Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study
Background: Gemcitabine is a nucleoside analog, widely used either alone or in combination, for the treatment of multiple cancers. However, gemcitabine may also be associated with cardiovascular adverse-drug-reactions (CV-ADR). Methods: First, we searched for all cases of cardiotoxicity associated w...
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MDPI AG
2020-10-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/13/10/325 |
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| author | Marc Hilmi Stéphane Ederhy Xavier Waintraub Christian Funck-Brentano Ariel Cohen Aurore Vozy Bénédicte Lebrun-Vignes Javid Moslehi Lee S. Nguyen Joe-Elie Salem |
| author_facet | Marc Hilmi Stéphane Ederhy Xavier Waintraub Christian Funck-Brentano Ariel Cohen Aurore Vozy Bénédicte Lebrun-Vignes Javid Moslehi Lee S. Nguyen Joe-Elie Salem |
| author_sort | Marc Hilmi |
| collection | DOAJ |
| description | Background: Gemcitabine is a nucleoside analog, widely used either alone or in combination, for the treatment of multiple cancers. However, gemcitabine may also be associated with cardiovascular adverse-drug-reactions (CV-ADR). Methods: First, we searched for all cases of cardiotoxicity associated with gemcitabine, published in MEDLINE on 30 May 2019. Then, we used VigiBase, the World Health Organization’s global database of individual case safety reports, to compare CV-ADR reporting associated with gemcitabine against the full database between inception and 1 April 2019. We used the information component (IC), an indicator value for disproportionate Bayesian reporting. A positive lower end of the 95% credibility interval for the IC (IC<sub>025</sub>) ≥ 0, is deemed significant. Results: In VigiBase, 46,898 reports were associated with gemcitabine on a total of 18,908,940 in the full database. Gemcitabine was associated with higher reporting for myocardial ischemia (MI, n: 119), pericardial diseases (n: 164), supraventricular arrhythmias (SVA, n: 308) and heart failure (HF, n: 484) versus full database with IC<sub>025</sub> ranging between 0.40 and 2.81. CV-ADR were associated with cardiovascular death in up to 17% of cases. Conclusion: Treatment with gemcitabine is associated with potentially lethal CV-ADRs, including MI, pericardial diseases, SVA and HF. These events should be considered in patient care and clinical trial design. |
| first_indexed | 2024-03-10T15:27:36Z |
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| language | English |
| last_indexed | 2024-03-10T15:27:36Z |
| publishDate | 2020-10-01 |
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| series | Pharmaceuticals |
| spelling | doaj.art-76b7f0dd77b44712ab43a212061e38ee2023-11-20T17:57:28ZengMDPI AGPharmaceuticals1424-82472020-10-01131032510.3390/ph13100325Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance StudyMarc Hilmi0Stéphane Ederhy1Xavier Waintraub2Christian Funck-Brentano3Ariel Cohen4Aurore Vozy5Bénédicte Lebrun-Vignes6Javid Moslehi7Lee S. Nguyen8Joe-Elie Salem9Department of Pharmacology, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, INSERM CIC-1901, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Cardiology, Saint-Antoine Hospital, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Cardiology, Pitié-Salpêtrière Hospital, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Pharmacology, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, INSERM CIC-1901, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Cardiology, Saint-Antoine Hospital, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Pharmacology, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, INSERM CIC-1901, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Pharmacology, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, INSERM CIC-1901, Sorbonne Université, AP-HP, 75006 Paris, FranceDivision of Cardiovascular Medicine, Cardio-Oncology Program, Vanderbilt University Medical Center, Nashville, TN 37232, USADepartment of Pharmacology, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, INSERM CIC-1901, Sorbonne Université, AP-HP, 75006 Paris, FranceDepartment of Pharmacology, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, INSERM CIC-1901, Sorbonne Université, AP-HP, 75006 Paris, FranceBackground: Gemcitabine is a nucleoside analog, widely used either alone or in combination, for the treatment of multiple cancers. However, gemcitabine may also be associated with cardiovascular adverse-drug-reactions (CV-ADR). Methods: First, we searched for all cases of cardiotoxicity associated with gemcitabine, published in MEDLINE on 30 May 2019. Then, we used VigiBase, the World Health Organization’s global database of individual case safety reports, to compare CV-ADR reporting associated with gemcitabine against the full database between inception and 1 April 2019. We used the information component (IC), an indicator value for disproportionate Bayesian reporting. A positive lower end of the 95% credibility interval for the IC (IC<sub>025</sub>) ≥ 0, is deemed significant. Results: In VigiBase, 46,898 reports were associated with gemcitabine on a total of 18,908,940 in the full database. Gemcitabine was associated with higher reporting for myocardial ischemia (MI, n: 119), pericardial diseases (n: 164), supraventricular arrhythmias (SVA, n: 308) and heart failure (HF, n: 484) versus full database with IC<sub>025</sub> ranging between 0.40 and 2.81. CV-ADR were associated with cardiovascular death in up to 17% of cases. Conclusion: Treatment with gemcitabine is associated with potentially lethal CV-ADRs, including MI, pericardial diseases, SVA and HF. These events should be considered in patient care and clinical trial design.https://www.mdpi.com/1424-8247/13/10/325gemcitabinepericarditismyocardial ischemiaheart failurearrhythmiascardio-oncology |
| spellingShingle | Marc Hilmi Stéphane Ederhy Xavier Waintraub Christian Funck-Brentano Ariel Cohen Aurore Vozy Bénédicte Lebrun-Vignes Javid Moslehi Lee S. Nguyen Joe-Elie Salem Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study Pharmaceuticals gemcitabine pericarditis myocardial ischemia heart failure arrhythmias cardio-oncology |
| title | Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study |
| title_full | Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study |
| title_fullStr | Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study |
| title_full_unstemmed | Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study |
| title_short | Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study |
| title_sort | cardiotoxicity associated with gemcitabine literature review and a pharmacovigilance study |
| topic | gemcitabine pericarditis myocardial ischemia heart failure arrhythmias cardio-oncology |
| url | https://www.mdpi.com/1424-8247/13/10/325 |
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