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RCTs: Peginesatide in patients with anaemia and chronic kidney disease
Source: N Engl J Med Area: News In the New England Journal of Medicine, researchers report the results of four event-driven, randomised, controlled, open-label trials that compared the efficacy and safety of standard erythropoiesis-stimulating agent (ESA) therapy with peginesatide (Omontys), a peptide based ESA approved in the US in March 2012 for the treatment of anaemia caused by chronic kidney disease in adults who are undergoing dialysis.   The EMERALD 1 and EMERALD 2 studies involved patients undergoing haemodialysis. Cardiovascular safety was evaluated by analysis of an adjudicated composite safety end poin...
Source: NeLM - News - January 24, 2013 Category: Drugs & Pharmacology Source Type: news

Valacyclovir and Acyclovir Neurotoxicity With Status Epilepticus
We present the case of a 52-year-old man with hypertension, diastolic congestive heart failure, end-stage renal disease on hemodialysis 3 times a week and a remote history of a hemorrhagic stroke who presented to the emergency department with a vesicular rash on his left arm. The rash was observed to be in a dermatomal distribution, and a diagnosis of herpes zoster was made. The patient was discharged home on valacyclovir 1 g 3 times a day for a duration of 7 days. The patient took 2 doses of valacyclovir before presenting to the hospital again with irritability and hallucinations. Over the next several days, the patient's...
Source: American Journal of Therapeutics - January 1, 2016 Category: Drugs & Pharmacology Tags: Case Reports Source Type: research

Efficacy and Cardiovascular Safety of Roxadustat in Dialysis-Dependent Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies
ConclusionRoxadustat improved hemoglobin similarly to ESA while demonstrating comparable cardiovascular and overall safety profiles in a wide spectrum of dialysis-dependent patients with anemia of CKD. Roxadustat represents an oral alternative to ESAs for achieving a target hemoglobin for anemia of CKD in dialysis-dependent patients.
Source: Advances in Therapy - September 14, 2021 Category: Drugs & Pharmacology Source Type: research

Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies
ConclusionThere was no evidence of increased risk of cardiovascular events or mortality with roxadustat compared with ESA in patients with anemia who have NDD or ID-DD CKD. Although TEAEs occurred commonly in both the roxadustat and ESA groups, patients infrequently discontinued the study drug because of an adverse event.Clinical Trial Registration NumbersDOLOMITES, 1517-CL-0610 [NCT02021318]; HIMALAYAS, FGCL-4592-063 [NCT02052310]; SIERRAS, FGCL-4592-064 [NCT02273726]; and ROCKIES, D5740C00002 [NCT02174731].
Source: Advances in Therapy - February 7, 2023 Category: Drugs & Pharmacology Source Type: research