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Clinical Neuroscience

JANUARY 30, 2016

[Financing of medicines for treatment of rare diseases of the nervous system. orphan drugs in rare neurological diseases]

SZEGEDI Márta, KOSZTOLÁNYI György, BONCZ Imre, MOLNÁR Mária Judit

[Objectives – Nervous system involvement is expected up to 60-70% in case of rare diseases. This article aims to present the financial methods and expenditures of rare neurological diseases’ orphan medicinal products being financed in the frame of Hungarian social insurance system in 2012. Methods – The subsidized orphan medicines were selected on the Orphanet portal 2012 while orphans financed by compessionate use were provided by the Hungarian National Insurance Fund Administration (OEP) database. Three products exist without orphan designation, however those are intended for the treatment of rare neurological ailments. The medicines were categorized by financial methods and determined by costs. Results – Numerically, out of 36 pieces of subsidized orphan or orphan criteria fulfilled medicines 17 were authorized for the treatments of rare neurological diseases in the year of 2012. Most of the drugs (14 pieces) were to be financed in the frame of compassionate use by the reimbursement system. The cost amount of social insurance for 387 rare neurological disease patients reached more than 4.5 billion HUF (1.4% of the total pharmaceutical budget in outpatient care). Conclusions – In Hungary half of the subsidized orphans are intended for the treatments of rare neurological ailments. 30% of the total amount of social insurance for rare diseases’ medicinal treatments were used to subsidizing rare neurological disease patients in 2012. Most of the orphan medicines were to be financed in the frame of compassionate use by the reimbursement system for outpatient care. Consequently, a great deal of crucial problems occurred in relation with the unconventional subsidizing method. At the end of 2012 new financial methods have been elaborated and introduced in a pilot phase from 1 January 2013. In spite of the high cost commitment, nearly the entire diagnosed rare disease subpopulation have been provided with subsidized treatments in Hungary. In order to facilitate the acces to orphan medicines, collaboration shall be achieved by financing authority and professionals for identificating the descently sustainable, affordable and viable financial method. ]

Clinical Neuroscience

MARCH 30, 2016

[The importance of anticoagulant therapy in patients with artial fibrillation in stroke prevention – summary of international data and novel therapeutic modalities]

MIROLOVICS Ágnes, PAPP Csaba, ZSUGA Judit, BERECZKI Dániel

[The most common cardiogenic cause of ischaemic stroke is atrial fibrillation which increases the probability of stroke five-fold and doubles case fatality. Based on international data the incidence of atrial fibrillation is approx. 2% however this rapidly increases with age. The necessity of using oral anticoagulants in the prevention of non-valvular atrial fibrillation related stroke is decided based on estimated stroke risk. The CHADS2 and the more predictive CHA2DS2-VASc scales are used for this purpose while the bleeding risk of patients treated with anticoagulant may be estimated by the HAS-BLED scoring scale. For decades oral anticoagulation meant using vitamin-K antagonists. Based on international data we can see that rate of anticoagulation is unacceptably low, furthermore most of the anticoagulated patients aren’t within the therapeutic range of INR (INR: 2-3). A lot of disadvantages of vitamin-K antagonists are known (e.g. food-drug interaction, need for regular coagulation monitoring, increased risk of bleeding), therefore compounds with new therapeutic target have been developed. The novel oral anticoagulants (NOAC) can be divided in two major subgroups: direct thrombin inhibitors (dabigatran etexilate) and Xa-factor inhibitors (rivaroxaban, apixaban, edoxaban). These products are administered in fix doses, they less frequently interact with other medications or food, and regular coagulation monitoring is not needed when using these drugs. Moreover several studies have shown that they are at least as effective in the prevention of ischaemic stroke than the vitamin-K antagonists, with no more haemorrhagic complications.]

Clinical Neuroscience

MARCH 30, 2020

Effects of valproate, carbamazepine and levetiracetam on Tp-e interval, Tp-e/QT and Tp-e/QTc ratio

YASAR Altun, ERDOGAN Yasar

Aim - To evaluate P-wave dispersion before and after antiepileptic drug (AED) treatment as well as to investigate the risk of ventricular repolarization using the Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio in patients with epileptic disorder. Methods - A total of 63 patients receiving AED therapy and 35 healthy adults were included. ECG recordings were obtained before and 3 months after anti-epileptic treatment among patients with epilepsy. For both groups, Tp-e and Tp-e/QT ratio were measured using a 12-lead ECG device. Results - Tp-e interval, Tpe/QT and Tp-e/QTc ratios were found to be higher in the patient group than in the control group (p<0.05, for all), while QTmax ratio was significantly lower in the patient group. After 3 months of AED therapy, significant increases in QT max, QTc max, QTcd, Tp-e, Tp-e/QT, and Tp-e/QTc were found among the patients (p<0.05). When the arrhythmic effects of the drugs before and after treatment were compared, especially in the valproic acid group, there were significant increases in Tp-e interval, Tp-e/QT and Tp-e/QTc values after three months of treatment (p<0.05). Carbamazepine and levetiracetam groups were not statistically significant in terms of pre- and post-treatment values. Conclusions - It was concluded that an arrhythmogenic environment may be associated with the disease, and patients who received AED monotherapy may need to be followed up more closely for arrhythmia.

Clinical Oncology

DECEMBER 10, 2018

[PI3K–AKT–mTOR pathway as a therapeutic target]

KOPPER László

[The PI3K-AKT-mTOR is one of the most busy signalling pathway, accepting and sending the message to the effector compartment. The pathway is very complex with activators (see the name), and inhibitors, as PTEN. Depending of the cell type this pathway participates in almost all functions of a given cell. The members of the pathway may have genetic failures, as a consequence, the risk for the development of different diseases, including cancer is high. Therefore it is logical to produce drugs to inhibit the dysregulated function. Unfortunately, despite the promising preclinical effectivity, so far only 4 drugs can be used to treat cancer patients. There are some hypothesis for the in effectivity, e.g. no useful marker for patient selection, high toxicity, false drivers for targeting. What is sure, combination therapy is much better than monotherapy]

Hypertension and nephrology

DECEMBER 12, 2019

[Serotoninergic drugs for weight loss. A review of efficacy and cardiovascular safety of lorcaserin]

SIMONYI Gábor

[Complex therapy of obesity consist the medical treatment. Several weight lowering drugs are available in the United States, one of which is 5-HT2c agonist lorcaserin. After failures with former non-selective serotoninergic agents (fenfluramine, dexfenfluramine), there was great anticipation and more questions about the release of lorcaserin, which proved its effectiveness and safety in several phase 3 studies. Lorcaserin is a selective agonist of 5-HT2c receptors, therefore free form adverse effects of former non-selective serotoninergic drugs on valvulopathy or pulmonary hypertension. The results of the recently published CAMELLIATIMI 61 study confirmed the cardiovascular safety of lorcaserin.]

Lege Artis Medicinae

NOVEMBER 15, 2019

[Hypertensive emergency conditions in Family practice]

TORZSA Péter

[Family doctors play an important role in the treatment of high blood pressure emergencies. There are two forms of these: hypertensive, non-life-threatening states (urgency) and the hypertensive crisis (emergency) with life-threatening complications. The boundary between these two forms is not sharp, and a non-life-threatening urgency can turn into a hypertensive crisis. Hypertensive emergency is defined as an acute, marked increase of blood pressure with concomitant life-threatening target organ dysfunction. Treatment always requires hospitalization and parenteral administration of antihypertensive agents. In the case of hypertensive urgency, the acute increase of blood pressure is not complicated with organ damage. In these cases treatment can be performed in primary care with oral drugs. ]

Lege Artis Medicinae

OCTOBER 20, 2019

[Thiazide- or thiazide-like diuretics should be used in the treatment of patients with hypertension? Particularities of the situation in Hungary]

VÁLYI Péter

[Diuretics have remained the cornerstone of the antihypertensive treatment since their widespreading in the 1960s. According to the 2018 ESC/ESH Guidelines for the management of arterial hypertension, in the absence of evidence from direct comparator trials and recognizing that many of the approved single-pill combinations are based on hydrochlorothiazide, this drug and thiazide-like indapamide can be considered suitable antihypertensive agents. In the 2018 Hungarian guidelines indapamide is named as the most efficacious diuretic in the treatment of patients with hypertension. The aim of the publication is redefining thiazide- and thiazide-like diuretic use in the treatment of hypertensive patients, with particular attention to presently available hydrochlorothia­zide and indapamide, and their combination drugs in Hungary.]

Lege Artis Medicinae

OCTOBER 20, 2019

[Population-level QALY gain estimates with the use of cariprazine for patients with negative symptoms of schizophrenia in Hungary]

BENDES Rita, NÉMETH Bertalan, PITTER János György, KÓCZIÁN Kristóf, GÖTZE Árpád, KALÓ Zoltán

[INTRODUCTION - The loss in quality of life caused by mental illnesses has been growing in developed countries. This study aims to quantify the possible gains in quality of life by advantages of cariprazine therapy while treating patients with negative symptoms of schizophrenia in Hungary. Comparator therapy was defined as the currently available second-generation oral antipsychotic drugs. METHODS - In order to estimate the reachable gain in quality of life with cariprazine, an 8-state deterministic Markov cohort model was developed. Data was gathered from relevant scientific literature and public databases. The main assumptions regarding patient pathways have been validated by clinical experts, based on their real-life experience. The number of patients with negative symptoms of schizophrenia was estimated by the same methods as well. Sensitivity analyses were conducted on the input parameters. RESULTS - When compared with currently available second-generation oral antipsychotics, cariprazine generated an estimated increase of 0.05 quality-adjusted life years per patient in 2 years run. The deterministic sensitivity analysis confirmed the robustness of the results. Based on data of the National Health Insurance Fund and the scientific literature, a total gain of 450 quality-adjusted life years is expected at national level over a time horizon of 2 years. Even higher gains of QALY can be expected for longer time horizons. CONCLUSION - Based on conservative estimates significant health gain can be ge­ne­rated, if all patients with negative symp­toms of schizophrenia would receive the adequate cariprazine therapy in Hungary in­stead of the currently used se­cond-ge­ne­ration oral antipsychotic drugs. ]

Clinical Neuroscience

JULY 30, 2019

Restless leg syndrome frequency in health workers

ÖCAL Ruhsen, ATGÜDEN Gizem, AYCAN Cagri, BALABAN Zeynep, SENAR Seran, YAVUZ Sena

Introduction - Restless Leg Syndrome (RLS) is a disease, primarily composed of sensational symptoms, caused by the urge to move lower extremities especially at night, and characterized by undesired feelings of the legs. Decreasing of the dopaminergic effect at night is thought to be responsible from these symptoms. RLS patients suffer from low quality of sleep affecting their daily life activities even causing socio-economic loss. Although RLS is a common and treatable disease, it can not be diagnosed easily due to the variability of symptoms. Aim - The purpose of this study is to determine the frequency of RLS among health workers and to define the disease causing factors. Method - A questionnaire was applied to 174 randomly selected health workers at Baskent University Medical Faculty (KA17/285). The demographic information, history of illnesses or usage of drugs, socioeconomic status, working hours and daytime sleepiness were questioned. Included in the questionnaire were diagnostic criteria for RLS, frequency assessment scale, and survey of sleep quality. We used “the diagnostic criteria of international RLS working group” for the diagnosis, and “Pittsburgh sleep quality index survey” to determine the quality of sleep. Reliability and validity studies were performed on both tests. Results - A significant relationship between socio-economic status and RLS was found (p<0.05) as an increase of RLS frequency in parallel with decreased socio-economic status. RLS was found to be common among health workers. We suggest that health workers should be checked regularly, and they should be informed about the disease in order to raise an awareness and hence increase their quality of life.

Lege Artis Medicinae

MAY 20, 2019

[Treating methods of obstructive sleep apnea syndrome and related difficulties in daily practice ]

MOLNÁR Márton, CSATLÓS Dalma, HARGITTAY Csenge, MOHOS András, TERRAY-HORVÁTH Attila, DOMBOVÁRI Magdolna

[Obstructive sleep apnea syndrome (OSAS) is the most common breathing disorder during sleep. Its incidence is between 2-4%, but in many cases, the disease is not recognized. It has many symptoms, but the most typical symptoms are loud snoring and daytime sleepiness. Treatment always consists of several elements depending on the patients’ specific needs. When deciding on which treatment to use efficiency and the patients’ compliance are the key factors. The necessity of the therapy can be determined by three criteria: clinical complaints (daytime discomfort), the severity of the breathing disorder and the accompanying cardiovascular diseases. Treating possibilities for the mild to moderate OSAS are lifestyle changes (losing weight, avoiding alcohol and sedative drugs), positional therapy, oral appliances, and varied surgical corrections. For patients with moderate to severe OSAS and mild OSAS with severe symptoms the first line therapy is continuous positive airway pressure. In addition to presenting new therapeutic options, the authors describe the role of the family physician in the care of apnea patients.]