SPEAKER: We have right now intervention trial using PCSK9, using both the antibodies that are currently available, evolocumab and alirocumab. The two drugs have been tested in two intervention trials, respectively for [INAUDIBLE] and Odyssey. And interesting enough, [INAUDIBLE] there was, particularly in the Odyssey, a reduction in cardiovascular events. But also, there was a reduction in overall mortality.

Now, this opened up, obviously, to a number of considerations. PCSK9 inhibitor is not a cheap treatment. Actually, it's quite expensive.

But really, in a diabetic individual with a prior cardiovascular event, where statin and ezetimibe can not provide the necessary reduction in LDL cholesterol and non-HDL cholesterol, or where the statins are not tolerated-- so preventing for achieving that LDL level-- we don't have very much. The only option we have really is PCSK9 inhibitors. In my institution, in my country-- Italy, for instance-- this is the current recommendation or the current criteria for reimbursement for the PCSK9.

That is diabetic individuals with a very high cardiovascular risk, not achieving the LDL target, by using the highest tolerated dose of statin together with ezetimibe, for those patients to risk the possibility to provide reimbursement for the PCSK9 inhibitors. And this, of course, goes along with the familiar hypercholesterolemia, which is the other condition which is approved for reimbursement, at least in my country.

So what I normally try to do in evaluating, in stratifying the cardiovascular risk of an individual is to try to identify those who are really-- the blood pressure control is achieved. The glycemic control is achieved. The anti- [INAUDIBLE] treatment is there. Blood pressure is treated, but LDL cholesterol is not yet at the target. For those individuals, I think that further effort is due to try to provide a better outcome in terms of mortality survival and cardiovascular events.