Search results for "Adverse effect"
showing 10 items of 1065 documents
1443Safety of red yeast rice supplementation: a systematic review and meta-analysis of randomized controlled trials
2019
Abstract Background Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Purpose Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve the lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Methods Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in asso…
OZONE THERAPY: TERATOGENIC STUDY OF OZONE. POSSIBLE INDICATIONS IN OBSTETRICS AND GYNECOLOGY
2018
Ozone is a powerful oxidant, surpassed, in this regard, only by fluorine. Its doubtless strong reactivity has contributed to establish the dogma that ozone is always toxic and its medical application must be proscribed. However, ozone therapy has been used for therapeutic purposes since the beginning of the last century and its use is increasingly demanded nowadays. For proper enlightenment and guidance of the person interested in the use of ozone for medical purposes, scientific documentation on the safety/toxicity profile of this acclaimed procedure becomes necessary. Taking into account that the National Health Regulatory Agencies require of documentation with scientific trials for sanit…
Safety and Outcome of Revascularization Treatment in Patients With Acute Ischemic Stroke and COVID-19: The Global COVID-19 Stroke Registry.
2023
Background and ObjectivesCOVID-19–related inflammation, endothelial dysfunction, and coagulopathy may increase the bleeding risk and lower the efficacy of revascularization treatments in patients with acute ischemic stroke (AIS). We aimed to evaluate the safety and outcomes of revascularization treatments in patients with AIS and COVID-19.MethodsThis was a retrospective multicenter cohort study of consecutive patients with AIS receiving intravenous thrombolysis (IVT) and/or endovascular treatment (EVT) between March 2020 and June 2021 tested for severe acute respiratory syndrome coronavirus 2 infection. With a doubly robust model combining propensity score weighting and multivariate regress…
Perioperative and anesthetic deaths: toxicological and medico legal aspects
2019
Abstract Background Anesthesia has become safer during decades, though there is still a preventable mortality; the complexity of medical and surgical interventions, increasingly older and sicker patients, has created a host of new hazards in anesthesiology. In this paper, some of these perioperative (PO) fatal adverse events are investigated in terms of health responsibility. Selective literature research in several data bases, concerning perioperative and anesthetic deaths and medical responsibility, was performed. Main text A generally accepted definition of the anesthesia and perioperatory-related death still remains one of the major concerns in forensic pathology, and the terms “operati…
A Prospective Open‐Label Observational Study of a Buffered Soluble 70 mg Alendronate Effervescent Tablet on Upper Gastrointestinal Safety and Medicat…
2021
Upper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (naïve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70 mg effervescent (ALN-EFF) tablet (Binosto®) and followed for 12 ± 3 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky-Green questi…
DI-032 Study of effectiveness and safety of foscarnet in cytomegalovirus treatment in haematopoietic stem cell transplantation recipients
2016
Background Cytomegalovirus disease is an important cause of morbidity and mortality in haematopoietic stem cell transplantation (HSCT) recipients. Foscarnet, an intravenous drug active against cytomegalovirus, represents an increasingly widespread alternative when there is resistance or intolerance to conventional treatments (ganciclovir/valganciclovir, acyclovir). More data about its use, effectiveness and safety in the clinical practice are necessary. Purpose To analyse the effectiveness and safety of the use of foscarnet against cytomegalovirus in HSCT recipients, and its adaptation to clinical practice guidelines and expert recommendations in order to optimise future treatment strategie…
Role of medical history and medication use in the aetiology of upper aerodigestive tract cancers in Europe: the ARCAGE study
2012
ABSTRACT Background The study aimed to investigate the role of medical history (skin warts, Candida albicans, herpetic lesions, heartburn, regurgitation) and medication use (for heartburn; for regurgitation; aspirin) in the aetiology of upper aerodigestive tract (UADT) cancer. Methods A multicentre (10 European countries) case–control study [Alcohol-Related CAncers and GEnetic susceptibility (ARCAGE) project]. Results There were 1779 cases of UADT cancer and 1993 controls. History of warts or C. albicans infection was associated with a reduced risk [odds ratio (OR) 0.80, 95% confidence interval (CI) 0.68–0.94 and OR 0.73, 95% CI 0.60–0.89, respectively] but there was no association with her…
Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohor…
2015
Background: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. Methods: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the i…
Association of maternal prenatal smoking GFI1-locus and cardio-metabolic phenotypes in 18,212 adults
2018
Background: DNA methylation at the GFI1-locus has been repeatedly associated with exposure to smoking from the foetal period onwards. We explored whether DNA methylation may be a mechanism that links exposure to maternal prenatal smoking with offspring's adult cardio-metabolic health.Methods: We meta-analysed the association between DNA methylation at GFI1-locus with maternal prenatal smoking, adult own smoking, and cardio-metabolic phenotypes in 22 population-based studies from Europe, Australia, and USA (n= 18,212). DNA methylation at the GFI1-locus was measured in whole-blood. Multivariable regression models were fitted to examine its association with exposure to prenatal and own adult s…
The dental management of patients at risk of medication-related osteonecrosis of the jaw: New paradigm of primary prevention
2018
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of antiresorptive and antiangiogenic agents; it is a potentially painful and debilitating condition that can considerably affect the quality of life of patients. Furthermore, even if its epidemiology and pathogenesis have still not been fully clarified, several risk factors related to MRONJ have been recognized in prevention protocols. Three main risk factors are as follows: (i) the type of ONJ-related medications: antiresorptive (e.g., Bisphosphonates, Denosumab) and antiangiogenic drugs (e.g., Bevacizumab, Sunitinib); (ii) the category of patient at MRONJ risk: cancer versus non-cancer patient; (iii) the typ…