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The prognosis for patients who have suffered a cerebral hemorrhage is serious.

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Interview with prof. PhD. Dr. med. Agnieszka Slowik, national consultant in neurology.

How common are hemorrhagic strokes caused by habans?

New generation oral anticoagulants, including habans, i.e. clotting factor inhibitors for atrial fibrillation not associated with heart defects. Both groups of drugs, in addition to their undoubted therapeutic benefits, can cause bleeding in a small percentage of patients, including cerebral hemorrhages. The risk of cerebral hemorrhages under the influence of new anticoagulants is reduced by half compared to drugs of the previous generation – vitamin K antagonists, which is a significant clinical advantage of these drugs.

Hemorrhagic strokes, also known as cerebral hemorrhages, occur in approximately 10,000 people. Poles throughout the year. About 1.5 thousand cerebral hemorrhages caused by anticoagulants are known. annually. It is not known exactly how many patients experience bleeding under the influence of haban and how many under the influence of dabigatran or vitamin K antagonists.

What is the prognosis for patients who experience them?

The prognosis for patients who have suffered a cerebral hemorrhage, regardless of the cause, is very serious. The 30-day mortality rate is approximately 50%. The occurrence of a cerebral hemorrhage, in addition to a high risk of death, also has other long-term consequences, such as permanent disability, behavioral or cognitive disorders.

What are the current recommendations for the use of habanas? How are these recommendations being implemented in Poland?

In Poland, the implementation of current recommendations regarding all the above-mentioned indications for the use of all anticoagulants is progressing very well. These drugs are prescribed by a variety of specialists, such as cardiologists, angiologists, orthopedists, neurologists, anesthesiologists and family medicine physicians.

What actions are you taking immediately before the introduction of generic haban and wider access to this treatment to make the antidote to haban available to Polish patients?

The path to introducing new treatment methods for Polish patients is strictly defined by law. The institution that formally decides on the possibilities and scope of reimbursement for new molecules is the Ministry of Health. The first step in this process is to submit a reimbursement request for the specific molecule. The need for a xaban antidote was reported to the Ministry of Health by the national consultant in emergency medicine and I in uniform Medical benefit cards.

Before deciding on reimbursement and its amount, the Ministry of Health obtains significant opinions from the Agency for Health Technology Assessment and the tariff system. It may also request such an opinion from national consultants in the fields of medicine in which the molecule is used or from other medical experts.

A professor from the National Health Fund took up the issue of analyzing the situation of patients taking habana and having suffered a hemorrhagic stroke. When can we expect applications? Can they support the decision of the Ministry of Health to provide the antidote to hospitals?

Analysts at the National Health Fund are preparing Polish data on cerebral hemorrhages, which will be presented shortly. Data on ischemic stroke over the past 5 years was published in an excellent factual report in October 2023.

An interdisciplinary, multi-community coalition was also formed to produce a report on this issue. When can we expect it to be published?

The report was prepared by a group of experts from many fields of medicine. I cannot answer the question of when we will be able to complete the work.

Is there data showing how many patients in Poland need haban antidotes?

In the case of cerebral hemorrhage caused by habans, it is expected that the number of patients in Poland who would meet the inclusion criteria for antidote administration would be 100–150 per year.

Interviewed by: Iwona Kazimierska

Prof. PhD. Agnieszka Slowik, national consultant in neurology, head of the department and clinic of neurology at the Jagiellonian University Medical College, head of the clinical department of neurology at the University Hospital in Krakow.

Stroke in numbers

  • Stroke is the second leading cause of death and the leading cause of disability among adults. Approx. 87 percent of all cerebral strokes are ischemic strokes (hemorrhagic strokes make up the remaining 13%).
  • Patients with atrial fibrillation have the highest risk of ischemic stroke. Introduction to the so-called therapy Modern oral anticoagulants (NOACs) have become a breakthrough in the prevention and treatment of thromboembolic complications, and in particular in the prevention of ischemic strokes in patients with atrial fibrillation.
  • NOAC drugs, due to their anticoagulant role, cause labor in 1.5%. patients are at risk of life-threatening and uncontrolled bleeding of various locations. Hemorrhagic stroke is the most serious complication of modern oral anticoagulants, with a mortality rate exceeding 50%. The mortality rate is significantly higher than the mortality rate for ischemic strokes, which is 20%.
  • Timing is of the essence in striking. In hemorrhagic strokes and in patients taking habana, it is extremely important to urgently limit the growth of the hematoma.

  • Innovation and pharmacy
  • Cardiovascular diseases
  • Neurological diseases

Source: Wprost

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