Medicina ClinicaPub Date : 2024-12-27Epub Date: 2024-10-16DOI: 10.1016/j.medcli.2024.07.021
Lucía Estévez Asensio, Montserrat García, Zoraida Verde Rello, Verónica Velasco-González, Ana M Fernández-Araque, María Sainz-Gil
{"title":"Drug-induced hyponatraemia and possible related signals: Analysis of 659 cases reported to the Spanish Pharmacovigilance System and disproportionality analysis.","authors":"Lucía Estévez Asensio, Montserrat García, Zoraida Verde Rello, Verónica Velasco-González, Ana M Fernández-Araque, María Sainz-Gil","doi":"10.1016/j.medcli.2024.07.021","DOIUrl":"10.1016/j.medcli.2024.07.021","url":null,"abstract":"<p><strong>Introduction: </strong>Hyponatraemia has negative effects on cognitive function and gait stability and is a risk factor for osteoporosis, falls, fractures and hospital mortality. Acute hyponatraemia can lead to neurological dysfunction due to cerebral oedema. Its rapid correction can also be fatal, leading to osmotic demyelination syndrome. For some antiepileptics, thiazides, benzodiazepines or antidepressants this reaction is widely described. Knowing which drugs are most likely to cause hyponatraemia will allow early detection and prevention of its complications, as well as individualising the prescription of these drugs according to the patient's characteristics.</p><p><strong>Objective: </strong>The main objectives are to identify potential new safety signals related to hyponatraemia and to analyse the cases of hyponatraemia reported to the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H).</p><p><strong>Method: </strong>A disproportionality and a descriptive analysis of individual case safety reports (ICSR) was performed in the SEFV-H database (FEDRA).</p><p><strong>Results: </strong>Six hundred and fifty-nine cases of suspected drug-induced hyponatraemia were found (0.6% of the total database). Over the 5 years period studied, there was a 57% increase in the number of hyponatraemia reports in Spain. Most of the reported cases were serious (93%). Patients were most often women (63.7%) and elderly (71.9%). The time to onset ranged from 1 to 7030 days (median, 79 days) and approximately 70% of the total occurred within the first year of treatment. Five hundred and forty-six patients (82.9%) showed complete recovery after the withdrawal of the suspected medicine. Diuretics (reported in 57.7% of the cases), antidepressants (in 25%), drugs acting on renin angiotensin system (in 24%) and antiepileptics (in 20.2%) were the most frequent involved drugs. Disproportionate reporting has been found for almost all the substances most frequently reported, higher for amiloride and oxcarbazepine. Regarding new safety signals, the Reporting Odds Ratio (ROR) (95% CI) was found to be statistically significant for valsartan [7.7 (5.1-11.5)], olmesartan [7.3 (4.7-11.1)], amlodipine [3.4 (2.1-5.4)], pregabalin [2.5 (1.4-4.5)], irbesartan [18.6 (9.6-35.9)], paliperidone [2.7 (1.3-5.7)], ritonavir [2.4 (1.1-5.5)], atosiban [29.7 (8.6-102.2)], melphalan [9.7 (3.5-26.8)] and clozapine [4.4 (1.6-11.8)]. These active ingredients do not include this reaction on their SPC and comply with the EMA criteria for a safety signals.</p><p><strong>Conclusion: </strong>There are increasing reports of drug-induced hyponatraemia. It can be serious and seems to most often affect women over 65 years of age who take more than 1 medication. The time to onset varies and can be very long, so patient monitoring should be continuous throughout treatment. Hydrochlorothiazide is the drug with the highest number of reported cases in our setting. In terms of disp","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":"600-608"},"PeriodicalIF":2.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142469865","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prediction model of hepatocellular carcinoma development in chronic hepatitis B virus infection in a Spanish cohort.","authors":"Paula Gavilán, Juan-Carlos Gavilán, Rocío Arnedo, Encarnación Clavijo, Isabel Viciana, José-Antonio González-Correa","doi":"10.1016/j.medcli.2024.07.022","DOIUrl":"10.1016/j.medcli.2024.07.022","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>To identify risk factors associated with the development of hepatocellular carcinoma (HCC) in an unselected cohort of patients with chronic B virus infection (CHB) in Spain. A predictive model was developed to assess the risk of HCC.</p><p><strong>Material and methods: </strong>A prospective open-cohort study recruited 446 unselected patients with chronic hepatitis B infection from two hospitals in Málaga (Spain). The follow-up time ranged from 0.5 to 31.5 years (mean: 13.8; SD: 9.5; median: 11.4 years). We used a Cox proportional hazard model to estimate the multivariable-adjusted hazard ratios of risk factors associated with the development of liver cancer and developed a clinical score, (HCCB score) to determine the risk of liver cancer, that categories patients into two risk levels for the development of HCC. We compared the diagnostic accuracy of our model with other previously published.</p><p><strong>Results: </strong>During the follow-up period, 4.80% of the patients developed liver cancer (21 out of 437), 0.33 cases per 100 patient-years. Multivariate Cox regression analysis revealed that age >45 years, male gender, hepatitis C coinfection, alkaline phosphatase >147IU/L, Child score >5 points, glucose >126mg/dL, and a viral load >4.3 log<sub>10</sub> IU/mL were independent risk factors. A risk score has been developed with a high predictive capacity for identifying patients at high risk of developing hepatocellular carcinoma. AUROC 0.87 (95% CI: 0.79-0.95).</p><p><strong>Conclusions: </strong>An HCCB score greater than 5.42 points identifies a subgroup of chronic hepatitis B patients at high risk of developing liver cancer, who could benefit from screening measures for the early diagnosis of HCC.</p>","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":"609-616"},"PeriodicalIF":2.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142469870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medicina ClinicaPub Date : 2024-12-10DOI: 10.1016/j.medcli.2024.10.021
Miguel A Pérez-Velasco, Julio Osuna-Sánchez, Mercedes Millán-Gómez, Michele Ricci, Almudena López-Sampalo, María-Rosa Bernal-López, Ricardo Gómez-Huelgas, Luis M Pérez-Belmonte
{"title":"In-hospital linagliptin for management simplification and hypoglycemia reduction in very old patients with type 2 diabetes.","authors":"Miguel A Pérez-Velasco, Julio Osuna-Sánchez, Mercedes Millán-Gómez, Michele Ricci, Almudena López-Sampalo, María-Rosa Bernal-López, Ricardo Gómez-Huelgas, Luis M Pérez-Belmonte","doi":"10.1016/j.medcli.2024.10.021","DOIUrl":"https://doi.org/10.1016/j.medcli.2024.10.021","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>The role of in-hospital dipeptidyl peptidase-4 inhibitors in very old patients has not been widely described. This work analyzes the simplification of in-hospital antihyperglycemic management (less insulin use) and reductions in hypoglycemia events using linagliptin in patients aged≥80 years with type 2 diabetes.</p><p><strong>Patients and methods: </strong>This real-world observational study included hospitalized patients≥80 years with type 2 diabetes treated with an antihyperglycemic protocol of either basal-bolus insulin or linagliptin between January 2016 and December 2023. A 1:1 propensity score matching analysis was performed.</p><p><strong>Results: </strong>Post-matching, 944 patients were included in each group. The total and basal insulin doses and number of daily injections were significantly lower in the linagliptin group than the basal-bolus insulin group with no differences in glycemic efficacy. Regarding safety, patients on the basal-bolus insulin regimen had more hypoglycemic events. The use of basal-bolus insulin regimen (odds ratio: 4.22; 95% confidence interval: 2.14-6.28; p<0.001), a higher total insulin dose (odds ratio: 3.55; 95% confidence interval: 2.02-5.36; p<0.001) and the number of insulin injections (odds ratio: 2.86; 95% confidence interval: 1.50-4.12; p=0.002) were associated with a greater risk of hypoglycemia. Other hypoglycemia risk factors were older age, moderate-severe functional dependence, moderate-severe dementia, polypharmacy, and complex health status.</p><p><strong>Conclusions: </strong>The linagliptin regimen simplified in-hospital antihyperglycemic management and reduced hypoglycemia events compared to basal-bolus insulin regimen in patients with type 2 diabetes aged≥80 years. Basal-bolus insulin use and clinical factors were associated with hypoglycemia. The linagliptin regimen could be considered as standard of care for older adult type 2 diabetes patients in the hospital setting.</p>","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medicina ClinicaPub Date : 2024-12-10DOI: 10.1016/j.medcli.2024.10.015
Julio C Salas-Alanís, Mauricio Salas-Garza, María G Moreno-Treviño, Ma G Treviño-Alanís, Gerardo Rivera-Silvac
{"title":"Black hairy tongue.","authors":"Julio C Salas-Alanís, Mauricio Salas-Garza, María G Moreno-Treviño, Ma G Treviño-Alanís, Gerardo Rivera-Silvac","doi":"10.1016/j.medcli.2024.10.015","DOIUrl":"https://doi.org/10.1016/j.medcli.2024.10.015","url":null,"abstract":"","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medicina ClinicaPub Date : 2024-12-10DOI: 10.1016/j.medcli.2024.10.014
José M Sala-Vivé Gallego, Laura Acevedo Ortiz, Xavier Galindo Ortegó
{"title":"Sudden hearing loss and vertigo following physical exercise.","authors":"José M Sala-Vivé Gallego, Laura Acevedo Ortiz, Xavier Galindo Ortegó","doi":"10.1016/j.medcli.2024.10.014","DOIUrl":"https://doi.org/10.1016/j.medcli.2024.10.014","url":null,"abstract":"","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medicina ClinicaPub Date : 2024-12-10DOI: 10.1016/j.medcli.2024.10.016
Andrea Ruberti, Luis Ortega-Paz, Salvatore Brugaletta
{"title":"Which patients need thromboprophylaxis for venous thromboembolism prevention after hospitalization due to COVID-19? A sub-analysis from the CV COVID-19 registry.","authors":"Andrea Ruberti, Luis Ortega-Paz, Salvatore Brugaletta","doi":"10.1016/j.medcli.2024.10.016","DOIUrl":"https://doi.org/10.1016/j.medcli.2024.10.016","url":null,"abstract":"","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medicina ClinicaPub Date : 2024-12-10DOI: 10.1016/j.medcli.2024.10.022
Alberto Elpidio Calvo-Elías, Manuel Méndez-Bailón, Francisco Javier Martín-Sánchez, Rubén Ángel Martín-Sánchez, Elpidio Calvo-Manuel, Prado Salamanca-Bautista, José Pérez-Silvestre, Manuel Montero-Pérez-Baquero
{"title":"Cardiovascular death in patients with acute heart failure in sinus rhythm: results from the RICA registry.","authors":"Alberto Elpidio Calvo-Elías, Manuel Méndez-Bailón, Francisco Javier Martín-Sánchez, Rubén Ángel Martín-Sánchez, Elpidio Calvo-Manuel, Prado Salamanca-Bautista, José Pérez-Silvestre, Manuel Montero-Pérez-Baquero","doi":"10.1016/j.medcli.2024.10.022","DOIUrl":"https://doi.org/10.1016/j.medcli.2024.10.022","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with heart failure in sinus rhythm may be at significant risk of major cardiovascular events, including cardiovascular death (CV death).</p><p><strong>Objective: </strong>To assess CV mortality at a one-year follow up of those patients with heart failure and sinus rhythm, according to LVEF subgroups.</p><p><strong>Methods: </strong>A prospective and multicentric study was conducted with patients in sinus rhythm included in the National Registry of Heart Failure. Firstly, a demographic, clinical and treatment analysis has been made comparing CV death. Secondly, a multivariate analysis of logistic regression was made including those CV death factors. Lastly, a Kaplan Meyer one year survival was made including LVEF.</p><p><strong>Results: </strong>Of all 2040 patients included 14,8% presented CV death. The mortality predictors were Barthel index (OR 0,987 (0,982-0,992) [p<0,001]), LVEF <40% (OR 1,514 (1,144-2,003) [p 0,003]) and Charlson index (OR 1,069 (1,016-1,124) [p 0,01]).</p><p><strong>Conclusion: </strong>According to our results CV death has been shown to be higher in those patients with reduced LVEF in sinus rhythm and worst score in Barthel index and Charlson scale.</p>","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medicina ClinicaPub Date : 2024-12-10DOI: 10.1016/j.medcli.2024.10.019
Míriam Carbó Díez, Gina Osorio Quispe, Lourdes Artajona García, Marie Anette Arce Marañón, Natalia Miota Hernández, Dora Sempertegui Gutiérrez, Milagrosa Perea Gainza, María Del Mar Ortega Romero
{"title":"Predictive factors of mortality in very old patients visited in Emergency Department and admitted for infection.","authors":"Míriam Carbó Díez, Gina Osorio Quispe, Lourdes Artajona García, Marie Anette Arce Marañón, Natalia Miota Hernández, Dora Sempertegui Gutiérrez, Milagrosa Perea Gainza, María Del Mar Ortega Romero","doi":"10.1016/j.medcli.2024.10.019","DOIUrl":"https://doi.org/10.1016/j.medcli.2024.10.019","url":null,"abstract":"<p><strong>Objective: </strong>To describe mortality predictive factors in patients 80years or older with infection who were visited at the emergency department and were admitted to hospital.</p><p><strong>Methods: </strong>Retrospective observational study. Patients ≥80years old who visited the emergency department (January 1st to December 31st, 2022), whose main diagnosis was infection and required admission, were included. Factors associated with mortality at the end of the episode were determined.</p><p><strong>Results: </strong>987 patients were included (mean age 87years, 53% women). Mortality at the end of the episode was 13% (n=127). Median survival of the series was 52days (95%CI: 44-60). The independent factors related to mortality were: age (HR: 1.07; 95%CI: 1.03-1.11; P<.001), frailty (Clinical Frailty Scale [CFS]) (HR: 1.51; 95%CI: 1.15-1.97; P=.003), qSOFA (HR: 1.35; 95%CI: 1.07-1.70; P=.01), SOFA (HR: 1.23; 95%CI: 1.15-1.38; P<.001), leukocyte count (HR: 1.04; 95%CI: 1.02-1.06; P<.001) and criteria for sepsis and/or septic shock (HR: 2.52; 95%CI: 1.63-3.87; P<.001). On the contrary, any type of microbiological isolation was associated with lower mortality (HR: 0.44; 95%CI: 0.29-0.64; P<.001).</p><p><strong>Conclusions: </strong>qSOFA and SOFA scores, the sepsis and septic shock criteria, as well as frailty are predictive factors of poor prognosis in very elderly patients who come to the emergency room due to infection. Knowing frailty would allow us to adapt the treatment and therapeutic effort to the patient's characteristics.</p>","PeriodicalId":18578,"journal":{"name":"Medicina Clinica","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}