Treatment of lipid disorders in Poland: for the elect or for the needy?

Mr. Doctor, cardiovascular diseases are unfortunately still a big public health problem in Poland - despite many preventive actions. Today we will talk about patients with lipid disorders. Let's say what kind of problem it is, how many such patients there are, why is it so important to implement effective treatment quickly?

Lipid disorders are one of the biggest problems in modern medicine. In terms of their prevalence, it is estimated that in Poland about 19 million of the adult population may have elevated LDL cholesterol levels. This, unfortunately, translates directly into the number of patients with symptomatic atherosclerosis, including patients who will develop acute coronary syndrome, or various other non-coronary syndromes, such as stroke or peripheral atherosclerosis, which produces symptoms that require either treatment, revascularization or even amputation.

For this reason, the earliest possible diagnosis of lipid disorders and the implementation of primary therapy of effective treatment can result in a significant reduction in the number of complications of the atherosclerotic process, and we have such large population studies that show that reducing LDL cholesterol by 1 millimol per liter, or 38-40 milligrams per deciliter, results in a reduction in mortality of up to 20%, so we have something to fight for in all patients. That's about mortality, not to mention morbidity, or various other things that we can achieve with proper treatment in these patients.

In view of this, let's talk about treatment, because patients with lipid disorders can benefit from treatment under the drug program B101 - Treatment of patients with lipid disorders. Please tell us what the inclusion criteria are for this program.

The B101 program is dedicated to patients with the most severe lipid disorders, in whom we are unable to achieve the therapeutic goal on full combination treatment with statin and ezetimibe. What does full combination treatment mean? Combination treatment is treatment that includes the maximum tolerated dose of statin with ezetimibe. If a patient does not achieve the therapeutic goal, then in that patient we can consider treatment. And now we have two arms of this B101 program. The first arm is dedicated to patients with familial hypercholesterolemia, heterozygous, in some patients with some drugs it's also the homozygous form of the disease, but if we would focus on this heterozygous form of familial hypercholesterolemia, then we have patients who have confirmed, whether by clinical criteria or by genetic criteria, familial hypercholesterolemia and at least 100 mg per deciliter of LDL cholesterol levels in these patients on full treatment. In such patients, we can implement therapy.

The second group of patients we can include in the program are post-infarction patients. This is the kind of thing where the patient has to have had an infarction to even think about inclusion in the program. And here these laboratory criteria are a little lower, because there it is 70 mg per deciliter, or 1.8 mmol per liter of LDL cholesterol concentration, but the additional criteria are different for inclusion. In addition to this infarction, it has to be either a second infarction or a multivessel coronary disease, or it is a patient with a first infarction but before the age of 50, or a patient who has had an infarction and before that some other revascularization whether it be coronary or non-coronary, or a patient after an infarction who will have atherosclerosis in another vascular bed like the carotid arteries or peripheral arteries. And only in these patients can we think about implementing treatment with the latest hypolipemic drugs.

I assume that these criteria that you mentioned, the doctor said, however, make this number of patients who could benefit from the advantages of this program limited, and this is probably not good, because if we say that you have to have consecutive cardiovascular incidents to benefit from the treatment, or in the case of familial hypercholesterolemia I understand you have to have genetic testing to meet the scoring scale, which is important, these are limitations. What might be the consequences of these restrictions?

You said yourself that one must first of all be that unlucky or that lucky to have a heart attack to even think about starting treatment in the B101 program. I am talking about this group of patients from the so-called very high cardiovascular risk part.

A patient who, for example, is post-stroke, who is post-implantation of stents into the carotid arteries, that is, treatment with some other revascularization of the carotid arteries, a patient who is post-intervention in the lower extremities, and who has not had the bad luck, that is, that it is an infarction, cannot think about inclusion in the drug program at all. Here, this myocardial infarction is such a critical point when it comes to inclusion. I understand very well the ideas that guided the creators of the B101 program, because it was initially dedicated mainly to cardiac patients. On the other hand, we can see at this point in time, as this program develops, that this is its limitation. We would have been able to avoid some of the heart attacks, some of the coronary revascularizations if we had had more opportunities to switch on drugs that block the PCSK9 protein system more quickly.

One more question, Doctor, can only cardiologists qualify for the B101 program?

There is no such provision in the program that only cardiologists, but unfortunately it so happens that probably 95% of all doctors qualifying for the program are cardiologists, because the program is dedicated mostly to patients, however, cardiology. When we take patients who are post-infarction, with familial hypercholesterolemia, who most often also have various other atherosclerosis risk factors, this patient most often goes to a cardiologist. And so it was accepted that in the first arrangements with the National Health Service, or the first contracting with the National Health Service, it was the cardiology centers that had the most of these patients at the time. At the moment it's a limitation that a patient who is under the care of a neurologist or under the care of a vascular surgeon must first go to a cardiologist to be included in this program.

But the problem is interdisciplinary, because I wanted to refer here to such an interdisciplinary position of as many as six scientific societies on expanding access to this program, published in March of this year. Why did you decide to make such an appeal, to take such steps? Is it already known what the results of this are?

The issue of this interdisciplinarity is fundamental. The very fact that patients who have diffuse atherosclerosis, those who have this atherosclerosis in at least one placenta, is a matter that has been known for many, many years. There's a big study, a big squeaky-clean registry, that shows that 60% of patients with atherosclerosis in a particular region of the body also have atherosclerosis - even maybe not necessarily clinically significant atherosclerosis - but they have this atherosclerosis in another placenta, that is, a coronary patient will have atherosclerosis in the cerebral arteries, a patient with peripheral atherosclerosis will have atherosclerosis in the coronary arteries as well, and this sooner or later in that patient will result in the need for additional treatment or additional procedures. Looking at how many of these patients there are, what the epidemiological situation is, we have come together simply to discuss all these patients who have this disseminated atherosclerosis and to try for better access to modern treatment for these patients.

That sums it up, Doctor, please tell us what changes are necessary in the drug program we are discussing?

We believe that there should be wider access to this therapy. These new handouts that the National Health Service will be doing were also available to neurologists, to vascular surgeons, who could also, for their part, refer patients or include them directly in the program.

The second issue is that myocardial infarction itself, which is this inclusion criterion in very high-risk patients, as the only disease entity, such a primate that will allow this, despite the fact that I am a cardiologist is also a bit of a limitation of this program, and I think that this possibility of including patients in the program should also be extended to patients with symptomatic atherosclerosis, be it carotid arteries, peripheral arteries or patients after strokes in general.

Doctor, thank you very much for this conversation, and I hope that these changes in the program that you mentioned the B101 program, the treatment of patients with lipid disorders, will take place.

Recording partner: Novartis