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drug dosing in renal disease

Julio Rosenstock, Vlado Perkovic, John H Alexander, Mark E Cooper, Nikolaus Marx, Michael J Pencina, Robert D Toto, Christoph Wanner, Bernard Zinman, David Baanstra, Egon Pfarr, Michaela Mattheus, Uli C Broedl, Hans-Juergen Woerle, Jyothis T George, Maximilian von Eynatten, Darren K McGuire
BACKGROUND: Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. METHODS: CARMELINA® is a randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries in T2D patients at high risk of CV and/or kidney events...
March 14, 2018: Cardiovascular Diabetology
Benjamin Wu, Murad Melhem, Raju Subramanian, Ping Chen, Bethlyn Jaramilla Sloey, Bruno Fouqueray, M Benjamin Hock, Gary L Skiles, Andrew T Chow, Edward Lee
Etelcalcetide, a d-amino acid peptide, is an intravenous calcimimetic approved for the treatment of secondary hyperparathyroidism. Etelcalcetide binds the calcium-sensing receptor and increases its sensitivity to extracellular calcium, thereby decreasing secretion of parathyroid hormone (PTH) by chief cells. Etelcalcetide and its low-molecular-weight transformation products are rapidly cleared by renal excretion in healthy subjects, but clearance is substantially reduced and dependent on hemodialysis in end-stage renal disease...
March 13, 2018: Journal of Clinical Pharmacology
Toni K Choueiri, James Larkin, Mototsugu Oya, Fiona Thistlethwaite, Marcella Martignoni, Paul Nathan, Thomas Powles, David McDermott, Paul B Robbins, David D Chism, Daniel Cho, Michael B Atkins, Michael S Gordon, Sumati Gupta, Hirotsugu Uemura, Yoshihiko Tomita, Anna Compagnoni, Camilla Fowst, Alessandra di Pietro, Brian I Rini
BACKGROUND: The combination of an immune checkpoint inhibitor and a VEGF pathway inhibitor to treat patients with advanced renal-cell carcinoma might increase the clinical benefit of these drugs compared with their use alone. Here, we report preliminary results for the combination of avelumab, an IgG1 monoclonal antibody against the programmed cell death protein ligand PD-L1, and axitinib, a VEGF receptor inhibitor approved for second-line treatment of advanced renal-cell carcinoma, in treatment-naive patients with advanced renal-cell carcinoma...
March 9, 2018: Lancet Oncology
Cathy Hardalo, Thomas P Lodise, Monique Bidell, Shawn Flanagan, Carisa De Anda, Steven Anuskiewicz, Philippe Prokocimer
BACKGROUND: We evaluated safety and tolerability of tedizolid phosphate at the 200-mg once-daily dose approved for 6-day treatment of skin and skin-structure infections. RESEARCH DESIGN AND METHODS: Clinical adverse event (AE) and laboratory data were pooled across completed clinical studies (13 phase 1, two phase 2, and two phase 3), for all participants who received ≥1 dose of tedizolid 200 mg, linezolid 600 mg (phase 3 only), or placebo (phase 1 only). RESULTS: 1280 participants received tedizolid (phase 1: n = 355; phase 2/3: n = 925)...
March 12, 2018: Expert Opinion on Drug Safety
Ayşe Tunçer Vural, Arzu Karataş Toğral, Ayşe Tülin Güleç, Mehmet Haberal
Solid-organ transplant recipients are at higher risk of developing Kaposi sarcoma, which is a multicentric vascular neoplasm of lymphatic endothelium-derived cells. Reducing doses of immunosuppressive drugs and switching from calcineurin inhibitors to the mammalian target of rapamycin inhibitor rapamycin have been suggested as an effective first-line treatment modality in most patients. Herein, we report a 64-year-old renal transplant recipient who developed multiple cutaneous and visceral Kaposi sarcoma lesions 2 months after transplant...
March 2018: Experimental and Clinical Transplantation
Toshihiko Komai, Shuji Sumitomo, Shuzo Teruya, Keishi Fujio
A 76-year-old man complicated with end-stage renal disease had latent tuberculosis infection (LTBI), and isoniazid (INH) 300 mg daily was started to prevent reactivation of LTBI before using biologic agents for rheumatoid arthritis. On the 8th day after administration of INH, he presented with a fever, petechiae, and myalgia. Serological studies revealed elevated myogenic enzymes and creatinine level. Based on the exclusion of other etiologies, rapid improvement with cessation of INH, and the recurrence of the fever and myalgia with re-administration of a reduced dose of INH, we diagnosed him with INH-induced rhabdomyolysis...
March 9, 2018: Internal Medicine
Ozgur Haki Yuksel, Caglar Yildirim, Ahmet Urkmez, Nurver Ozbay, Fatih Uruc, Aytac Sahin, Serkan Akan, Ayhan Verit
OBJECTIVES: The most important treatment strategy for obstructive nephropathy is to protect renal tissue from the deleterious effects of fibrosis. Therefore, we sought to investigate the renoprotective effects of darbepoetin alfa on unilateral ureteral obstructions. METHODS: We used 12 female and 12 male 3-monthold Wistar rats weighing between 250 and 350 g. The rats were divided equally into sham, darbepoetin and control groups. With the exception of the sham group, left unilateral obstructions were applied to all of the rats...
March 2018: Archivos Españoles de Urología
Nada Abdulaziz, Anjali R Shah, William J McCune
PURPOSE OF REVIEW: Antimalarial drugs including chloroquine, its less toxic quinolone-derivative hydroxychloroquine (HCQ), and quinacrine have become cornerstones in the treatment of autoimmune diseases including systemic lupus, rheumatoid arthritis, sarcoidosis, and Sjogren syndrome; cutaneous disorders, antiphospholipid syndrome, and have recently been employed at higher dioses in oncology. Benefits include anti-inflammatory effects, protection against thrombosis, and improved control of hyperglycemia and hyperlipidemia...
March 6, 2018: Current Opinion in Rheumatology
Hsien-Chun Chiu, Chen-Yuan Chiu, Rong-Sen Yang, Ding-Cheng Chan, Shing-Hwa Liu, Chih-Kang Chiang
BACKGROUND: A global consensus on the loss of skeletal muscle mass and function in humans refers as sarcopenia and cachexia including diabetes, obesity, renal failure, and osteoporosis. Despite a current improvement of sarcopenia or cachexia with exercise training and supportive therapies, alternative and specific managements are needed to discover for whom are unable or unwilling to embark on these treatments. Alendronate is a widely used drug for osteoporosis in the elderly and postmenopausal women...
March 6, 2018: Journal of Cachexia, Sarcopenia and Muscle
Lili Xu, Yueniu Zhu, Jing Yu, Mengyan Deng, Xiaodong Zhu
RATIONALE: Stevens-Johnson syndrome (SJS) is an acute blistering disease of the skin and mucous membranes. SJS in children is not common but potentially serious disease. But the epidemiology of SJS in China is not well defined. PATIENT CONCERNS: A 6-year-old boy was initially diagnosed as pneumonia admitted to hospital after admission, and the body appears red rash with blisters, skin damage, lip debaucjed, repeated high fever, and rapid progression. DIAGNOSES: SJS often results from an allergy reaction response to a range of drugs...
January 2018: Medicine (Baltimore)
Chih-Ning Cheng, Shu-Wen Lin, Chien-Chih Wu
Linezolid, an oxazolidinone antibiotic, does not required dose adjustment in patients with Child's class A and B liver cirrhosis. The dose adjustment data for Child's class C liver cirrhosis is inadequate. We reported a case of Child's class C liver cirrhosis, in which lactic acidosis, an adverse effect related to prolonged use, occurred only after two weeks of linezolid treatment. A 63-year old male had underlying diseases, such as end-stage renal disease (ESRD) and Child's class C liver cirrhosis, and was admitted for hepatic encephalopathy management and liver transplantation evaluation...
March 1, 2018: Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy
Ke Wang, Bryan Kestenbaum
The secretion of small molecules by the proximal tubules of the kidneys represents a vital homeostatic function for rapidly clearing endogenous solutes and medications from the circulation. After filtration at the glomerulus, renal blood flow is directed through a network of peritubular capillaries, where transporters of the proximal tubules actively secrete putative uremic toxins and hundreds of commonly prescribed drugs into the urine, including protein-bound substances that cannot readily cross the glomerular basement membrane...
February 28, 2018: Clinical Journal of the American Society of Nephrology: CJASN
Ricardo H Alvarez, Rabih I Bechara, Michael J Naughton, Javier A Adachi, James M Reuben
Substantial improvements in the early detection and treatment of breast cancer have led to improvements in survival, but breast cancer remains a significant cause of morbidity and mortality in women. In 2012, the mammalian target of rapamycin (mTOR) inhibitor everolimus was approved by the U.S. Food and Drug Administration for the treatment of advanced breast cancer in patients resistant to endocrine therapy. Although everolimus is generally well tolerated, mTOR inhibitor-associated pneumonitis is one of the most common adverse drug events leading to treatment discontinuation...
February 27, 2018: Oncologist
Sunil Taneja, Ajay Duseja, Arka De, Manu Mehta, Raja Ramachandran, Vivek Kumar, Harbir Singh Kohli, Krishan Lal Gupta, Radha Krishan Dhiman, Yogesh Chawla
BACKGROUND AND AIMS: There is sparse data on the use of Sofosbuvir based directly acting antiviral (DAA) drug regimens in chronic hepatitis C (CHC) patients with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 . We evaluated the safety and efficacy of low-dose Sofosbuvir plus full-dose Daclatasvir in CHC patients with CKD. METHODS: Sixty-five CHC patients with CKD with eGFR less than 30 mL/min/1.73 m2 [54 (83%) patients with ESRD on hemodialysis] were included...
February 26, 2018: Digestive Diseases and Sciences
Loredana Colla, Davide Diena, Maura Rossetti, Ana Maria Manzione, Luca Marozio, Chiara Benedetto, Luigi Biancone
Care of pregnant woman, including fertility and procreation counseling, has become a significant part of the nephrological practice in the last years. In this context, the management of immunosuppression assumes a primary role both for autoimmune diseases and for post-transplant follow up. The present review analyzes the latest evidence on immunosuppressive drugs of current use in nephrology and kidney transplantation. Although the placenta inactivates prednisone and prednisolone, it is advisable to limit the dose to the minimal effective one, to prevent side effects...
February 23, 2018: Journal of Nephrology
G Sakalauskienė, G Civinskienė, A Antuševas, P Civinskas
Edematous states caused by an excessesive extracellular fluid retention are major components of cardiovascular and renal disorders including chronic kidney disease, nephrotic syndrome, and heart failure. The use of diuretic drugs from various groups including loop duiretics are important means of pharmacological correction of these clinical conditions. Moreover, diuretics used to lower bood pressure as a part of antihypertensive treatment, reduce cardiovascular events. The response of patients to the dose of a diuretic is reflected by a sigmoid dose-response curve which can be affected by changes of sodium content in the body...
January 2018: Kardiologiia
Ella J Ariza-Heredia, Roy F Chemaly, Lokesh R Shahani, Ying Jang, Richard Champlin, Victor E Mulanovich
Acyclovir is commonly used to prevent and treat herpes simplex virus (HSV) reactivation after hematopoietic cell transplant (HCT), and only few reports have been published on acyclovir-resistant HSV in HCT recipients. We reviewed the medical records of patients with a microbiologic diagnosis of acyclovir-resistant HSV by plaque reduction test who received an HCT from 2002 through 2014. A total of 4028 HCTs were performed during the study period, and 18 of the recipients met the diagnostic criteria for acyclovir-resistant HSV...
February 21, 2018: Transplant International: Official Journal of the European Society for Organ Transplantation
Stephen P McAdoo, Nicholas Medjeral-Thomas, Seerapani Gopaluni, Anisha Tanna, Nicholas Mansfield, Jack Galliford, Megan Griffith, Jeremy Levy, Thomas D Cairns, David Jayne, Alan D Salama, Charles D Pusey
Background: Current guidelines advise that rituximab or cyclophosphamide should be used for the treatment of organ-threatening disease in anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV), although few studies have examined the efficacy and safety of these agents in combination. Methods: We conducted a single-centre cohort study of 66 patients treated with a combination of oral corticosteroids, rituximab and low-dose pulsed intravenous cyclophosphamide followed by a maintenance regimen of azathioprine and tapered steroid for the treatment of biopsy-proven renal involvement in AAV...
February 14, 2018: Nephrology, Dialysis, Transplantation
Ruijuan Xu, Weihong Ge, Qing Jiang
PURPOSE: Rivaroxaban is a direct oral anticoagulant with a large inter-individual variability. The present study is to develop a physiologically based pharmacokinetic (PBPK) model to predict several scenarios in clinical practice. METHODS: A whole-body PBPK model for rivaroxaban, which is metabolized by the cytochrome P450 (CYP) 3A4/5, 2J2 pathways and excreted via kidneys, was developed to predict the pharmacokinetics at different doses in healthy subjects and patients with hepatic or renal dysfunction...
February 17, 2018: European Journal of Clinical Pharmacology
Kristen B McCullough, Miriam A Hobbs, Jithma P Abeykoon, Prashant Kapoor
PURPOSE OF REVIEW: The purpose of this review was to evaluate management strategies for common adverse effects of novel therapies in multiple myeloma (MM), including immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, and a histone deacetylase inhibitor. RECENT FINDINGS: There are several adverse effects that occur across multiple classes of antimyeloma drugs, including rash, peripheral neuropathy, infusion reactions, and cardiotoxicity, but most can be managed without complete discontinuation of the agent or abandonment of the class...
February 15, 2018: Current Hematologic Malignancy Reports
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