Atrial fibrillation in patients treated with intravenous zoledronic or pamidronic acid: a pharmacoepidemiological study

2021 ◽  
Vol 184 (3) ◽  
pp. 441-448
Author(s):  
Luc Pijnenburg ◽  
Joe-Elie Salem ◽  
Bénédicte Lebrun-Vignes ◽  
Jean Sibilia ◽  
Rose-Marie Javier ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Zoledronic Acid ◽  
Pamidronic Acid ◽  
Real Life ◽  
World Health ◽  
Disproportionality Analysis ◽  
Pharmacoepidemiological Study ◽  
Systematic Analysis ◽  
The World ◽  
Pharmacovigilance Database

Objective Atrial fibrillation (AF) may be triggered by intravenous bisphosphonates (IVBPs) such as zoledronic acid or pamidronic acid. Our objective was to confirm the association between AF and IVBPs in a real-life large pharmacovigilance database. Design A systematic analysis of VigiBase, the World Health Organization's pharmacovigilance database. Methods Analysis of adverse events reported as ‘atrial fibrillation’ (according to the Medical Dictionary for Drug Regulatory Activities) associated with the use of zoledronic acid or pamidronic acid, in VigiBase, the World Health Organization's global Individual Case Safety Report (ICSR) database. All ICSRs reporting AF associated with zoledronic acid or pamidronic acid were included in a disproportionality analysis determining the lower end of the 95% credibility interval for the information component (IC025), showing a statistical association when >0. Results 530 ICSRs reporting on the association between AF and IVBPs were extracted. Bayesian disproportionality analysis detected a significant association between AF and use of zoledronic acid (IC025 = 1.83) and pamidronic acid (IC025 = 2.16). Further analysis of these ICSRs determined that AF was severe in 85.0% of cases and with a mortality of 17.7%. The risk of severe AF was increased (OR: 2.98 (95% CI: 1.17–7.57), P = 0.02) following zoledronic acid vs pamidronic acid, after adjustment for age and gender. Conclusions This is the first VigiBase pharmacoepidemiological study confirming the association between IVBPs and AF. Most AF were severe, with a high frequency of lethal outcome. The risk of severe AF was increased following zoledronic acid use compared to pamidronic acid, advocating for a cautious use of IVBPs.

scholarly journals Associations between osteoporosis and drug exposure: a post-marketing study of the World Health Organization pharmacovigilance database (VigiBase®)

Bone ◽  
2021 ◽  
pp. 116137
Author(s):  
Benjamin Batteux ◽  
Youssef Bennis ◽  
Sandra Bodeau ◽  
Kamel Masmoudi ◽  
Anne-Sophie Hurtel-Lemaire ◽  
...  
Keyword(s):  
World Health Organization ◽  
Drug Exposure ◽  
World Health ◽  
The World ◽  
Pharmacovigilance Database ◽  
Post Marketing ◽  
Health Organization

Abstract 12541: Features and Causes of Death of Patients With Atrial Fibrillation Seen in French Hospitals in 2012

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Laurent Fauchier ◽  
Adeline Samson ◽  
Gwendoline Chaize ◽  
Anne-Françoise Gaudin ◽  
Alexandre Vainchtock ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real Life ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Systematic Analysis ◽  
Disease States ◽  
Previous Diagnosis ◽  
Cause Of Deaths ◽  
Cv Disease ◽  
Causes Of Deaths

Introduction/Hypothesis: Atrial fibrillation (AF) has been associated with worse clinical outcomes in many cardiovascular (CV) disease states. There is a lack of data on real world specific causes of deaths in AF patients. The objective of this study was to provide features and causes of deaths of patients with AF seen in French hospitals. Methods: This French cohort study was based on the national hospitalization database (PMSI) covering hospital care for the entire population. All discharged dead patients in 2012 with a previous diagnosis of AF were identified. Cause of death was defined as the principal diagnosis of the last hospitalization stay. Thromboembolic risk scores (HAS-BLED, HEMORR2HAGES and ATRIA) and bleeding risk scores (CHADS2 and CHA2DS2-VASc) calculations were based on a 5-year look-back period of medical history. Results: In 2012, 533,044 AF patients were identified through the PMSI; among them 50,165 (9.4%) died in French hospitals. Deceased patients were older than patients discharged alive (82.3±9.3 vs. 78.0±11.4; p<0.001). They more often suffered from hypertension (73% vs. 70%), diabetes (27% vs. 24%), renal failure (39% vs. 23%), cancer (30% vs. 19%) and, liver failure (9% vs. 5%) (p<0.001 in all cases). Mean stroke and bleeding risk scores were significantly higher for dead patients: CHADS2 was 2.7±1.3 vs. 2.3±1.3 (p<0.001), CHA2DS2-VASc was 4.6±1.6 vs. 4.0±1.8 (p<0.001), HAS-BLED was 2.6±1.1 vs. 2.2±1.1 (p<0.001), HEMORR2HAGES was 3.0±1.4 vs. 2.3±1.5 (p<0.001) and ATRIA was 4.4±2.4 vs. 3.3±2.4 (p<0.001). Cardiovascular (CV)-related deaths represented 34% of all deaths, including heart failures (15.0%), strokes (8.5%), hemorrhages (1.4%) and, TIA/Systemic embolism (1.3%) (cf. Table1). Conclusions: In this systematic analysis of a real-life contemporary AF population, about 10% of deaths were related to stroke/TIA/SE. Despite CV events were a major cause of deaths; a greater part of deaths was related to non-CV causes.

Impact of the “French Levothyrox crisis” on signal detection in the World Health Organization pharmacovigilance database

2018 ◽  
Vol 27 (12) ◽  
pp. 1427-1428 ◽  
Author(s):  
Charles Khouri ◽  
Bruno Revol ◽  
Marion Lepelley ◽  
Michel Mallaret ◽  
Jean-Luc Cracowski
Keyword(s):  
Signal Detection ◽  
World Health Organization ◽  
World Health ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization

Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database

2020 ◽  
Author(s):  
Joachim Alexandre ◽  
Joe-Elie Salem ◽  
Javid Moslehi ◽  
Marion Sassier ◽  
Camille Ropert ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Anticancer Drugs ◽  
Kinase Inhibitors ◽  
Descriptive Analysis ◽  
Individual Case ◽  
World Health ◽  
European Medicines Agency ◽  
Individual Case Safety Report ◽  
Pharmacovigilance Database ◽  
Haematologic Malignancies

Abstract Aims The explosion of novel anticancer therapies has meant emergence of cardiotoxicity signals including atrial fibrillation (AF). Reliable data concerning the liability of anticancer drugs in inducing AF are scarce. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and AF. Methods and results A disproportionality analysis evaluating the multivariable-adjusted reporting odds ratios for AF with their 99.97% confidence intervals was performed for 176 U.S. Food and Drug Administration (FDA)- or European Medicines Agency (EMA)-labelled anticancer drugs in VigiBase®, followed by a descriptive analysis of AF cases for the anticancer drugs identified in VigiBase®. ClinicalTrial registration number: NCT03530215. A total of 11 757 AF cases associated with at least one anticancer drug were identified in VigiBase® of which 95.8% were deemed serious. Nineteen anticancer drugs were significantly associated with AF of which 14 (74%) are used in haematologic malignancies and 9 (45%) represented new AF associations not previously confirmed in literature including immunomodulating agents (lenalidomide, pomalidomide), several kinase inhibitors (nilotinib, ponatinib, midostaurin), antimetabolites (azacytidine, clofarabine), docetaxel (taxane), and obinutuzumab, an anti-CD20 monoclonal antibody. Conclusion Although cancer malignancy itself may generate AF, we identified 19 anticancer drugs significantly associated with a significant increase in AF over-reporting. This pharmacovigilance study provides evidence that anticancer drugs themselves could represent independent risk factors for AF development. Dedicated prospective clinical trials are now required to confirm these 19 associations. This list of suspected anticancer drugs should be known by physicians when confronted to AF in cancer patients, particularly in case of haematologic malignancies.

The world-wide burden of musculoskeletal diseases: a systematic analysis of the World Health Organization Burden of Diseases Database

2019 ◽  
Vol 78 (6) ◽  
pp. 844-848 ◽  
Author(s):  
Eden Sebbag ◽  
Renaud Felten ◽  
Flora Sagez ◽  
Jean Sibilia ◽  
Hervé Devilliers ◽  
...  
Keyword(s):  
Musculoskeletal Diseases ◽  
World Health ◽  
Years Of Life Lost ◽  
Future Health ◽  
Systematic Analysis ◽  
Median Proportion ◽  
Life Years ◽  
The World ◽  
Icd 10 ◽  
Health Organization

BackgroundMusculoskeletal (MSK) diseases are expected to have a growing impact worldwide.ObjectiveTo analyse the worldwide burden of MSK diseases from 2000 to 2015.MethodsDisability-adjusted life years (DALYs), which combines the years of life lost (YLLs) and the years lived with disability (YLDs), were extracted for 183 countries from the WHO Global Health Estimates Database. We analysed the median proportion of DALYS, YLLs and YLDs for MSK diseases (ICD-10: M00–M99) among the 23 WHO categories of diseases. Mixed models were built to assess temporal changes.ResultsWorldwide, the total number of MSK DALYs increased significantly from 80,225,634.6 in 2000 to 107,885,832.6 in 2015 (p < 0.001), with the total number of MSK YLDs increasing from 77,377,709.4 to 103,817,908.4 (p = 0.0008) and MSK diseases being the second cause of YLDs worldwide. YLLs due to MSK diseases increased from 2,847,925.2 to 4,067,924.2 (p = 0.03). In 2015, the median proportion of DALYs attributed to MSK diseases was 6.66% (IQR: 5.30 – 7.88) in Europe versus 4.66% (3.98 – 5.59) in the Americas (p < 0.0001 vs Europe), 4.17% (3.14 – 6.25) in Asia (p < 0.0001), 4.14% (2.65 – 5.57) in Oceania (p = 0.0008) and 1.33% (1.03 – 1.92) in Africa (p < 0.0001). We observed a significant correlation (r = 0.85, p < 0.0001) between the proportion of MSK DALYs and the gross domestic product per capita for the year 2015.ConclusionsThe burden of MSK diseases increased significantly between 2000 and 2015 and is high in Europe. These results are crucial to health professionals and policy makers to implement future health plan adjustments for MSK diseases.

scholarly journals Epidemiology of COVID-19: What have we learnt until now?

2021 ◽  
Vol 72 (3) ◽  
pp. 8-11
Author(s):  
Tatjana Pekmezović
Keyword(s):  
Herd Immunity ◽  
Real Life ◽  
Rapid Expansion ◽  
World Health ◽  
Unknown Etiology ◽  
Atypical Pneumonia ◽  
First Case ◽  
The World ◽  
Severity Of The Disease ◽  
Health Organization

The first case in the outbreak of atypical pneumonia of unknown etiology, later confirmed as disease caused by SARS-CoV-2, was described in Wuhan (China) on December 8, 2019. The rapid expansion of COVID-19 cases prompted the World Health Organization (WHO) to declare a global health emergency, and on March 11, 2020, COVID-19 was officially classified as a pandemic disease by the WHO. It is generally accepted that both genders and all ages in the population are susceptible to SARS-CoV-2 infection. Data from the real life also show difficulties in reaching the threshold of herd immunity. Thanks to the vaccination, some populations are approaching the theoretical threshold of immunity, but the spread of the virus is still difficult to stop. If we add to that the fact that we still do not know how long immunity lasts after the infection, the conclusion is that vaccination is unlikely to completely stop the spread of the virus, and that we must think about it. Vaccines certainly significantly reduce the hospitalization rate and mortality rate, and the assumption is that the virus will not disappear soon, but the severity of the disease and its fatality will be of marginal importance. The development of the epidemiological situation related to the COVID-19 is constantly changing and it significantly differs in various parts of the world, which is affected by differences in financial resources, health infrastructure and awareness of prevention and control of the COVID-19. Attempts are being made to make dynamically adjusted strategies in response to the COVID-19 pandemic, that is, the new normality.

scholarly journals EFFECT OF PROBLEM BASED INSTRUCTION (PBI) LEARNING METHOD ON BEHAVIOR PREVENTION OF HIV/AIDS PREVENTION IN ADOLESCENT

2018 ◽  
Vol 2 (02) ◽  
pp. 197-204
Author(s):  
Sri Sudarsih ◽  
Ade Ayu Putriananingrum
Keyword(s):  
Real Life ◽  
Wilcoxon Test ◽  
World Health ◽  
P Value ◽  
Health Crisis ◽  
Problem Solving Skills ◽  
The World ◽  
Based Instruction ◽  
Prevention Of Hiv ◽  
Hiv Aids

HIV/AIDS is one of the health problems that concern the world today because of the increase in patient population causing health crisis in the world. The highest number of AIDS cases according to the World Health Organization (WHO) indicates that people are infected while still in middle adolescence stage. Teens need to be provided with Problem Based Instruction (PBI) method, because PBI can improve knowledge and creativity. This study aims to determine the effect of Problem Based Instruction (PBI) learning methods on prevention behavior of HIV/AIDS in adolescents. The research design used pre-experimental pre-test post-test one group design. The population is all adolescents class VIII in SMP Negeri 1 Mojoanyar Mojokerto regency as many as 180 people with a sample of 36 people using cluster random sampling technique. The results of this study indicate that there is a change of negative behavior before given Problem Based Instruction Learning (72,2%) turns into positive after given Learning Problem Based Instruction (61,1%). Wilcoxon test analysis results show that P value <α so that H1 accepted, meaning there is influence of Problem Based Instruction Learning to behavior prevention of HIV / AIDS transmission in adolescent. PBIs are developed to help students develop thinking and problem-solving skills, through engagement in real-life experiences and become autonomous and self-reliant learners. Schools working together with health workers are expected to create large posters or billboards about the prevention of HIV / AIDS transmission with attractive design to make it easier for students to read.

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