| アブストラクト | OBJECTIVE: The risk of mucocutaneous ulcerations associated with nicorandil remains a well-described adverse effect (AE). In case of a suspected AE, early diagnosis and immediate discontinuation of nicorandil are recommended. The aim of this study is to update pharmacovigilance data. METHODS: Two sources of data were used for this study over the period from January 2017 to the end of November 2024: pharmacovigilance reports registered in the French PharmacoVigilance Database (FPVD) and data related to this AE and nicorandil extracted from the Toulouse hospital discharge database [programme de medicalisation des systemes d'information (PMSI)]. RESULTS: We collected a total of 62 cases: 28 cases were registered in the FPVD and 34 additional cases could be identified in PMSI (n=62). None of these cases were reported to the Toulouse Pharmacovigilance Center. Patients were aged 56 to 97 years (sex-ratio 0.94). Nicorandil was discontinued for 36 patients (11 immediately). Six patients died, three of them despite nicorandil discontinuation, mainly due to digestive complications or sepsis. In 61% of FPVD cases (n=17) the AE was classified as severe. The median time to onset of the ulceration was 407 days (IQR: 123 to 1826 days). Cutaneous ulcerations were mainly localized on the lower limbs and mucosal ulcerations mainly affected the oral and digestive mucosa. CONCLUSION: Despite a decline in nicorandil sales since 2017 and several communications from the health authorities, our findings indicate the persistence of serious adverse reactions with nicorandil. Delayed discontinuation of the drug results in unnecessary investigations and potentially fatal outcomes. This study has shown that the PMSI and then the Clinical Data Warehouse (CDW), operational at the Toulouse Universitary Hospital Center since 18 June 2025, is a data source that contributes to reducing the under-reporting rate of unknown, albeit "expected" AE and to confirming the persistence of a validated pharmacovigilance signal. |
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| ジャーナル名 | Therapie |
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| Pubmed追加日 | 2025/9/24 |
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| 投稿者 | Batty, Liliane; Lapalus, Joanna; Trime, Elsa; Schiro, Pauline; Barus, Romain; Fabre, Didier; Bene, Johana; Moragny, Julien; Prontskus, Viktoryia; Bagheri, Haleh |
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| 組織名 | Departement de pharmacologie medicale et clinique, centre de pharmacovigilance et;de pharmacoepidemiologie, faculte de medecine, hopital universitaire de Toulouse,;31000 Toulouse, France.;Departement d'informations medicales, hopital universitaire de Toulouse, 31000;Toulouse, France.;Centre de pharmacovigilance, hopital universitaire de Lille, 59000 Lille, France.;Centre de pharmacovigilance, hopital universitaire d'Amiens, 80000 Amiens,;France.;Centre de pharmacovigilance, hopital universitaire de Nancy, 54000 Nancy, France.;31000 Toulouse, France. Electronic address: haleh.bagheri@utoulouse.fr. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40987646/ |
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