This week, the FDA agreed to expand the labeling for the statin drug Crestor (rosuvastatin, AstraZeneca), as had been recommended by an FDA advisory panel in December.
The new labeling was based on the results of the JUPITER trial, which was reported in late 2008. The JUPITER trial showed that, for patients who had normal LDL cholesterol levels, but elevated levels of C-reactive protein (CRP), taking Crestor significantly reduced the risk of heart attack, stroke and the need for coronary artery revascularization procedures (i.e., stents or bypass surgery).
Specifically, the FDA felt there was enough evidence to justify the use of Crestor in the following patients:
- men at least 50 years old, or women at least 60 years old who have
- LDL cholesterol less than 130 mg/dl, and
- CRP levels of 2.0 or higher, and
- at least one additional risk factor for cardiovascular disease, such as high blood pressure, low HDL levels, or a family history or premature coronary artery disease.
The FDA approval is more conservative than some observers had desired, since the JUPITER trial did not require the "one additional risk factor" that is included in the new FDA labeling.
- Read here about the JUPITER trial and its implications.
- Read more here about CRP, and when to measure it.
The Framingham study evidence underlying the “lipid hypothesis” was never strong to start with. Since then a massive lipid lowering campaign has shown no effect on heart disease rates. While an elegant and seemingly intuitive hypothesis, more and more openly people are rightly questioning the wisdom of the cholesterol lowering campaign.
Cholesterol is an essential component of every cell membrane and important for myriad physiologic functions. When Dr. Uffe Ravnskov, MD PhD looked at the medical literature he found something quite surprising had been documented there. On average people with higher cholesterol live longer. Cholesterol is a mediator in heart disease but blood cholesterol levels have next to no effect on heart disease rates again heart disease rates mostly unchanged since the advent of the massive cholesterol lowering campaign. Here is something else to consider, as any chemist will tell you, cholesterol is a single molecule. How then are there “good” and “bad” cholesterol molecules. It is at best scientifically imprecise and at worst a crass marketing ploy to talk about the levels of high and low denisty lipoprotein (say it again lipoprotein i.e. a protein – they are carrier proteins) as implying different cholesterol molecules. Then again the statin cholesterol lowering drug class alone is a 30 billion dollar a year industry. This latest attempt to expand cholesterol lowering “medication” to healthy individuals with normal cholesterol is both absurd and offensive.
http://healthjournalclub.blogspot.com/