Abstract:
BACKGROUND:Deferasirox (DFX) is an effective and well-tolerated oral iron chelator elevating the adherence to iron chelating therapy among patients with iron overload. However, the US Food and Drug Administration issued a warning about the potential adverse events associated with DFX in 2010. METHODS:To examine the risks of gastrointestinal (GI) bleeding, acute liver necrosis, and acute renal failure among DFX users compared with desferrioxamine (DFO) users in a real-world setting, first-time users of DFX or DFO between 2005 and 2008 in Taiwan's National Health Insurance database were observed in this population-based retrospective cohort study. The risks of different adverse events were individually analyzed by Cox proportional hazards models and adjusted by age, sex, concomitant medications, and prior medical conditions. RESULTS:Deferasirox users had the highest incidence rates of GI bleeding (2.03 per 10 000 patient-days), acute liver necrosis (0.26 per 10 000 patient-days) and acute renal failure (1.45 per 10 000 patient-days) compared with other iron chelator users. Compared with DFO users, DFX users were not associated with the risk of GI bleeding (adjusted HR 1.03, 95% CI 0.61-1.74, p = 0.90) and the risk of acute liver necrosis (adjusted HR 2.13, 95% CI 0.49-9.33, p = 0.32). The association between DFX use and acute renal failure was found to be statistically significant (HR 2.18, 95% CI 1.18-4.02, p = 0.01; adjusted HR 2.41, 95% CI 1.27-4.58, p = 0.01). CONCLUSION:In this study, we found statistically significant higher risk of acute renal failure and non-statistically significant higher risk of GI bleeding and acute liver necrosis associated with DFX use. More researches are warranted to evaluate the association between DFX use and potential adverse events.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Huang WF,Chou HC,Tsai YW,Hsiao FYdoi
10.1002/pds.3657subject
Has Abstractpub_date
2014-11-01 00:00:00pages
1176-82issue
11eissn
1053-8569issn
1099-1557journal_volume
23pub_type
杂志文章abstract:PURPOSE:Meta-analysis is a quantitative approach to summarize the findings from several studies and has been applied with increasing frequency to clinical trials. Because of their sample size and duration limitations, experimental studies (ESs) could not be able to detect late or rare adverse events (AEs), which may be...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.2260
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:The Canadian Network for Observational Drug Effect Studies (CNODES), a network of pharmacoepidemiologists and other researchers from seven provincial sites, provides evidence on the benefits and risks of drugs used by Canadians. The Knowledge Translation Team, one of CNODES' four main teams, evaluates the impac...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4738
更新日期:2020-01-01 00:00:00
abstract:PURPOSE:Evidence is growing that early use of disease-modifying anti-rheumatic drugs (DMARDs) and combinations of these drugs provide optimal care for people with rheumatoid arthirits. The aim of this study was to describe objectively the pattern of consumption of DMARDs in the Australian community (community-based pre...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1256
更新日期:2006-07-01 00:00:00
abstract:PURPOSE:To assess the pattern of in-hospital changes in drug use in older patients from 2010 to 2016. METHODS:People aged 65 years or more acutely hospitalized in those internal medicine and geriatric wards that did continuously participate to the REgistro POliterapie Società Italiana di Medicina Interna register from...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4330
更新日期:2017-12-01 00:00:00
abstract:INTRODUCTION:Since the introduction of therapeutic risk management regulatory guidance, an increase in the number of risk minimization interventions (RMIs) published in the literature has been observed. Methods used to evaluate their effectiveness remain, however, poorly examined. OBJECTIVE:This paper aimed to conduct...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.3596
更新日期:2014-06-01 00:00:00
abstract::A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants spec...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.749
更新日期:2002-12-01 00:00:00
abstract:PURPOSE:Risk assessment for natural health products (NHPs) may not be evaluated similarly to therapeutic products by Health Canada in terms of notification of harms to consumers and health professionals. In this descriptive study, we evaluated risk communications (RCs) issued by Health Canada for NHPs and for therapeut...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2137
更新日期:2011-10-01 00:00:00
abstract:PURPOSE:This study aimed to evaluate the risks of upper gastrointestinal (GI) adverse events across a variety of oral and parenteral coxibs and nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in the general population of Taiwan. METHODS:In a case-crossover study, all patients aged ≥20 years who were hospi...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2140
更新日期:2011-07-01 00:00:00
abstract::Sixteen pathologically confirmed and 14 suspected cases of a new disease entity, fibrosing colonopathy, have been described in the UK and the US in children with cystic fibrosis since 1991. The patterns of use of pancreatic enzyme supplements in cases were compared with use in controls and in the market, in the 2 year...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199709/10)6:5<347::AID-PDS
更新日期:1997-09-01 00:00:00
abstract:PURPOSE:Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveil...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1509
更新日期:2007-12-01 00:00:00
abstract:BACKGROUND:Stimulants and atomoxetine should generally not be used or used only with caution in adults with pre-existing cardiovascular conditions. The extent to which pre-existing cardiovascular conditions influence initiation of these ADHD medications in adults is not known. METHODS:We performed a retrospective coho...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1931
更新日期:2010-05-01 00:00:00
abstract:PURPOSE:Breast cancer is the most common cancer in women worldwide. We attempted to investigate the association between the risk of breast cancer and use of captopril and other antihypertensive medication. METHODS:We performed a cohort study with a nested case-control analysis using the General Practitioner Research D...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.910
更新日期:2004-08-01 00:00:00
abstract:PURPOSE:Multimorbidity (MM) (presence of more than one chronic condition within a same patient) imposes a heavy burden on patients and health care systems. In contrast to high-income countries, the epidemiology of this phenomenon is unclear in low- and middle-income countries, particularly among Iranian population. ME...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4925
更新日期:2020-01-01 00:00:00
abstract::We review the concept of time-dependent confounding by using the example in paper "Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure" by Desai et al. and illustrate how to adjust for it by using inverse probability of treatment weighting t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 评论,杂志文章
doi:10.1002/pds.2306
更新日期:2012-03-01 00:00:00
abstract:OBJECTIVE:To assess the extent, characteristics and determinants of benzodiazepine prescription in outpatient Primary Health Care. METHODS:A clinical audit of a stratified random sample of Primary Health Care Centres in the seven islands and 1.6 million inhabitants region of 'Canarias' in Spain was carried out. From t...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199905/06)8:3<207::AID-PDS
更新日期:1999-05-01 00:00:00
abstract:PURPOSE:To evaluate whether the risk of coronary heart disease (CHD) differs among adult diabetic patients treated with thiazolidinediones (TZDs) and similar patients treated with combined oral metformin and sulfonylurea (M + S) therapy. METHODS:We conducted a retrospective cohort study involving 25 140 diabetic patie...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1356
更新日期:2007-05-01 00:00:00
abstract:PURPOSE:To assess the effect of moderate alcohol consumption on Adverse Drug Reactions (ADRs) among older adults admitted to acute care hospitals and to examine the consistency of this effect across gender and age groups. METHODS:We used the GIFA (Italian Group of Pharmacoepidemiology in the Elderly) database, which i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.721
更新日期:2002-07-01 00:00:00
abstract:INTRODUCTION:The analgesic metamizole (dipyrone) is not recommended during pregnancy due to limited experience. In several countries, metamizole has no market authorization because of agranulocytosis as a rare but severe adverse effect. However, in others, metamizole is available and widely used as a pain reliever, and...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4277
更新日期:2017-10-01 00:00:00
abstract:PURPOSE:To conduct a systematic review of current evidence regarding the use of health information technology (HIT) interventions to improve drug monitoring in ambulatory care. METHODS:We searched PubMed, CINAHL, the Cochrane Library, and other computerized databases from 1 January 1998 to 30 June 2008 using the key w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1831
更新日期:2009-12-01 00:00:00
abstract:PURPOSE:To examine the utility of electronic health records from a routine care setting in assessing comparative effectiveness of fourth-line anti-hypertensive drugs to treat resistant hypertension. METHODS:We conducted a cohort study using the Clinical Practice Research Datalink: a repository of electronic health rec...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4808
更新日期:2019-09-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the level of use and therapy profile of antibacterial agents in hospitals. Further to explore whether type, size or geographical situation influenced antibacterial agents used. METHODS:Antibacterial use during 1998-1999, in 13 hospitals, including emergency, referral...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1080
更新日期:2005-09-01 00:00:00
abstract:PURPOSE:Following safety concerns regarding trimetazidine, the European Medicines Agency (EMA) recommended restrictions on its use. Our objective was to determine the impact of regulatory actions on trimetazidine utilization in Portugal. METHODS:Retrospective interrupted time-series analysis of monthly ambulatory phar...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4585
更新日期:2018-09-01 00:00:00
abstract:PURPOSE:This study aims to examine the associations between proton pump inhibitors (PPIs), traditional nonsteroidal anti-inflammatory drugs (tNSAIDs), PPI + tNSAID co-exposure, and the development of the following: (i) acute interstitial nephritis (AIN), a specific kidney injury often attributed to these drugs, and (ii...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3329
更新日期:2012-11-01 00:00:00
abstract:PURPOSE:Prior event rate ratio (PERR) adjustment method has been proposed to control for unmeasured confounding. We aimed to assess the performance of the PERR method in realistic pharmacoepidemiological settings. METHODS:Simulation studies were performed with varying effects of prior events on the probability of subs...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3724
更新日期:2015-05-01 00:00:00
abstract::Pharmaceutical manufacturers are faced with the challenge of when and how to conduct pharmacoeconomic (PE) evaluations to satisfy formulary decision-makers. To illustrate the usefulness of decision analysis for strategic planning in drug development, a model was created to compare the cost-benefit of three PE design o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199711/12)6:6<399::AID-PDS
更新日期:1997-11-01 00:00:00
abstract:PURPOSE:To evaluate the extent, characteristics and determinants of adverse drug reaction (ADR)-related hospitalisations on a population-based level in 2003. METHODS:We performed a cohort study in the Integrated Primary Care Information (IPCI) database, a general practitioners (GPs) research database with longitudinal...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1565
更新日期:2008-04-01 00:00:00
abstract::The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable u...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1215
更新日期:2007-01-01 00:00:00
abstract:PURPOSE:To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France. METHODS:A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1002/pds.3471
更新日期:2013-09-01 00:00:00
abstract::Growth in health information systems presents opportunities to enhance postmarketing safety surveillance of medical products. Spontaneous suspected side effect reports provide the foundation, but we need to 'proactively' improve their quality and our strategies to seek signals. In our more familiar 'reactive' mode, we...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.587
更新日期:2001-05-01 00:00:00
abstract:PURPOSE:This study evaluated the safety of oseltamivir during the 2009 influenza pandemic. METHODS:Case reports were obtained from the Roche safety database. The incidence of adverse events (AEs) during the pandemic (1 May 2009 to 31 December 2009) was compared with that beforehand (during previous influenza seasons) ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2136
更新日期:2011-05-01 00:00:00