The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents.

Adverse effect, Contrast agents, Contrast-enhanced ultrasonography, Ultrasound

The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations / Piscaglia, F; Bolondi, L; Aiani, L; Angeli M., Luigi; Arienti, V; Barozzi, L; Basilico, R; Bertolotto, M; Biasini, E; Busilacchi, P; Calliada, F; Caremani, M; Caturelli, E; Celli, N; Colecchia, A; Cova, L; Cova M., Assunta; Crocetti, L; de Sio, I; Drudi, F; Ferraioli, G; Filice, C; Fornari, F; Gaiani, S; Giangregorio, F; Giorgio, A; Ierace, T; Lencioni, R; Livraghi, T; Magnolfi, F; Martegani, A; Meloni, F; Menozzi, G; Pelosi, G; Pompili, M; Riccardi, L; Ricci, P; Rubaltelli, L; Sacerdoti, D; Serafini, G; Serra, C; Solbiati, L; Tacconi, D; Valentino, M; Vidili, Gianpaolo; Vitali, F.. - In: ULTRASOUND IN MEDICINE AND BIOLOGY. - ISSN 0301-5629. - 32:9(2006), pp. 1369-1375. [10.1016/j.ultrasmedbio.2006.05.031]

The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations

VIDILI, Gianpaolo;
2006

Abstract

Adverse effect, Contrast agents, Contrast-enhanced ultrasonography, Ultrasound
The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue® (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents.
The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations / Piscaglia, F; Bolondi, L; Aiani, L; Angeli M., Luigi; Arienti, V; Barozzi, L; Basilico, R; Bertolotto, M; Biasini, E; Busilacchi, P; Calliada, F; Caremani, M; Caturelli, E; Celli, N; Colecchia, A; Cova, L; Cova M., Assunta; Crocetti, L; de Sio, I; Drudi, F; Ferraioli, G; Filice, C; Fornari, F; Gaiani, S; Giangregorio, F; Giorgio, A; Ierace, T; Lencioni, R; Livraghi, T; Magnolfi, F; Martegani, A; Meloni, F; Menozzi, G; Pelosi, G; Pompili, M; Riccardi, L; Ricci, P; Rubaltelli, L; Sacerdoti, D; Serafini, G; Serra, C; Solbiati, L; Tacconi, D; Valentino, M; Vidili, Gianpaolo; Vitali, F.. - In: ULTRASOUND IN MEDICINE AND BIOLOGY. - ISSN 0301-5629. - 32:9(2006), pp. 1369-1375. [10.1016/j.ultrasmedbio.2006.05.031]
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11388/46252
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