Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.

Abstract:

AIMS:To evaluate putative associations between drugs and dilated cardiomyopathy. METHODS:We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. RESULTS:Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were 'suspect'. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. CONCLUSIONS:The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors . . .), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals.

journal_name

Br J Clin Pharmacol

authors

Montastruc G,Favreliere S,Sommet A,Pathak A,Lapeyre-Mestre M,Perault-Pochat MC,Montastruc JL,French Association of Regional PharmacoVigilance Centres.

doi

10.1111/j.1365-2125.2009.03596.x

subject

Has Abstract

pub_date

2010-03-01 00:00:00

pages

287-94

issue

3

eissn

0306-5251

issn

1365-2125

pii

BCP3596

journal_volume

69

pub_type

杂志文章
  • The effect of ranitidine on the plasma clearance and hepatic extraction of indocyanine green in patients with chronic liver disease.

    abstract::Since hepatic clearance of ICG is reduced by H2-receptor antagonists in normal subjects, it has been suggested that they reduce liver blood flow. We have studied the effect of intravenous ranitidine on ICG clearance in twelve patients with chronic liver disease. Wedged and free hepatic venous pressure were measured be...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1983.tb04973.x

    authors: Dunk AA,Jenkins WJ,Burroughs AK,Walt RP,Osuafor TO,Sherlock S,Mackie S,Dick R

    更新日期:1983-08-01 00:00:00

  • Integrating pharmacology and clinical pharmacology in pharmaceutical companies.

    abstract::Integration of clinical and preclinical pharmacology in pharmaceutical companies could be improved by several key recommendations: Companies should ensure that there is an adequate pool of trained clinical pharmacologists and preclinical pharmacologists. Training should include topics that allow clinical pharmacologis...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2012.04239.x

    authors: Hunter JA

    更新日期:2012-06-01 00:00:00

  • Changes in blood chemistry in hypertensive patients during propranolol therapy.

    abstract::Propranolol induced changes in blood plasma chemistry were followed in thirty hypertensive patients (WHO I-II) who were seen each week during 14-15 weeks. The initial 4 weeks were a drug free period and the next 2 weeks were a drug adjustment period. After that the patients were on an unchanged propranolol dose for 8 ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1984.tb02341.x

    authors: Andreasen F,Jakobsen P,Kornerup HJ,Pedersen EB,Pedersen OL,Weeke J

    更新日期:1984-03-01 00:00:00

  • Public health impact of adverse bone effects of oral corticosteroids.

    abstract:AIMS:The objective of this study was to estimate the number of fractures attributed to oral corticosteroid use. METHODS:Information was obtained from the General Practice Research Database which contains medical records of general practitioners in the UK. The total number of corticosteroid-related fractures during a c...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1046/j.0306-5251.2001.1385.x

    authors: van Staa TP,Abenhaim L,Cooper C,Zhang B,Leufkens HG

    更新日期:2001-06-01 00:00:00

  • Effects of locally administered anticholinesterase agents on the secretory response of human eccrine sweat glands to acetylcholine and carbachol.

    abstract::The effects of locally administered physostigmine and di-isopropylphosphorofluoridate (DFP) were compared on the secretory response of sweat glands to intradermally injected acetylcholine and carbachol in healthy male volunteers (physostigmine: six subjects; DFP: one subject). The response to acetylcholine reached its...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1986.tb05166.x

    authors: Longmore J,Jani B,Bradshaw CM,Szabadi E

    更新日期:1986-02-01 00:00:00

  • Pharmacokinetic/pharmacodynamic modelling of the antimalarial effect of Actelion-451840 in an induced blood stage malaria study in healthy subjects.

    abstract:AIMS:The aim of this study was to use data from an experimental induced blood stage malaria clinical trial to characterize the antimalarial activity of the new compound Actelion-451840 using pharmacokinetic/pharmacodynamic (PK/PD) modelling. Then, using simulations from the model, the dose and dosing regimen necessary ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.12962

    authors: Krause A,Dingemanse J,Mathis A,Marquart L,Möhrle JJ,McCarthy JS

    更新日期:2016-08-01 00:00:00

  • Influence of APOE genotypes and VKORC1 haplotypes on warfarin dose requirements in Asian patients.

    abstract:WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT:Recent studies on pharmacogenetics of warfarin have implicated apolipoprotein E (APOE) polymorphisms to influence the vitamin K dependent coagulation cascade and hence the efficacy of warfarin. Studies among Caucasian and African Americans showed a significant but conflicting ro...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2007.03053.x

    authors: Lal S,Sandanaraj E,Jada SR,Kong MC,Lee LH,Goh BC,Lee SC,Chowbay B

    更新日期:2008-02-01 00:00:00

  • Population pharmacokinetics of (R)-, (S)- and rac-methadone in methadone maintenance patients.

    abstract:AIM:To construct a population pharmacokinetic model for methadone enantiomers in the setting of methadone maintenance treatment for opioid dependence. METHODS:A population pharmacokinetic model was developed using P-Pharm software for rac-, (R)- and (S)-methadone using data (8-13 plasma samples per subject) obtained f...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1111/j.1365-2125.2004.02079.x

    authors: Foster DJ,Somogyi AA,White JM,Bochner F

    更新日期:2004-06-01 00:00:00

  • Impact of the haplotypes of the human pregnane X receptor gene on the basal and St John's wort-induced activity of cytochrome P450 3A4 enzyme.

    abstract:WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT:Human pregnane X receptor (PXR/NR1I2) is a key regulator of cytochrome P450 3A4. To date, there are 198 reported SNPs for the human PXR/NR1I2 gene. Some of these SNPs are found to affect the inducing ability of PXR to CYP3A4. WHAT THIS STUDY ADDS:This study, for the first time,...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2008.03344.x

    authors: Wang XD,Li JL,Su QB,Guan S,Chen J,Du J,He YW,Zeng J,Zhang JX,Chen X,Huang M,Zhou SF

    更新日期:2009-02-01 00:00:00

  • Integrated semi-physiological pharmacokinetic model for both sunitinib and its active metabolite SU12662.

    abstract:AIMS:Previously published pharmacokinetic (PK) models for sunitinib and its active metabolite SU12662 were based on a limited dataset or lacked important elements such as correlations between sunitinib and its metabolite. The current study aimed to develop an improved PK model that circumvented these limitations and to...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.12550

    authors: Yu H,Steeghs N,Kloth JS,de Wit D,van Hasselt JG,van Erp NP,Beijnen JH,Schellens JH,Mathijssen RH,Huitema AD

    更新日期:2015-05-01 00:00:00

  • The antitussive effect of dextromethorphan in relation to CYP2D6 activity.

    abstract:AIMS:To test the hypothesis that inhibition of cytochrome P450 2D6 (CYP2D6) by quinidine increases the antitussive effect of dextromethorphan (DEX) in an induced cough model. METHODS:Twenty-two healthy extensive metaboliser phenotypes for CYP2D6 were studied according to a double-blind, randomised cross-over design af...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1365-2125.1999.00029.x

    authors: Abdul Manap R,Wright CE,Gregory A,Rostami-Hodjegan A,Meller ST,Kelm GR,Lennard MS,Tucker GT,Morice AH

    更新日期:1999-09-01 00:00:00

  • Role of TDM-based dose adjustments for taxane anticancer drugs.

    abstract::The classical taxanes (paclitaxel, docetaxel), the newer taxane cabazitaxel and the nanoparticle-bound nab-paclitaxel are among the most widely used anticancer drugs. Still, the optimal use and the value of pharmacological personalization of the taxanes is still controversial. We give an overview on the pharmacologica...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1111/bcp.14678

    authors: Muth M,Ojara FW,Kloft C,Joerger M

    更新日期:2020-11-28 00:00:00

  • Antiseizure drugs and risk of developing smoking-related chronic obstructive pulmonary disease or lung cancer: A population-based case-control study.

    abstract:AIMS:To determine whether enzyme-inducing antiseizure drugs (ASDs) affect the risk of developing chronic obstructive pulmonary disease (COPD) or lung cancer in smokers. METHODS:Cases of COPD and lung cancer and matched controls without these conditions were identified from a population of smokers with ≥1 prescription ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.14501

    authors: Leuppi-Taegtmeyer AB,Reinau D,Yilmaz S,Rüegg S,Krähenbühl S,Jick SS,Leuppi JD,Meier CR

    更新日期:2020-08-01 00:00:00

  • Assessment of potential drug interactions by characterization of human drug metabolism pathways using non-invasive bile sampling.

    abstract:AIM:Characterization of the biliary disposition of GSK1325756, using a non-invasive bile sampling technique and spectrometric analyses, to inform the major routes of metabolic elimination and to enable an assessment of victim drug interaction risk. METHOD:Sixteen healthy, elderly subjects underwent non-invasive bile c...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2012.04352.x

    authors: Bloomer JC,Nash M,Webb A,Miller BE,Lazaar AL,Beaumont C,Guiney WJ

    更新日期:2013-02-01 00:00:00

  • Effect of azole antifungals ketoconazole and fluconazole on the pharmacokinetics of dexloxiglumide.

    abstract:AIMS:Dexloxiglumide is a new CCK(1) receptor antagonist under investigation for treatment of functional gastrointestinal disorders and is metabolized by CYP3A4 and CYP2C9. The objectives of these two separate randomized, two-period, two-treatment crossover studies were to investigate the effects of steady-state ketocon...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1111/j.1365-2125.2005.02465.x

    authors: Jakate AS,Roy P,Patel A,Abramowitz W,Persiani S,Wangsa J,Kapil R

    更新日期:2005-11-01 00:00:00

  • Management of hypertension in the elderly: attitudes of general practitioners and hospital physicians.

    abstract::1. The attitudes of general practitioners and hospital physicians to the management of hypertension in the elderly, were examined by responses to a postal questionnaire distributed within the Northern Region, concerning the management of a healthy 75 year old male non-smoker with sustained diastolic or isolated systol...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1995.tb04481.x

    authors: Ford GA,Asghar MN

    更新日期:1995-05-01 00:00:00

  • A study of nadolol to determine its effect on ambulatory blood pressure over 24 hours, and during exercise testing.

    abstract::1 The effect of once daily nadolol therapy in sixteen ambulant patients with essential hypertension has been closely assessed during exercise and over 24 h by continuous intra-arterial recording. 2 The drug was well tolerated and showed similar efficacy to other beta-adrenoceptor blocking agents. Whilst blood pressure...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1982.tb04938.x

    authors: Hornung RS,Gould BA,Kieso H,Raftery EB

    更新日期:1982-07-01 00:00:00

  • Direct oral anticoagulants for stroke prevention in patients with atrial fibrillation: meta-analysis by geographic region with a focus on European patients.

    abstract:AIMS:To analyse clinical outcomes with direct oral anticoagulants in patients with atrial fibrillation according to geographic region. METHODS:We systematically searched MEDLINE, CENTRAL, websites of regulatory agencies, clinical trials registers and conference proceedings for randomized controlled trials of direct or...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,meta分析,评审

    doi:10.1111/bcp.13005

    authors: Gómez-Outes A,Terleira-Fernández AI,Calvo-Rojas G,Suárez-Gea ML,Vargas-Castrillón E

    更新日期:2016-09-01 00:00:00

  • The rise and fall of serum theophylline concentration: a comparison of sustained-release formulations in volunteers with rapid theophylline clearance.

    abstract::The pharmacokinetics of four sustained-release formulations of theophylline have been examined after single doses (Nuelin SA, Phyllocontin, Slo-phyllin and Theo-Dur) and at steady-state (Phyllocontin, Theo-Dur) in six healthy adult volunteers, selected because they all eliminated theophylline rapidly after an intraven...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1985.tb05116.x

    authors: Mucklow JC,Kuhn S

    更新日期:1985-12-01 00:00:00

  • High dose methotrexate chemotherapy: pharmacokinetics, folate and toxicity in osteosarcoma patients.

    abstract:AIMS:To investigate the relationships between pretreatment folate concentrations, MTX pharmacokinetics and acute toxicities following high dose methotrexate (HD MTX) therapy. METHODS:MTX and its major extracellular metabolite 7-OH-MTX were measured in eight serum samples per HD MTX cycle in 65 consecutive osteosarcoma...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2011.04054.x

    authors: Holmboe L,Andersen AM,Mørkrid L,Slørdal L,Hall KS

    更新日期:2012-01-01 00:00:00

  • Evaluation of the effect on heart rate variability of a beta2-adrenoceptor agonist and antagonist using non-linear scatterplot and sequence methods.

    abstract:AIMS:To examine the impact on heart rate variability (HRV), of agonism or antagonism at the cardiac beta2-adrenoceptor in healthy volunteers, using standard time-domain summary statistics and non-linear methods (scatterplot and quadrant analysis). METHODS:Under double-blind and randomised conditions (Latin square desi...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1365-2125.1999.00862.x

    authors: Hanratty CG,Silke B,Riddell JG

    更新日期:1999-02-01 00:00:00

  • Effects of xamoterol (ICI 118,587) in asthmatic patients.

    abstract::To study the cardioselectivity of xamoterol, eight asthmatic patients took part in a randomised, double-blind, cross-over study, in which xamoterol or saline were infused, followed by four increasing doses of terbutaline i.v. Circulatory studies showed a significant increase of systolic blood pressure after xamoterol ...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1111/j.1365-2125.1984.tb02510.x

    authors: Löfdahl CG,Svedmyr N

    更新日期:1984-10-01 00:00:00

  • Induction of P-glycoprotein in lymphocytes by carbamazepine and rifampicin: the role of nuclear hormone response elements.

    abstract:AIMS:Carbamazepine (CBZ) is an inducer of cytochrome P450 enzymes, which have been implicated in many drug interactions. However, for immunosuppressant and anti-HIV drugs, whose main site of action is the lymphocyte, induction of P-glycoprotein (Pgp) may also be important. In this study, we have investigated whether CB...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2006.02587.x

    authors: Owen A,Goldring C,Morgan P,Park BK,Pirmohamed M

    更新日期:2006-08-01 00:00:00

  • Nonlinear protein binding of phenytoin in clinical practice: Development and validation of a mechanistic prediction model.

    abstract:AIMS:To individualize treatment, phenytoin doses are adjusted based on free concentrations, either measured or calculated from total concentrations. As a mechanistic protein binding model may more accurately reflect the protein binding of phenytoin than the empirical Winter-Tozer equation that is routinely used for cal...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.14053

    authors: Ter Heine R,Kane SP,Huitema ADR,Krasowski MD,van Maarseveen EM

    更新日期:2019-10-01 00:00:00

  • The effect of inhaled 5-hydroxytryptamine (5-HT, serotonin) on airway calibre in man.

    abstract::Since platelet activation has been incriminated in the pathogenesis of asthma, we have investigated the effect of one of its major granule-derived mediators, 5-hydroxytryptamine (5-HT, serotonin) on airway calibre in normal (12), atopic non-asthmatic (12) and atopic asthmatic subjects (16). On separate days subjects i...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1111/j.1365-2125.1986.tb02923.x

    authors: Cushley MJ,Wee LH,Holgate ST

    更新日期:1986-10-01 00:00:00

  • Adverse drug reactions - examples of detection of rare events using databases.

    abstract::It is recognised that randomised controlled trials are not feasible for capturing rare adverse events. There is an increasing trend towards observational research methodologies using large population-based health databases. These databases offer more scope for adequate sample sizes, allowing for comprehensive patient ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1111/bcp.12474

    authors: Chan EW,Liu KQ,Chui CS,Sing CW,Wong LY,Wong IC

    更新日期:2015-10-01 00:00:00

  • Pinacidil monotherapy for hypertension.

    abstract::Ten patients with mild to moderate hypertension were treated for 9 weeks with a tablet formulation of pinacidil. Mean supine blood pressure fell from 174/100 to 148/84 mm Hg and mean supine pulse increased by 3 beats/min. Daily dosage was 40-100 mg, given in two or three divided doses. Plasma urea increased significan...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1984.tb02456.x

    authors: Ward JW

    更新日期:1984-08-01 00:00:00

  • Some effects of mianserin on monoamine metabolism in the rat brain.

    abstract::1 Mianserin does not affect the uptake of biogenic amines into rat brain, in contrast to tricyclic antidepressants which block amine uptake. 2 Mianserin increases the turnover of noradrenaline (NA) in rat brain after acute or chronic administration, whereas tricyclic antidepressants reduce turnover of NA and 5-hydroxy...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:

    authors: Leonard BE

    更新日期:1978-01-01 00:00:00

  • Clinical and pharmacological study of a novel controlled release preparation of salbutamol.

    abstract::This study compared the efficacy of 8 mg controlled release (CR) salbutamol tablets twice daily with standard 4 mg salbutamol tablets four times daily in patients with chronic obstructive airways disease. There was significant bronchodilation in both treatment groups as measured by standard spirometry (P less than 0.0...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1111/j.1365-2125.1990.tb03683.x

    authors: Milroy R,Carter R,Carlyle D,Boyd G

    更新日期:1990-05-01 00:00:00

  • Effect of food on the absorption of frusemide and bumetanide in man.

    abstract::1. The influence of food on the absorption of frusemide and bumetanide was compared in two separate randomized crossover studies. 2. On three separate occasions frusemide 40 mg was administered to eight healthy male volunteers intravenously, orally in the fasting state and orally after a standard breakfast. Blood and ...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1365-2125.1996.00494.x

    authors: McCrindle JL,Li Kam Wa TC,Barron W,Prescott LF

    更新日期:1996-12-01 00:00:00