Evaluation of risk profiles for gastrointestinal and cardiovascular adverse effects in nonselective NSAID and COX-2 inhibitor users: a cohort study using pharmacy dispensing data in The Netherlands.

Abstract:

BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to benefit from the prescribed drug and/or are more prone to adverse drug reactions. Therefore, it is difficult to unravel whether observed risks or increases in risk of new drugs are real, i.e. related to the pharmacology, or whether these are related to selective prescribing to patients who are more susceptible to adverse events because of some underlying risk factor(s). The channelling paradox may exist for cyclo-oxygenase (COX)-2 selective inhibitors ('coxibs') instead of traditional nonselective NSAIDs in relation to both gastrointestinal (GI) and cardiovascular (CV) safety. OBJECTIVE:To evaluate the risk profiles for GI and CV adverse effects in nonselective NSAID and coxib new-user populations over time, in terms of a quantitative measure since the introduction of coxibs. METHODS:This was a population-based cohort study using the Dutch pharmaceutical claims database (Foundation for Pharmaceutical Statistics). Eligible patients (>/=18 years) were those where the date of their first prescription (index date) of an NSAID (first-line [e.g. ibuprofen] or second-line [e.g. piroxicam] nonselective NSAID, COX-2 preferential NSAID or coxib) was between January 1999 and December 2003. For each patient, GI and CV risk profiles at index date were defined by a cumulative score derived from dispensing data (patient age, sex and history of medication use within 6 months of index date). Risk scores were categorized as low (score = 0), medium (1) or high (2+). Patients were recorded as switchers based on other NSAID use prior to the index date. Other information collected included the Chronic Disease Score (CDS). Crude odds ratios (ORs) were calculated for risk factors for each NSAID group versus first-line nonselective NSAID users as the reference cohort. The effect of calendar time was examined by plotting mean CV or GI risk score by quarter-year. Correlation between GI and CV scores was examined using the Pearson correlation coefficient (R). Data were stratified by patients' history of switching. RESULTS:The four cohorts comprised patients using: first-line nonselective NSAIDs (n = 42 750); second-line nonselective NSAIDs (n = 1771); COX-2 preferential NSAIDs (n = 3661) and coxibs (n = 4861) patients. New coxib users were most likely to have high GI and CV risk scores (OR 5.3 [95% CI 5.0, 5.6] and OR 2.2 [95% CI 2.1, 2.4], respectively). At the individual patient level, GI and CV risk profiles were moderately well correlated for all NSAID cohorts (R range 0.48 to 0.62). There was no remarkable change in mean GI or CV risk profile of patients over calendar time since the market introduction of coxibs. DISCUSSION:Of the four NSAID cohorts, new coxib users tended to have the highest numbers of GI and CV risk factors, with no obvious change over calendar time. There was also evidence of correlation between GI and CV risk scores. Thus, selective prescribing of coxibs applies to people with co-existing CV as well as GI risk factors. This is important when comparing the safety and/or efficacy of new therapies to existing therapies, and emphasizes the difficulties encountered by prescribers in assessing levels of risk when initiating coxib treatment.

journal_name

Drug Saf

journal_title

Drug safety

authors

Layton D,Souverein PC,Heerdink ER,Shakir SA,Egberts AC

doi

10.2165/00002018-200831020-00004

subject

Has Abstract

pub_date

2008-01-01 00:00:00

pages

143-58

issue

2

eissn

0114-5916

issn

1179-1942

pii

3124

journal_volume

31

pub_type

杂志文章
  • Risks and benefits of drugs used in the management of the hyperactive child.

    abstract::Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199309010-00004

    authors: Fox AM,Rieder MJ

    更新日期:1993-07-01 00:00:00

  • Patient Reporting in the EU: Analysis of EudraVigilance Data.

    abstract:INTRODUCTION:New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received fr...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-017-0534-1

    authors: Banovac M,Candore G,Slattery J,Houÿez F,Haerry D,Genov G,Arlett P

    更新日期:2017-07-01 00:00:00

  • How do we best detect toxic effects of drugs taken during pregnancy? A EuroMap paper.

    abstract::It is a major clinical and public health problem that there is no clear strategy as to how we best make use of information obtained when pregnant women take drugs. For this reason, some pregnant women are not treated as they should be and some are given drugs they should not use. We suggest a monitoring system that co...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200225010-00003

    authors: Olsen J,Czeizel A,Sørensen HT,Nielsen GL,de Jong van den Berg LT,Irgens LM,Olesen C,Pedersen L,Larsen H,Lie RT,de Vries CS,Bergman U

    更新日期:2002-01-01 00:00:00

  • Levodopa in Parkinson's disease: neurotoxicity issue laid to rest?

    abstract::Orally administered levodopa remains the most effective symptomatic treatment for Parkinson's disease. The introduction of levodopa therapy is often delayed, however, because of the fear that it might be toxic for the remaining dopaminergic neurons, and thus accelerate the deterioration of the patient's condition. Evi...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199921050-00001

    authors: Murer MG,Raisman-Vozari R,Gershanik O

    更新日期:1999-11-01 00:00:00

  • Application of the bradford hill criteria to assess the causality of cisapride-induced arrhythmia: a model for assessing causal association in pharmacovigilance.

    abstract:INTRODUCTION:The Bradford Hill criteria are a widely used, useful tool for the assessment of biomedical causation. We have examined their application to pharmacovigilance using the example of cisapride-induced QTc interval prolongation/arrhythmia. METHODS:A literature search was conducted using MEDLINE, EMBASE, Reacti...

    journal_title:Drug safety

    pub_type: 杂志文章,meta分析

    doi:10.2165/00002018-200730040-00006

    authors: Perrio M,Voss S,Shakir SA

    更新日期:2007-01-01 00:00:00

  • Drug-induced cardiovascular disorders.

    abstract::As the variety and range of pharmaceutical agents available to the medical profession continues to expand, one unavoidable effect will be an increase in drug-induced disease, including cardiovascular disorders. However, given the high rates of cardiovascular disease and prevalence of recognised cardiovascular risk fac...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200730090-00005

    authors: Murphy CA,Dargie HJ

    更新日期:2007-01-01 00:00:00

  • Epidemiology of adverse drug reactions in Europe: a review of recent observational studies.

    abstract::Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Include...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-015-0281-0

    authors: Bouvy JC,De Bruin ML,Koopmanschap MA

    更新日期:2015-05-01 00:00:00

  • Age at First Rotavirus Vaccination and Risk of Intussusception in Infants: A Public Health Modeling Analysis.

    abstract:INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-016-0424-y

    authors: Yung CF,Chong CY,Thoon KC

    更新日期:2016-08-01 00:00:00

  • Treatment with Selective Serotonin Reuptake Inhibitors in the Third Trimester of Pregnancy : Effects on the Infant.

    abstract::Pharmacotherapy in pregnant women is often necessary to treat chronic or relapsing depression or anxiety disorders. Studies that have evaluated the safety of selective serotonin reuptake inhibitors (SSRIs) in early pregnancy have not shown an enhanced risk of major congenital malformations and these results may have c...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200528070-00002

    authors: Nordeng H,Spigset O

    更新日期:2005-07-01 00:00:00

  • Risk management and outcomes of adverse events to pioglitazone in primary care in the UK: an observational study.

    abstract:BACKGROUND:Pioglitazone is an antidiabetic drug that belongs to the thiazolidinedione (TZD) class of insulin-sensitizing agents. Adverse events to pioglitazone of potential severity are listed in the 'special warnings and special precautions for use' section of the pioglitazone summary of product characteristics (SPC),...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200932030-00005

    authors: Fogg C,Kasliwal R,Shakir SA

    更新日期:2009-01-01 00:00:00

  • Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.

    abstract::Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-017-0517-2

    authors: Inokuma Y

    更新日期:2017-06-01 00:00:00

  • Drug administration in chronic liver disease.

    abstract::Cirrhosis encompasses a range of pathophysiological changes that may alter drug disposition. Drugs that are dependent primarily on the liver for their systemic clearance are more likely to be subject to reduced elimination and subsequent accumulation. Drug accumulation may lead to excessive plasma drug concentrations ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199717010-00004

    authors: Westphal JF,Brogard JM

    更新日期:1997-07-01 00:00:00

  • Principles of signal detection in pharmacovigilance.

    abstract::Adverse drug effects are manifold and heterogenous. Many situations may hamper the signalling (i.e. the detection of early warning signs) of adverse effects and new signals often differ from previous experiences. Signals have qualitative and quantitative aspects. Different categories of adverse effects need different ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199716060-00002

    authors: Meyboom RH,Egberts AC,Edwards IR,Hekster YA,de Koning FH,Gribnau FW

    更新日期:1997-06-01 00:00:00

  • Risk-benefit assessment of drugs used in the treatment of inflammatory bowel disease.

    abstract::Although the aetiology of inflammatory bowel disease remains elusive, many agents are available for the control of symptoms and inflammation. Knowledge of drug pharmacology, indications and side effects is essential to ensure the best possible clinical care while minimising toxicity and inappropriate use. Sulfasalazin...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199106030-00005

    authors: Hanauer SB,Stathopoulos G

    更新日期:1991-05-01 00:00:00

  • Eosinophilic pneumonia in patients treated with daptomycin: review of the literature and US FDA adverse event reporting system reports.

    abstract:BACKGROUND:Eosinophilic pneumonia (EP) has been noted in association with daptomycin use. The product labelling was recently updated to include EP in the Warnings and Precautions and Post-Marketing Experience sections. OBJECTIVE:The objective of this study was to analyse adverse event (AE) reports submitted to the US ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/11597460-000000000-00000

    authors: Kim PW,Sorbello AF,Wassel RT,Pham TM,Tonning JM,Nambiar S

    更新日期:2012-06-01 00:00:00

  • Airway subsensitivity with long-acting beta 2-agonists. Is there cause for concern?

    abstract::Regular treatment with both long- and short-acting beta 2-agonists results in tolerance to their bronchoprotective effects, although the relevance of this phenomenon in terms of long term asthma control remains unclear. However, there appears to be no appreciable difference between the 2 long-active beta 2-agonists, s...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199716050-00002

    authors: Lipworth BJ

    更新日期:1997-05-01 00:00:00

  • Managing Risks with Immune Therapies in Multiple Sclerosis.

    abstract::Since the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heteroge...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-018-0782-8

    authors: Förster M,Küry P,Aktas O,Warnke C,Havla J,Hohlfeld R,Mares J,Hartung HP,Kremer D

    更新日期:2019-05-01 00:00:00

  • Quantitative Risk-Benefit Analysis of Probiotic Use for Irritable Bowel Syndrome and Inflammatory Bowel Disease.

    abstract::Probiotics have seen widespread use for a variety of gastrointestinal problems, especially in two common disorders: irritable bowel syndrome and inflammatory bowel disease. Since a wide variety of probiotic preparations has been used, and despite a large number of studies performed, a great deal of heterogeneity exist...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-015-0349-x

    authors: Bennett WE Jr

    更新日期:2016-04-01 00:00:00

  • Cytokine-induced autoimmune disorders.

    abstract::Cytokines are now commonly used in the treatment of many conditions, especially cancer, haematological malignancies and chronic viral hepatitis. With some of these cytokines, clinical induction and/or exacerbation of autoimmune manifestations have been observed. This has been the case with interferon-alpha and interfe...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199717020-00002

    authors: Miossec P

    更新日期:1997-08-01 00:00:00

  • Today's challenges in pharmacovigilance: what can we learn from epoetins?

    abstract::Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/11586350-000000000-00000

    authors: Ebbers HC,Mantel-Teeuwisse AK,Moors EH,Schellekens H,Leufkens HG

    更新日期:2011-04-01 00:00:00

  • Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrénées region (PharmacoMIP) network 2-year pilot study.

    abstract:BACKGROUND:Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting. OBJECTIVE:The aim of this pilot study was to assess the e...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11319170-000000000-00000

    authors: Gony M,Badie K,Sommet A,Jacquot J,Baudrin D,Gauthier P,Montastruc JL,Bagheri H

    更新日期:2010-05-01 00:00:00

  • Oral contraception and venous thromboembolism. A New Zealand perspective.

    abstract::Several recent case control studies have shown an excess rate of venous thromboembolism in women using third generation progestogen-containing combined contraceptive pills compared to second generation combined contraceptive pills. This excess is about 1 in 10,000 women per year of use. It is likely that second and th...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-199716020-00001

    authors: Roke C

    更新日期:1997-02-01 00:00:00

  • Complications of regional anaesthesia Incidence and prevention.

    abstract::The complications of failure, neural injury and local anaesthetic toxicity are common to all regional anaesthesia techniques, and individual techniques are associated with specific complications. All potential candidates for regional anaesthesia should be thoroughly evaluated and informed of potential complications. I...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200124060-00002

    authors: Faccenda KA,Finucane BT

    更新日期:2001-01-01 00:00:00

  • Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients.

    abstract::In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the un...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-015-0389-2

    authors: Baksh SN,Gellad WF,Alexander GC

    更新日期:2016-05-01 00:00:00

  • Methods for retrospective detection of drug safety signals and adverse events in electronic general practice records.

    abstract:BACKGROUND:Examination of clinical data routinely recorded in general practice provides significant opportunities for identifying and quantifying medicine-related adverse events not captured by spontaneous adverse reaction reporting systems. Robust pharmacovigilance methods for detecting and monitoring adverse events d...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/BF03261970

    authors: Tomlin A,Reith D,Dovey S,Tilyard M

    更新日期:2012-09-01 00:00:00

  • Impact of electrocardiographic data quality on moxifloxacin response in thorough QT/QTc studies.

    abstract:BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-014-0142-2

    authors: Johannesen L,Garnett C,Malik M

    更新日期:2014-03-01 00:00:00

  • Safety aspects of parenteral iron in patients with end-stage renal disease.

    abstract::Absolute and functional iron deficiency is the most common cause of epoetin (recombinant human erythropoietin) hyporesponsiveness in renal failure patients. Diagnostic procedures for determining iron deficiency include measurement of serum iron levels, serum ferritin levels, saturation of transferrin and percentage of...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199717040-00004

    authors: Sunder-Plassmann G,Hörl WH

    更新日期:1997-10-01 00:00:00

  • Cholinesterase inhibitors in the treatment of Alzheimer's disease: a comparison of tolerability and pharmacology.

    abstract::Cholinesterase inhibitors are currently the most established treatment strategy in Alzheimer's disease. The treatment effect appears mainly to be symptomatic. Effects on progression of the disease following long term treatment, and possible neuroprotective effects, have been investigated. Delay until nursing home plac...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199819060-00004

    authors: Nordberg A,Svensson AL

    更新日期:1998-12-01 00:00:00

  • Correction to: Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase.

    abstract::Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. ...

    journal_title:Drug safety

    pub_type: 杂志文章,已发布勘误

    doi:10.1007/s40264-018-0672-0

    authors: Patras de Campaigno E,Kebir I,Montastruc JL,Rueter M,Maret D,Lapeyre-Mestre M,Sallerin B,Despas F

    更新日期:2018-08-01 00:00:00

  • Management options for cancer therapy-related anaemia.

    abstract::Anaemia is common in patients with haematological malignancy, occurring in the majority of patients with malignant disease who are treated with chemotherapy. Most patients will have their anaemia attributed to the cytokine-mediated anaemia of chronic disease. Many of these patients with anaemia will be symptomatic wit...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200225070-00006

    authors: Littlewood TJ

    更新日期:2002-01-01 00:00:00