From the Authors:

Mr Vos’ comments highlight the need for randomized clinical trials with prespecified, clinically relevant end points. When such clinical trials are undertaken, the benefit and safety of statin therapy, including atorvastatin, are clearly demonstrated based on prespecified end points and recognized statistical analysis. This consistent and reproducible evidence that lower LDL-C levels, achieved through competent LDL-C-lowering therapy such as statin therapy, are associated with improved outcomes in higher-risk patients, has now been recognized and incorporated into LDL-C-lowering guidelines around the world. When sample size or design of the study does not allow an evaluation of an important end point such as total mortality, we have to rely on available meta-analyses, although limitations of this approach should be acknowledged. The limitations are even greater when lower LDL-C is associated with higher mortality in epidemiological studies, because the bias of the comorbid conditions, particularly cancer, cannot be accounted for. In summary, the issue of whether lower LDL-C is better for our patients at higher risk of cardiovascular events has been resolved in clinical trials, and we now need to settle on reliable and cost efficient ways of delivering evidence-based care to our patients.