Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: What a clinician should know on disproportionality analysis of spontaneous reporting systems

Sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently demonstrated a clinically significant reduction of cardiovascular mortality. However, their safety in clinical practice is still incompletely characterized, and post-marketing monitoring is required considering the expected increase in clinical use. Different analyses of international spontaneous reporting systems, known as disproportionality analyses (DAs), have highlighted the occurrence of ketoacidosis, amputations, acute renal failure and skin toxicity.
Source: Nutrition, Metabolism, and Cardiovascular Diseases : NMCD - Category: Nutrition Authors: Tags: Viewpoint Source Type: research

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Authors: Jha VK, Jairam A, Mahapatra D Abstract Oral anticoagulants are commonly prescribed in patients with kidney diseases having atrial fibrillation and thromboembolic risk. It is very important to understand their clinical pharmacology and changes that may occur as GFR declines. Risks and benefits of newer oral anticoagulants are different in patients with CKD and patients with ESRD. Patients with GFR
Source: Journal of the Association of Physicians of India - Category: General Medicine Tags: J Assoc Physicians India Source Type: research
CONCLUSIONS: The adaptation of the AAQ-II questionnaire to the HD context led to a valid and reliable measurement of PI in these types of patients and our results also seem to support the relationship between PI and health and quality of life parameters in patients with chronic conditions. PMID: 31791655 [PubMed - as supplied by publisher]
Source: Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia - Category: Urology & Nephrology Tags: Nefrologia Source Type: research
Publication date: Available online 4 December 2019Source: Revista Clínica Española (English Edition)Author(s): Á. Torralba-Morón, J.M. Guerra-Vales, F.J. Medrano-Ortega, M.A. Navarro-Puerto, D. Lora-Pablos, I. Marín-León, E. Calderón-Sandubete, A. Gómez-de la CámaraAbstractBackground and objectivesHeart failure (HF) is a frequent condition that deteriorates quality of life and results in high morbidity and mortality. A considerable number of studies have been implemented in recent years to determine the factors that affect the prognosis of HF; however, few stud...
Source: Revista Clinica Espanola - Category: Internal Medicine Source Type: research
We have recently demonstrated that amniotic fluid stem cells (AFSC) express renal progenitor markers and can be differentiated in vitro into renal lineage cell types, viz, juxtaglomerular and renal proximal tu...
Source: Stem Cell Research and Therapy - Category: Stem Cells Authors: Tags: Research Source Type: research
AbstractPurpose of ReviewTo examine several current issues in the management of patients undergoing orthotopic liver transplantation (OLT) with significant renal injury.Recent FindingsReview of the recent literature suggests that the actual cause of acute kidney injury (AKI) in cirrhotic patients undergoing OLT may significantly influence outcomes. Strategies such a simultaneous liver-kidney transplant (SLK) and intraoperative renal replacement therapy have been employed to achieve comparable results to either single organ transplant or those without pre-OLT AKI.SummaryWith the dramatic rise in acuity at the time of transp...
Source: Current Transplantation Reports - Category: Transplant Surgery Source Type: research
This study evaluated year ‐to‐year changes in treatment choices in a cohort of patients aged 66 or older in the Surveillance, Epidemiology, and End Results (SEER)‐Medicare registry diagnosed with MM between 2007 and 2011. We found that while the usage of PIs among elderly MM patients increased significantly replacing I MiD‐based regimens (with or without alkylating agents but not with PI) between 2007 and 2011, this significant shift did not increase the proportion of treated patients. AbstractThe landscape of treatment for  multiple myeloma (MM) has significantly changed over the last decade due to&...
Source: Cancer Medicine - Category: Cancer & Oncology Authors: Tags: ORIGINAL RESEARCH Source Type: research
ConclusionsDuring the first year of availability, the rate of prescription of PCSK9 inhibitors appears below expectations. Patients were mainly in secondary prevention and had been slightly persistent to previous LLTs. During follow-up, the PCSK9 inhibitor monotherapy showed high levels of adherence and persistence. This real-world study sets the stage for future longer-term investigations useful to improve our knowledge on the appropriateness, drug access and public healthcare sustainability of PCSK9 inhibitors.
Source: Clinical Drug Investigation - Category: Drugs & Pharmacology Source Type: research
The objective of this paper is to determine whether WRF in HF patients hospitalised for LVAD implantation is associated with increased 1-year mortality and to identify risk factors for WRF.
Source: Heart, Lung and Circulation - Category: Cardiology Authors: Tags: Original Article Source Type: research
AbstractAimsCathepsin D is a ubiquitous lysosomal protease that is primarily secreted due to oxidative stress. The role of circulating cathepsin D in heart failure (HF) is unknown. The aim of this study is to determine the association between circulating cathepsin D levels and clinical outcomes in patients with HF and to investigate the biological settings that induce the release of cathepsin D in HF.Methods and resultsCathepsin D levels were studied in 2174 patients with HF from the BIOSTAT ‐CHF index study. Results were validated in 1700 HF patients from the BIOSTAT‐CHF validation cohort. The primary combined outcome...
Source: European Journal of Heart Failure - Category: Cardiology Authors: Tags: Research Article Source Type: research
CONCLUSION: Acute pancreatitis is considered as one of the idiosyncratic adverse reactions to antiepileptic drugs. Previous reports were mainly on the pediatric patients with increased propensity to idiosyncratic drug effects, or the adult chronic renal failure patients with sodium valproate-induced pancreatitis due to the retention of intermediate metabolites in their bodies. In this study, even though our patient exhibited no high risk of developing pancreatitis, he was treated for drug-induced acute pancreatitis in three hospitals. As rare as drug-induced acute pancreatitis can be, it should not be overlooked, Moreover,...
Source: BMC Pharmacology and Toxicology - Category: Drugs & Pharmacology Tags: BMC Pharmacol Toxicol Source Type: research
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