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 language | Italian |
|---|---|
| Pages (from-to) | 411-415 |
| Number of pages | 5 |
| Journal | Clinica Terapeutica |
| Volume | 151 |
| Issue number | 6 |
| Publication status | Published - 2000 |
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ASJC Scopus subject areas
- Medicine(all)
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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 journal › Article
}
TY - JOUR
T1 - Relazione di causalità delle reazioni avverse a farmaci
T2 - Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV
AU - Bonfanti, P.
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
Y1 - 2000
N2 - 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.
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.
KW - Cohort study
KW - HIV
KW - Pharmacovigilance
UR - http://www.scopus.com/inward/record.url?scp=0040620284&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0040620284&partnerID=8YFLogxK
M3 - Articolo
C2 - 11211474
AN - SCOPUS:0040620284
VL - 151
SP - 411
EP - 415
JO - Clinica Terapeutica
JF - Clinica Terapeutica
SN - 0009-9074
IS - 6
ER -