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April 23/30, 2003

Lipid-Lowering Therapy and Risk of Coronary Events

JAMA. 2003;289(16):2070. doi:10.1001/jama.289.16.2070-b

To the Editor: The ALLHAT-LLT authors concluded that "pravastatin did not reduce either all-cause mortality or CHD significantly."1 This conclusion is misleading because it suggests that, despite considerable prior evidence that statins reduce CHD events, statins are not effective in this population, with this drug, or in this trial.

In fact, the data show that the effect of pravastatin on CHD events was exactly as expected from previous data. Figure 1 presents data from Table 5 of the ALLHAT-LLT article. The regression line is plotted from the 8 previous statin trials without the ALLHAT-LLT data. I have plotted percentage change in cholesterol as the independent variable and the odds of cardiovascular events as the dependent variable. The ALLHAT-LLT investigators found that pravastatin produced a 0.91 reduction in the risk of CHD events and a difference in total cholesterol of 9.6%. The reduction in CHD events expected from the regression equation, for that difference in cholesterol, is almost identical at 0.906. Of course, unless there is a threshold effect, the "real" relationship would pass through the origin (0,1) where no change in cholesterol would produce no change in events. If so, either the effect of cholesterol lowering on CHD events is nonlinear (greater with greater changes in cholesterol) or the relationship calculated from the available data does not reflect the truth.