Assessing the clinical benefits of drugs for dyslipidaemia
Dear Sirs,
A recent editorial in the New England Journal of Medicine1 highlights several challenging issues in the development of new treatments for lipid disorders. There is now uncertainty regarding the regulatory approach of approving drugs on the basis of favourable lipid effects and evaluating clinical benefit after approval.
In numerous trials and several meta-analyses of outcome trials, the reduction of low-density lipoprotein (LDL) cholesterol has been shown to be associated with outcome benefit.2–4 Most of these studies have been performed with statins. The first demonstrat