Lege Artis Medicinae

[Dabigatran: a new oral anticoagulant agent for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation]

KANCZ Sándor

SEPTEMBER 20, 2012

Lege Artis Medicinae - 2012;22(08-09)

[In this article, we summarise the available information on dabigatran, focusing on clinical practice, in particular on the prevention of stroke and systemic embolism, the critical aspects of anticoagulant treatment with dabigatran, potential drug-drug interactions and adverse reactions in nonvalvular atrial fibrillation. The most important molecular characteristics of dabigatran are also described. We highlight the implications of safety issues that have emerged during everyday clinical practice.]

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[Stress load and health risk behaviour among medical, dental and pharmacy school students]

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[INTRODUCTION - This study aims to analyse interrelations of stress load, mental state and work related symptoms with health risk behaviour of medical, dental and pharmacy school students. SAMPLE AND METHODS - 473 fourthyear students participated, 73.4% of medical, 10.1% of dental and 16.5% of pharmacy school. Measuring stress, we used the validated version of Anderson's questionnaire for mental, physical and work related divisions. Those with high level of stress on the score system entered the risk groups in the relevant divisions. Among health risks, tobacco smoking, alcohol consume, illegal drugs and psychoactive pharmaceuticals were measured. RESULTS - 15.2% of students perceived mental and 7.8% physical complaints. Work related symptoms were in 26.0% indicated. The overall prevalence of health risks were found to be 12.1% for smoking, 36.2% for drinking, 30.9% for drug use and 9.1% for taking pharmaceuticals. There was a significant (p<0.001) association between taking pharmaceuticals and all the three risk divisions. CONCLUSIONS - The prevalence of smoking is low in all student groups, but three out of ten students are regularly consuming alcohol and some kind of illegal drugs, yet there is no significant association between these health risks and the stress phenomena. Using pharmaceuticals is relatively less frequent, but it must be concerned that these drugs are taken primarily to manage stress related problems.]

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[Ayahuasca, which originates from the Amazon Basin, is a psychoactive brew of two components. Its active agents are betacarboline and tryptamine derivatives. Near the spring of the Amazon River this brew is still a central component of many healing and tribal rituals. During the past few decades, the substance has become known among both laymen and scientistss and nowadays its use is spreading all over in Europe. In the present paper we give an overview of the scientific research and describe ayahuasca's main features, the main questions raised over its use, the risk factors and potential benefits. A growing number of scientific results seem to support the psychotherapeutic potential of ayahuasca, which has a strong serotonergic effect, whereas studies on its effect on the immune system also raise the possibility that certain ethno-medical observations can be scientifically proved.]

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[Cardiovascular disease is a leading cause of death. The incidence of type 2 diabetes is increasing worldwide as well as in Hungary. Diabetes mellitus is a high-risk state, and if associated with coronary disease, it is considered a very high-risk condition. According to the 5th Cardiovascular Consensus Conference and ESC/EAS, the target level of LDL-cholesterol should be <2.5 mmol/l in high-risk condition and <1.8 mmol/l in very high-risk condition. In diabetes, one of the main goals is to achieve target LDL-cholesterol levels, which require lifestyle changes as a first step, followed by statin treatment, in combination with with ezetimibe if necessary. Statins are also known to have diabetogenic effects, which are dose-dependent. The advantage of the preventive cardiovascular effects observed in nondiabetic patients substantially outweighs the risk of potentially developing diabetes mellitus, therefore, this risk should not hinder the use of statins. Statin treatment can substantially reduce cardiovascular events in patients with diabetes mellitus. The greatest reduction in LDL-cholesterol level can be achieved by the most efficient statin, rosuvastatin.]

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[Non-valvular AF is the most common cardiac arrhytmia. Its incidence increases with age. AF is an independent risk factor for ischaemic stroke, representing a five times higher risk for it, associated with a high mortality rate. Beside AF, there are several other risk factors which influence the risk of stroke. Stroke risk calculator can be used to assess the risk of patient having a stroke. The most endangered group of patients with AF are those who have already suffered from cerebrovascular event. The only effective medication for prevention of stroke due to AF had been the application of vitamin K antagonists (VKA) which considerably decrease the rate of ischaemic event in a patient with AF providing that the INR is in the therapeutic range. VKA have several limitations of use in clinical practice and the fear of bleeding complications results an underusing of these drugs. Only 50% of all patients treated with VKA reaches the therapeutic range of INR. The breakthrough of prevention of stroke in recent years is undisputedly the coming out of novel oral anticoagulants (NOACs, thrombin and Xa-factor inhibitors). Recent studies suggest that these novel drugs prove the same efficacy as VKA drugs, furthermore dabigatran in a dose of 2×150 mg or apixaban in 2×5mg was statistically superior to warfarin in the prevention of stroke. NOACs have shown a large reduction in intracranial hemorrhage compared with warfarin. They are given as a fixed dose and do not require persistent monitoring making them much more convenient. NOACs at guidelines of European Society of Cardiology act as a preferable drugs in case of ischaemic stroke with AF. Probably the extended use of NOACs in clinical practice will be the mainstream of stroke prevention in the future.]

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[Introduction - Among antidotes in development for reversal of novel oral anticoagulants, dabigatran-specific idarucizumab was the first one to reach the market. Case presentation - We present the first Hungarian case of intracerebral hemorrhage under treatment with dabigatran, where idarucizumab was administered to suspend anticoagulation. Discussion - Our report is concordant with prior publications, confirming the efficacy of the antidote in reversing the effect of dabigatran, and thus, preventing intracerebral hematoma progression in the acute phase. Conclusion - Since there is no proven alternative to idarucizumab, conducting randomized clinical trials would be unethical. Therefore, besides case reports, positive results of prospective studies could help us revise therapeutic guidelines, and thus, improve the prognosis of dabigatran-associated intracerebral hemorrhages.]

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

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[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.]

LAM Extra for General Practicioners

[DABIGATRAN: A NEW ORAL ANTICOAGULANT AGENT FOR THE PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN NONVALVULAR ATRIAL FIBRILLATION]

KANCZ Sándor

[In this article, we summarise the available information on dabigatran, focusing on clinical practice, in particular on the prevention of stroke and systemic embolism, the critical aspects of anticoagulant treatment with dabigatran, potential drug-drug interactions and adverse reactions in nonvalvular atrial fibrillation. The most important molecular characteristics of dabigatran are also described. We highlight the implications of safety issues that have emerged during everyday clinical practice.]

Lege Artis Medicinae

[Perioperative management of patients taking new oral anticoagulants - dabigatran in focus]

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[Appearance of new oral anticoagulants (NOAC) on the market requires a basically new approach from the doctors compared to vitamin K antagonists (VKA), the only oral anticoagulants used for several decades. These new drugs are at least as effective in the prevention of thrombotic events as the old ones and have the advantage that no regular laboratory monitoring is needed. Compared to the VKA a different management is required also in the perioperative care of patients taking NOAC. There is no need for bridge therapy, i.e. low-molecular-weight heparin (LMWH). The smaller surgical procedures can be performed 24 hours after the last dose of NOAC if it is administered once a day or 12 hours in case of agents administered twice a day. When a large surgical procedure is planned the drug should be stopped 24-96 hours before. The therapy should be resumed 6-8 hours after the procedure in low, 48-72 hours later in high bleeding risk cases. In a Canadian prospective study a protocol was used in which the stopping and resumption of dabigatran was recommended based on the bleeding risk and its half-life depending on the renal function. In 541 surgeries (60% with standard, 40% with increased bleeding risk) the occurrence of serious bleeding events was 1.8%, that of minor bleedings 5.2%. During the study one thrombotic event (TIA) occurred (0.2%). At the end of the article the author also makes a recommendation for stopping and resuming dabigatran therapy in case of tooth extraction, endoscopic biopsy and cholecystectomy.]