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.
{"title":"[Risk of mucocutaneous ulcerations associated with nicorandil: Recent data of the French Pharmacovigilance DataBase and Toulouse Hospital Discharge DataBase (NICORUC)].","authors":"Liliane Batty, Joanna Lapalus, Elsa Trime, Pauline Schiro, Romain Barus, Didier Fabre, Johana Béné, Julien Moragny, Viktoryia Prontskus, Haleh Bagheri","doi":"10.1016/j.therap.2025.08.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.08.001","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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)].</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145132060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01DOI: 10.1016/j.therap.2025.03.004
Emna Chtourou , Fatma Charfi , Imen Chabchoub , Hanen Ghozzi , Ahmed Hakim , Kammoun Thouraya , Khaled Zeghal , Lobna Ben Mahmoud
{"title":"Rapid desensitization to insulin in a patient with diabetic ketoacidosis and insulin allergy","authors":"Emna Chtourou , Fatma Charfi , Imen Chabchoub , Hanen Ghozzi , Ahmed Hakim , Kammoun Thouraya , Khaled Zeghal , Lobna Ben Mahmoud","doi":"10.1016/j.therap.2025.03.004","DOIUrl":"10.1016/j.therap.2025.03.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 616-618"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<div><h3>Introduction</h3><div>Les opioïdes sont des médicaments essentiels, cependant, leur consommation s’accompagne de risques. Le programme POP « Prévention et réduction des risques des surdoses liées aux opioïdes en région PACA » vise à améliorer la prise en charge des patients à risque de surdose et la diffusion de naloxone. Nous avons réalisé un état des lieux auprès de pharmaciens dont l’objectif était d’évaluer leurs connaissances, pratiques, difficultés et besoins concernant la prise en charge des patients utilisateurs d’opioïdes et la prévention des surdoses et de leur proposer des supports d’information adaptés à leurs besoins.</div></div><div><h3>Matériels et méthodes</h3><div>Dans le cadre du programme POP, des pharmaciens ont été sollicités via un questionnaire en ligne (février–mars 2024) et entretiens semi-directifs (avril 2024).</div></div><div><h3>Résultat</h3><div>Au total, 107 pharmaciens ont répondu au questionnaire et 10 ont participé aux entretiens. Soixante-quatorze pour cent ont indiqué avoir été confrontés à des patients présentant un trouble de l’usage d’un médicament opioïde. L’échelle de repérage <em>Prescription Opioid Misuse Index</em> est peu connue (92 %). Seuls 37 % des pharmaciens déclaraient avoir connaissance de la disponibilité de naloxone prête à l’emploi et 87 % ne se sentent pas à l’aise avec les conseils associés à sa dispensation. Les actions en cas de mésusage incluent un contact avec le prescripteur (76 %), un refus de dispensation (76 %), une dispensation adaptée ou fractionnée (60 %). Concernant les besoins, 95 % étaient intéressés par une formation, 44 % par des outils pratiques, et 41 % par des documents à destination des patients. À partir des besoins exprimés, des actions d’information et d’aller vers ont été réalisées.</div></div><div><h3>Conclusion</h3><div>Les résultats soulignent la nécessité d’améliorer les connaissances des pharmaciens sur le risque de surdose et la naloxone. Il est essentiel de proposer régulièrement des formations et de diffuser des outils pratiques.</div></div><div><h3>Introduction</h3><div>Opioids are essential medicines, but their use is associated with risks. The POP program “Prevention and risk reduction of Opioid-related overdoses in the PACA region” aims to improve the management of patients at risk of overdose and the distribution of naloxone. We have conducted a survey of pharmacist with the aim was to assess their knowledge, practices, difficulties and needs concerning the management of opioid users and overdose prevention and naloxone diffusion, and to propose training materials adapted to their needs.</div></div><div><h3>Materials and methods</h3><div>In the context of POP programme, pharmacists were approached via an online questionnaire (February–March 2024) and semi-structured interviews (April 2024).</div></div><div><h3>Results</h3><div>A total of 107 pharmacists completed the questionnaire and 10 took part in the interviews. Seventy-four per cent said th
{"title":"Prévention du mésusage et du risque des surdoses d’opioïdes et diffusion de naloxone : état des lieux des pratiques, besoins et perspectives auprès des pharmaciens d’officine","authors":"Armelle Chan Soc Foh , Salim Mezaache , Franck Turlure , Nathalie Fredon , Stéphane Pichon , Laurent Peillard , Joelle Micallef , Elisabeth Frauger","doi":"10.1016/j.therap.2025.02.006","DOIUrl":"10.1016/j.therap.2025.02.006","url":null,"abstract":"<div><h3>Introduction</h3><div>Les opioïdes sont des médicaments essentiels, cependant, leur consommation s’accompagne de risques. Le programme POP « Prévention et réduction des risques des surdoses liées aux opioïdes en région PACA » vise à améliorer la prise en charge des patients à risque de surdose et la diffusion de naloxone. Nous avons réalisé un état des lieux auprès de pharmaciens dont l’objectif était d’évaluer leurs connaissances, pratiques, difficultés et besoins concernant la prise en charge des patients utilisateurs d’opioïdes et la prévention des surdoses et de leur proposer des supports d’information adaptés à leurs besoins.</div></div><div><h3>Matériels et méthodes</h3><div>Dans le cadre du programme POP, des pharmaciens ont été sollicités via un questionnaire en ligne (février–mars 2024) et entretiens semi-directifs (avril 2024).</div></div><div><h3>Résultat</h3><div>Au total, 107 pharmaciens ont répondu au questionnaire et 10 ont participé aux entretiens. Soixante-quatorze pour cent ont indiqué avoir été confrontés à des patients présentant un trouble de l’usage d’un médicament opioïde. L’échelle de repérage <em>Prescription Opioid Misuse Index</em> est peu connue (92 %). Seuls 37 % des pharmaciens déclaraient avoir connaissance de la disponibilité de naloxone prête à l’emploi et 87 % ne se sentent pas à l’aise avec les conseils associés à sa dispensation. Les actions en cas de mésusage incluent un contact avec le prescripteur (76 %), un refus de dispensation (76 %), une dispensation adaptée ou fractionnée (60 %). Concernant les besoins, 95 % étaient intéressés par une formation, 44 % par des outils pratiques, et 41 % par des documents à destination des patients. À partir des besoins exprimés, des actions d’information et d’aller vers ont été réalisées.</div></div><div><h3>Conclusion</h3><div>Les résultats soulignent la nécessité d’améliorer les connaissances des pharmaciens sur le risque de surdose et la naloxone. Il est essentiel de proposer régulièrement des formations et de diffuser des outils pratiques.</div></div><div><h3>Introduction</h3><div>Opioids are essential medicines, but their use is associated with risks. The POP program “Prevention and risk reduction of Opioid-related overdoses in the PACA region” aims to improve the management of patients at risk of overdose and the distribution of naloxone. We have conducted a survey of pharmacist with the aim was to assess their knowledge, practices, difficulties and needs concerning the management of opioid users and overdose prevention and naloxone diffusion, and to propose training materials adapted to their needs.</div></div><div><h3>Materials and methods</h3><div>In the context of POP programme, pharmacists were approached via an online questionnaire (February–March 2024) and semi-structured interviews (April 2024).</div></div><div><h3>Results</h3><div>A total of 107 pharmacists completed the questionnaire and 10 took part in the interviews. Seventy-four per cent said th","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 507-518"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To describe cardiovascular adverse reactions reported after intravitreal injections of vascular endothelial growth factor inhibitors (I-VEGF) as registered in the French Pharmacovigilance Database (FPVDB).
Methods
This retrospective study assessed spontaneous adverse drug reactions reported to the French pharmacovigilance system and registered in the FPVDB from April 2007 to June 2023. Eligible cases of thromboembolic events and arterial hypertension associated with three I-VEGFs (aflibercept, ranibizumab and bevacizumab) were selected.
Results
A total of 127 cases were included (83 for ranibizumab, 37 for aflibercept, and 7 for bevacizumab), including 21 cases of arterial hypertension and 106 cases of thromboembolic events. The median onset time for thromboembolic events ranged from 1 to 119 days following injection, and from 0 to 30 days for arterial hypertension. The median number of injections ranged from 1 to 24 before the occurrence of an adverse drug reaction. In 23% of cases, no risk factor was found for the occurrence of a cardiovascular or thromboembolic adverse event. In two cases, a positive rechallenge was documented.
Conclusion
The rational use of pharmacological data, some relevant spontaneous reports and some pharmacoepidemiological studies are a prompt to health professionals to take precautions in patients with risk factors requiring I-VEGF. However, European Summaries of Product Characteristics do not give a clear picture to healthcare professionals concerning the precautions to take for patients with risk factors.
{"title":"Intravitreal vascular endothelial growth factor inhibitors and cardiovascular adverse drug reactions: Added value of the data of the French pharmacovigilance spontaneous reporting assessment","authors":"Aurélie Bobet , Leila Chebane , Annie-Pierre Jonville-Bera , Marina Babin , Thomas Soeiro , Haleh Bagheri","doi":"10.1016/j.therap.2025.02.008","DOIUrl":"10.1016/j.therap.2025.02.008","url":null,"abstract":"<div><h3>Aim</h3><div><span><span>To describe cardiovascular adverse reactions reported after </span>intravitreal injections<span> of vascular endothelial growth factor inhibitors (I-VEGF) as registered in the French </span></span>Pharmacovigilance Database (FPVDB).</div></div><div><h3>Methods</h3><div>This retrospective study assessed spontaneous adverse drug reactions<span> reported to the French pharmacovigilance system and registered in the FPVDB from April 2007 to June 2023. Eligible cases of thromboembolic<span> events and arterial hypertension associated with three I-VEGFs (aflibercept, ranibizumab and bevacizumab) were selected.</span></span></div></div><div><h3>Results</h3><div><span>A total of 127 cases were included (83 for ranibizumab, 37 for aflibercept, and 7 for bevacizumab), including 21 cases of arterial hypertension and 106 cases of thromboembolic events. The median onset time for thromboembolic events ranged from 1 to 119</span> <!-->days following injection, and from 0 to 30<!--> <!-->days for arterial hypertension. The median number of injections ranged from 1 to 24 before the occurrence of an adverse drug reaction. In 23% of cases, no risk factor was found for the occurrence of a cardiovascular or thromboembolic adverse event. In two cases, a positive rechallenge was documented.</div></div><div><h3>Conclusion</h3><div>The rational use of pharmacological data, some relevant spontaneous reports and some pharmacoepidemiological studies are a prompt to health professionals to take precautions in patients with risk factors requiring I-VEGF. However, European Summaries of Product Characteristics do not give a clear picture to healthcare professionals concerning the precautions to take for patients with risk factors.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 589-597"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<div><h3>Objectifs</h3><div>Les réactions liées à la perfusion avec les immunoglobulines sont bien connues. L’objectif était de les caractériser à partir des données recueillies en vie réelle afin de fournir des informations utiles en pratique clinique.</div></div><div><h3>Méthodes</h3><div>Cette étude descriptive a analysé les cas de réaction aux perfusions issues de la base nationale de pharmacovigilance française concernant les immunoglobulines administrées par voie intraveineuse ou sous-cutanée jusqu’au 27 décembre 2023.</div></div><div><h3>Résultats</h3><div>Sur la période étudiée, 239 cas de réaction à la perfusion ont été rapportés, principalement avec des immunoglobulines intraveineuses (97,4 %). Dans un peu plus de la moitié des cas (51 %), les réactions à la perfusion se manifestaient par un syndrome pseudo-grippal. Elles se produisaient généralement lors de la première cure pour les immunoglobulines intraveineuses et de la quatrième pour les immunoglobulines sous-cutanées. Suite à la survenue d’une réaction à la perfusion, la perfusion était en majorité arrêtée (87,7 %) ou le débit était diminué (9,1 %). Pour 64 cas, la résolution de la réaction à la perfusion permettait de reprendre la cure avec une diminution du débit de perfusion (65 %), une prémédication (28 %) ou l’association des deux (7 %). La reprise de la cure n’engendrait pas de récurrence de la réaction à la perfusion dans 60 % des cas. Pour les cures suivantes, l’administration de la même spécialité (<em>n</em> <!-->=<!--> <!-->100) entraînait une récurrence dans 40 % des cas et pour un changement de spécialité (<em>n</em> <!-->=<!--> <!-->16) dans 75 % des cas.</div></div><div><h3>Conclusion</h3><div>Les réactions liées à la perfusion avec les immunoglobulines se manifestent le plus souvent par des syndromes pseudo-grippaux ou des troubles cardiovasculaires, résolutifs à la diminution de débit ou à l’arrêt. La reprise de la perfusion après résolution est possible avec un débit réduit ou une prémédication. Les résultats suggèrent qu’un changement de spécialité (de même voie d’administration) ne présente pas de bénéfice en pratique.</div></div><div><h3>Objectives</h3><div>Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information.</div></div><div><h3>Methods</h3><div>This descriptive study analyzed cases of infusion-related reactions reported in the French National Pharmacovigilance Database for immunoglobulins administered via intravenous or subcutaneous routes up to December 27, 2023.</div></div><div><h3>Results</h3><div>During the study period, 239 cases of infusion-related reactions were reported, primarily associated with intravenous immunoglobulins (97.4%). In over half of the cases (51%), the reactions presented as flu-like syndromes. These reactions typically occurred during the first cycle for IV immunoglobulins and the fourth cycl
{"title":"Les réactions liées à la perfusion avec les immunoglobulines polyvalentes humaines : analyse de la base nationale de pharmacovigilance française","authors":"Aurélie Bobet , Justine Bravo , Eyrian Aubin-Beale , Blandine Bertin , François Montastruc , Romain Barus","doi":"10.1016/j.therap.2025.01.002","DOIUrl":"10.1016/j.therap.2025.01.002","url":null,"abstract":"<div><h3>Objectifs</h3><div>Les réactions liées à la perfusion avec les immunoglobulines sont bien connues. L’objectif était de les caractériser à partir des données recueillies en vie réelle afin de fournir des informations utiles en pratique clinique.</div></div><div><h3>Méthodes</h3><div>Cette étude descriptive a analysé les cas de réaction aux perfusions issues de la base nationale de pharmacovigilance française concernant les immunoglobulines administrées par voie intraveineuse ou sous-cutanée jusqu’au 27 décembre 2023.</div></div><div><h3>Résultats</h3><div>Sur la période étudiée, 239 cas de réaction à la perfusion ont été rapportés, principalement avec des immunoglobulines intraveineuses (97,4 %). Dans un peu plus de la moitié des cas (51 %), les réactions à la perfusion se manifestaient par un syndrome pseudo-grippal. Elles se produisaient généralement lors de la première cure pour les immunoglobulines intraveineuses et de la quatrième pour les immunoglobulines sous-cutanées. Suite à la survenue d’une réaction à la perfusion, la perfusion était en majorité arrêtée (87,7 %) ou le débit était diminué (9,1 %). Pour 64 cas, la résolution de la réaction à la perfusion permettait de reprendre la cure avec une diminution du débit de perfusion (65 %), une prémédication (28 %) ou l’association des deux (7 %). La reprise de la cure n’engendrait pas de récurrence de la réaction à la perfusion dans 60 % des cas. Pour les cures suivantes, l’administration de la même spécialité (<em>n</em> <!-->=<!--> <!-->100) entraînait une récurrence dans 40 % des cas et pour un changement de spécialité (<em>n</em> <!-->=<!--> <!-->16) dans 75 % des cas.</div></div><div><h3>Conclusion</h3><div>Les réactions liées à la perfusion avec les immunoglobulines se manifestent le plus souvent par des syndromes pseudo-grippaux ou des troubles cardiovasculaires, résolutifs à la diminution de débit ou à l’arrêt. La reprise de la perfusion après résolution est possible avec un débit réduit ou une prémédication. Les résultats suggèrent qu’un changement de spécialité (de même voie d’administration) ne présente pas de bénéfice en pratique.</div></div><div><h3>Objectives</h3><div>Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information.</div></div><div><h3>Methods</h3><div>This descriptive study analyzed cases of infusion-related reactions reported in the French National Pharmacovigilance Database for immunoglobulins administered via intravenous or subcutaneous routes up to December 27, 2023.</div></div><div><h3>Results</h3><div>During the study period, 239 cases of infusion-related reactions were reported, primarily associated with intravenous immunoglobulins (97.4%). In over half of the cases (51%), the reactions presented as flu-like syndromes. These reactions typically occurred during the first cycle for IV immunoglobulins and the fourth cycl","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 553-560"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Candiduria, is becoming increasingly common among hospitalized and immunocompromised patients. This infection poses a therapeutic challenge due to the rise in fluconazole resistance among Candida species. When fluconazole is unsuitable due to resistance or drug interactions, amphotericin B (AmB) is recommended. However, AmB's systemic use is limited by nephrotoxicity, which has led to interest in intravesical (bladder-administered) AmB.
Methods
A retrospective study was conducted at Reims University Hospital on adult patients treated with intravesical AmB. Patient demographics, infection characteristics, and treatment details were extracted from medical records. Efficacy was determined by the absence of candiduria or rehospitalization, and renal safety was evaluated through serum creatinine and renal clearance before and after treatment. Adverse effects were graded by severity.
Results
Sixteen patients were included (10 female patients (62.5%), mean age 69.8 ± 15 years). Eight patients (50.0%) were admitted in urology department and diabetes mellitus was present in 9 patients (56.2%). Candida glabrata, resistant to fluconazole, was the most frequently isolated organism. Intravesical AmB was administered at a standard dose of 50 mg diluted in 1 liter of sterile water, delivered over 24 hours among almost all patients. Two patients were rehospitalized. Among patients with follow-up urine cultures, 66% (4 out of 6) achieved candiduria eradication. Two patients reported minor adverse effects, including mild catheter-related discomfort. No significant increase of serum creatinine level was observed after treatment.
Discussion and conclusion
Intravesical AmB appear effective and safe for treating fluconazole-resistant candiduria, especially in high-risk, elderly patients. While promising, these findings are based on a small sample, highlighting the need for larger studies with prospective design to further elucidate the optimal management strategies for candiduria in vulnerable patients.
{"title":"Evaluation of efficacy and tolerance of intravesical amphotericin B irrigation for the management of Candiduria","authors":"Zahoua Kartit , Maud Hulin , Dominique Hettler , Antoine Huguenin , Morgane Bonnet , Yohan N’Guyen","doi":"10.1016/j.therap.2025.02.010","DOIUrl":"10.1016/j.therap.2025.02.010","url":null,"abstract":"<div><h3>Introduction</h3><div><span><span>Candiduria, is becoming increasingly common among hospitalized and </span>immunocompromised patients<span>. This infection poses a therapeutic challenge due to the rise in fluconazole resistance among </span></span><em>Candida</em><span><span> species. When fluconazole is unsuitable due to resistance or drug interactions, </span>amphotericin B<span> (AmB) is recommended. However, AmB's systemic use is limited by nephrotoxicity, which has led to interest in intravesical (bladder-administered) AmB.</span></span></div></div><div><h3>Methods</h3><div><span><span>A retrospective study was conducted at Reims University Hospital on adult patients treated with intravesical AmB. Patient demographics, infection characteristics, and treatment details were extracted from medical records. Efficacy was determined by the </span>absence of candiduria or rehospitalization, and renal safety was evaluated through serum creatinine and </span>renal clearance<span> before and after treatment. Adverse effects were graded by severity.</span></div></div><div><h3>Results</h3><div>Sixteen patients were included (10 female patients (62.5%), mean age 69.8<!--> <!-->±<!--> <span>15 years). Eight patients (50.0%) were admitted in urology department and diabetes mellitus was present in 9 patients (56.2%). </span><span><em>Candida glabrata</em></span>, resistant to fluconazole, was the most frequently isolated organism. Intravesical AmB was administered at a standard dose of 50<!--> <!-->mg diluted in 1 liter of sterile water, delivered over 24<!--> <span>hours among almost all patients. Two patients were rehospitalized. Among patients with follow-up urine cultures, 66% (4 out of 6) achieved candiduria eradication. Two patients reported minor adverse effects, including mild catheter-related discomfort. No significant increase of serum creatinine level was observed after treatment.</span></div></div><div><h3>Discussion and conclusion</h3><div>Intravesical AmB appear effective and safe for treating fluconazole-resistant candiduria, especially in high-risk, elderly patients. While promising, these findings are based on a small sample, highlighting the need for larger studies with prospective design to further elucidate the optimal management strategies for candiduria in vulnerable patients.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 598-606"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This study has two main objectives: 1/ to validate the International Classification of Diseases, 10th revision (ICD-10) diagnostic codes of skin ulcer in one French hospital using medical charts; 2/ to validate an out-hospital algorithm against ICD-10 codes using a healthcare database.
Methods
We first validated in-hospital ICD-10 codes for pressure, diabetic and vascular skin ulcers using the Grenoble University Hospital medical charts. Secondly, we assessed the validity of an out-hospital algorithm using dressing reimbursements, medical exams and comorbidities to identify skin ulcers using the French “échantillon généraliste des benéficiaires” database. We then compared the type of skin ulcers in patients hospitalized 1 year around the out-hospital skin ulcer identification date. We calculated specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV).
Results
The performances of ICD-10 codes for identifying patients with vascular, diabetic and pressure ulcers were all superior to 70%. The out-hospital identification of skin ulcers selected very different patients, younger and with less comorbidities than those hospitalized for skin ulcers. In patients hospitalized 1 year before or after the first dispensation of wound dressings, the concordance with ICD-10 codes was modest. Indeed, patients are wrongly classified as pressure ulcers, vascular ulcers and diabetic foot ulcers in respectively 27.7%, 52.0% and 48.8% of skin ulcers.
Conclusion
We found that performances of the in-hospital identification of pressure, vascular and diabetic foot ulcers were high allowing to use them to conduct observational studies in healthcare databases. However, outpatient identification retrieved heterogeneous performance, we therefore advise researchers using the latter to perform a sensitivity analysis restricted to hospitalized patients.
{"title":"Validation of in-hospital diagnosis codes in one French hospital and out-hospital algorithm to identify skin ulcers in healthcare databases in France","authors":"Clément Jambon-Barbara , N’dah Mathieu Ouattara , Claire Bernardeau , Frédéric Olive , Sophie Blaise , Jean-Luc Cracowski , Charles Khouri","doi":"10.1016/j.therap.2025.02.003","DOIUrl":"10.1016/j.therap.2025.02.003","url":null,"abstract":"<div><h3>Purpose</h3><div>This study has two main objectives: 1/ to validate the International Classification of Diseases, 10th revision (ICD-10) diagnostic codes of skin ulcer in one French hospital using medical charts; 2/ to validate an out-hospital algorithm against ICD-10 codes using a healthcare database.</div></div><div><h3>Methods</h3><div>We first validated in-hospital ICD-10 codes for pressure, diabetic and vascular skin ulcers using the Grenoble University Hospital medical charts. Secondly, we assessed the validity of an out-hospital algorithm using dressing reimbursements, medical exams and comorbidities to identify skin ulcers using the French “<em>échantillon généraliste des benéficiaires</em>” database. We then compared the type of skin ulcers in patients hospitalized 1 year around the out-hospital skin ulcer identification date. We calculated specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV).</div></div><div><h3>Results</h3><div>The performances of ICD-10 codes for identifying patients with vascular, diabetic and pressure ulcers were all superior to 70%. The out-hospital identification of skin ulcers selected very different patients, younger and with less comorbidities than those hospitalized for skin ulcers. In patients hospitalized 1 year before or after the first dispensation of wound dressings, the concordance with ICD-10 codes was modest. Indeed, patients are wrongly classified as pressure ulcers, vascular ulcers and diabetic foot ulcers in respectively 27.7%, 52.0% and 48.8% of skin ulcers.</div></div><div><h3>Conclusion</h3><div>We found that performances of the in-hospital identification of pressure, vascular and diabetic foot ulcers were high allowing to use them to conduct observational studies in healthcare databases. However, outpatient identification retrieved heterogeneous performance, we therefore advise researchers using the latter to perform a sensitivity analysis restricted to hospitalized patients.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 5","pages":"Pages 519-525"},"PeriodicalIF":1.8,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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