Hypertension and nephrology

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

KISS István

SEPTEMBER 20, 2011

Hypertension and nephrology - 2011;15(04)

[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.]

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Hypertension and nephrology

[Prominents in Hungarian nephrology Professor Gyula Petrányi (1912–2000). I. part]

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[A nation can only survive and keep its identity through its traditions. This is why the initiative to launch this series coming from professor János Radó is worthy of attention. Gyula Petrányi is an outstanding personality in 20th century internal medicine, to be more precise in nephrology and immunology, his activity being wide-ranging. The first part of the current summmary of his work deals with a tribute to his personality, and his role in immunomodularity treatment in glomerulonephritis. The second part shall cover his role in spreading renal biopsy, screening and caring kidney patients, dialysis, in developing kidney patients’ care, furthermore in clinicopharmacology and renal transplantation.]

Hypertension and nephrology

[Advantages of fixed combinations in the treatment of hypertensive patients]

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Hypertension and nephrology

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[Overweight [body mass index (BMI) = 25-30 kg/m2] and obesity (BMI ≥30 kg/m2) have become mass phenomena with a pronounced upward trend in prevalence in most countries throughout the world and are associated with increased cardiovascular risk and poor survival. In patients with end stage renal disease (ESRD) undergoing maintenance hemodialysis an “obesity paradox” has been consistently reported, i.e., a higher BMI is incrementally associated with better survival. Whereas this “reverse epidemiology” of obesity is relatively consistent in maintenance hemodialysis patients, studies in peritoneal dialysis patients have yielded mixed results. However, BMI is unable to differentiate between adiposity and muscle mass and may not be an acceptable metric to assess the body composition of ESRD patients. Assessing lean body mass, in particular skeletal muscle, and fat mass separately are needed in ESRD patients using gold standard techniques such as imaging techniques. Alternatively, inexpensive and routinely measured surrogate markers such as serum creatinine, waist and hip circumference or mid-arm muscle circumference can be used. We have reviewed and summarized salient recent data pertaining to body composition and clinical outcomes about the association of survival and body composition in peritoneal and hemodialysis patients.]

Hypertension and nephrology

[Coexistence of diabetes mellitus and (nephrogenic) diabetes insipidus]

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[In this report we describe a patient with nephrogenic diabetes insipidus associated with diabetes mellitus. The 44-year-old patient was seen by us for the first time when she was 5 years old in 1972, as a member of a family with nephrogenic diabetes insipidus associated with other congenital renal diseases. Surveying five generations by family history we found in four genarations (supported with investigations in three genarations) five patients suffering from the combination of renal tubular acidosis, polycystic kidney disease and nephrogenic diabetes insipidus. Nephrogenic diabetes insipidus was confirmed with blood and urine osmolality measurements performed during water deprivation as well as during administration of synthetic vasopressins. Renal tubular acidosis was confirmed with blood and urine gas analysis and bicarbonate and acid loadings. Polycystic kidney disease was diagnosed with physical findings, imaging and in the case of a deceased patient by necropsy. The autosomal dominant trait was obvious in the family characteristic to the distal renal tubular acidosis and polycystic kidney disease. The clinical picture was dominated by the polydipsia and polyuria. Significant interindividual differences were found in vazopressin resistance responsible for the nephrogenic diabetes insipidus. In our patient metabolic syndrome (diabetes mellitus, hypertension, obesity, abnormal lipid and uric acid levels) and disturbances in calcium metabolism (nephrolithiasis and osteomalacia) were associated with renal disorders. The 39 year long observation period (with some discontinuations) the patient was treated almost without pauses with bicarbonate, desmopressin, thiazide, NSAIDs supplemented with the administration of vitamin D3, antidiabetics etc. Despite of the listed and other diseases the patient’s mood is quite good, her physical condition is relatively satisfactory while she is working regularly physically.]

Hypertension and nephrology

[Role of calcimimetics in the treatment of secondary hyperparathyroidism in dialysed patients ]

[The authors summarize the pathophysiology and main clinical features of the condition which was previously called secondary hyperparathyroidism (sHTP) and renal osteodystrophy (ROD) in chronic kidney disease patients. Recently this entity has been renamed as chronic kidney disease - mineral and bone disorders (CKD-MBD), which more accurately describes the complexity of the condition including changes in laboratory parameters, bone turnover and vascular calcification. The calcium sensing receptor (CaR) plays a central role in the pathophysiology of CKD-MBD. Calcimimetics, which increase the sensitivity of the CaR to calcium, represent a novel and potentially advantageous class of medications for the management of the condition. Currently cinacalcet is the only available calcimimetic for clinical practice. Robust preclinical and human clinical trials have demonstrated that calcimimetics increase the expression of calcium sensing and the vitamin D receptors, attenuate parathyroid hyperplasia, decrease all four laboratory parameters (iPTH, Ca, P and Ca × P), optimize bone turnover and may slow down vascular calcification. As a results, cinacalcet based therapy is preferable and beneficial strategy in the treatment of CKD-MBD in patients on maintenance dialysis.]

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