Usually the words “breakthrough” and “blockbuster: are reserved for tabloid headlines. But not always. Dr. Steven Nissen of the famous Cleveland Clinic used then to describe a study published in the New England Journal of Medicine that reported a significant reduction in heart disease in apparently healthy patients taking a cholesterol lowering drug in the statin category. “It’s a breathtaking study. It’s a blockbuster. It’s absolutely paradigm-shifting,” he said. Powerful words. Dr. W. Douglas Weaver, president of the American College of Cardiology was equally emphatic. “This takes prevention to a whole new level. Yesterday you would not have used a statin for a patient whose cholesterol was normal. Today you will.” Given such breathtaking verbiage, it isn’t surprising that the press was all over this study, trumpeting the fact that the use of statins reduced the heart attack death rate by close to 100%. Sure sounds impressive. But the study does merit a closer look. Close to 19,000 healthy people over the age of 50, with normal cholesterol levels, but high levels of C-reactive protein in their blood were recruited. C-reactive protein is an indicator of inflammation and high levels have been linked with a greater risk of heart disease. Half the subjects were treated with daily with 20 mg of rosuvastatin, trade name Crestor, while the rest got a placebo. Surprisingly, the trial was stopped just short of two years when a significant reduction in heart disease was noted in the group taking the statin.
The 100% reduction in cardiovascular events sounds very impressive, but it is more meaningful to take a look at absolute numbers. Here they are. 83 out of 8901 in the statin group had a major event as opposed to 157 out of 8901 in the placebo group. So we are really talking about helping 74 people out of 8901, meaning that about 120 people have to be treated to save one cardiac event. Certainly not insignificant but not quite as impressive as stating that cardiac events were cut in half. So the question becomes whether it is worthwhile to put 120 people on medication, and an expensive one at that, to possible avoid one event. Of course the test for C-reactive protein also involves an expense. And there was also the observation that more patients in the statin group developed diabetes than in the placebo group. Furthermore, since the study was stopped after just two years, we don’t know the long term consequences of this therapy. Interestingly, the majority of the subjects were overweight, so the results may not apply to normal weight people. The decrease in cholesterol level was very significant and there is the possibility that such a dramatic reduction may also be a problem. Long term side effects of statins, such as liver issues and muscle pains also have to be taken into account. While this study is an interesting one, it shifts attention from lifestyle factors to drug therapy. I would suggest that in this patient population a regimen of weight loss and appropriate exercise and dietary changes would yield a benefit to more than just 1 out of every 120 people.
