Crestor Study Ended Due to Good Results

Now this is something you don’t often see. A study on a drug, in this case Crestor, an anti-cholesterol drug, is ended early because the results were just too good. What is even more interesting is that this same drug had a hard time getting approved for marketing by the FDA several years back because it appeared to have a high incidence of rhabdomyolosis (rhabdo). Rhabdo, as its come to be known, is a condition where the muscle tissue breaks down and releases a substance known as myoglobin into your bloodstream and ultimately it can clog up your kidneys and lead to kidney failure. I became very familiar with this condition back in 2001 when I became involved in representing many consumers who took the anti-cholesterol drug Baycol and developed this condition. Baycol was ultimately taken off the market and Bayer, the drug manufacturer, settled thousands of claims of consumers who took this drug and developed rhabdo. Now it is known that these types of anti-cholesterol drugs, which would include Lipitor and Zocor, known as statins, can cause this condition, but Baycol caused it at a statisically higher rate than the other similar type drugs like Lipitor and Zocor. It was, as it is referred to, “an outlayer” in these class of drugs.
This brings us around to Crestor. As mentioned, when Crestor was going through the approval process, which was during the time Baycol and its problems with rhabdo were front page news, there were concerns raised that it too had a high rate of rhabdo. However, the drug was ultimately approved by the FDA and Astra Zeneca has been highly touting and marketing the drug ever since. Clearly, this is great news for Astra Zeneca, especially considering the concerns now being raised with other anti-cholesterol drugs Zetia and Vytorin. But honestly, I am just waiting for the other shoe to drop. I expect in this study they also looked at adverse events. When the information is ultimately published on this study, I will be interested to see what, if any information is disclosed about adverse events reported in the study.
One other interesting tidbit. It is reported byAstra Zeneca that the study participants, of which there are over 15,000, had no existing evidence of cardiovascular disease and the end point (what they were looking at in these patients given Crestor vs. a placebo) was if the drug would reduce major cardiovascular events. Well, you picked people to be in the study who had no prior history of heart problems, so how do you know your drug helped them vs. the fact that they were individuals with no evidence of heart disease to start with. Now the participants did have elevated C reactive protein which is an indication of inflammation and associated (not cause) with a higher risk of cardiovascular events. We will now see Astra Zeneca telling everybody Crestor protects people from heart attacks based on this study, when in fact they give it to a population at a lower risk for heart attacks and in fact that may be the reason why there was such a reduced incidence of cardiovascular events. Such is the way of big pharma and its manipulation of data. This will be an interesting drug to continue to follow.