[Risk of mucocutaneous ulcerations associated with nicorandil: Recent data of the French Pharmacovigilance DataBase and Toulouse Hospital Discharge DataBase (NICORUC)].
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引用次数: 0
Abstract
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 médicalisation des systèmes 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.
期刊介绍：
Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject.
The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.
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