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LAM Extra for General Practicioners

SEPTEMBER 20, 2014

[REGIONAL ADVISORY BOARD POSITION STATEMENT ON OPTIMAL PNEUMOCOCCAL VACCINATION IN ADULTS. UPDATE TO 2011 CONSENSUS ON ADULT PNEUMOCOCCAL DISEASE: UPDATE ON OPTIMAL PNEUMOCOCCAL VACCINATION IN ADULTS]

LUDWIG Endre, SERHAT Ünal, MIRON Bogdan, ROMAN Chlíbek, YAVOR Ivanov, ROMAN Kozlov, HARTMUT Lode, MÉSZNER Zsófia, ROMAN Prymula, GALIA Rahav, SKOCZYNSKA Anna, SOLOVIC Ivan, ABDULLAH Sayiner

[BACKGROUND - An important development in the field of adult pneumococcal vaccination since the last Consensus Statement, published by the Expert Panel of Central and Eastern Europe and Israel (the Region) in September 2012, was the licensure of the 13-valent pneumococcal conjugate vaccine (PCV13) for adults aged 50 years and older. DISCUSSION - The Expert Panel has developed this Position Statement as an update to its previous Consensus to address the following topics which are likely to be on the agenda of national scientific societies during the ongoing updates of vaccination recommendations in the Region: the availability of a pneumococcal conjugate vaccine for adults over 50 years of age, the available clinical evidence on its use in adults, and the future place of conjugate vaccines in adult pneumococcal vaccination. The Expert Panel concluded that there is sufficient epidemiologic immunogenicity and safety evidence to use PCV13 in adults over 50 years of age. RESULTS - The use of conjugate vaccine induces immunological memory and can overcome some limitations associated with the plain polysaccharide vaccine (PPV). It was also agreed that, if the use of PPV is considered appropriate, PCV13 should be administered first, regardless of prior pneumococcal vaccination status.]

Lege Artis Medicinae

NOVEMBER 20, 2013

[Therapeutic strategies in rheumatoid arthritis]

VÁNCSA Andrea, SZEKANECZ Zoltán

[In this review, we follow the consecutive steps of the internationally accepted therapeutic strategy of rheumatoid arthritis (RA). We summarise in brief the current European recommendations, and provide some advice on methotrexate (MTX) therapy. The initiation, maintenance and, if needed, switch of biological therapy is also discussed. Having reached remission or low disease activity (LDA), tapering or discontinuation of biologics may be considered. Finally, we review the possibilities and the most important biomarkers of personalised treatment.]

Hypertension and nephrology

SEPTEMBER 20, 2011

[Biosimilar erythropoesis stimulating agents - from registration to clinical practice]

KISS István

[The original patent drugs appear immediately on expiry of all rights in generic and biosimilar drugs in the pharmaceutical market, favorable supply option which helps in the rational management of medicines, mainly for generic drugs cheaper to allow more patient care. Of course, this is a well-organized legal and regulatory framework, thoughtful strategy can be successful in every respect. In another non-identical molecular structure biosimilar drugs in different immunogenicity of knowledge and risk is not defined in clinical practice and therefore the risk is still underestimated and not well regulated in the world, and increasing the number reported is the antibody formation case of a biosimilar erythropioetin also. The immunogenicity of original biological and of biosimilar drugs in identifying, defining a prominent role in the post-marketing surveillance, pharmacovigilance, and the special methods of control of immunogenicity. The original and the biosimilar medicines interchangeability, marketability of the assets relating to the regulations are not uniform in Europe or the European registration scheme is an important new biosimilar medicinal products, is that the medicinal product, the documentation is not expected to be accompanied by a risk management plan, as well as action to ensure the safety (pharmacovigilance) as part of the collection and reporting of adverse reactions to the official. It is important that the professional management of renal anemia guidelines - the practice of nephrology erythropoietin therapy - clearly define the biological medicines (originator and biosimilar erythropoietin) application requirements and suggestions. Consequently, this summary wants to draw attention to the therapeutic potential of biosimilar drugs, generic drugs to distinguish between explicit and the potential risks and the need to reduce the risks of professional and health policy decisions.]

Lege Artis Medicinae

APRIL 20, 2002

[Rapid-acting human insulin analogues: new possibilities in the therapy of diabetes mellitus]

KERÉNYI ZSUZSA, TAMÁS GYULA

[Modifications of the insulin molecule at the end of the B chain resulted in the development of some new, more physiological meal-related insulins, the rapid acting human insulin analogues. This survey summarises the characteristics (structure, absorption, immunogenicity, efficacy and safety) and the conditions of clinical application of the rapid-acting insulin analogues available at the moment in Hungary. Furthermore, authors evaluate the effect of application of rapid-acting insulin analogues on the quality of life and glycaemic control of the patients. The collaboration between the well-prepared health-care team and the well-educated and cooperative diabetic patient using rapid-acting insulin analogue could lead to a level of freedom of lifestyle that approximates that of healthy people.]

Lege Artis Medicinae

JUNE 10, 2009

[Tumor necrosis factor-alpha blockade: adverse clinical consequences and safety issues]

MŰZES Györgyi

[The pleiotropic cytokine tumor necrosis factor (TNF)-α seems to be fundamentally involved in the pathogenesis of a variety of immune-mediated (partly autoimmune) chronic inflammatory disorders; therefore, its blockade has allowed a remarkable advance in treatment strategies. Safety and tolerability profile of TNF-antagonists is generally favorable, their overall risk/benefit ratio is definitely positive. Possible adverse consequences related to TNF-α blocking monoclonal antibodies and soluble receptors can be classified as class-specific side effects that are related to their mode of action, and individual, molecule-specific effects. Immunogenic potential of immunoglobulins (Ig) eliciting an anti-(Ig-) antibody immune response may reduce or eliminate their therapeutic benefit, increase the risk of resistance or intolerance to biologic agents, and also lead to other adverse clinical effects. The immunogenicity profile of TNFantagonists is mainly related to their hetero- (xeno-), allo- (iso-)genic or idiotypic antigen character. By means of generating fully human monoclonal antibodies, more tolerable drugs could be introduced into clinical practice.]

Lege Artis Medicinae

AUGUST 20, 2010

[Clinical pharmacologic principles and problems related to the clinical use of innovative and similar biological medicines]

KERPEL-FRONIUS Sándor

[The active substances in the biological medicinal products are macromolecules, primarily proteins most of which are currently produced by various biotechnological methods in different biological systems. The spatial structure of the macromolecular active substances cannot be accurately determined by the presently available methods. Therefore, both physico-chemical and biological methods are needed for the control of their quality and production. The active proteins induce immunologic reactions in the organism. The appearance of neutralizing antibodies frequently leads to the inhibition of the effect of the biological medicines. The European Medicines Agency (EMA) registers the medicinal products containing similar macromolecular active substances produced by biotechnological methods as biosimilar agents, since their chemical identity cannot be proven. The similarities and differences of their biological and immunological effects can be evaluated only in comparative non-clinical and clinical trials. The frequent exchange of biological medicines increases the appearance of antibodies in the patients, therefore the substitution of biological drugs should be done only by the treating physicians if clinically necessary.]