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Amet S.,Service ICAR | Bronowicki J.-P.,Nancy University Hospital Center | Thabut D.,Hopital Pitie Salpetriere | Benhamou Y.,Hopital Pitie Salpetriere | And 4 more authors.
Liver International | Year: 2015

Background & Aims: Few data are available on the prevalence of renal abnormalities in chronic hepatitis B virus (HBV)-infected patients. The multicentric cross-sectional HARPE study evaluated the prevalence of kidney disease indicators, in chronic HBV surface antigen carriers patients (HBsAg+) with active or inactive infection. Patients and methods: Two hundred and sixty-eight HBsAg+ adult patients, naïve of any oral antihepatitis B virus treatment were prospectively included over 2 years. Data for renal assessment were collected once from patient files. Univariate tests and multiple linear regressions were performed with the SAS software, version 8.02 (SAS, Inc., Cary, NC, USA). Results: Among the 260 patients analysed, 58% were men, the mean age was 42 ± 14 years, 59.6% were inactive carriers whereas 47 patients, mostly active, were about to start an antiviral therapy. Prevalence of proteinuria, haematuria, glycosuria, uninfectious leukocyturia was 38.1%, 20.6%, 3.9% and 9% respectively. According to the international definition, a total of 64.6% of patients were found to have kidney disease. Diabetes, hypertension and dyslipidaemia were observed, respectively, in 4.6%, 9.2% and 38.8% patients. There were no significant differences in these results within the three subgroups. Conclusion: Renal abnormalities are highly prevalent in our population and pre-exist before the initiation of any antihepatitis B virus treatment. This emphasizes the need for: (i) a baseline renal evaluation in all HBs antigen-positive patients; (ii) a regular renal monitoring before and during antihepatitis B virus treatment to diagnose and manage renal impairment and adjust antihepatitis B virus treatment doses to renal function when necessary. © 2015 John Wiley & Sons Ltd.


Thariat J.,French National Center for Scientific Research | Etienne-Grimaldi M.-C.,Oncopharmacology Unit | Launay-Vacher V.,Service ICAR | Soto-Matos A.,PharmaMar | And 7 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2011

Purpose: The pharmacokinetics of trabectedin has never been reported in patients with impaired renal function or in patients on hemodialysis. Methods: We examined trabectedin PK in a patient on hemodialysis, starting trabectedin therapy at a standard dose for recurrence of a retroperitoneal myxoid liposarcoma that had occurred under immunosuppressive drugs for kidney transplant. Results: As compared with a population with normal renal function, the study patient presented a higher C max and AUC, with lower clearance, terminal half-life, and volume of distribution. The low dialysis clearance, accounting for a minor part of the total body clearance and the absence of detectable trabectedin in the dialysate samples, suggests that hemodialysis does not efficiently clear trabectedin. Trabectedin tolerance was good. Conclusions: This case reports for the first time the feasibility of trabectedin therapy in a hemodialyzed patient. Given the rising incidence of cancer in patients with end-stage renal disease, it is crucial to provide data that improve the management of anticancer drugs in dialyzed patients. © 2011 Springer-Verlag.


Scotte F.,Hopital Europeen Georges Pompidou | Rey J.B.,Institute Jean Godinot | Launay-Vacher V.,Service ICAR
Supportive Care in Cancer | Year: 2012

Background Venous thromboembolism (VTE) and renal insufficiency are common in cancer patients. Prompt treatment is necessary to reduce the high rates of VTE-related mortality and morbidity. VTE prophylaxis is underused in cancer patients. We review current recommendations for the treatment and prevention of VTE in cancer patients and discuss low molecular weight heparin (LMWH) use in cases of renal failure. Design This study is a retrospective literature review. Results There are few published recommendations for LMWH use in cancer patients with renal insufficiency. Treatment guidelines largely follow recommendations for other patients with renal failure. Enoxaparin therapy is complicated by the need for regular monitoring of renal function and anti-Xa levels and for dosage adjustment to prevent bleeding. Few data are available to support the systematic use of dalteparin. Tinzaparin is least likely to bioaccumulate in patients with renal failure. Conclusion VTE is the second most common cause of death in cancer patients. Renal insufficiency is present in 50-60 % of cancer patients. Data from renal patients suggest that tinzaparin may be safe and effective for VTE treatment and prevention in cancer patients with renal failure. © Springer-Verlag 2012.


Aapro M.,Institute Multidisciplinaire dOncologie | Launay-Vacher V.,Service ICAR
Cancer Treatment Reviews | Year: 2012

Monitoring renal function in patients with solid tumors and hematologic malignancies is vital to the safe administration of therapeutic agents. Renal impairment is frequent in elderly patients (i.e., age≥65) with cancer, despite normal serum creatinine levels in most patients. Because serum creatinine levels do not accurately reflect clearance rates, renal function should be estimated by calculation (either Cockcroft-Gault or abbreviated Modification of Diet in Renal Disease [aMDRD] equations) or by measuring creatinine clearance using a 24-h urine collection. Additionally, patients with cancer often have preexisting comorbidities or other risk factors that increase the probability of renal impairment before receiving potentially nephrotoxic therapies. Patient age, preexisting renal dysfunction, and chronic comorbidities (e.g., diabetes, kidney disease, hypertension, and cardiac insufficiency) all contribute to the risk of renal impairment. Furthermore, both cancer and its therapies may lead to renal impairment. A number of cancer therapy agents are nephrotoxic, including chemotherapy agents, molecular targeted agents, pain management agents, radiopharmaceuticals, contrast agents used in radiology, and antiresorptive agents, and contrast agents used in radiology are nephrotoxic as well. Undetected decreases in clearance rates by the kidneys can greatly increase exposure to treatment agents, possibly decreasing the safety of treatment and exacerbating renal impairment. In conclusion, all cancer patients, not only those receiving potentially nephrotoxic agents, require renal monitoring. © 2011 Elsevier Ltd.


Anemia is frequent in nephrology and can be observed in chronic renal insufficiency patients when the glomerular filtration rate falls under 60 mL/min/1.73m 2. The main causes of anemia in these patients are a deficit of endogenous erythropoietin EPO production by the kidney and iron deficiency. Thus, the management of anemia includes first the diagnosis of chronic renal insufficiency, and then the exploration of anemia, with the iron deficiency according to the available recommendations. Treatments include the correction of the iron deficiency with IV iron complexes and the use of ESA (erythropoiesis stimulating agent) in order to reach the recommended target of hemoglobinemia, ferritinemia and transferrin saturation coefficient. Therefore, ESA and/or IV iron complexes is the basement of the therapeutic strategy, but these products are not equivalent to each other in terms of efficacy, safety and handling.


Renal insufficiency is frequent. It can lead to complications and have consequences for the handling of drugs in terms of dose adjustment or drug nephrotoxicity. Thus, its diagnosis and monitoring are essential. There are several methods to measure renal function. The first ones involve exogenous markers and complex techniques (51Cr-EDTA, iothalamate or iohexol). The others methods use an exogenous marker, serum creatinine. However, the value of serum creatinine should not be interpreted alone. Therafter, formulae for estimating kidney function incorporating serum creatinine have been developed. Among them we find the Cockcroft-Gault, MDRD formulae (then aMDRD) and more recently the CKD-EPI formula. However, these formulae are not equivalent. Indeed, the aMDRD formula is particularly effective in specific population, such as elderly patients, when compared with the Cockcroft-Gault formula. It is therefore important to be attentive to the patient profile before assessing kidney function with a formula for estimating renal function.


Zimner-Rapuch S.,Service ICAR | Launay-Vacher V.,Service ICAR
Journal de Pharmacie Clinique | Year: 2011

Patients with chronic kidney disease (CKD), dialyzed or not, have renal impairment that can affect the kidney capacity of elimination. Patients with renal insufficiency are not able to eliminate drugs as well as patients with a normal renal function. Moreover, renal insufficiency can affect all of the pharmacokinetic profile of drugs. Therefore, it is crucial to take these parameters into account and to adjust drugs dosage, according to renal insufficiency stage. In this article, we will see all the pharmacokinetics modifications due to renal insufficiency. The different ways to find the information about drug dosage adjustment will be explored. Finally, administration of drugs in patients experimenting dialysis will be developed and explained.


Launay-Vacher V.,Service ICAR
Seminars in Nephrology | Year: 2010

Kidney disease has been shown to be highly prevalent in cancer patients in the IRMA studies (Renal Insufficiency and Anticancer Medications). Furthermore, anticancer drugs used in those patients, among which half have abnormal renal function, necessitate dosage adjustment in case of reduced renal function and/or is potentially toxic to the kidneys in the vast majority of cases. Observations performed in IRMA-2 showed that the survival rate at 2 years was significantly lower for patients with KD (aMDRD<60). This reduced survival has been hypothesized to be related to the cardiovascular complications of KD or as a consequence of inappropriate drug dosage adjustment. © 2010 Elsevier Inc.


Renal insufficiency is a common disease, in the general population as well as in some specific diseases such as HIV infection or cancer. The vast majority of medicines requires a dosage adjustment in case of renal dysfunction. It is thus of a crucial importance to know how to evaluate appropriately renal function, on one hand, but also to have access to reliable information sources on how to handle the drugs in such cases. Most often, the Summary of Drug Characteristics (SmPC) only provides partial information, wich may even be false in some cases. However, some information sources exist, reliable, updated, and easily accessible.


PubMed | Service ICAR
Type: Journal Article | Journal: Liver international : official journal of the International Association for the Study of the Liver | Year: 2015

Few data are available on the prevalence of renal abnormalities in chronic hepatitis B virus (HBV)-infected patients. The multicentric cross-sectional HARPE study evaluated the prevalence of kidney disease indicators, in chronic HBV surface antigen carriers patients (HBsAg+) with active or inactive infection.Two hundred and sixty-eight HBsAg+ adult patients, nave of any oral antihepatitis B virus treatment were prospectively included over 2 years. Data for renal assessment were collected once from patient files. Univariate tests and multiple linear regressions were performed with the SAS software, version 8.02 (SAS, Inc., Cary, NC, USA).Among the 260 patients analysed, 58% were men, the mean age was 42 14 years, 59.6% were inactive carriers whereas 47 patients, mostly active, were about to start an antiviral therapy. Prevalence of proteinuria, haematuria, glycosuria, uninfectious leukocyturia was 38.1%, 20.6%, 3.9% and 9% respectively. According to the international definition, a total of 64.6% of patients were found to have kidney disease. Diabetes, hypertension and dyslipidaemia were observed, respectively, in 4.6%, 9.2% and 38.8% patients. There were no significant differences in these results within the three subgroups.Renal abnormalities are highly prevalent in our population and pre-exist before the initiation of any antihepatitis B virus treatment. This emphasizes the need for: (i) a baseline renal evaluation in all HBs antigen-positive patients; (ii) a regular renal monitoring before and during antihepatitis B virus treatment to diagnose and manage renal impairment and adjust antihepatitis B virus treatment doses to renal function when necessary.

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