Pharmacoepidemiology and Drug Safety Journal Impact Factor & Information

Publisher: International Society for Pharmacoepidemiology; International Society of Pharmacovigilance, Wiley

Journal description

The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data methods and opinion in the emerging discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research invited reviews and a variety of guest editorials and commentaries embracing scientific medical statistical and legal aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Communication. Particular areas of interest include: design results analysis and interpretation of post-marketing surveillance and other studies looking at specific drugs populations and outcomes methods for detection and evaluation of drug-associated adverse events assessments of risk versus benefit ratios in drug therapy patterns of drug utilization relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines The Publishers recognize the need of journal users to access articles through a variety of channels and are committed to providing a wide range of options in the future. The Publishers are also aware that new communication media increase the threat to authors' own rights through unauthorized distribution alteration or attribution. To enable the Publishers to make the published version of articles available as widely as possible while protecting authors' rights to be associated with their work it is essential that a Copyright Transfer Agreement form is signed for every article which is to be considered for publication in the journal. The form can be photocopied from the journal or copies can be obtained on request from the Publisher or printed from this Web site. Inclusion of a signed form with the manuscript at the original submission stage will speed up processing and eventual publication of the article.

Current impact factor: 3.17

Impact Factor Rankings

2015 Impact Factor Available summer 2015
2013 / 2014 Impact Factor 3.172
2012 Impact Factor 2.897
2011 Impact Factor 2.528
2010 Impact Factor 2.339
2009 Impact Factor 2.527
2008 Impact Factor 2.516
2007 Impact Factor 2.475
2006 Impact Factor 2.155
2005 Impact Factor 1.773
2004 Impact Factor 2.098
2003 Impact Factor 1.257
2002 Impact Factor 1.092
2001 Impact Factor 1.33
2000 Impact Factor 0.867
1999 Impact Factor 0.848

Impact factor over time

Impact factor

Additional details

5-year impact 2.91
Cited half-life 4.70
Immediacy index 1.30
Eigenfactor 0.01
Article influence 1.06
Website Pharmacoepidemiology and Drug Safety website
Other titles Pharmacoepidemiology and drug safety (Online), Pharmacoepidemiology and drug safety
ISSN 1099-1557
OCLC 44084438
Material type Document, Periodical, Internet resource
Document type Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details


  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author cannot archive a post-print version
  • Restrictions
    • 12 months embargo
  • Conditions
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    • On author's personal website, institutional repositories, arXiv, AgEcon, PhilPapers, PubMed Central, RePEc or Social Science Research Network
    • Author's pre-print may not be updated with Publisher's Version/PDF
    • Author's pre-print must acknowledge acceptance for publication
    • On a non-profit server
    • Publisher's version/PDF cannot be used
    • Publisher source must be acknowledged with citation
    • Must link to publisher version with set statement (see policy)
    • If OnlineOpen is available, BBSRC, EPSRC, MRC, NERC and STFC authors, may self-archive after 12 months
    • If OnlineOpen is available, AHRC and ESRC authors, may self-archive after 24 months
    • Publisher last contacted on 07/08/2014
    • This policy is an exception to the default policies of 'Wiley'
  • Classification
    ​ yellow

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: The case-crossover (CXO) and self-controlled case series (SCCS) designs are increasingly used in pharmacoepidemiology. In both, relative risk estimates are obtained within persons, implicitly controlling for time-fixed confounding variables. To examine the consistency of relative risk estimates of hip/femur fractures (HFF) associated with the use of benzodiazepines (BZD) across case-only designs in two databases (DBs), when a common protocol was applied. CXO and SCCS studies were conducted in BIFAP (Spain) and CPRD (UK). Exposure to BZD was divided into non-use, current, recent and past use. For CXO, odds ratios (OR; 95%CI) of current use versus non-use/past were estimated using conditional logistic regression adjusted for co-medications (AOR). For the SCCS, conditional Poisson regression was used to estimate incidence rate ratios (IRR; 95%CI) of current use versus non/past-use, adjusted for age. To investigate possible event-exposure dependence the relative risk in the 30 days prior to first BZD exposure was also evaluated. In the CXO current use of BZD was associated with an increased risk of HFF in both DBs, AORBIFAP = 1.47 (1.29-1.67) and AORCPRD = 1.55 (1.41-1.70). In the SCCS, IRRs for current exposure was 0.79 (0.72-0.86) in BIFAP and 1.21 (1.13-1.30) in CPRD. However, when we considered separately the 30-day pre-exposure period, the IRR for current period was 1.43 (1.31-1.57) in BIFAP and 1.37 (1.27-1.47) in CPRD. CXO designs yielded consistent results across DBs, while initial SCCS analyses did not. Accounting for event-exposure dependence, estimates derived from SCCS were more consistent across DBs and designs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3822
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    ABSTRACT: We use simulations and an empirical example to evaluate the performance of disease risk score (DRS) matching compared with propensity score (PS) matching when controlling large numbers of covariates in settings involving newly introduced treatments. We simulated a dichotomous treatment, a dichotomous outcome, and 100 baseline covariates that included both continuous and dichotomous random variables. For the empirical example, we evaluated the comparative effectiveness of dabigatran versus warfarin in preventing combined ischemic stroke and all-cause mortality. We matched treatment groups on a historically estimated DRS and again on the PS. We controlled for a high-dimensional set of covariates using 20% and 1% samples of Medicare claims data from October 2010 through December 2012. In simulations, matching on the DRS versus the PS generally yielded matches for more treated individuals and improved precision of the effect estimate. For the empirical example, PS and DRS matching in the 20% sample resulted in similar hazard ratios (0.88 and 0.87) and standard errors (0.04 for both methods). In the 1% sample, PS matching resulted in matches for only 92.0% of the treated population and a hazard ratio and standard error of 0.89 and 0.19, respectively, while DRS matching resulted in matches for 98.5% and a hazard ratio and standard error of 0.85 and 0.16, respectively. When PS distributions are separated, DRS matching can improve the precision of effect estimates and allow researchers to evaluate the treatment effect in a larger proportion of the treated population. However, accurately modeling the DRS can be challenging compared with the PS. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3810
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    ABSTRACT: This study aims to develop and evaluate diagnostic algorithms for AIDS, hepatitis C status, alcohol abuse and illicit drug use in the administrative healthcare database of the Province of Quebec, Canada (Régie de l'assurance-maladie du Québec (RAMQ)). We selected HIV-positive patients contributing to both the RAMQ database and a local clinical database, which was used as gold standard. We developed algorithms to identify the diagnoses of interest in RAMQ using data from hospital discharge summaries and medical and pharmaceutical claims databases. We estimated and compared sensitivity, specificity, positive predictive and negative predictive values and area under receiver operating curve for each algorithm. Four hundred twenty patients contributed to both databases. Prevalence of conditions of interest in the clinical database was as follows: AIDS 233 (55%), hepatitis C infection 105 (25%), alcohol abuse 106 (25%), illicit drug use 144 (34%) and intravenous drug use 107 (25%). Sensitivity to detect AIDS, hepatitis C, alcohol abuse, illicit drug use and intravenous drug use was 46% [95%CI: 39-53], 26% [18-35], 50% [37-57], 64% [55-72] and 70% [61-79], respectively. Specificity to detect these conditions was 91% [86-95], 97% [94-98], 92% [88-95], 95% [92-97] and 90% [87-93], respectively. Positive predictive values were 87% [80-92], 71% [54-85], 68% [56-78], 87% [79-93] and 72% [62-80], respectively. Area under receiver operating curve varied from 0.62 [0.57-0.65] for hepatitis C to 0.80 [0.76-0.85] for intravenous drug use. Sensitivity was low to detect AIDS, alcohol abuse, illicit drug use and especially hepatitis C in RAMQ. Researchers must be aware of the potential for residual confounding and must consider additional methods to control for confounding. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3808
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    ABSTRACT: Results from observational studies may be inconsistent because of variations in methodological and clinical factors that may be intrinsically related to the database (DB) where the study is performed. The objectives of this paper were to evaluate the impact of applying a common study protocol to study benzodiazepines (BZDs) (anxiolytics, hypnotics, and related drugs) and the risk of hip/femur fracture (HFF) across three European primary care DBs and to investigate any resulting discrepancies. To measure the risk of HFF among adult users of BZDs during 2001-2009, three cohort and nested case control (NCC) studies were performed in Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) (Spain), Clinical Practice Research Datalink (CPRD) (UK), and Mondriaan (The Netherlands). Four different models (A-D) with increasing levels of adjustment were analyzed. The risk according to duration and type of BZD was also explored. Adjusted hazard ratios (cohort), odds ratios (NCC), and their 95% confidence intervals were estimated. Adjusted hazard ratios (Model C) were 1.34 (1.23-1.47) in BIFAP, 1.66 (1.54-1.78) in CPRD, and 2.22 (1.55-3.29) in Mondriaan in cohort studies. Adjusted odds ratios (Model C) were 1.28 (1.16-1.42) in BIFAP, 1.60 (1.49-1.72) in CPRD, and 1.48 (0.89-2.48) in Mondriaan in NCC studies. A short-term effect was suggested in Mondriaan, but not in CPRD or BIFAP. All DBs showed an increased risk with the concomitant use of anxiolytic and hypnotic drugs. Applying similar study methods to different populations and DBs showed an increased risk of HFF in BZDs users but differed in the magnitude of the risk, which may be because of inherent differences between DBs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3816
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    ABSTRACT: Recent evidence suggested that oral form of domperidone may possess pro-arrhythmic effects and increase the risk of ventricular arrhythmia. The concomitant use of cytochrome P450 (CYP) 3A4 isoenzyme inhibitors may further potentiate this association. Nevertheless, empirical data supporting these associations are very limited. The aim of this study was to investigate the association between oral domperidone, CYP 3A4 inhibitors, and ventricular arrhythmia. We identified 25 356 patients who were admitted or were seen in the emergency room for ventricular arrhythmia between 2000 and 2011 from Taiwan's Longitudinal Health Insurance Database. We adopted a case-crossover study design to compare the exposure to oral domperidone for the same patient within a "case period" and within a "control period". Conditional logistic regression models showed that domperidone use was significantly associated with an increased odds of ventricular arrhythmia (aOR 1.56, 95%CI [1.41-1.72]). The association was stronger with a higher daily dose of domperidone (>30 mg, aOR 1.98, 95%CI [1.50-2.63]). Furthermore, the co-exposure of domperidone and CYP 3A4 inhibitors was significantly associated with an increased odds of ventricular arrhythmia, especially considering the lasting effect of CYP 3A4 inhibitors (1 day apart: aOR 1.91, 95%CI [1.33-2.75], 3 days apart: aOR 1.90, 95%CI [1.33-2.71], 7 days apart: aOR 1.80, 95%CI [1.28-2.54]). Our results suggested that oral domperidone was significantly associated with an increased odds of ventricular arrhythmia and that the association was stronger with exposure to >30 mg of domperidone. In addition, our study reported increased odds of ventricular arrhythmia among those who concomitantly used domperidone and CYP 3A4 inhibitors. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3814
  • Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3821
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    ABSTRACT: It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3813
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    ABSTRACT: Whereas some studies suggest that statins exert a gastroprotective effect against gastrointestinal hemorrhage, others report that statin use is associated with increased risk of gastrointestinal hemorrhage. Aim of report: To investigate the risk of gastrointestinal hemorrhage among statin-users compared with non-users. This was a retrospective cohort study using clinical, administrative, and pharmacy data encompassing October 2003 to March 2012 from patients enrolled in the San Antonio military health care system. Two treatment groups were defined: statin-users (use for at least 90 days) and non-users (never received statin). A propensity score-matched cohort was generated to match statin-users and non-users based on 82 variables. Main outcome measures were defined by the International Classification of Diseases, ninth revision-clinical modification diagnoses codes or procedural codes for gastrointestinal hemorrhage, gastritis/doudenitis, gastroduodenal ulcers, endoscopy procedures, and endoscopy procedures related to gastrointestinal hemorrhage. A total of 43 438 patients were identified; 13 626 (31.4%) were statin-users and 29 812 were non-users. We propensity score-matched 6342 non-users with 6342 statin-users. The risk of outcomes was similar between the two groups for gastrointestinal hemorrhage (Odds Ratio [OR]: 1.0; 95% confidence interval [95%CI]: 0.91, 1.11); gastrointestinal ulcers (OR: 0.99; 95%CI [0.80, 1.24]); gastritis/duodenitis (OR: 0.92; 95%CI [0.83, 1.02]); and endoscopic procedures (OR: 1.07; 95%CI [0.98, 1.17]). Statin use was not significantly associated with either an increased or decreased risk of gastrointestinal hemorrhage. Choice of statin therapy should not be limited in those patients at risk of gastrointestinal hemorrhage. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3817
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    ABSTRACT: Prior studies of psychotropic medication use among US veterans are limited in their ability to generalize estimates to the full veteran population and make comparisons with non-veterans. This study estimated the prevalence of psychotropic medication use and trends over time among male US veterans, compared their use of psychotropic medications with non-veteran males, and examined differences among veteran subpopulations. The data for our analysis came from the National Health and Nutrition Examination Survey (1999-2010), a cross-sectional, nationally representative study of the civilian, non-institutionalized US population. The percentage of male veterans who used any psychotropic medication increased from 10.4% in 1999-2002 to 14.3% in 2003-2006, then remained stable in 2007-2010 (14.0%). During the same time period, the percentage of non-veteran males who used psychotropic medications remained relatively stable (7.0%, 8.3%, and 9.2%, respectively). Veterans were more likely to use psychotropic medication, specifically antidepressants, than non-veterans. The percentage of non-Hispanic white veterans and veterans aged 60 years and over who used psychotropic medications increased between 1999-2002 and 2003-2006, but the percentages remained stable between 2003-2006 and 2007-2010. In 2003-2006 and 2007-2010, a higher percentage of non-Hispanic white veterans used psychotropic medications than non-Hispanic black veterans. This study found that the use of psychotropic medications and antidepressants was higher among male veterans than male non-veterans, and that prevalence of use increased between 1999-2002 and 2007-2010 for male veterans but remained relatively stable for non-veterans. There were significant variations in the use of psychotropic medications among veteran subpopulations. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3809
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    ABSTRACT: Statistical shrinkage is a potential statistical method to improve the accuracy of signal detection results and avoid spurious associations detected by disproportionality analyses. In this study, we introduced statistical shrinkage influence on disproportionality methods in spontaneous reporting system in China. We added the shrinkage parameters in the numerator and denominator, denoted as in the formula of disproportionality analysis. The shrinkage parameters were subjectively set to between 0 and 5, with an interval of 0.1. Adverse drug reaction product label database was deemed as a proxy of golden standard to evaluate the effect of statistical shrinkage. Reports in the years of 2010-2011 were extracted from the national spontaneous reporting system database as the data source for analysis in this study. When α was around 0.5, the Youden index reached the maximum for each disproportionality methods in this study. The value of 0.6 was suggested as the most appropriate statistical shrinkage parameter for reporting odds ratio and proportional reporting ratio and 0.2 for information component based on the spontaneous reporting system of China. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3811
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    ABSTRACT: PurposeThe 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 be used to evaluate the effectiveness of antidepressants.Methods Using prescription and healthcare visit Medicaid claims (2000-2007), we identified 28 493 women with a depression diagnosis and antidepressant fill in the 90 days before their last menstrual period. Antidepressant continuation was defined based on prescription fills during the first trimester. Depression hospitalizations and deliberate self-harm served as measures of the effectiveness of treatment continuation during pregnancy. Propensity score and instrumental variable analyses were used to attempt to account for confounding.ResultsRelative to women who discontinued antidepressant therapy, women who continued were more likely to have a depression inpatient stay (odds ratio [OR] = 2.2, 95% confidence interval [95%CI]: 2.0-2.4) and deliberate self-harm code (OR = 1.4, 95%CI: 0.7-2.7). Accounting for measured covariates in the propensity score analysis, including age, race, comorbidities, comedications, features of the depression diagnosis, and antidepressant class, led to slightly attenuated estimates (OR = 2.0, 95%CI: 1.8-2.2; OR = 1.1, 95%CI: 0.5-2.4). Similar associations were estimated in subgroups with different levels of baseline depression severity. Proposed preference-time, calendar-time-based, and geography-based instruments were unlikely to meet the required conditions for a valid analysis.Conclusions Our findings suggest that either antidepressant medications do not reduce the risk of depression relapse in pregnant women, or that administrative data alone could not be used to validly estimate the effectiveness of psychotropic medications during pregnancy.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3798
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    ABSTRACT: Many factors can increase the risk of hip fracture, including medicines. Traditional observational studies have assessed the risk, but results may be confounded by unmeasured factors. The case-crossover design is an alternative approach that controls for patient-specific, time-invariant confounding factors. This study aimed to assess associations between psychoactive medicines and hip fracture in the elderly using the case-crossover method. Data were sourced from the Australian Government Department of Veterans' Affairs healthcare claims database. The study population comprised beneficiaries aged over 65 years who were hospitalised for hip fracture between 2009 and 2012. The case-crossover method was used to compare individuals' medicine exposure immediately before hip fracture (case window) with their exposure at an earlier time (control window). Conditional logistic regression was employed to quantify associations between medicine use and hip fracture. Alternative exposure windows were assessed in sensitivity analyses. Eight thousand eight hundred twenty-eight patients were hospitalised for hip fracture. Their median age was 88 years, and 63% were female. Odds of hip fracture were increased for opioids (odds ratio [OR] = 1.62, 95% confidence interval [CI] = 1.42-1.84), selective serotonin reuptake inhibitors (OR = 1.54, 95% CI = 1.28-1.86) and antipsychotics (OR = 1.47, 95% CI = 1.21-1.80). There was no significant association for tricyclic antidepressants in the primary analysis (OR = 1.18, 95% CI = 0.91-1.52), but there was a significant association in the sensitivity analysis using an alternative, earlier control window (OR = 1.43, 95% CI = 1.11-1.83). Increased risk of hip fracture in older people was found for opioids, selective serotonin reuptake inhibitors and antipsychotics. The choice of control window influenced the result for tricyclic antidepressants. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; 24(6):576-582. DOI:10.1002/pds.3785
  • Pharmacoepidemiology and Drug Safety 06/2015; 24(6). DOI:10.1002/pds.3784
  • Pharmacoepidemiology and Drug Safety 06/2015; 24(6). DOI:10.1002/pds.3794
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    ABSTRACT: PurposeSpontaneous adverse event reporting systems are critical tools for monitoring the safety of licensed medical products. Commonly used signal detection algorithms identify disproportionate product–adverse event pairs and may not be sensitive to more complex potential signals. We sought to develop a computationally tractable multivariate data-mining approach to identify product–multiple adverse event associations.Methods We describe an application of stepwise association rule mining (Step-ARM) to detect potential vaccine-symptom group associations in the US Vaccine Adverse Event Reporting System. Step-ARM identifies strong associations between one vaccine and one or more adverse events. To reduce the number of redundant association rules found by Step-ARM, we also propose a clustering method for the post-processing of association rules.ResultsIn sample applications to a trivalent intradermal inactivated influenza virus vaccine and to measles, mumps, rubella, and varicella (MMRV) vaccine and in simulation studies, we find that Step-ARM can detect a variety of medically coherent potential vaccine-symptom group signals efficiently. In the MMRV example, Step-ARM appears to outperform univariate methods in detecting a known safety signal.Conclusions Our approach is sensitive to potentially complex signals, which may be particularly important when monitoring novel medical countermeasure products such as pandemic influenza vaccines. The post-processing clustering algorithm improves the applicability of the approach as a screening method to identify patterns that may merit further investigation. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 06/2015; DOI:10.1002/pds.3797
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    ABSTRACT: Concerns were raised about the safety of antiplatelet thienopyridine derivatives after a randomized control trial reported increased risks of cancer and cancer deaths in prasugrel users. We investigate whether clopidogrel, a widely used thienopyridine derivative, was associated with increased risk of cancer-specific or all-cause mortality in cancer patients. Colorectal, breast and prostate cancer patients, newly diagnosed from 1998 to 2009, were identified from the National Cancer Data Repository. Cohorts were linked to the UK Clinical Practice Research Datalink, providing prescription records, and to the Office of National Statistics mortality data (up to 2012). Unadjusted and adjusted hazard ratios (HRs) for cancer-specific and all-cause mortality in post-diagnostic clopidogrel users were calculated using time-dependent Cox regression models. The analysis included 10 359 colorectal, 17 889 breast and 13 155 prostate cancer patients. There was no evidence of an increase in cancer-specific mortality in clopidogrel users with colorectal (HR = 0.98 95% confidence interval (CI) 0.77, 1.24) or prostate cancer (HR = 1.03 95%CI 0.82, 1.28). There was limited evidence of an increase in breast cancer patients (HR = 1.22 95%CI 0.90, 1.65); however, this was attenuated when removing prescriptions in the year prior to death. This novel study of large population-based cohorts of colorectal, breast and prostate cancer patients found no evidence of an increased risk of cancer-specific mortality among colorectal, breast and prostate cancer patients using clopidogrel. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 05/2015; DOI:10.1002/pds.3807
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    ABSTRACT: Guideline-recommended therapy has been proven beneficial in heart failure (HF), but general implementation remains poor. The aim of this study was to evaluate the adherence to drug therapy, quality of primary non-drug medical care (NDMC) and its impact on HF outcome. From 13 Austrian health insurance funds, we identified 36 829 patients (77.1 ± 10.8 years, 44.8% men) hospitalised for HF who survived more than 90 days after discharge in the period between April 2006 and June 2010. Drug adherence was analysed from prescriptions filled and NDMC from numbers of physician consultations and diagnostic tests relevant for HF per quarter of a year (medical care index (MedCI)) claimed from the insurance funds. Kaplan-Meier and multivariate Cox regression analyses were performed to identify the association of outcome (survival and death without further admission for HF, readmission for HF) with drug adherence and NDMC. Readmission due to HF or death without prior readmission for HF occurred in 19.7% and 22.5%, respectively. Adherence to angiotensin-converting-enzyme inhibitors or angiotensin receptor blockers, beta-blockers and aldosterone antagonists was 49.3%, 40.4% and 16.1%, respectively, and was associated with better survival by Kaplan-Meier analysis. NDMC was consumed less frequently by deceased (76.0%; MedCI 2.55 ± 3.04) than surviving (79.3%; 3.60 ± 3.81) or readmitted (78.4%; 3.80 ± 4.13) patients (p < 0.001 for deceased vs both other). Drug adherence and NDMC were independent factors associated with better survival by multivariate regression analysis. Guideline-recommended drug therapy remains underutilised in Austria. Drug adherence and quality of NDMC are associated with better outcome in HF patients. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 05/2015; DOI:10.1002/pds.3790
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    ABSTRACT: This study aimed to validate a predefined algorithm for osteonecrosis of the jaw (ONJ) among cancer patients in the Danish National Registry of Patients and to assess the nature of clinical information recorded in medical charts of ONJ patients. We identified potential ONJ cases recorded in 2005-2010 among cancer patients at the hospital Departments of Oral and Maxillofacial Surgery (DOMS) in three Danish regions, using a set of codes from the International Classification of Diseases, 10th revision (ICD-10). We abstracted DOMS charts of the potential cases, had the ONJ status adjudicated by an expert ONJ adjudication committee (ONJAC), and computed positive predictive values. For patients with ONJAC-confirmed ONJ, we abstracted the charts for information on ONJ clinical course. Sensitivity of the algorithm was computed using a separate sample of 101 known ONJ cases accrued in 2005-2011. We identified 212 potential ONJ cases, of which 197 (93%) had charts available for abstraction. Eighty-three potential cases were confirmed by ONJAC, with a positive predictive value of 42% (95% confidence interval [CI] 35%-49%). DOMS charts of these 83 cases contained complete information on ONJ clinical course. Information about antiresorptive treatment was recorded for 84% of the patients. Among the 101 known ONJ cases, 74 had at least one prespecified ICD-10 code recorded in the Danish National Registry of Patients within ±90 days of the ONJ diagnosis (sensitivity 73%; 95%CI [64%-81%]). The predefined algorithm is not adequate for monitoring ONJ in pharmacovigilance studies. Additional case-finding approaches, coupled with adjudication, are necessary to estimate ONJ incidence accurately. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 05/2015; DOI:10.1002/pds.3786