Developing alerting thresholds for prospective drug safety monitoring.

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

authors： Alves C,Batel-Marques F,Macedo AF

更新日期：2012-01-01 00:00:00

abstract：PURPOSE:Administration of pegylated interferon-alpha (IFN-alpha) and ribavirin in adults with chronic hepatitis C (CHC) is a recommended therapeutic standard. Nevertheless, this therapeutic regimen rises numerous controversies. The aim of this study was to analyze adverse effects during the treatment with pegylated IFN...

journal_title：Pharmacoepidemiology and drug safety

authors： Kowala-Piaskowska A,Mozer-Lisewska I,Figlerowicz M,Słuzewski W

更新日期：2007-10-01 00:00:00

abstract：PURPOSE:We evaluated national outpatient antimicrobial prescription trends in relation to the first United States case of inhalational anthrax due to the intentional delivery of Bacillus anthracis (B. anthracis) spores. METHODS:We queried IMS HEALTH's National Prescription Audit Plus7 database for two 6-month periods ...

journal_title：Pharmacoepidemiology and drug safety

authors： Shaffer D,Armstrong G,Higgins K,Honig P,Coyne P,Boxwell D,Beitz J,Leissa B,Murphy D

更新日期：2003-04-01 00:00:00

abstract：BACKGROUND:High-grade cervical dysplasia or cervical intraepithelial neoplasia grade 2 or worse has been widely used as a surrogate endpoint in cervical cancer screening or prevention trials. METHODS:To identify high-grade cervical dysplasia and cervical cancer, we developed claims-based algorithms that incorporated a...

journal_title：Pharmacoepidemiology and drug safety

authors： Kim SC,Gillet VG,Feldman S,Lii H,Toh S,Brown JS,Katz JN,Solomon DH,Schneeweiss S

更新日期：2013-11-01 00:00:00

abstract：PURPOSE:To describe a bias that can occur in the analysis of data from certain randomized trials. METHODS AND RESULTS:Although randomized trials are effective at preventing confounding, a potentially strong confounding can arise in certain therapeutic drug trials in which follow-up is extended in an open-label phase t...

journal_title：Pharmacoepidemiology and drug safety

authors： Rothman KJ

更新日期：2004-05-01 00:00:00

abstract：PURPOSE:The decision whether to continue antidepressant use for depression during pregnancy requires weighing maternal and child risks and benefits. Little is known about the effectiveness of antidepressant therapy during pregnancy. The goal of this study is to evaluate whether standard administrative claims data can b...

journal_title：Pharmacoepidemiology and drug safety

authors： Swanson SA,Hernandez-Diaz S,Palmsten K,Mogun H,Olfson M,Huybrechts KF

更新日期：2015-09-01 00:00:00

abstract：PURPOSE:An increasing consumption of opioids in the general population has been reported in several countries also among pregnant women. Limited information is available regarding the effect of prenatal exposure to analgesic opioids on long-term neurocognitive function in children. The primary aim of the study was to d...

journal_title：Pharmacoepidemiology and drug safety

authors： Skovlund E,Handal M,Selmer R,Brandlistuen RE,Skurtveit S

更新日期：2017-06-01 00:00:00

abstract：PURPOSE:The aim of this study was to examine trends in potentially inappropriate medication (PIM) prescribing in Norwegian nursing homes. METHODS:Patients aged ≥70 years were included from three cross-sectional studies conducted in 1997, 2005 and 2011. PIMs were analyzed according to the Norwegian General Practice-Nur...

journal_title：Pharmacoepidemiology and drug safety

authors： Halvorsen KH,Selbaek G,Ruths S

更新日期：2017-02-01 00:00:00

abstract：PURPOSE:Stimulant medications used for treating attention deficit hyperactivity disorder (ADHD) can be associated with an increased risk of seizures. Atomoxetine is a non-stimulant medication approved for treating ADHD. This retrospective cohort analysis evaluated risk of seizures among pediatric patients naïve to ADHD...

journal_title：Pharmacoepidemiology and drug safety

authors： McAfee AT,Landon J,Jones M,Bangs ME,Acharya N,Hornbuckle K,Wong J

更新日期：2013-04-01 00:00:00

abstract：PURPOSE:Use of albumin (indications and quantities involved) has not been assessed in France since major changes occurred after the publication of Cochrane group meta-analysis. The objectives of this study were to measure the repartition of albumin indications in three French university hospitals in 2004 and to assess ...

journal_title：Pharmacoepidemiology and drug safety

authors： Pradel V,Tardieu S,Micallef J,Signoret A,Villano P,Gauthier L,Vanelle P,Blin O,Albumin Study Group.

更新日期：2007-01-01 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

authors： Leonard CE,Freeman CP,Newcomb CW,Reese PP,Herlim M,Bilker WB,Hennessy S,Strom BL

更新日期：2012-11-01 00:00:00

abstract：PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...

journal_title：Pharmacoepidemiology and drug safety

authors： Requena G,Wolf A,Williams R,Dedman D,Quint JK,Murray-Thomas T,Pimenta JM

更新日期：2020-12-27 00:00:00

abstract：PURPOSE:To measure changes in drug utilisation following a national general practice education program aimed at improving prescribing for hypertension. METHODS:A series of nationally implemented, multifaceted educational interventions using social marketing principles focusing on prescribing for hypertension, was comm...

journal_title：Pharmacoepidemiology and drug safety

authors： Horn FE,Mandryk JA,Mackson JM,Wutzke SE,Weekes LM,Hyndman RJ

更新日期：2007-03-01 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

authors： Ungar W

更新日期：1997-11-01 00:00:00

abstract：PURPOSE:Quantitative benefit-risk (B-R) assessments are used to characterize treatment by combining key benefits and risks into a single metric but have historically been done for the "average" patient. Our aim was to conduct an individualized assessment for the oral antiplatelet vorapaxar by combining trial and real-w...

journal_title：Pharmacoepidemiology and drug safety

authors： Pinto CA,Tervonen T,Marsh K,Lambrelli D,Schultze A,Tershakovec A,Hyacinthe J,Prawitz T,Hammad TA

更新日期：2019-04-01 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

authors： Brown JS,Kulldorff M,Chan KA,Davis RL,Graham D,Pettus PT,Andrade SE,Raebel MA,Herrinton L,Roblin D,Boudreau D,Smith D,Gurwitz JH,Gunter MJ,Platt R

更新日期：2007-12-01 00:00:00

abstract：PURPOSE:We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveil...

journal_title：Pharmacoepidemiology and drug safety

authors： Curtis LH,Weiner MG,Boudreau DM,Cooper WO,Daniel GW,Nair VP,Raebel MA,Beaulieu NU,Rosofsky R,Woodworth TS,Brown JS

更新日期：2012-01-01 00:00:00

abstract：PURPOSE:During the past two decades, many novel immunosuppressive drugs have been approved for transplant recipients. Trends in the use of maintenance immunosuppressants after liver transplantation in Asia are unclear. Thus, we aimed to analyze the prescription trends in maintenance immunosuppressive drugs among liver ...

journal_title：Pharmacoepidemiology and drug safety

authors： Huang YY,Hsu CC,Chou CL,Loong CC,Wu MS,Chou YC

更新日期：2016-06-01 00:00:00

abstract：PURPOSE:Propensity scores are used in observational studies to adjust for confounding, although they do not provide control for confounders omitted from the propensity score model. We sought to determine if tests used to evaluate logistic model fit and discrimination would be helpful in detecting the omission of an imp...

journal_title：Pharmacoepidemiology and drug safety

authors： Weitzen S,Lapane KL,Toledano AY,Hume AL,Mor V

更新日期：2005-04-01 00:00:00

abstract：PURPOSE:To determine the validity of pregnancy variables recorded in administrative databases of Quebec using patient medical charts as the gold standard among asthmatic pregnant women. METHODS:Three administrative databases were linked and provided information on maternal, pregnancy and infant characteristics for 726...

journal_title：Pharmacoepidemiology and drug safety

authors： Vilain A,Otis S,Forget A,Blais L

更新日期：2008-04-01 00:00:00

abstract：BACKGROUND:Previous reports have suggested that new evidence of the comparative effectiveness of different medication classes from randomized controlled trials (RCTs) does not always alter treatment decisions for first-line anti-hypertensive therapy. OBJECTIVES:To evaluate the association of RCT evidence in December 2...

journal_title：Pharmacoepidemiology and drug safety

authors： Delaney JA,McClelland RL,Furberg CD,Cooper R,Shea S,Burke G,Psaty BM

更新日期：2009-09-01 00:00:00

abstract：PURPOSE:Pre-licensure studies have limited ability to detect rare adverse events (AEs) to vaccines, requiring timely post-licensure studies. With the increasing availability of electronic health records (EHR) near real-time vaccine safety surveillance using these data has emerged as an option. We reviewed methods curre...

journal_title：Pharmacoepidemiology and drug safety

authors： Leite A,Andrews NJ,Thomas SL

更新日期：2016-03-01 00:00:00

abstract：BACKGROUND/AIM:The number of patients receiving amiodarone will increase in future years. As clinically significant hepatotoxicity associated with oral amiodarone is infrequent and difficult to predict, a new Bayesian-developed model is proposed to help in the causality assessment of amiodarone-induced liver injury. M...

journal_title：Pharmacoepidemiology and drug safety

authors： Llanos L,Moreu R,Peiró AM,Pascual S,Francés R,Such J,Horga JF,Pérez-Mateo M,Zapater P

更新日期：2009-04-01 00:00:00

abstract：PURPOSE:Although sales of prescribed and over-the-counter (OTC) medication are rising, little is known about individual drug intake. This study was aimed to obtain complementary information about drug intake. METHOD:Information on drug utilization was obtained in a female cohort for five different time points (TP): 36...

journal_title：Pharmacoepidemiology and drug safety

authors： Hoeke H,Roeder S,Bertsche T,Borte M,von Bergen M,Wissenbach DK

更新日期：2016-04-01 00:00:00

abstract：PURPOSE:Complex medication management in older people with multiple chronic conditions can introduce practice variation in polypharmacy prevalence. This study aimed to determine the inter-practice variation in polypharmacy prevalence and examine how this variation was influenced by patient and practice characteristics....

journal_title：Pharmacoepidemiology and drug safety

authors： Sinnige J,Braspenning JC,Schellevis FG,Hek K,Stirbu I,Westert GP,Korevaar JC

更新日期：2016-09-01 00:00:00

abstract：:An information-theoretic definition of similarity proposed by Dekang Lin in 1998 appears to have attractive properties for identifying medically similar cases in a large database. Examination of similar cases that appear following vaccination may provide a way of detecting previously unexpected associations. A key ele...

journal_title：Pharmacoepidemiology and drug safety

authors： Walker AM

更新日期：2010-03-01 00:00:00

abstract：PURPOSE:This study mainly aimed at describing the prevalence of psychotropic medication consumption in the Spanish elderly population between the years 1993 and 2003. METHODS:Descriptive, cross-sectional study covering the Spanish population aged 65 years and over, using data drawn from the 1993 and 2003 Spanish Natio...

journal_title：Pharmacoepidemiology and drug safety

authors： Carrasco-Garrido P,Jiménez-García R,Astasio-Arbiza P,Ortega-Molina P,de Miguel AG

更新日期：2007-04-01 00:00:00

abstract：PURPOSE:This study compared the effectiveness of rosuvastatin (RSV) to other statins prescribed in clinical practice in prevention of cardiovascular (CV) events. METHODS:This longitudinal inception cohort study, using Thomson Healthcare's MarketScan databases, included patients aged > or = 18 starting statin therapy d...

journal_title：Pharmacoepidemiology and drug safety

authors： Motsko SP,Russmann S,Ming EE,Singh VP,Vendiola RM,Jones JK

更新日期：2009-12-01 00:00:00

abstract：:The General Practice Research Database (GPRD) is the world's largest computerized database of anonymized longitudinal patient records from general practice and is a unique public health research tool. Several issues have threatened the viability of the database in recent years; in April 1999 responsibility for its man...

journal_title：Pharmacoepidemiology and drug safety

authors： Wood L,Coulson R

更新日期：2001-08-01 00:00:00

abstract：PURPOSE:We conducted a nested case-control study to evaluate the association between risk of cancer and mirtazapine use in depression patients in Taiwan. METHODS:We obtained data from the Taiwan National Health Insurance Research Database to conduct a population-based nested case-control study. The study cohort includ...

journal_title：Pharmacoepidemiology and drug safety

authors： Sun LM,Lin MC,Liang JA,Chang YJ,Chang SN,Sung FC,Muo CH,Kao CH

更新日期：2013-12-01 00:00:00