Contribution of Italian Clinical Research for Contrast Media-Induced Nonrenal Adverse Drug Reactions over the Last Three Decades: A Systematic Review
Maurizio Sessa1,2★, Claudia Rossi3, Annamaria Mascolo1, Antonella Scafuro4, Rosanna Ruggiero1, Gabriella di Mauro1, Salvatore Cappabianca3, Roberto Grassi3, Liberata Sportiello1, Concetta Rafaniello1★ Corresponding author
- 1Department of Experimental Medicine, Campania Pharmacovigilance and Pharmacoepidemiology Regional Centre, Section of Pharmacology “L. Donatelli”, University of Campania “L. Vanvitelli”, Naples, Italy.
- 2Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
- 3Department of Clinical and Experimental Medicine “Magrassi‑Lanzara”, Section of Radiology and Radiotherapy, University of Campania “L. Vanvitelli”, Naples, Italy.
- 4Department of Experimental Medicine, University of Campania “L. Vanvitelli”, Naples, Italy.
CORRESPONDENCE
Maurizio Sessa
Department of Experimental Medicine, Campania Pharmacovigilance and Pharmacoepidemiology Regional Centre, Section of Pharmacology “L. Donatelli”, University of Campania “L. Vanvitelli”, Naples, Italy.
Received: 09-07-2018; Revised: 25-08-2018; Accepted: 03-10-2018.
Volume 9, Issue 3 · pp. 131–146 · PUBLISHED 2018 · DOI: 10.4103/jpp.JPP_92_18
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ABSTRACT
The aim of this study was to investigate the scientific contribution of Italian clinical research for contrast media‑induced nonrenal adverse drug reactions over the last three decades. Ovid Embase, Ovid MEDLINE, Web of Science, and Cochrane Methodology Register were used as data sources to identify Italian descriptive studies, observational studies, meta‑analyses, and clinical trials assessing contrast media‑induced nonrenal adverse drug reactions as a safety outcome. The population of interest was men and women exposed to a contrast medium. Between 1990 and 2017, 24 original articles investigating contrast‑induced nonrenal adverse drug reactions were identified. The cohort study was the most representative study design (10/24; 41.7%). The 24 studies were conducted mainly as monocenter studies (14/24; 58.3%) and without receiving funding (17/24; 70.8%). Seventeen out of 24 studies provided a level of evidence ranging from III‑2 (11/24; 45.8%) to IV (6/24; 25.0%) on a Merlin scale. In total, 14 of 24 (58.3%) studies were published in a scientific journal ranked in the first quartile of their subject area. The 24 original articles mainly focused on adverse drug reactions already observed during clinical trials (i.e., idiosyncratic systemic reactions). In conclusion, during the last three decades and a burst was not observed in the Italian clinical research investigating contrast-induced nonrenal adverse drug reactions. High‑quality clinical research is needed especially for procedures to prevent the onset of the aforementioned events, to identify risk factors, to minimize the risk of their occurrence, and to optimize their related prognosis.
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Sessa, M., Rossi, C., Mascolo, A., Scafuro, A., Ruggiero, R., Mauro, G. D., Cappabianca, S., Grassi, R., Sportiello, L., & Rafaniello, C. (2018). Contribution of Italian Clinical Research for Contrast Media-Induced Nonrenal Adverse Drug Reactions over the Last Three Decades: A Systematic Review. Journal of Pharmacology and Pharmacotherapeutics, 9(3), 131–146. https://doi.org/10.4103/jpp.JPP_92_18
