The use of a large pharmacoepidemiological database to study exposure to oral corticosteroids and risk of fractures: validation of study population and results.

Abstract:

:Purpose - The objective of this study was an evaluation of the sensitivity of findings of the relationship between oral corticosteroid use and the risk of fracture. We found in earlier work that the risk of fracture was significantly higher during oral corticosteroid treatment, with increases of 61% in hip and 160% in vertebral fractures.Methods - Information was obtained from the General Practice Research Database which contains medical records of general practitioners in the UK. The study included 244,235 oral corticosteroid users and 244,235 controls.Results - The validation of fracture cases showed that the hip fractures, as recorded in the GPRD, were confirmed by the GP on the questionnaire in 90.7% of the cases and by discharge summary in 86.5%. The relative rate of non-vertebral fracture during oral corticosteroid use did not vary substantially between patients with different diseases, age, or gender. The sensitivity analysis, modifying the type of analysis or inclusion of patients, did not materially change the findings.Conclusions - We found a high level of validity of the GPRD with respect to hip and vertebral fractures. The sensitivity analysis indicated internal validity and consistency of the findings on fracture risks of oral corticosteroid therapy. Copyright (c) 2000 John Wiley & Sons, Ltd.

authors

Van Staa TP,Abenhaim L,Cooper C,Zhang B,Leufkens HG

doi

10.1002/1099-1557(200009/10)9:5<359::AID-PDS507>3.

subject

Has Abstract

pub_date

2000-09-01 00:00:00

pages

359-66

issue

5

eissn

1053-8569

issn

1099-1557

journal_volume

9

pub_type

杂志文章
  • Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans.

    abstract:PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4646

    authors: Hirota S,Yamaguchi T

    更新日期:2018-11-01 00:00:00

  • The risk of esophageal obstruction associated with an anti-allergy medication (Claritin-D 24-Hour--original formulation).

    abstract:PURPOSE:To investigate a possible increased risk of esophageal obstruction among users of loratadine and pseudoephedrine (Claritin-D 24-Hour [C-D 24], the original, round, extended-release formulation) compared to two other tablet formulations of loratadine. METHODS:Pharmacy data of 12 managed care plans were screened...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.816

    authors: Manda B,Drinkard CR,Shatin D,Graham DJ

    更新日期:2004-01-01 00:00:00

  • The knowledge, perceptions and practice of pharmacovigilance amongst community pharmacists in Lagos state, south west Nigeria.

    abstract:PURPOSE:Community Pharmacists both have an important responsibility in monitoring the ongoing safety of medicines and are widely accessible to do it. This study aims to investigate the knowledge, perceptions and practice of Pharmacovigilance amongst community pharmacists in Lagos State, South West Nigeria METHODS:A cr...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2021

    authors: Oreagba IA,Ogunleye OJ,Olayemi SO

    更新日期:2011-01-01 00:00:00

  • Hospital usage of antibacterial agents in relation to size and type of hospital and geographical situation.

    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

    authors: Blix HS,Hartug S

    更新日期:2005-09-01 00:00:00

  • Adverse drug reaction-related hospitalisations: a population-based cohort study.

    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

    authors: van der Hooft CS,Dieleman JP,Siemes C,Aarnoudse AJ,Verhamme KM,Stricker BH,Sturkenboom MC

    更新日期:2008-04-01 00:00:00

  • Evaluation of a program of integrated care to reduce recurrent osteoporotic fractures.

    abstract:PURPOSE:To evaluate the outcomes of patients participating in a program of integrated care for osteoporosis in terms of medication supply, fracture incidence and expenses. METHODS:Outcomes were assessed from secondary data provided by the AOK PLUS health insurance for 2455 participants of the program and the same numb...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3399

    authors: Goltz L,Degenhardt G,Maywald U,Kirch W,Schindler C

    更新日期:2013-03-01 00:00:00

  • Trends in antipsychotic prescriptions for Japanese outpatients during 2006-2012: a descriptive epidemiological study.

    abstract:PURPOSE:This study aimed to assess the trends in antipsychotic prescriptions for outpatients in Japan, where a community-based approach to mental healthcare is emphasized. METHODS:This descriptive epidemiological study used claims data from 1038 community pharmacies across Japan. Outpatients who were ≥18 years old and...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4187

    authors: Kochi K,Sato I,Nishiyama C,Tanaka-Mizuno S,Doi Y,Arai M,Fujii Y,Matsunaga T,Ogawa Y,Furukawa TA,Kawakami K

    更新日期:2017-06-01 00:00:00

  • Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.

    abstract:PURPOSE:Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS:Data were obtained ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2155

    authors: Qureshi ZP,Seoane-Vazquez E,Rodriguez-Monguio R,Stevenson KB,Szeinbach SL

    更新日期:2011-07-01 00:00:00

  • Proton pump inhibitors and traditional nonsteroidal anti-inflammatory drugs and the risk of acute interstitial nephritis and acute kidney injury.

    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

    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

  • Optimizing information on drug exposure by collection of package code information in questionnaire surveys.

    abstract:PURPOSE:The thorough analysis of special drug characteristics requires information on the specific brand of a drug. This information is often not sought in pharmacoepidemiologic surveys although in many countries packages are labelled with an unequivocal code (in Germany called Pharmazentralnummer (PZN)). We aimed to a...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1406

    authors: Quinzler R,Schmitt SP,Szecsenyi J,Haefeli WE

    更新日期:2007-09-01 00:00:00

  • Does use of tetracyclic antidepressant-mirtazapine reduce cancer risk in depression patients?

    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

    pub_type: 杂志文章

    doi:10.1002/pds.3523

    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

  • Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations.

    abstract:PURPOSE:To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability. METHODS:Eighty-four qual...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1754

    authors: Mazor KM,Sabin JE,Goff SL,Smith DH,Rolnick S,Roblin D,Raebel MA,Herrinton LJ,Gurwitz JH,Boudreau D,Meterko V,Dodd KS,Platt R

    更新日期:2009-07-01 00:00:00

  • Antidepressant drugs: prevalence, incidence and indication of use in general practice of Southern Italy during the years 2003-2004.

    abstract:PURPOSE:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1303

    authors: Trifirò G,Barbui C,Spina E,Moretti S,Tari M,Alacqua M,Caputi AP,UVEC group.,Arcoraci V

    更新日期:2007-05-01 00:00:00

  • Analysis of factors related to the occurrence of important drug-specific postmarketing safety-related regulatory actions: A cohort study focused on first-in-class drugs.

    abstract:PURPOSE:First-in-class (FIC) drugs with novel modes of action pose concerns regarding important postmarketing safety issues. The purpose of this study was to analyze the factors related to the occurrence of postmarketing safety-related regulatory actions (PSRAs) for drugs approved in the United States (US), with a focu...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4634

    authors: Ikeda J,Kaneko M,Narukawa M

    更新日期:2018-12-01 00:00:00

  • Using fractional polynomials to model the effect of cumulative duration of exposure on outcomes: applications to cohort and nested case-control designs.

    abstract:PURPOSE:Determining the nature of the relationship between cumulative duration of exposure to an agent and the hazard of an adverse outcome is an important issue in environmental and occupational epidemiology, public health and clinical medicine. The Cox proportional hazards regression model can incorporate time-depend...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3607

    authors: Austin PC,Park-Wyllie LY,Juurlink DN

    更新日期:2014-08-01 00:00:00

  • Adverse drug events among children presenting to a hospital emergency department in Newfoundland and Labrador, Canada.

    abstract:OBJECTIVES:The aim of this study was to examine epidemiologic characteristics of Adverse Drug Events (ADEs) among children and adolescents presenting to an Emergency Department (ED) in Newfoundland and Labrador (NL), Canada. MATERIALS AND METHODS:This study was conducted in three phases and included an ED chart review...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1900

    authors: Sikdar KC,Alaghehbandan R,Macdonald D,Barrett B,Collins KD,Gadag V

    更新日期:2010-02-01 00:00:00

  • Conducting pharmacoepidemiologic research in Denmark.

    abstract::Denmark has one of the worlds most comprehensive registration of its citizens' use of medical and social services. Most databases are population-based and of very high quality. Virtually all employ a mutual person identifier, which renders it technically possible to link any of them with others. There are two prescrip...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.638

    authors: Hallas J

    更新日期:2001-12-01 00:00:00

  • vigiRank for statistical signal detection in pharmacovigilance: First results from prospective real-world use.

    abstract:PURPOSE:vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggeste...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4247

    authors: Caster O,Sandberg L,Bergvall T,Watson S,Norén GN

    更新日期:2017-08-01 00:00:00

  • Modeling exposures of medications used episodically during pregnancy: Triptans as a motivating example.

    abstract:PURPOSE:To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using triptans for migraine as the motivating example. METHODS:We compared self-reported triptan use durin...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.5089

    authors: Harris GE,Wood M,Nordeng H

    更新日期:2020-09-01 00:00:00

  • Birth outcomes among women exposed to neuraminidase inhibitors during pregnancy.

    abstract:PURPOSE:To compare birth outcomes between women exposed and unexposed to the antiviral medications oseltamivir or zanamivir during pregnancy. METHODS:This was an observational cohort study including women who gave birth to singletons in Sweden 2005-2007 and their infants. We obtained information from the national heal...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2194

    authors: Svensson T,Granath F,Stephansson O,Kieler H

    更新日期:2011-10-01 00:00:00

  • Association between drug-specific indicators of prescribing quality and quality of drug treatment: a validation study.

    abstract:PURPOSE:To evaluate the concurrent validity of three European sets of drug-specific indicators of prescribing quality METHODS:In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was asses...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/pds.3827

    authors: Wallerstedt SM,Belfrage B,Fastbom J

    更新日期:2015-09-01 00:00:00

  • Psychosocial factors at the workplace--do they affect substance use? Evidence from the Tyrolean workplace study.

    abstract:BACKGROUND:To determine the prevalence of drug consumption and the impact of workplace demands and burdens for substance use, we conducted a survey in a representative sample of Tyrolean employees. METHODS:This analysis was restricted to the 700 respondents (395 male, 305 female; age 18-60 years) in the year 2001 by t...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.955

    authors: Traweger C,Kinzl JF,Traweger-Ravanelli B,Fiala M

    更新日期:2004-06-01 00:00:00

  • Feasibility of using Clinical Practice Research Datalink data to identify patients with chronic obstructive pulmonary disease to enrol into real-world trials.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.5188

    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

  • A potential bias in safety evaluation during open-label extensions of randomized clinical trials.

    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

    pub_type: 杂志文章

    doi:10.1002/pds.943

    authors: Rothman KJ

    更新日期:2004-05-01 00:00:00

  • Statins in the prevention of dementia and Alzheimer's disease: a meta-analysis of observational studies and an assessment of confounding.

    abstract:BACKGROUND:Studies demonstrate the potential for statins to prevent dementia and Alzheimer's disease (AD), but the evidence is inconclusive. OBJECTIVE:Conduct a meta-analysis to estimate any benefit of statins in preventing dementia and examine the potential effect of study design and confounding on the benefit of sta...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,meta分析

    doi:10.1002/pds.3381

    authors: Wong WB,Lin VW,Boudreau D,Devine EB

    更新日期:2013-04-01 00:00:00

  • Performance of a computable phenotype for identification of patients with diabetes within PCORnet: The Patient-Centered Clinical Research Network.

    abstract:PURPOSE:PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. METHODS:We adapted e...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4718

    authors: Wiese AD,Roumie CL,Buse JB,Guzman H,Bradford R,Zalimeni E,Knoepp P,Morris HL,Donahoo WT,Fanous N,Epstein BF,Katalenich BL,Ayala SG,Cook MM,Worley KJ,Bachmann KN,Grijalva CG,Rothman RL,Chakkalakal RJ

    更新日期:2019-05-01 00:00:00

  • A ranked presentation of the MHRA/CSM (Medicines & Health Care Regulatory Agency/Committee on Safety of Medicines) Drug Analysis Print (DAP) data on practolol.

    abstract:PURPOSE:To display a ranked presentation of the data given in the Drug Analysis Prints (DAPs) provided by the MHRA/CSM so that the monitoring clinician may be readily alerted to the most important findings. The practolol DAP is taken as an example of the presentation. METHOD:The data for the ranked system organ classe...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1144

    authors: Mann RD

    更新日期:2005-10-01 00:00:00

  • Prescribing quality for older people in Norwegian nursing homes and home nursing services using multidose dispensed drugs.

    abstract:PURPOSE:To examine and compare the quality of drug prescribing for older patients in nursing homes and home nursing services. METHODS:Cross-sectional study comprising 11,254 patients aged ≥ 65 years in nursing homes (n = 2986) and home nursing services (n = 8268). Potentially inappropriate medications were identified ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2232

    authors: Halvorsen KH,Granas AG,Engeland A,Ruths S

    更新日期:2012-09-01 00:00:00

  • Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy.

    abstract:PURPOSE:Because preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling must come from postapproval controlled observational studies. Common designs have included pregnancy registries and case-control studies. Recently, pregnancy cohort...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.4789

    authors: Huybrechts KF,Bateman BT,Hernández-Díaz S

    更新日期:2019-07-01 00:00:00

  • Increase in the duration of antidepressant treatment from 1994 to 2003: a nationwide population-based study from Finland.

    abstract:OBJECTIVE:We examined the length and continuity of antidepressant treatment and factors associated with long-term of treatment among adults. METHODS:Nationwide data from all reimbursed antidepressant prescriptions in 1994-2003 were linked with patients' data retrieved from Statistics Finland and the Finnish Hospital D...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2017

    authors: Sihvo S,Wahlbeck K,McCallum A,Sevon T,Arffman M,Haukka J,Keskimäki I,Hemminki E

    更新日期:2010-11-01 00:00:00