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

Fabio Piscaglia; Luigi Bolondi; L. Aiani; M. Luigi Angeli; V. Arienti; L. Barozzi; R. Basilico; M. Bertolotto; E. Biasini; P. Busilacchi; F. Calliada; M. Caremani; E. Caturelli; N. Celli; A. Colecchia; L. Cova; M. Assunta Cova; L. Crocetti; I. de Sio; F. Drudi; G. Ferraioli; C. Filice; F. Fornari; S. Gaiani; F. Giangregorio; A. Giorgio; T. Ierace; R. Lencioni; T. Livraghi; F. Magnolfi; A. Martegani; F. Meloni; G. Menozzi; G. Pelosi; M. Pompili; L. Riccardi; P. Ricci; L. Rubaltelli; D. Sacerdoti; G. Serafini; C. Serra; L. Solbiati; D. Tacconi; M. Valentino; G. Vidili; F. Vitali

doi:10.1016/j.ultrasmedbio.2006.05.031

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

Fabio Piscaglia, Luigi Bolondi, L. Aiani, M. Luigi Angeli, V. Arienti, L. Barozzi, R. Basilico, M. Bertolotto, E. Biasini, P. Busilacchi, F. Calliada, M. Caremani, E. Caturelli, N. Celli, A. Colecchia, L. Cova, M. Assunta Cova, L. Crocetti, I. de Sio, F. DrudiG. Ferraioli, C. Filice, F. Fornari, S. Gaiani, F. Giangregorio, A. Giorgio, T. Ierace, R. Lencioni, T. Livraghi, F. Magnolfi, A. Martegani, F. Meloni, G. Menozzi, G. Pelosi, M. Pompili, L. Riccardi, P. Ricci, L. Rubaltelli, D. Sacerdoti, G. Serafini, C. Serra, L. Solbiati, D. Tacconi, M. Valentino, G. Vidili, F. Vitali

Research output: Contribution to journal › Article › peer-review

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. (E-mail: Piscagl@med.unibo.it).

Original language	English
Pages (from-to)	1369-1375
Number of pages	7
Journal	Ultrasound in Medicine and Biology
Volume	32
Issue number	9
DOIs	https://doi.org/10.1016/j.ultrasmedbio.2006.05.031
Publication status	Published - Sep 2006

Keywords

Adverse effect
Contrast agents
Contrast-enhanced ultrasonography
Ultrasound

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

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Piscaglia, F., Bolondi, L., Aiani, L., Luigi Angeli, M., Arienti, V., Barozzi, L., Basilico, R., Bertolotto, M., Biasini, E., Busilacchi, P., Calliada, F., Caremani, M., Caturelli, E., Celli, N., Colecchia, A., Cova, L., Assunta Cova, M., Crocetti, L., de Sio, I., ... Vitali, F. (2006). The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations. Ultrasound in Medicine and Biology, 32(9), 1369-1375. https://doi.org/10.1016/j.ultrasmedbio.2006.05.031

The safety of Sonovue® in abdominal applications : Retrospective analysis of 23188 investigations. / Piscaglia, Fabio; Bolondi, Luigi; Aiani, L.; Luigi Angeli, M.; Arienti, V.; Barozzi, L.; Basilico, R.; Bertolotto, M.; Biasini, E.; Busilacchi, P.; Calliada, F.; Caremani, M.; Caturelli, E.; Celli, N.; Colecchia, A.; Cova, L.; Assunta Cova, M.; 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, G.; Vitali, F.

In: Ultrasound in Medicine and Biology, Vol. 32, No. 9, 09.2006, p. 1369-1375.

Research output: Contribution to journal › Article › peer-review

Piscaglia, F, Bolondi, L, Aiani, L, Luigi Angeli, M, Arienti, V, Barozzi, L, Basilico, R, Bertolotto, M, Biasini, E, Busilacchi, P, Calliada, F, Caremani, M, Caturelli, E, Celli, N, Colecchia, A, Cova, L, Assunta Cova, M, 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, G & Vitali, F 2006, 'The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations', Ultrasound in Medicine and Biology, vol. 32, no. 9, pp. 1369-1375. https://doi.org/10.1016/j.ultrasmedbio.2006.05.031

Piscaglia, Fabio ; Bolondi, Luigi ; Aiani, L. ; Luigi Angeli, M. ; Arienti, V. ; Barozzi, L. ; Basilico, R. ; Bertolotto, M. ; Biasini, E. ; Busilacchi, P. ; Calliada, F. ; Caremani, M. ; Caturelli, E. ; Celli, N. ; Colecchia, A. ; Cova, L. ; Assunta Cova, M. ; 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, G. ; Vitali, F. / The safety of Sonovue® in abdominal applications : Retrospective analysis of 23188 investigations. In: Ultrasound in Medicine and Biology. 2006 ; Vol. 32, No. 9. pp. 1369-1375.

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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{\textregistered} (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. (E-mail: Piscagl@med.unibo.it).",

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AU - Piscaglia, Fabio

AU - Bolondi, Luigi

AU - Aiani, L.

AU - Luigi Angeli, M.

AU - Arienti, V.

AU - Barozzi, L.

AU - Basilico, R.

AU - Bertolotto, M.

AU - Biasini, E.

AU - Busilacchi, P.

AU - Calliada, F.

AU - Caremani, M.

AU - Caturelli, E.

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AU - Assunta Cova, M.

AU - Crocetti, L.

AU - de Sio, I.

AU - Drudi, F.

AU - Ferraioli, G.

AU - Filice, C.

AU - Fornari, F.

AU - Gaiani, S.

AU - Giangregorio, F.

AU - Giorgio, A.

AU - Ierace, T.

AU - Lencioni, R.

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AU - Magnolfi, F.

AU - Martegani, A.

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AU - Menozzi, G.

AU - Pelosi, G.

AU - Pompili, M.

AU - Riccardi, L.

AU - Ricci, P.

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AU - Tacconi, D.

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AU - Vidili, G.

AU - Vitali, F.

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