Illustration of the Weibull Shape Parameter Signal Detection Tool Using Electronic Healthcare Record Data

Sauzet, Odile; Carvajal, Alfonso; Escudero, Antonio; Molokhia, Mariam; Cornelius, Victoria

doi:10.1007/s40264-013-0061-7

Cited by 94 publications

(107 citation statements)

References 12 publications

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“…Analysis of time-toonset using the Weibull shape parameter (WSP) has recently been proposed to detect the signals for AEs by utilizing timeto-event data without requiring a reference population. [17][18][19][20] The WSP can describe the varying incidence of AEs and can * To whom correspondence should be addressed. e-mail: mnakamura@gifu-pu.ac.jp evaluate hazard functions for detecting AEs.…”

Section: -16)mentioning

confidence: 99%

“…If β is greater than 1 and the 95% CI of β excludes the value of 1, the hazard is considered to increase over time. [17][18][19][20]24,25) We investigated the relation between the number of reports and seasonality of DIP. We analyzed the onset day of AEs and then obtained the number of AE reports per month between April 2004 and November 2016 from REAC table of JADER.…”

Section: 23)mentioning

confidence: 99%

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Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

Nakao

Hatahira

Sasaoka

et al. 2017

Biological & Pharmaceutical Bulletin

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Drug-induced photosensitivity (DIP) refers to the development of cutaneous disorders caused by the combined effects of different medications and light. The aim of this study was to obtain new information on drug risk comparisons and on DIP onset profiles, including seasonal variations, for clinically used prescription drugs. We analyzed reports of DIP recorded in the Japanese Adverse Drug Event Report (JADER) database using a reporting odds ratio (ROR). We also used Key words photosensitivity; Japanese Adverse Drug Event Report database; seasonal variation; ketoprofen; hydrochlorothiazide Drug-induced photosensitivity (DIP) refers to the development of cutaneous disorders caused by the combined effects of a variety medications (oral, intravenous, and dermal) and light.1) Although the pathogenesis of DIP reactions is not fully understood, they can be classified as phototoxic or photoallergic drug eruptions.2) The clinical manifestation of phototoxicity is an exaggerated sunburn with blistering, desquamation, and hyperpigmentation, while that of photoallergy is dermatitis.3) Many drugs are associated with photosensitivity. The common photosensitizing medications include antibiotics, antifungals, antihistamines, cholesterol-lowering drugs, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), oral contraceptives and estrogens, phenothiazines, psoralens, retinoids, sulfonamides, sulfonylureas used for type 2 diabetes, and alpha-hydroxy acids used in cosmetics.

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Section: -16)mentioning

confidence: 99%

Section: 23)mentioning

confidence: 99%

Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

Nakao

Hatahira

Sasaoka

et al. 2017

Biological & Pharmaceutical Bulletin

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“…Moreover, we performed the time-to-onset analysis using Weibull distribution and we examined the expression proˆle of adverse events for each drug. 18) DiŠerent atypical and typical antipsychotics were not administered at the same time. For duplicate entries of the same atypical and typical antipsychotics in the same case, we adopted the most recent atypical and typical antipsychotics entry in order to identify the beginning of the time of a subject'sˆrst prescription.…”

Section: Construction Of Databasementioning

confidence: 99%

Evaluation of the Expression Profile of Extrapyramidal Symptoms Due to Antipsychotics by Data Mining of Japanese Adverse Drug Event Report (JADER) Database

Kose

Uno²,

Hayashi³

2017

YAKUGAKU ZASSHI

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Typical antipsychotics are easily expressed as adverse events such as extrapyramidal symptom (EPS). On the other hand, incidence of adverse events due to atypical antipsychotics is low. Therefore, currently, atypical antipsychotics are widely used to treat schizophrenia. However, it has been reported that there is no diŠerence in the frequency of EPS in atypical and typical antipsychotics. This study aimed to evaluate the expression proˆle of EPS in atypical and typical antipsychotics treatment using the Japanese Adverse Drug Event Report (JADER) database. We analyzed reports of EPS in the JADER database and calculated the reporting odds ratio (ROR) of antipsychotics potentially associated with EPS. We applied the Weibull shape parameter to time-to-event data in the JADER database. Consequently, there was little information to distinguish between the ROR of atypical and typical antipsychotics. A signiˆcant diŠerence related to the time of onset of EPS in both antipsychotics was not recognized. However, when comparing each drug, Paliperidone, Perospirone, Blonanserin, and Aripiprazole were relatively developed as EPS in the early stage. On the other hand, Risperidone, Clozapine, Olanzapine, and Quetiapine were developed as EPS not only at an early stage but also after long-term use. In addition, thisˆnding was suggested from the result of the cumulative incidence of EPS in each drug and of the time-to-onset analysis using Weibull distribution. Theseˆndings may contribute to future clinical practice because we revealed the expression proˆle of EPS in treatment with atypical and typical antipsychotics.

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“…During the period of drug use, the risk of developing the ADR is not necessarily a constant but can be seen as a function that changes over time. Previous studies seem to indicate that parametric TTO modeling can be used as a signal detection tool in cohorts of patients starting treatment [10,11] and using registry data of spontaneous reports of adverse events [12]. The parametric methods either statistically test for a nonconstant hazard (rate of occurrence of the adverse event) [10,11] or allow for visual inspection of the hazard over time for the parametric model providing the best fit to the data [12].…”

Section: What Is New?mentioning

confidence: 99%

Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs

Scholl

Ven

Puijenbroek

2015

Journal of Clinical Epidemiology

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Illustration of the Weibull Shape Parameter Signal Detection Tool Using Electronic Healthcare Record Data

Cited by 94 publications

References 12 publications

Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

Evaluation of the Expression Profile of Extrapyramidal Symptoms Due to Antipsychotics by Data Mining of Japanese Adverse Drug Event Report (JADER) Database

Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs

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