Statistics: Analysis and Presentation of Safety Data

Evans, Stephen; Nitsch, Dorothea

doi:10.1002/9780470975053.ch6

Cited by 9 publications

(3 citation statements)

References 75 publications

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“…TTO SD may be useful as a complementary tool to DPA SD for four reasons: TTO SD is designed to detect any kind of difference in the distribution (e.g., differences in central tendency, dispersion, or skewness), whereas DPA are designed to detect only unexpected numbers of events. TTO SD is not affected by the “masking effect”. This problem occurs frequently with DPA methods if a particular V–E pair is massively reported: it inflates the overall reporting rates for both the vaccine and the event, sometimes to the extent that excessive reporting rates for the same vaccine with another event or for another vaccine with the same event are masked TTO SD is expected to be less sensitive to reporting biases than DPA.…”

Section: Discussionmentioning

confidence: 99%

Using time‐to‐onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study

Holle

Zeinoun

Bauchau

et al. 2012

Pharmacoepidemiology and Drug

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Section: Discussionmentioning

confidence: 99%

Using time‐to‐onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study

Holle

Zeinoun

Bauchau

et al. 2012

Pharmacoepidemiology and Drug

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“…We calculated a ROR to compare risk of exposure to different drugs in cases and noncases previously described. The RORs are given with their 95% CIs . The 95% CIs were calculated using the Woolf's method .…”

Section: Methodsmentioning

confidence: 99%

Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database

Colin

Favrelière

Quillet

et al. 2016

Fundam Clin Pharmacol

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Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period. To assess the association between PML and drug intake, we calculated an adverse drug report odds ratio (ROR) with its 95% confidence interval. We have studied the delay of onset of PML for each drug concerned. Among the 101 cases of PML, 39 drugs were mentioned as suspect. The main therapeutic classes suspected with significant ROR were antineoplastic agents (n = 85), immunosuppressants (n = 67), and corticosteroids. A latent interval from the time of drug initiation to the development of PML is established: the median time to onset was 365 days (123-1095 days). The onset of PML is highly variable and differs among drug classes [from 1 to 96 months (IQR: 39.0-126)]. An association between PML and some immunosuppressant drugs was found as expected, but also with antineoplastic agents and glucocorticoids. An important delay of PML onset after stopping treatment is suspected and should alert prescribers. Prescribers but also patients should be informed about the potential associations with all these drugs. Monitoring could be necessary for many drugs to early detect PML.

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“…We calculated an ADR ROR in order to compare the risk of exposure to the different classes of drugs in ‘cases’ and ‘noncases’. RORs were given with their 95% CI as crude RORs [15].…”

Section: Methodsmentioning

confidence: 99%

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

Montastruc

Favrelière

Sommet

et al. 2010

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Dilated cardiomyopathy is a frequent disease, responsible for 40–50% of cases of heart failure. • Several aetiologies have been reported: idiopathic, familial/genetic, viral and/or immune but also toxic agents (alcohol, cobalt, carbon monoxide, lead, cocaine, mercury or drugs). • Among drugs, anthracyclines are well known to induce such an adverse drug reaction. WHAT THIS STUDY ADDS • This study describes an association with already suspected drugs (anthracyclines, antiretrovirals). • It also found a signal with other drugs (antipsychotics, lithium, antidepressants, retinoids). • This pharmacovigilance signal should be confirmed by further prospective studies. 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.

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Statistics: Analysis and Presentation of Safety Data

Cited by 9 publications

References 75 publications

Using time‐to‐onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study

Using time‐to‐onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study

Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database

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

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