Evaluation of pregabalin-induced oedema using the adverse event spontaneous reporting database and the prescription claims database.
Objectives Pregabalin may reduce the quality of life due to oedema, which may lead to further adverse events if co-administered with diuretics. This study investigated the occurrence of oedema and loop diuretic prescriptions in Japanese patients treated with pregabalin, including the temporal charac...
| Published in: | International Journal of Pharmacy Practice Vol. 33; no. 3; pp. 340 - 347 |
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| Main Authors: | , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Oxford University Press / USA
Jun2025
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=185870757&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 185870757 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09617671 1311 jtl: International Journal of Pharmacy Practice issn: 09617671 maglogo: N pubinfo: dt: Jun2025 vid: 33 iid: 3 pid: 622 pub: Oxford University Press / USA artinfo: ui: 185870757 185870757 185870757 10.1093/ijpp/riaf012 185870757 ppf: 340 ppct: 7 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Evaluation of pregabalin-induced oedema using the adverse event spontaneous reporting database and the prescription claims database. aug: au: Ito, Hitoshi Hasegawa, Yoshitaka Maeda, Mamoru Tsukioka, Ryota Tsuchiya, Masao Yasuno, Nobuhiro Oishi, Miya affil: AIN Holdings Inc., Shibuya-ku, Tokyo 151-0053, Japan sug: subj: Pregabalin Adverse Effects Pregabalin Administration and Dosage Edema Chemically Induced Edema Epidemiology Adverse Drug Event Resource Databases Time Factors Diuretics Adverse Effects Diuretics Therapeutic Use Prescriptions, Drug Human Male Female Aged Japan Data Analysis Software Descriptive Statistics Multiple Logistic Regression Odds Ratio Confidence Intervals Age Factors Sex Factors Comparative Studies Aged: 65+ years Male Female ab: Objectives Pregabalin may reduce the quality of life due to oedema, which may lead to further adverse events if co-administered with diuretics. This study investigated the occurrence of oedema and loop diuretic prescriptions in Japanese patients treated with pregabalin, including the temporal characteristics of the onset and factors associated with oedema. Methods Using the Japanese Adverse Drug Event Report database, we performed logistic regression analysis to calculate adjusted reporting odds ratios to assess the association between pregabalin and oedema, and time-of-onset analysis to identify the timing of oedema onset. Using the prescription claims database of the Japanese pharmacy group, we assessed the occurrence of loop diuretic prescriptions associated with pregabalin by calculating the adjusted sequence ratios in the prescription sequence symmetry analysis, and identified the associated factors in subgroup analyses. Key findings The adjusted reporting odds ratio was 6.89 (95% confidence interval: 5.96–7.91) for pregabalin, adjusted for age and sex as covariates. The median time to onset of oedema was 16.0 days (interquartile range: 6.0–42.0 days). The adjusted sequence ratio was 1.17 (95% confidence interval: 1.09–1.25), with subgroup analyses confirming a significant association at starting doses of 150 mg/day and more. Conclusions This study suggests that oedema and loop diuretic prescriptions are associated with pregabalin use. Pregabalin-induced oedema was more common early in treatment and loop diuretics were more likely to be prescribed when the starting dose of pregabalin was 150 mg/day or more. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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