[Notes to the regulatory Appendix 13 of the Italian Committee for Drugs]

The Italian Committee for Drugs has recently modified "Appendix 13" to a recent Italian regulation related to reimbursement of hypolipidemic agents for primary or secondary prevention of heart diseases. There is some confusion in concepts, terminology and phrasing, also dealing with disease definition, which need comment. Moreover, "Appendix 13" suggests to estimate risk based on charts derived from the Framingham experience, which are inappropriate when applied to Italy. Finally, "Appendix 13" is not clear as to how categorize high risk individuals. There has been a growing interest in estimating coronary risk since 1994, probably as the result of primary and, secondary intervention trials with statins used to lower blood cholesterol levels. On the other hand, European guidelines have been published, accompanied by risk charts (derived from the Framingham study) helping to index individuals who may benefit from treatment of coronary risk factors. At least thirteen such or similar instruments have been produced worldwide (and three of these in Italy) to estimate coronary risk. In Italy, there are other instruments in preparation. Data are reviewed wherefrom it is possible to conclude that it is inadequate, since substantially erroneous, to use risk functions to estimate absolute coronary risk when these are derived from largely different populations as to those in which practical applications are looked for.