The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations
Academic Article
Publication Date:
2006
Short description:
The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations / Piscaglia, F., Bolondi, L., Aiani, L., Angeli M., L., 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., A., Crocetti, L., de Sio, I., Drudi, F., et al.. - In: ULTRASOUND IN MEDICINE AND BIOLOGY. - ISSN 0301-5629. - 32:9(2006), pp. 1369-1375. [10.1016/j.ultrasmedbio.2006.05.031]
abstract:
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.
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.
Iris type:
1.1 Articolo in rivista
Keywords:
Adverse effect; Contrast agents; Contrast-enhanced ultrasonography
List of contributors:
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.
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