Lege Artis Medicinae

[Protection of gastrointestinal system in cardiovascular diseases]


MARCH 20, 2015

Lege Artis Medicinae - 2015;25(03)

[Cardiovascular preventive drugs (nonsteroidal antiinflammatory drugs, aspirin, inhibitors of platelet aggregation, anticoagulants) are among the most frequently used medicines all over the world. Gastrointestinal (GI) complications (hemorrhage, ulceration, perphoration) are among the most frequent side effects of these drugs, however, differences in their pharmacodynamics properties and other pleiotropic effects may substantially modify these unwanted events. Authors, based on international and Hungarian guidelines, summarize the most important data for GI protection, focusing on the use of H-2 receptor blockers and proton pump inhibitors.]



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[The role of hypoxia in tissue regeneration and in development of amplified aggressive fenotypes in malignant cancer]


[Several diseases are accompanied by hypoxic stress; elimination of it is an important physiological process. Our body provides a protective function which delays damage and destruction by hypoxia. In case of necrosis, it provides the mop up of the damaged area. This security system starts the regeneration in cells of the hypoxic zone which surrounds the necrotic area, resulting in the survival of the cells in hypoxic environment and ensuring the handling of the necrosis. The key molecules of the system are the hypoxia-induced factor molecules. The review discusses the physiological role of tissue hypoxia and normoxia and its effects on tissue regeneration. The physiological system triggered by the hypoxia-induced factor plays an important role in embryonic development, in wound healing and in numerous diseases (eg. myocardial infarction, stroke, vaculities, etc). Unfortunately, this system also plays a key role in several malignant tumors by rising the development of cells with increased aggressive fenotypes as well. The physiological process of regeneration starts in the hypoxic tumor cells aided by the hypoxia-induced factor system. The process results in neovascularization, and in the case of tissue damage, in the mop up of the necrotic tissue and in the restoration of tissue oxygenisation. However, after the formation of the new vascular network, tumor cells accustomed to hypoxia will not die but keep their original uncontrolled proliferation and anaerobic nature. Moreover the malignant nature of the cells will be increased by the genetic changes generated by the system of hypoxia- induced factors. The role of the hypoxia-induced factor system in tumor progression is discussed by the example of one of the most malignant tumors, malignant melanoma.]

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[Biosimilar insulins on the horizon]


[Nowadays human insulins and insulin analogues are exclusively used in the clinical practice, when insulin therapy is needed. The patents of human insulins are expired and will expire soon for glargine, the first long-acting, basal insulin analogue preparation. The reliable production of biosimilar insulins is a new challenge for the pharmaceutical industry. Independently developed insulins with appreciable clinical efficacy have already become available in some countries where the quality criteria of regulatory process in place are less strict than in the European Union. The first approval for true biosimilar insulin, i.e. for biosimilar glargine was given in Europe in 2014. In this article, the characteristics of biosimilar insulins, especially the difficulties in the manufacturing process are reviewed in comparison with generic drugs. It is of note that potential efficacy and safety differences may occur due to even minor changes in the production, formulation and storage of the biological drugs. Therefore, biosimilarity should be investigated by detailed comparative pharmacokinetic and pharmacodynamic studies. Moreover, similar clinical efficacy and safety should be documented by randomized, comparative clinical trials. The potential impact of altered immunologic profile of biosimilar insulins should also be carefully monitored. ]

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[Risk of nonsteroidal antiinflammatory drugs. Focus on aceclofenac]


[Nonsteroidal antiinflammatory drugs (NSAIDs) are among the most frequently used pharmaceuticals. Nevertheless, a number of studies emphasized that NSAIDs were damaging not only the gastrointestinal (GI), but also the cardiovascular (CV) system, could increase the blood pressure, the frequency of coronary events (angina, myocardial infarction) and stroke incidence, as well as they might deterio­rate renal functions. The National Institute for Health and Care Excellence (NICE) did not find evidence that administering NSAIDs could increase the risk of developing COVID-19 or worsened the condition of COVID-19 patients. However, unwanted effects of specific drugs differ substantially in their occurrence and seriousness as well. It seemed to be for a long time that the NSAIDs provoked higher GI-risk was closely related to the COX1/COX2 selectivity, like the cardiovascular (CV) risk to the COX2/COX1 selectivity, however, the recent data did not prove it clearly. Based on the available literature while pondering the gastrointestinal and cardiovascular adverse events, among all NSAIDs the aceclofenac profile seemed to be the most favourable.]

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[Statins represent the most important drug among antilipidemic therapy modalities playing dominant roles against atherosclerotic burden. Statin’s outstanding importance is due partly to cholesterol lowering capacity, however their anti-inflammatoric, antiproliferative, antioxidant and vasodilatative efficacies as a pleiotropic potential indicates much more impact on prompt retardation of atherosclerotic progression. The results concerning statin pleiotropic influence are reviewed which are in association with their new indication in ACS management. The second part of this review delineates suspected side effects of statin use. Only one concern brings safety information: it is a fact that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus, but the cardiovascular and mortality benefits of statin therapy exceed the diabetes hazard.]

Lege Artis Medicinae

[The cardiovascular risk of nonsteroidal antiinflammatory drugs]

AMBRUS Csaba, KISS István

[Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most common pain relief and anti-inflammatory medications all over the World, and many formulations are also available over-the-counter. Beyond the well-known gastrointestinal risks, emerging evidence supports increased incidence of cardiovascular events associated with the use of NSAIDs. This cardiovascular risk seems to be independent of the cyclooxygenase selectivity of these drugs. Distinct side effect profiles of various NSAIDs were summarized in a former issue of the Journal: LAM 2014;24(7): 327. In this paper, we aimed to summarize some of the yet unpublished results of a major research project of the European Medicines Agency (EMA), that was conducted in order to establish the relative risk of CV outcomes (myocardial infarction, ischaemic stroke and hospitalization for heart failure) associated with the use of various NSAIDs. In this epidemiological study, seven European healthcare databases on a source population of 35 million subjects were linked and analyzed. Most of the results are currently only available on the project homepage; however, analyses of heart failure data have already been published in a recent issue of The BMJ. ]

Lege Artis Medicinae

[Cardiovascular risk of non-steroidal antiinflammatory drugs]


[During the past decade, a number of original publications, reviews and metaanalyses were published on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). As this group of medicines is among the most frequently used ones and many preparations are available over the counter, it seems to be prudent to summarise the most important results on the safety of these drugs, and underline their potentially harmful cardiovascular side effects. Nevertheless, it can also be emphasized that there are substantial differences between different compounds, and the cardiovascular risk does not depend on the ratio of COX-1/COX-2 selectivity. Cardiovascular risk can be increased by all NSAIDs with the possible exception of naproxen.]

Lege Artis Medicinae

[The risk of non steroid antiinflammatory drugs]


[Nonsteroidal antiinflammatory drugs (NSAIDs) are among the most frequently used medicines all over the world. In the year 2012 in the LAM, we summarized data on cardiovascular (CV) safety of these drugs. We emphasized that all NSAIDs may potentially be harmful on the CV system, as they can increase the blood pressure, the risk of coronary events (angina, myocardial infarction), and that of stroke, as well as they may deteriorate renal functions. We also outlined that in this respect there are substantial differences between different compounds, and the CV risk does not depend on the ratio of COX- 1/COX-2 selectivity. The newly available data of original papers and metaanalyses shed light on further details. Even naproxen which drug was previously considered the less harmful on CV system can increase the risk of blood pressure, stroke, and gastrointestinal (GI) complications. We have to emphasize that the most important risk of NSAIDs is still the GI bleeding. This adverse effect is significantly less for drugs which are more selective for COX-2 than COX-1 enzyme, but other, pleiotropic effects can also beneficially modify the GI as well as the CV risk. E.g. the aceclofenac was found to be among NSAIDs with the less adverse effects on GI system and is also among those having the less CV risk.]