Relazione di causalità delle reazioni avverse a farmaci: Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV

Translated title of the contribution: Cause and effect relationship of drug adverse events: Our experience using protease inhibitors of HIV

P. Bonfanti, L. Valsecchi, F. Parazzini, S. Carradori, L. Pusterla, P. Fortuna, L. Timillero, F. Alessi, G. Ghiselli, A. Gabbuti, E. Ricci, C. Martinelli, I. Faggion, S. Landonio, T. Quirino

Research output: Contribution to journalArticle

Abstract

Purpose: To establish the exact cause and effect relationship between protease inhibitors (PIs) and adverse events. Materials and Method: Prospective, cohort, multicenter study on HIV-positive patients who are beginning treatment with a PI. Causal relationships are evaluated using the RUCAM algorithm. Results: Since the beginning of the study 1207 patients have been enrolled. Average time of observation is 10.7 months. To date, 784 adverse events have been observed, distributed as follows: excluded 3.8%, improbable 18.5%, possible 41.3%, probable 30.1%, and highly probable 6.3%. Saquinavir shows a statistically significant difference in the rate of non-correlated events with respect to other groups. Conclusions: Over 20% of adverse events during PI treatment are shown to be non-correlated to these drugs. Saquinavir shows the highest rate of non-correlated events.

Original languageItalian
Pages (from-to)411-415
Number of pages5
JournalClinica Terapeutica
Volume151
Issue number6
Publication statusPublished - 2000

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HIV Protease Inhibitors
Protease Inhibitors
Drug-Related Side Effects and Adverse Reactions
Saquinavir
Multicenter Studies
Cohort Studies
Observation
HIV
Therapeutics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Bonfanti, P., Valsecchi, L., Parazzini, F., Carradori, S., Pusterla, L., Fortuna, P., ... Quirino, T. (2000). Relazione di causalità delle reazioni avverse a farmaci: Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV. Clinica Terapeutica, 151(6), 411-415.

Relazione di causalità delle reazioni avverse a farmaci : Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV. / Bonfanti, P.; Valsecchi, L.; Parazzini, F.; Carradori, S.; Pusterla, L.; Fortuna, P.; Timillero, L.; Alessi, F.; Ghiselli, G.; Gabbuti, A.; Ricci, E.; Martinelli, C.; Faggion, I.; Landonio, S.; Quirino, T.

In: Clinica Terapeutica, Vol. 151, No. 6, 2000, p. 411-415.

Research output: Contribution to journalArticle

Bonfanti, P, Valsecchi, L, Parazzini, F, Carradori, S, Pusterla, L, Fortuna, P, Timillero, L, Alessi, F, Ghiselli, G, Gabbuti, A, Ricci, E, Martinelli, C, Faggion, I, Landonio, S & Quirino, T 2000, 'Relazione di causalità delle reazioni avverse a farmaci: Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV', Clinica Terapeutica, vol. 151, no. 6, pp. 411-415.
Bonfanti, P. ; Valsecchi, L. ; Parazzini, F. ; Carradori, S. ; Pusterla, L. ; Fortuna, P. ; Timillero, L. ; Alessi, F. ; Ghiselli, G. ; Gabbuti, A. ; Ricci, E. ; Martinelli, C. ; Faggion, I. ; Landonio, S. ; Quirino, T. / Relazione di causalità delle reazioni avverse a farmaci : Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV. In: Clinica Terapeutica. 2000 ; Vol. 151, No. 6. pp. 411-415.
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AU - Valsecchi, L.

AU - Parazzini, F.

AU - Carradori, S.

AU - Pusterla, L.

AU - Fortuna, P.

AU - Timillero, L.

AU - Alessi, F.

AU - Ghiselli, G.

AU - Gabbuti, A.

AU - Ricci, E.

AU - Martinelli, C.

AU - Faggion, I.

AU - Landonio, S.

AU - Quirino, T.

PY - 2000

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AB - Purpose: To establish the exact cause and effect relationship between protease inhibitors (PIs) and adverse events. Materials and Method: Prospective, cohort, multicenter study on HIV-positive patients who are beginning treatment with a PI. Causal relationships are evaluated using the RUCAM algorithm. Results: Since the beginning of the study 1207 patients have been enrolled. Average time of observation is 10.7 months. To date, 784 adverse events have been observed, distributed as follows: excluded 3.8%, improbable 18.5%, possible 41.3%, probable 30.1%, and highly probable 6.3%. Saquinavir shows a statistically significant difference in the rate of non-correlated events with respect to other groups. Conclusions: Over 20% of adverse events during PI treatment are shown to be non-correlated to these drugs. Saquinavir shows the highest rate of non-correlated events.

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KW - HIV

KW - Pharmacovigilance

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