This is a story on the results of two recently published studies that found that more intensive lowering of LDL cholesterol levels was associated with greater reductions in future risk of cardiac outcomes. While there was good information about the sorts of outcomes that were reduced in the group using the increased dose of the statins, there was not a thorough analysis of the evidence. On the plus side, the story did mention that cancer outcomes were not affected by the change in cardiovascular events, and the story did include information about the harms associated with statin medication. The story also, however, had a few modest errors. It said, for example, “The reduction in LDL cholesterol from the higher dose ended up decreasing the risk of a major cardiac event by 6 percent, the researchers found, although the statistic in itself was not clinically significant.” We think they meant not statistically significant. Elsewhere, the story says, “Researchers also found that seven participants had creatine kinase levels higher than 40 times the upper limit of normal — a possible indicator of kidney damage.” Creatine kinase (CK) is an indicator of muscle damage. It is not in and of itself a measure of kidney damage (which would be measured with serum creatinine). Of course, more muscle damage makes kidney damage more likely, but that is slightly different than what was written.
Statins are definitely out of the honeymoon period, but reporters still are too quick to praise them for some new benefit that they supposedly offer. More stories need to take a hard look at the evidence.
There was no mention of the costs of these drugs or the cost ramifications of the increased dosages. This ought to have included the simple increase in costs due to the increased dosage of the medication and also at least a nod to the costs associated with the increase in adverse events.
The story failed to provide information about the absolute benefit that might be expected to be obtained with higher statin dose use. For example, by presenting the 13% reduction in cardiovascular death or heart attack rate, a reader has no way of knowing what the actual rate was to start with.
The story presented information about the increased incidence of myopathy and the more severe rhabdomyolysis observed with higher dosage statin use. The story did, however, contain an error in referring to creatine kinase as an indicator of kidney damage. It is an indicator of muscle damage.
The story presented information about the data found in the studies mentioned but failed to provide information about the absolute reduction in risk brought about by increasing dosages of statin medication. The story ought to have put the risks and benefits in perspective for individuals with different levels of risk to start. Some of the data in the story seemed to contradict facts presented earlier in the piece. Also, readers would have to be confused by indicating that the 6% reduction in major cardiac events observed in one study was “not clinically significant.” This is most likely a misstatement, which ought to have been that the 6% reduction was not statistically significant.
The story did not engage in overt disease mongering.
The story included comments from one source beyond those involved in the study and accompanying editorial. The story also mentioned that one study was in part financed by a company that makes one of the statins. However, there were no experts quoted providing perspective about the downside of high-dose statins. Because this is such an important subject and because the medical community is not as unified in favor of higher dose statins as this story would suggest, we rated this category unsatisfactory.
The main comparison with the higher doses of statins studied is to lower doses of this class of medication, and this was covered in this story. We would have liked to have seen at least some discussion of how statin use compared to diet and exercise in reducing risk for heart attacks and stroke.
The class of medications, statins, discussed in the story are commercially available as indicated.
The story was clear that the studies reported on were examining the potential for benefit by increasing dosage levels of widely used statin medications.
The story does not appear to rely on a news release.