancer in past 5 years; were on hormone replacement therapy; had a history of alcohol or drug abuse; if they’d ever been on lipid-lowering meds or were taking any immunosuppressant medications or oral glucocorticoids; if their triglyceride levels were >500mg/L or LDL-cholesterol levels >130mg/dL; and another 856 people for unstated reasons. The participants’ CRP levels also had to be ≥2mg/L (which describes two-thirds of seniors their age). The men had to be 50 years of age or older, and the women 60 years of age and older.


From 89,890 people initially screened, 23,231 then underwent a four-week trial on the placebo, meaning anyone exhibiting potential compliance problems could be screened out. The authors excluded another 1,521 during this run-in test. Finally, 17,802 people (38.2% women) were randomly assigned to receive daily doses of rosuvastatin or a placebo.
While the authors said they only lost 81 people in follow-up during the 1.9 years, compliance rates were unusually low. At the time the study was terminated, only 75% of participants were taking their study pills, they reported. Having nearly 15% of participants a year stop taking their pills is higher than any other statin trial and if this rate had continued, there would have been few people left participating after five years. The authors don’t reveal which arm of the trial these drop-outs occurred in, but people so rigorously screened and motivated to participate in a clinical trial don’t independently stop taking their pills without some reason. This lends added precaution in interpreting the side effects reported in this study, especially in light of the safety problems reported to the FDA, as we’ll examine."
--I recommend that you read this lady's entire post if the topic is of interest


Dr. Mike Eades: http://www.proteinpower.com//cardiovascular-disease/1853/
"But, let’s assume I’m taking this study at its absolute worst.  Let’s look at it in the best light possible.  If we do, we find that a small group of unusual patients – those with low LDL-cholesterol AND high C-reactive protein – may slightly decrease their risk for all-cause mortality by taking a drug that costs them almost $1,300 per year and slightly increases their risk for developing diabetes.  That’s the best spin possible given the data from this study.  Compare that to the spin the media is giving it."


http://diabetesupdate.blogspot.com/2008/11/should-you-be-taking-statin-what.html
"First of all, they were older people. The median age was 66. Secondly, though they had normal cholesterol they had other significant risk factors for heart disease and stroke:
They were overweight. The median BMI was 28.3. That would translate into a weight of 165 lbs for the average 5' 4" woman or 192 lbs for the average 5' 9" male.
More importantly, they had higher than normal blood sugars. The median A1c was 5.7% which I have been told by an endocrinologist is high enough to suggest undiagnosed diabetes.
The interquartile range(a measure of the area in which most values concentrate) for this study group was 5.4% - 5.9%. These figures alone tell us that these people had a higher than normal risk of heart attack since several large studies have shown that the risk of heart attack rises in lock step with the rise of A1c as it goes over 4.7%. At 5.7% the risk is already significantly higher than at true normal.
Finally, These people had elevated blood pressure--which is another well known pointer to early heart disease. The median blood pressure was 134/80. Doctors now believe 120/80 is the upper bound of normal. 

there were more fatal heart attacks in the group taking Crestor.
The way that this is reported is thus:
Nonfatal myocardial infarction: Crestor 22 Placebo 62
Any myocardial infarction: Crestor 31 Placebo 68
Subtract "Nonfatal myocardial infarctions" from "Any myocardial infarctions" and you get Fatal Myocardial infarctions, a statistic which is NOT reported in the list of "end points." But simple math gives us the information that there were 9 fatals in the Crestor group as opposed to 6 in the placebo group.

But here's the bad news buried in this study: Both A1c and the incidence of diagnosed diabetes rose in the group taking Crestor.
There were 54 more cases of diabetes diagnosed in the Crestor group than in the placebo group. This is brushed off as barely significant by the authors, though, in fact, it is greater than the difference in heart attack, stroke, etc. "

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