Rheumatological Immune-related Adverse Events of Checkpoints Inhibitors: a Narrative Review for the Latin American Rheumatologist

2021 ◽  
Author(s):  
Lilian Guadalupe Cano-Cruz ◽  
Ana Barrera-Vargas ◽  
Abigail Mateos-Soria ◽  
Enrique Soto-Perez-de-Celis ◽  
Javier Merayo-Chalico
Keyword(s):  
Adverse Events ◽  
Latin American ◽  
Narrative Review

scholarly journals Neurocognitive effects associated with proprotein convertase subtilisin-kexin type 9 inhibitor use: a narrative review

2021 ◽  
Vol 12 ◽  
pp. 204209862095927
Author(s):  
Wei C. Yuet ◽  
Didi Ebert ◽  
Michael Jann
Keyword(s):  
Cognitive Impairment ◽  
Adverse Events ◽  
The United States ◽  
Narrative Review ◽  
Lipid Lowering ◽  
Patient Specific ◽  
Proprotein Convertase ◽  
Pcsk9 Inhibitors ◽  
Pcsk9 Inhibitor ◽  
Receptor Modulation

Neurocognitive adverse events have been observed with the widespread use of 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors or “statins,” which reduce low-density lipoprotein cholesterol (LDL-C) levels and subsequently cardiovascular risk. The United States Food and Drug Association directed manufacturers of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors to monitor for neurocognitive adverse events due to their potent effects on LDL-C reduction, which is a proposed mechanism for neuronal cell dysfunction. Other proposed mechanisms for PCSK9 inhibitor-associated neurocognitive adverse events include N-methyl-d-aspartate receptor modulation, dysregulation of lipid and glucose metabolism, and patient-specific risk factors for cognitive impairment. The purpose of this narrative review article is to describe the proposed mechanisms, incidence of neurocognitive adverse events from phase II and III trials for PCSK9 inhibitors, neurocognitive assessments utilized in clinical trials, and clinical implications. Given the increasing prevalence of PCSK9 inhibitor use and the neurocognitive adverse events observed with prior lipid-lowering therapies, clinicians should be aware of the risks associated with PCSK9 inhibitors, especially when therapy is indicated for patients at high risk for cardiovascular events. Overall, the incidence of PCSK9 inhibitor-associated neurocognitive appears to be uncommon. However, additional prospective studies evaluating cognitive impairment may be beneficial to determine the long-term safety of these agents.

Managing adverse events after endoscopic ultrasound‐guided (EUS) drainage of the biliary tract and pancreatic fluid collections: a narrative review (with video)

2021 ◽  
Author(s):  
Mateus Pereira Funari ◽  
Igor Braga Ribeiro ◽  
Marcos Eduardo Lera dos Santos ◽  
Sergio Eiji Matuguma ◽  
Eduardo Guimarães Hourneaux de Moura
Keyword(s):  
Adverse Events ◽  
Biliary Tract ◽  
Endoscopic Ultrasound ◽  
Narrative Review ◽  
Ultrasound Guided ◽  
Pancreatic Fluid Collections ◽  
Pancreatic Fluid ◽  
Fluid Collections

scholarly journals SGLT2 inhibitors: a narrative review of efficacy and safety

2021 ◽  
Vol 121 (2) ◽  
pp. 229-239
Author(s):  
Donald S. Nelinson ◽  
Jose M. Sosa ◽  
Robert J. Chilton
Keyword(s):  
Adverse Events ◽  
Sglt2 Inhibitor ◽  
Sglt2 Inhibitors ◽  
Narrative Review ◽  
Atherosclerotic Cardiovascular Disease ◽  
Comorbid Conditions ◽  
Postprandial Plasma Glucose ◽  
Renal Outcomes ◽  
Glucose Levels ◽  
Wide Range

Abstract Type 2 diabetes mellitus (T2DM) is a cardio-renal-metabolic condition that is frequently associated with multiple comorbidities, including atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and chronic kidney disease (CKD). The sodium-glucose co-transporter-2 (SGLT2) inhibitors, which lower glycated hemoglobin, fasting and postprandial plasma glucose levels, body weight, and blood pressure, as well as reduce the risk of a range of cardiovascular and renal outcomes without increasing hypoglycaemic risk, have heralded a paradigm shift in the management of T2DM. These drugs are compatible with most other glucose-lowering agents and can be used in patients with a wide range of comorbid conditions, including ASCVD, HF, and CKD, and in those with estimated glomerular filtration rates as low as 30 mL/min/1.73 m2. However, there are misunderstandings surrounding the clinical implications of SGLT2 inhibitors’ mechanism of action and concerns about the key adverse events with which this class of drugs has been associated. This narrative review summarizes the data that support the efficacy of SGLT2 inhibitors in reducing the risks of cardiovascular and renal outcomes in patients with T2DM and comorbid conditions and clarifies information relating to SGLT2 inhibitor-related adverse events.

scholarly journals 5α-Reductase Inhibitors for Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 70 (2) ◽  
Author(s):  
Jennifer E J Jun ◽  
Angus Kinkade ◽  
Anthony C H Tung ◽  
Aaron M Tejani
Keyword(s):  
Adverse Events ◽  
Latin American ◽  
Acute Urinary Retention ◽  
Health Sciences ◽  
Prostatic Hyperplasia ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Rétention Urinaire ◽  
Number Of Patients ◽  
Latin American And Caribbean

<p><strong>ABSTRACT</strong></p><p><strong>Background:</strong> Finasteride and dutasteride are competitive inhibitors of 5a-reductase enzymes and are commonly used to treat symptomatic benign prostatic hyperplasia (BPH).</p><p><strong>Objective:</strong> To compare the efficacy and safety of finasteride and dutasteride in terms of clinically important outcomes.</p><p><strong>Data Sources:</strong> A literature search was performed using the search terms “prostatic hyperplasia”, “prostatic hypertrophy”, “dutasteride”, “finasteride”, “quality of life”, “adverse drug reaction”, and “mortality”. The Embase, PubMed, Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature databases were searched from inception to December 2015.</p><p><strong>Study Selection and Data Extraction:</strong> Randomized controlled trials, quasi-randomized trials, and systematic reviews comparing finasteride with dutasteride, either as monotherapy or in combination with a-blockers, for treatment of men with BPH were included. The outcomes of interest included need for prostate-related surgery, episodes of acute urinary retention, withdrawals due to adverse events, number of patients experiencing serious adverse events, mortality, and sexual dysfunction.</p><p><strong>Data Synthesis:</strong> Four studies involving a total of 1879 patients were included in the analysis. There were no significant differences in any of the clinically important outcomes examined: for prostate-related surgery, odds ratio (OR) 2.01 (95% confidence interval [CI] 0.18–22.24); for episodes of acute urinary retention, OR 1.47 (95% CI 0.68–3.19); for number of withdrawals due to adverse events, OR 1.10 (95% CI 0.68–1.75); for total number of patients experiencing adverse events, OR 0.94 (95% CI 0.78–1.14); for number of patients experiencing serious adverse events, OR 1.31 (95% CI 0.87–1.97); and for sexual dysfunction, OR 0.83 (95% CI 0.64–1.08).</p><p><strong>Conclusion:</strong> There is insufficient evidence to suggest that either finasteride or dutasteride offers an advantage in efficacy or safety over the other, in terms of clinically important outcomes.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte :</strong> Le finastéride et le dutastéride sont des inhibiteurs compétitifs de l’enzyme 5 alpha-réductase. Ils sont fréquemment employés comme traitement symptomatique de l’hyperplasie bénigne de la prostate (HBP).</p><p><strong>Objectif :</strong> Comparer l’efficacité et l’innocuité du finastéride et du dutastéride en ce qui concerne les résultats thérapeutiques cliniquement importants.</p><p><strong>Sources des données :</strong> Une recherche documentaire a été effectuée à l’aide des termes « hyperplasie de la prostate », « hypertrophie de la prostate », « dutastéride », « finastéride », « qualité de vie », « réaction indésirable aux médicaments » et « mortalité ». Les bases de données Embase, PubMed, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature et Latin American and Caribbean Health Sciences Literature ainsi que le Registre central Cochrane des essais comparatifs ont été interrogées pour la période allant de leur création à décembre 2015.</p><p><strong>Sélection des études et extraction des données :</strong> Les essais comparatifs à répartition aléatoire, les essais quasi-aléatoires et les analyses systématiques qui comparent le finastéride et le dutastéride, en monothérapie ou en association avec des a-bloquants, pour le traitement de la HBP chez l’homme, ont été retenus. Parmi les résultats d’intérêt, on comptait : la nécessité de recourir à une chirurgie de la prostate, les épisodes de rétention urinaire aiguë, les retraits de l’étude pour cause d’événements indésirables, le nombre total de patients ayant subi des événements indésirables graves, la mortalité et le dysfonctionnement sexuel.</p><p><strong>Synthèse des données :</strong> Quatre études comptant au total 1879 patients ont été retenues pour l’analyse. Aucune différence significative n’a été relevée en ce qui touche les résultats thérapeutiques cliniquement importants : la nécessité de recourir à une chirurgie de la prostate (risque relatif approché [RRA] de 2,01, intervalle de confiance [IC] à 95 % de 0,18 à 22,24), les épisodes de rétention urinaire aiguë (RRA de 1,47, IC à 95 % de 0,68 à 3,19), le nombre de retraits de l’étude pour cause d’événements indésirables (RRA de 1,10, IC à 95 % de 0,68 à 1,75), le nombre total de patients ayant subi des événements indésirables (RRA de 0,94, IC à 95 % de 0,78 à 1,14); le nombre de patients ayant subi des événements indésirables graves (RRA de 1,31, IC à 95 % de 0,87 à 1,97) et le dysfonctionnement sexuel (RRA de 0,83, IC à 95 % de 0,64 à 1,08).</p><p><strong>Conclusion :</strong> Il n’y a pas suffisamment de données probantes pour croire que le finastéride ou le dutastéride offrent, l’un par rapport à l’autre, un avantage quant à l’efficacité ou à l’innocuité, en ce qui concerne les résultats thérapeutiques cliniquement importants.</p>

scholarly journals Risk Analysis for Patient Safety in Surgical Departments: Cross-Sectional Design Usefulness

2020 ◽  
Vol 17 (7) ◽  
pp. 2516
Author(s):  
Verónica Aranaz Ostáriz ◽  
María Teresa Gea Velázquez de Castro ◽  
Francisco López Rodríguez-Arias ◽  
José Lorenzo Valencia Martín ◽  
Carlos Aibar Remón ◽  
...  
Keyword(s):  
Patient Safety ◽  
Adverse Events ◽  
Latin American ◽  
Health Care Quality ◽  
Health Impact ◽  
Cross Sectional Study ◽  
Care Quality ◽  
Cross Sectional ◽  
Improve Health Care Quality ◽  
Health Organization

(1) Background: Identifying and measuring adverse events (AE) is a priority for patient safety, which allows us to define and prioritise areas for improvement and evaluate and develop solutions to improve health care quality. The aim of this work was to determine the prevalence of AEs in surgical and medical-surgical departments and to know the health impact of these AEs. (2) Methods: A cross-sectional study determining the prevalence of AEs in surgical and medical-surgical departments was conducted and a comparison was made among both clinical areas. A total of 5228 patients were admitted in 58 hospitals in Argentina, Colombia, Costa Rica, Mexico, and Peru, within the Latin American Study of Adverse Events (IBEAS), led by the Spanish Ministry of Health, the Pan American Health Organization, and the WHO Patient Safety programme. (3) Results: The global prevalence of AEs was 10.7%. However, the prevalence of AEs in surgical departments was 11.9%, while in medical-surgical departments it was 8.9%. The causes of these AEs were associated with surgical procedures (38.6%) and nosocomial infections (35.4%). About 60.6% of the AEs extended hospital stays by 30.7 days on average and 25.8% led to readmission with an average hospitalisation of 15 days. About 22.4% resulted in death, disability, or surgical reintervention. (4) Conclusions: Surgical departments were associated with a higher risk of experiencing AEs.

scholarly journals Sorafenib treatment by Child–Pugh score in Latin American patients with hepatocellular carcinoma

2020 ◽  
Vol 16 (31) ◽  
pp. 2511-2520
Author(s):  
Laura L de Guevara ◽  
Lucy Dagher ◽  
Vanessa MV Arruda ◽  
Keiko Nakajima ◽  
Masatoshi Kudo
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Latin American ◽  
Treatment Option ◽  
Real World ◽  
Safety Profile ◽  
Treatment Duration ◽  
Sorafenib Treatment ◽  
Safety And Efficacy ◽  
Grade 3

Aim: To evaluate sorafenib treatment in Latin American patients with unresectable hepatocellular carcinoma in the real-world GIDEON study. Patients & methods: Sorafenib administration, safety and efficacy were analyzed by Child–Pugh status. Results: Of 90 evaluable patients (37% Child–Pugh A, 46% Child–Pugh B and 3% Child–Pugh C at study entry), 97% started sorafenib at 800 mg/day. Patients with Child–Pugh B7 had the longest median treatment duration of sorafenib (33.1 weeks). Sorafenib-related adverse events occurred in 58% of patients with Child–Pugh A (21% grade 3/4) and 46% with Child–Pugh B (7% grade 3/4). Conclusion: Sorafenib had a similar safety profile across patients with Child–Pugh A and B and is a treatment option for both groups.

scholarly journals Preoperative nutritional factors and outcomes after radical cystectomy: A narrative review

2017 ◽  
Vol 11 (12) ◽  
pp. 419-24
Author(s):  
Janie Allaire ◽  
Tal Ben-Zvi ◽  
Benoît Lamarche ◽  
Karine Robitaille ◽  
Yves Fradet ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adverse Events ◽  
Nutritional Status ◽  
Radical Cystectomy ◽  
Mortality Risk ◽  
Prospective Studies ◽  
Intervention Studies ◽  
Narrative Review ◽  
Nutritional Factors ◽  
The Impact

Only a few nutritional factors have been identified to predict the risk of developing complications after radical cystectomy (RC). This narrative review delineates the current known effects of preoperative nutritional status factors in this context. The report highlights the heterogeneity between study methods and results. We determined that low albuminemia values increase mortality risk and overall complications. In addition, obesity tends to increase the risk of developing venous thromboembolism and adverse events. Additional prospective studies, using standardized methods to both define and report complications, should be conducted to strengthen the connections between preoperative nutritional status factors and post-RC complications. Furthermore, intervention studies testing the impact of strategies to improve nutritional status on the risk of complications after RC are also needed.

scholarly journals Evaluation of short-term safety of COVID-19 vaccines in patients with multiple sclerosis from Latin America

2021 ◽  
Vol 7 (4) ◽  
pp. 205521732110615
Author(s):  
Ricardo Alonso ◽  
Aníbal Chertcoff ◽  
Felisa del V Leguizamón ◽  
Lorna Galleguillos Goiry ◽  
Maria B Eizaguirre ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Latin American ◽  
Adenovirus Vector ◽  
Cross Sectional Study ◽  
Serious Adverse Events ◽  
Cross Sectional ◽  
Web Based ◽  
Patient Organizations ◽  
Latin American Countries

Background To date, there are no data available on the safety of COVID-19 vaccines in Latin American patients with Multiple Sclerosis (MS). Objective Characterize safety of COVID-19 vaccines in Latin American (LATAM) patients with Multiple Sclerosis (pwMS). Methods A cross-sectional study between February 1, 2021, and April 30, 2021. Individuals with MS from LATAM countries were invited to participate in a self-administered web-based survey, through MS patient organizations from the region. Results 393 vaccinated pwMS from 10 different Latin American countries were included. The vaccines administered were: inactivated virus vaccines (IVV) in 38.2% of patients, adenovirus vector vaccines (AdV) in 48.8% and mRNA vaccines 13%. All patients received at least one dose of any of the COVID-19 vaccines and 123 (31.3%) declared receiving a second dose. Mean (SD) age 41.5 (11.8) years, 82.4% female, MS disease duration: 8.4 (8.2) years. No serious adverse events were reported with any of the COVID-19 vaccines after either the first or second dose. A lower frequency of adverse events was found with IVV (22%) in comparison with AdV (46.4%) and mRNA (35.3%) ( p < 0.01). Five participants reported having an MS relapse after IVV first dose. Conclusion COVID-19 vaccines applied in LATAM proved safe for MS patients.

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