29 results on '"Timillero, A."'
Search Results
2. A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia
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Bianca Rocca, Francesca Palandri, Giovanna Petrucci, Chiara Paoli, Cristina Bucelli, Benedetta Porro, Nicola Vianelli, Francesco Rodeghiero, Elena Rossi, Alessandra Iurlo, Carlo Patrono, Irene Bertozzi, Alessandro M. Vannucchi, Maria Luigia Randi, Andrea Timillero, Monica Carpenedo, Mauro Di Ianni, Giuseppe Carli, Alfredo Dragani, Silvia Betti, Denise Soldati, Elena Maria Elli, Eloise Beggiato, Valerio De Stefano, Daniele Cattaneo, Giuseppe Lanzarone, Alberto Tosetto, Viviana Cavalca, Marco Ruggeri, Giorgina Specchia, Alessandra Ricco, and Paola Ranalli
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Adult ,medicine.medical_specialty ,Randomization ,Immunology ,030204 cardiovascular system & hematology ,Biochemistry ,Gastroenterology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,Antithrombotic ,medicine ,Humans ,Cyclooxygenase Inhibitors ,Platelet ,Platelet activation ,Aged ,Aspirin ,Essential thrombocythemia ,business.industry ,Cell Biology ,Hematology ,Middle Aged ,medicine.disease ,Epoprostenol ,Thromboxane B2 ,Regimen ,chemistry ,030220 oncology & carcinogenesis ,Cyclooxygenase 1 ,business ,Platelet Aggregation Inhibitors ,Thrombocythemia, Essential ,medicine.drug - Abstract
Essential thrombocythemia (ET) is characterized by abnormal megakaryopoiesis and enhanced thrombotic risk. Once-daily low-dose aspirin is the recommended antithrombotic regimen, but accelerated platelet generation may reduce the duration of platelet cyclooxygenase-1 (COX-1) inhibition. We performed a multicenter double-blind trial to investigate the efficacy of 3 aspirin regimens in optimizing platelet COX-1 inhibition while preserving COX-2–dependent vascular thromboresistance. Patients on chronic once-daily low-dose aspirin (n = 245) were randomized (1:1:1) to receive 100 mg of aspirin 1, 2, or 3 times daily for 2 weeks. Serum thromboxane B2 (sTXB2), a validated biomarker of platelet COX-1 activity, and urinary prostacyclin metabolite (PGIM) excretion were measured at randomization and after 2 weeks, as primary surrogate end points of efficacy and safety, respectively. Urinary TX metabolite (TXM) excretion, gastrointestinal tolerance, and ET-related symptoms were also investigated. Evaluable patients assigned to the twice-daily and thrice-daily regimens showed substantially reduced interindividual variability and lower median (interquartile range) values for sTXB2 (ng/mL) compared with the once-daily arm: 4 (2.1-6.7; n = 79), 2.5 (1.4-5.65, n = 79), and 19.3 (9.7-40; n = 85), respectively. Urinary PGIM was comparable in the 3 arms. Urinary TXM was reduced by 35% in both experimental arms. Patients in the thrice-daily arm reported a higher abdominal discomfort score. In conclusion, the currently recommended aspirin regimen of 75 to 100 once daily for cardiovascular prophylaxis appears to be largely inadequate in reducing platelet activation in the vast majority of patients with ET. The antiplatelet response to low-dose aspirin can be markedly improved by shortening the dosing interval to 12 hours, with no improvement with further reductions (EudraCT 2016-002885-30).
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- 2020
3. Association of Platelet Thromboxane Inhibition by Low-Dose Aspirin With Platelet Count and Cytoreductive Therapy in Essential Thrombocythemia
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Giuseppe Gaetano Loscocco, Daniele Cattaneo, Alfredo Dragani, Maria Luigia Randi, Francesco Rodeghiero, Elena Rossi, Carlo Patrono, Andrea Timillero, Alessandro M. Vannucchi, Paola Ranalli, Mauro Di Ianni, Giuseppe Carli, Cristina Bucelli, Francesca Palandri, Giovanna Petrucci, Alessandra Iurlo, Eloise Beggiato, Silvia Betti, Denise Soldati, Valerio De Stefano, Benedetta Porro, Alessandra Ricco, Irene Bertozzi, Giorgina Specchia, Marco Ruggeri, Giuseppe Lanzarone, Viviana Cavalca, Stefania Priolo, Bianca Rocca, Elena Maria Elli, Aspirin Regimens in EsSential thrombocythemia (Ares) Investigators, Nicola Vianelli, and Alberto Tosetto
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medicine.medical_specialty ,Thromboxane ,Gastroenterology ,Essential ,Internal medicine ,medicine ,Humans ,Thrombocythemia ,Pharmacology (medical) ,Platelet ,Dosing ,Myeloproliferative neoplasm ,Pharmacology ,Aspirin ,biology ,Essential thrombocythemia ,business.industry ,Platelet Count ,Thromboxanes ,Cytoreduction Surgical Procedures ,medicine.disease ,Settore MED/15 - MALATTIE DEL SANGUE ,Regimen ,biology.protein ,Cyclooxygenase ,business ,Platelet Aggregation Inhibitors ,medicine.drug ,Thrombocythemia, Essential - Abstract
Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterized by enhanced platelet production and thrombotic complications. The inhibition of platelet cyclooxygenase (COX) activity by the standard once-daily aspirin is mostly incomplete due to accelerated thrombopoiesis. The phase II Aspirin Regimens in EsSential thrombocythemia (ARES) trial has recently compared the efficacy of once- vs. twice- or three-times daily low-dose aspirin in inhibiting platelet thromboxane (TX) A2 production, as reflected by serum (s) TXB2 measurements. The present substudy characterized the determinants of the highly variable response to the standard aspirin 100 mg once-daily regimen in fully compliant patients with ET and the effects of the experimental dosing regimens on response variability. By multivariable analysis, the platelet count (directly) and cytoreductive treatment (inversely) were significantly associated with sTXB2 values in 218 patients with ET. However, the platelet count positively correlated with sTXB2 in patients not being treated with cytoreductive drugs (ρ = 0.51, P
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- 2021
4. Prevalence and Risk Factors for Nosocomial Infections in Hospitals of the Veneto Region, North-Eastern Italy
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Pellizzer, G., Mantoan, P., Timillero, L., Allegranzi, B., Fedeli, U., Schievano, E., Benedetti, P., Saia, M., Sax, H., and Spolaore, P.
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- 2008
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5. Association of Platelet Thromboxane Inhibition by Low‐Dose Aspirin With Platelet Count and Cytoreductive Therapy in Essential Thrombocythemia.
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Tosetto, Alberto, Rocca, Bianca, Petrucci, Giovanna, Betti, Silvia, Soldati, Denise, Rossi, Elena, Timillero, Andrea, Cavalca, Viviana, Porro, Benedetta, Iurlo, Alessandra, Cattaneo, Daniele, Bucelli, Cristina, Dragani, Alfredo, Di Ianni, Mauro, Ranalli, Paola, Palandri, Francesca, Vianelli, Nicola, Beggiato, Eloise, Lanzarone, Giuseppe, and Ruggeri, Marco
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ASPIRIN ,BLOOD platelets ,THROMBOCYTOSIS ,MYELOPROLIFERATIVE neoplasms ,GENE frequency ,BLOOD platelet aggregation ,PLATELET count ,OLDER patients - Abstract
Essential thrombocythemia (ET) is a myeloproliferative neoplasm characterized by enhanced platelet production and thrombotic complications. The inhibition of platelet cyclooxygenase (COX) activity by the standard once‐daily aspirin is mostly incomplete due to accelerated thrombopoiesis. The phase II Aspirin Regimens in EsSential thrombocythemia (ARES) trial has recently compared the efficacy of once‐ vs. twice‐ or three‐times daily low‐dose aspirin in inhibiting platelet thromboxane (TX) A2 production, as reflected by serum (s) TXB2 measurements. The present substudy characterized the determinants of the highly variable response to the standard aspirin 100 mg once‐daily regimen in fully compliant patients with ET and the effects of the experimental dosing regimens on response variability. By multivariable analysis, the platelet count (directly) and cytoreductive treatment (inversely) were significantly associated with sTXB2 values in 218 patients with ET. However, the platelet count positively correlated with sTXB2 in patients not being treated with cytoreductive drugs (ρ = 0.51, P < 0.01, n = 84), but not in patients on cytoreduction. Patients in the lowest sTXB2 quartile were older, more often on cytoreductive drugs, had lower platelet count and Janus‐Associated Kinase2 (JAK2)‐V617F allele frequency as compared with patients in the upper sTXB2 quartiles. After 2 weeks of a twice‐ or 3‐times daily aspirin regimen, the association between the platelet count and sTXB2 became similar in cytoreduced and non‐cytoreduced patients. In conclusion, the platelet count appears the strongest determinant of TXA2 inhibition by once‐daily low‐dose aspirin in ET, with different patterns depending of cytoreductive treatment. More frequent aspirin dosing restores adequate platelet inhibition and reduces interindividual variability, independently of cytoreduction. [ABSTRACT FROM AUTHOR]
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- 2022
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6. A randomized, double-blind trial of three aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia
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Rocca, Bianca, Tosetto, Alberto, Betti, Silvia, Soldati, Denise, Petrucci, Giovanna, Rossi, Elena, Timillero, Andrea, Cavalca, Viviana, Porro, Benedetta, Iurlo, Alessandra, Cattaneo, Daniele, Bucelli, Cristina, Dragani, Alfredo, Di Ianni, Mauro, Ranalli, Paola, Palandri, Francesca, Vianelli, Nicola, Beggiato, Eloise, Lanzarone, Giuseppe, Ruggeri, Marco, Carli, Giuseppe, Elli, Elena Maria, Carpenedo, Monica, Bertozzi, Irene, Paoli, Chiara, Randi, Maria L, Ricco, Alessandra, Specchia, Giorgina, Vannucchi, Alessandro Maria, Rodeghiero, Francesco, Patrono, Carlo, and De Stefano, Valerio
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Settore MED/15 - MALATTIE DEL SANGUE ,essential thrombocythemia ,Settore BIO/14 - FARMACOLOGIA - Published
- 2020
7. A randomized double-blind trial of 3 aspirin regimens to optimize antiplatelet therapy in essential thrombocythemia
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Rocca, Bianca, primary, Tosetto, Alberto, primary, Betti, Silvia, primary, Soldati, Denise, primary, Petrucci, Giovanna, primary, Rossi, Elena, primary, Timillero, Andrea, primary, Cavalca, Viviana, primary, Porro, Benedetta, primary, Iurlo, Alessandra, primary, Cattaneo, Daniele, primary, Bucelli, Cristina, primary, Dragani, Alfredo, primary, Di Ianni, Mauro, primary, Ranalli, Paola, primary, Palandri, Francesca, primary, Vianelli, Nicola, primary, Beggiato, Eloise, primary, Lanzarone, Giuseppe, primary, Ruggeri, Marco, primary, Carli, Giuseppe, primary, Elli, Elena Maria, primary, Carpenedo, Monica, primary, Randi, Maria Luigia, primary, Bertozzi, Irene, primary, Paoli, Chiara, primary, Specchia, Giorgina, primary, Ricco, Alessandra, primary, Vannucchi, Alessandro Maria, primary, Rodeghiero, Francesco, primary, Patrono, Carlo, primary, and De Stefano, Valerio, primary
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- 2020
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8. Incidence of adverse reactions in HIV patients treated with protease inhibitors: a cohort study
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Bonfanti, Paolo, Valsecchi, Laura, Parazzini, Fabio, Carradori, Silvia, Pusterla, Luigi, Fortuna, Paolo, Timillero, Lia, Alessi, Federica, Ghiselli, Giancarlo, Gabbuti, Andrea, Di Cintio, Elisabetta, Martinelli, Canio, Faggion, Ivano, Landonio, Simona, and Quirino, Tiziana
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Ritonavir -- Adverse and side effects ,Protease inhibitors -- Adverse and side effects ,Health - Abstract
The protease inhibitor ritonavir appears to have more side effects than other protease inhibitors, according to a study of 1,207 patients who were taking a protease inhibitor. Saquinavir HGC and nelfinavir had the fewest side effects.
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- 2000
9. Linkage of microbiology reports and hospital discharge diagnoses for surveillance of surgical site infections
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Spolaore, P., Pellizzer, G., Fedeli, U., Schievano, E., Mantoan, P., Timillero, L., and Saia, M.
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- 2005
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10. Prevalence and risk factors for nosocomial infections in 19 hospitals of Veneto Region (Italy)
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Pellizzer, G., Timillero, L., Mantoan, P., Allegranzi, B., Saia, M., Benedetti, P., Pegoraro, E., and Spolaore, P.
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- 2004
11. A computerised system of administrative data for nosocomial infection monitoring
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Saia, M., Timillero, L., Mantoan, P., Allegranzi, B., Pellizzer, G., and Spolaore, P.
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- 2004
12. Regional and systemic prophylaxis with teicoplanin in total knee arthroplasty A tissue penetration study
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Lazzarini, Luca, Novelli, Andrea, Marzano, Nicola, Timillero, Lia, Fallani, Stefania, Viola, Renato, and de Lalla, Fausto
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- 2003
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13. Risk factors for lipodystrophy in the CISAI cohort
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Bonfanti, Paolo, Gulisano, Cecilia, Ricci, Elena, Timillero, Lia, Valsecchi, Laura, Carradori, Silvia, Pusterla, Luigi, Fortuna, Paolo, Miccolis, Sebastiano, Magnani, Carlo, Gabbuti, Andrea, Parazzini, Fabio, Martinelli, Canio, Faggion, Ivano, Landonio, Simona, Quirino, Tiziana, and Vigevani, GianMarco
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- 2003
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14. The Aspirin Regimens in Essential Thrombocythemia (ARES) phase II randomized trial design: Implementation of the serum thromboxane B
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Valerio, De Stefano, Bianca, Rocca, Alberto, Tosetto, Denise, Soldati, Giovanna, Petrucci, Eloise, Beggiato, Irene, Bertozzi, Silvia, Betti, Giuseppe, Carli, Monica, Carpenedo, Daniele, Cattaneo, Viviana, Cavalca, Alfredo, Dragani, Elena, Elli, Guido, Finazzi, Alessandra, Iurlo, Giuseppe, Lanzarone, Laura, Lissandrini, Francesca, Palandri, Chiara, Paoli, Alessandro, Rambaldi, Paola, Ranalli, Maria Luigia, Randi, Alessandra, Ricco, Elena, Rossi, Marco, Ruggeri, Giorgina, Specchia, Andrea, Timillero, Linda, Turnu, Nicola, Vianelli, Alessandro M, Vannucchi, Francesco, Rodeghiero, and Carlo, Patrono
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Male ,Aspirin ,Patient Selection ,Disease Management ,Thrombosis ,Article ,Thromboxane B2 ,Clinical Protocols ,Research Design ,Humans ,Female ,Biomarkers ,Platelet Aggregation Inhibitors ,Thrombocythemia, Essential - Abstract
Once-daily (od), low-dose aspirin (75–100 mg) is recommended to reduce the thrombotic risk of patients with essential thrombocytemia (ET). This practice is based on data extrapolated from other high-risk patients and an aspirin trial in polycythemia vera, with the assumption of similar aspirin pharmacodynamics in the two settings. However, the pharmacodynamics of low-dose aspirin is impaired in ET, reflecting accelerated renewal of platelet cyclooxygenase (COX)-1. ARES is a parallel-arm, placebo-controlled, randomized, dose-finding, phase II trial enrolling 300 ET patients to address two main questions. First, whether twice or three times 100 mg aspirin daily dosing is superior to the standard od regimen in inhibiting platelet thromboxane (TX)A2 production, without inhibiting vascular prostacyclin biosynthesis. Second, whether long-term persistence of superior biochemical efficacy can be safely maintained with multiple vs. single dosing aspirin regimen. Considering that the primary study end point is serum TXB2, a surrogate biomarker of clinical efficacy, a preliminary exercise of reproducibility and validation of this biomarker across all the 11 participating centers was implemented. The results of this preliminary phase demonstrate the importance of controlling reproducibility of biomarkers in multicenter trials and the feasibility of using serum TXB2 as a reliable end point for dose-finding studies of novel aspirin regimens.
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- 2018
15. The Aspirin Regimens in Essential Thrombocythemia (ARES) phase II randomized trial design: Implementation of the serum thromboxane B(2) assay as an evaluation tool of different aspirin dosing regimens in the clinical setting
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Irene Bertozzi, Elena Maria Elli, Giuseppe Lanzarone, Bianca Rocca, Daniele Cattaneo, Viviana Cavalca, Chiara Paoli, Alessandro Rambaldi, Linda Turnu, Silvia Betti, Alessandra Ricco, Denise Soldati, Andrea Timillero, Nicola Vianelli, Carlo Patrono, Monica Carpenedo, Giorgina Specchia, Francesca Palandri, Giovanna Petrucci, Marco Ruggeri, Laura Lissandrini, Francesco Rodeghiero, Elena Rossi, Alfredo Dragani, Alberto Tosetto, Alessandra Iurlo, Alessandro M. Vannucchi, Guido Finazzi, Maria Luigia Randi, Paola Ranalli, Giuseppe Carli, Eloise Beggiato, and Valerio De Stefano
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Oncology ,medicine.medical_specialty ,030204 cardiovascular system & hematology ,lcsh:RC254-282 ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Polycythemia vera ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Dosing ,Essential Thrombocythemia ,Aspirin ,biology ,business.industry ,Hematology ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,Clinical trial ,Regimen ,Settore MED/15 - MALATTIE DEL SANGUE ,Pharmacodynamics ,biology.protein ,Cyclooxygenase ,business ,030215 immunology ,medicine.drug - Abstract
Once-daily (od), low-dose aspirin (75–100 mg) is recommended to reduce the thrombotic risk of patients with essential thrombocytemia (ET). This practice is based on data extrapolated from other high-risk patients and an aspirin trial in polycythemia vera, with the assumption of similar aspirin pharmacodynamics in the two settings. However, the pharmacodynamics of low-dose aspirin is impaired in ET, reflecting accelerated renewal of platelet cyclooxygenase (COX)-1. ARES is a parallel-arm, placebo-controlled, randomized, dose-finding, phase II trial enrolling 300 ET patients to address two main questions. First, whether twice or three times 100 mg aspirin daily dosing is superior to the standard od regimen in inhibiting platelet thromboxane (TX)A2 production, without inhibiting vascular prostacyclin biosynthesis. Second, whether long-term persistence of superior biochemical efficacy can be safely maintained with multiple vs. single dosing aspirin regimen. Considering that the primary study end point is serum TXB2, a surrogate biomarker of clinical efficacy, a preliminary exercise of reproducibility and validation of this biomarker across all the 11 participating centers was implemented. The results of this preliminary phase demonstrate the importance of controlling reproducibility of biomarkers in multicenter trials and the feasibility of using serum TXB2 as a reliable end point for dose-finding studies of novel aspirin regimens.
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- 2018
16. Predictors of protease inhibitor-associated adverse events
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Bonfanti, P., Ricci, E., Landonio, S., Valsecchi, L., Timillero, L., Faggion, I., and Quirino, T.
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- 2001
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17. RUVIVAL Publication Series Volume 1
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Hügel, Stefan, Timillero, Giovanni, Schaldach, Ruth, Otterpohl, Ralf, Vrbavac, Isidora, and Carmesin, Tina
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literature review ,sustainable rural development ,Terrassenbau ,erosion control ,Ingenieurwissenschaften [620] ,nachhaltige ländliche Entwicklung ,Agroforstwirtschaft ,agroforestry ,check dams ,Erosionsschutz ,ddc:620 ,living terraces ,Geröllsprerre - Abstract
The RUVIVAL Publication Series is part of the open source learning project RUVIVAL. All topics of RUVIVAL Volume 1 are related on several levels and are part of restoration engineering. Each contribution in this publication is connected to further interactive multimedia material, which can be reached under http://www.hoou.de. The literature review papers are a collaboration of Master students, PhD students and researchers at the Institute of Wastewater Management and Water Protection (AWW) at Hamburg University of Technology. This volume consists of 3 literature review papers. The first reviews agroforestry, the practice of including trees or other woody perennial plants into agricultural systems, including crop and livestock production. It explains the challenges and benefits of this practice and provides an example of its implementation within the Slope Farming Project in Arba Minch, Ethiopia. The second paper introduces the concept of living terraces, which constitute a combination of erosion control measures on slopes. They are similar to contour hedgerows, but are constructed with the aim of accumulating soil on the uphill side of the tree row, so that in the long run, bench terraces are formed on their own. Their role as part of rainwater harvesting practices is explained in more depth in the paper. Finally, the third literature review provides insight into check dams, structures built across channels to reduce erosion by lowering water speed and accumulating sediments during floods. Check dams are often introduced in degraded areas and they represent one of the most used stabilisation measures worldwide, because of their relative simplicity and easy implementation. This paper also introduces a well-known case study in the Loess Plateau, China. Die RUVIVAL-Publikationsreihe ist Teil des Open-Source-Lernprojekts RUVIVAL. Alle Themen von RUVIVAL Volume 1 stehen auf mehreren Ebenen miteinander in Beziehung und sind Teil des Restaurierungsingenieurwesens. Jeder Beitrag in dieser Publikation ist mit weiteren interaktiven Lerninhalten verbunden, die unter http://www.hoou.de eingesehen werden können. Die Literaturübersichten sind eine Zusammenarbeit von Masterstudent*innen, Doktorand*innen und Forschenden des Instituts für Abwasserwirtschaft und Gewässerschutz (AWW) der Technischen Universität Hamburg. Diese Ausgabe besteht aus 3 Literaturübersichten. Die erste befasst sich mit der Agroforstwirtschaft, der Praxis der Einbeziehung von Baumarten oder anderen mehrjährigen Holzpflanzen in landwirtschaftliche Systeme, einschließlich der Nutzpflanzen- und Tierproduktion. Erläutert werden die Herausforderungen und Vorteile dieser Praxis, ergänzt durch ein Beispiel für ihre Umsetzung im Rahmen des Slope Farming Project in Arba Minch, Äthiopien. Der zweite Beitrag stellt das Konzept der lebenden Terrassen vor, die eine Kombination von Erosionsschutzmaßnahmen an Hängen darstellen. Sie ähneln den Kontur-Hecken, werden aber mit dem Ziel konstruiert, an der Hangseite der Gehölzreihen Boden anzustauen, so dass sich auf lange Sicht selbständig Terassenbänke bilden. Ihre Rolle als Teil der Regenwassernutzung wird in der Publikation näher erläutert. Schließlich gibt die dritte Literaturübersicht Einblicke in die Thematik der Geröllsprerren, die über Wasserläufe gebaut werden, um die Erosion durch Senkung der Wassergeschwindigkeit und Anhäufung von Sedimenten bei Überschwemmungen zu verringern. Geröllsprerren werden häufig in von Erosion beeinträchtigten Gegenden angewandt und stellen aufgrund ihrer relativen Einfachheit und leichten Umsetzbarkeit eine der weltweit am häufigsten verwendeten Stabilisierungsmaßnahmen dar. Des weiteren stellt diese Publikation auch eine Fallstudie im Löss-Plateau in China vor.
- Published
- 2017
18. Risk factors for lipodystrophy in the CISAI cohort
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Fabio Parazzini, GianMarco Vigevani, C. Magnani, Elena Ricci, Paolo Bonfanti, Canio Martinelli, Simona Landonio, Andrea Gabbuti, Cecilia Gulisano, Laura Valsecchi, Timillero L, Luigi Pusterla, Fortuna P, Sebastiano Miccolis, Ivano Faggion, Tiziana Quirino, Silvia Carradori, Bonfanti, P, Gulisano, C, Ricci, E, Timillero, L, Valsecchi, L, Carradori, S, Pusterla, L, Fortuna, P, Miccolis, S, Magnani, C, Gabbuti, A, Parazzini, F, Martinelli, C, Faggion, I, Landonio, S, Quirino, T, and Vigevani, G
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Adult ,Male ,medicine.medical_specialty ,Lipodystrophy ,Cohort Studies ,Risk Factors ,Internal medicine ,Antiretroviral Therapy, Highly Active ,Epidemiology ,medicine ,Humans ,Age Factor ,Risk factor ,HIV Protease Inhibitor ,Pharmacology ,Acquired Immunodeficiency Syndrome ,business.industry ,Risk Factor ,Stavudine ,Age Factors ,General Medicine ,HIV Protease Inhibitors ,Adverse reaction ,medicine.disease ,Confidence interval ,Surgery ,Antiretroviral therapy ,Protease inhibitor ,Cohort ,Ritonavir ,Drug Therapy, Combination ,Female ,Cohort Studie ,business ,Cohort study ,medicine.drug ,Human - Abstract
Purpose. - This study set out to describe the frequency of lipodystrophy, and identify its risk factors, in HIV-positive patients treated with HAART containing at least one protease inhibitor (PI). We analyzed the data collected in the CISAI study. Method. - The CISAI is a multicenter cohort study that has enrolled 1480 patients. We assessed whether patients had lipodystrophy at a medical visit, with follow-up visits by the same physician at least every 2 months, and also on the basis of patients' own reports. Results. - The lipodystrophy syndrome was detected in about 25% of the patients. Multivariate analysis showed the risk of lipodystrophy was correlated with female sex (RR 1.5; 95% confidence interval, CI, 1.2-2.1), with older age, with homosexuality (RR 1.5; 95% CI 1.0-2.4), with overt disease (RR 1.4; 95% CI 1.1-1.8) and with the duration of treatment before entering this study. The RR for ritonavir was higher than for the other PI (RR 1.4; 95% CI 0.9-1.9). Among patients receiving concomitant antiretroviral therapy the risk of lipodystrophy was greater with stavudine (RR 1.7; 95% CI 1.3-2.3). Conclusions. - The study confirmed the high frequency of the lipodystrophy syndrome among patients treated with PI. © 2003 Éditions scientifiques et médicales Elsevier SAS. All rights reserved.
- Published
- 2003
19. Comparison of dual nucleoside-analogue reverse-transcriptase inhibitor regimens with HIV-1 who have not previously been treated: the PENTA 5 randomized trial
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J. P. Aboulker, A. Babiker, A. Compagnucci, J. H. Darbyshire, M. Debré, C. Giaquinto, D. M. Gibb, L. Harper, Y. Saidi, AS Walker, J. Darbyshire, D. Johnson, P. Kelleher, L. McGee, A Newberry, A. Poland, A. S. Walker, J P. Aboulker, I. Carrière, V. Eliette, S. Leonardo, M. Gersten, A. Jones, S. Blanche, A. B. Bohlin, K Butler, G. Castelli Gattinara, P. Clayden, R De Groot, A. Faye, C. Griscelli, I Grosch Wörner, C. Kind, H. Lyall, J. Levy, M. Mellado Pena, D. Nadal, C Peckham, J. T. Ramos Amador, L. Rosado, C. Rudin, H. Scherpbier, M Sharland, P. A. Tovo, G. Tudor Williams, N. Valerius, A. Volny Anne, U Wintergerst, V. Wahn, C. Hill, P Lepage, A. Pozniak, S. Vella, M. Hainaut, A. Peltier, S. Carlier, G. Zissis, M. Della Negra, W. Queiroz, L. P. Feitosa, D Oliveira, F. Mechinaud, F. Ballerau, A. Lepelletier, S. Billaudel, V. Ferre, I. Grosch Wörner, R. Weigel, K. Seel, C. Feiterna Sperling, D. Ohlendorf, G. Riße, C. Müller, T. Niehues, J. Ndagijimana, G. Horneff, N. Vente, R. Ganschow, T. Simon, R. Vossen, H Pfister, U. Wintergerst, G. Notheis, G. Strotmann, S Schlieben, K. Butler, E. Hayes, M. O’Mara, J. Fanning, F. Goggins, S. Moriarty, M. Byrne, L. Battisti, M. Duse, S. Timpano, E. Uberti, P. Crispino, P. Carrara, F. Fomia, A. Manca, L. Galli, M. de Martino, F. Fioredda, E. Pontali, M. Cellini, C. Baraldi, M. Portolani, M. Meacci, P. Pietrosemoli, R. Berni Canani, P. Laccetti, M. Gobbo, V. Giacomet, R. D’Elia, O. Rampon, E. Ruga, A. de Rossi, M. Zanchetta, D. Caselli, A. Maccabruni, E. Cattaneo, V Landini, S. Bernardi, A. Krzysztofiak, C. Tancredi, P. Rossi, L. Pansani, E. Palomba, C. Gabiano, A. Mazza, G. Rossetti, R. Nicolin, A. Timillero, F. Candeias, G Santos, M. L. Ramos Ribeiro, M. C. Almeida, M. H. Lourenço, R. Antunes, M. J. Mellado Pena, M L. Carillo de Albornoz, P. Martinez Santos, L. Ciria Calavia, J. Serra Devecchi, O. Delgado, N. Matamoros, A. Foot, H. Kershaw, C. Kelly, O. Caul, W. Tarnow Mordi, J. Petrie, A. McDowell, P. McIntyre, K. Appleyard, K. Sloper, V. Shah, K. Cheema, A. Aali, J. Mok, R. Russell, A. Brewster, N. Richardson, S. Burns, D. Gibb, V. Novelli, N. Klein, S. Ewen, V. Yeung, C. Ball, K. Himid, D. Nayagam, D. Graham, A. Barrie, K. Stringer, S. Jones, N. Weerasooriya, M. Zuckerman, P. Bracken, E. Cooper, T. Fisher, R. Barrie, U. Patel, V. Van Someren, K. Moshal, L. Perry, T. Gundlach, J. Norman, M. Sharland, M. Richardson, S. Donaghy, Z. Mitchla, C. Wells, J. Booth, A. Shipp, J. White, S. Head, S. Lambers, K. O’Hara, C. Stainsby, G. Du Mont, T. Solanki, S. Swanton, S. O’Shea, A. Tilsey, S. Kaye, A. Finn, S. Choo, R. Lakshman, L. Barr, G. Bell, A. Siddens, GUARINO, ALFREDO, SPAGNUOLO, MARIA IMMACOLATA, Aboulker, J. P., Babiker, A., Compagnucci, A., Darbyshire, J. H., Debré, M., Giaquinto, C., Gibb, D. M., Harper, L., Saidi, Y., Walker, A, Darbyshire, J., Johnson, D., Kelleher, P., Mcgee, L., Newberry, A, Poland, A., Walker, A. S., Aboulker, J P., Carrière, I., Eliette, V., Leonardo, S., Gersten, M., Jones, A., Blanche, S., Bohlin, A. B., Butler, K, Castelli Gattinara, G., Clayden, P., R De Groot, Faye, A., Griscelli, C., I Grosch Wörner, Kind, C., Lyall, H., Levy, J., Mellado Pena, M., Nadal, D., Peckham, C, Ramos Amador, J. T., Rosado, L., Rudin, C., Scherpbier, H., Sharland, M, Tovo, P. A., Tudor Williams, G., Valerius, N., Volny Anne, A., Wintergerst, U, Wahn, V., Hill, C., Lepage, P, Pozniak, A., Vella, S., Hainaut, M., Peltier, A., Carlier, S., Zissis, G., Della Negra, M., Queiroz, W., Feitosa, L. P., Oliveira, D, Mechinaud, F., Ballerau, F., Lepelletier, A., Billaudel, S., Ferre, V., Grosch Wörner, I., Weigel, R., Seel, K., Feiterna Sperling, C., Ohlendorf, D., Riße, G., Müller, C., Niehues, T., Ndagijimana, J., Horneff, G., Vente, N., Ganschow, R., Simon, T., Vossen, R., Pfister, H, Wintergerst, U., Notheis, G., Strotmann, G., Schlieben, S, Butler, K., Hayes, E., O’Mara, M., Fanning, J., Goggins, F., Moriarty, S., Byrne, M., Battisti, L., Duse, M., Timpano, S., Uberti, E., Crispino, P., Carrara, P., Fomia, F., Manca, A., Galli, L., de Martino, M., Fioredda, F., Pontali, E., Cellini, M., Baraldi, C., Portolani, M., Meacci, M., Pietrosemoli, P., Guarino, Alfredo, Spagnuolo, MARIA IMMACOLATA, Berni Canani, R., Laccetti, P., Gobbo, M., Giacomet, V., D’Elia, R., Rampon, O., Ruga, E., de Rossi, A., Zanchetta, M., Caselli, D., Maccabruni, A., Cattaneo, E., Landini, V, Bernardi, S., Krzysztofiak, A., Tancredi, C., Rossi, P., Pansani, L., Palomba, E., Gabiano, C., Mazza, A., Rossetti, G., Nicolin, R., Timillero, A., Candeias, F., Santos, G, Ramos Ribeiro, M. L., Almeida, M. C., Lourenço, M. H., Antunes, R., Mellado Pena, M. J., Carillo de Albornoz, M L., Martinez Santos, P., Ciria Calavia, L., Serra Devecchi, J., Delgado, O., Matamoros, N., Foot, A., Kershaw, H., Kelly, C., Caul, O., Tarnow Mordi, W., Petrie, J., Mcdowell, A., Mcintyre, P., Appleyard, K., Sloper, K., Shah, V., Cheema, K., Aali, A., Mok, J., Russell, R., Brewster, A., Richardson, N., Burns, S., Gibb, D., Novelli, V., Klein, N., Ewen, S., Yeung, V., Ball, C., Himid, K., Nayagam, D., Graham, D., Barrie, A., Stringer, K., Jones, S., Weerasooriya, N., Zuckerman, M., Bracken, P., Cooper, E., Fisher, T., Barrie, R., Patel, U., Van Someren, V., Moshal, K., Perry, L., Gundlach, T., Norman, J., Sharland, M., Richardson, M., Donaghy, S., Mitchla, Z., Wells, C., Booth, J., Shipp, A., White, J., Head, S., Lambers, S., O’Hara, K., Stainsby, C., Du Mont, G., Solanki, T., Swanton, S., O’Shea, S., Tilsey, A., Kaye, S., Finn, A., Choo, S., Lakshman, R., Barr, L., Bell, G., and Siddens, A.
- Abstract
Introduction Treatment options for children with HIV-1 are limited. We aimed to compare activity and safety of three dualnucleoside analogue reverse-transcriptase inhibitor (NRTI) regimens with or without a protease inhibitor in previously untreated children with HIV-1. Methods In our multicentre trial, we randomly assigned 36 children to zidovudine and lamivudine, 45 to zidovudine and abacavir, and 47 to lamivudine and abacavir. Children who were symptomfree (n=55) were also randomly assigned to receive nelfinavir or placebo. Children with more advanced disease received open-label nelfinavir (73). Primary endpoints were change in plasma HIV-1 RNA at 24 and 48 weeks for the NRTI comparison and occurrence of serious adverse events for both randomised comparisons. Analyses were by intention to treat. Findings Children had a median CD4 percentage of 22% (IQR 15–29) and a mean HIV-1 RNA concentration of 5·0 log copies/mL (SD 0·8). One child was lost to follow-up and one died of sepsis. At 48 weeks, in the zidovudine/lamivudine, zidovudine/abacavir, and lamivudine/abacavir groups, mean HIV-1 RNA had decreased by 1·71, 2·19, and 2·63 log copies/mL, respectively (estimated in absence of nelfinavir) (p=0·02 after adjustment for baseline factors). One child had a hypersensitivity reaction to abacavir; and three with possible reactions stopped abacavir. There were 24 serious adverse events—six in the symptom-free children (all on nelfinavir), but none were attributed to nelfinavir. Interpretation Regimens containing abacavir were more effective than zidovudine/lamivudine. Such regimens could be combined with protease inhibitors and non-nucleoside reverse transcriptase inhibitors for safe and effective treatment of previously untreated children with HIV-1.
- Published
- 2002
20. Predictors of protease inhibitor-associated adverse events
- Author
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Simona Landonio, Elena Ricci, Tiziana Quirino, Ivano Faggion, Timillero L, Paolo Bonfanti, Laura Valsecchi, Bonfanti, P, Ricci, E, Landonio, S, Valsecchi, L, Timillero, L, Faggion, I, and Quirino, T
- Subjects
Adult ,Male ,Safety Management ,medicine.medical_specialty ,Efavirenz ,HIV Infections ,Lower risk ,Cohort Studies ,chemistry.chemical_compound ,Risk Factors ,Antiretroviral Therapy, Highly Active ,Internal medicine ,medicine ,Humans ,Protease Inhibitors ,Prospective Studies ,Risk factor ,Adverse effect ,Pharmacology ,Surveillance ,business.industry ,Stavudine ,Lamivudine ,General Medicine ,Adverse reaction ,chemistry ,Protease inhibitor ,Immunology ,HIV-1 ,Regression Analysis ,Female ,Ritonavir ,business ,Saquinavir ,medicine.drug - Abstract
Risk factors in the development of adverse reactions in HIV-1-infected patients treated with highly active antiretroviral therapy (HAART) containing protease inhibitors are poorly understood. To identify predictors of protease inhibitor-associated adverse events, we are conducting a prospective, cohort, multicenter study on HIV-positive patients starting treatment with at least one protease inhibitor. Rate ratios (RR) of adverse events were calculated, and logistic regression was used to adjust simultaneously for the potentially confounding effects of selected variables, according to the Cox model. A total of 1477 patients have been enrolled up to April 2000, having an average age of 37.1 years (SD ± 8.1); 1066 (72.2%) were male. Where risk factors for HIV infection are concerned, the distribution was as follows: 48.1% intravenous drug users, 31.6% heterosexual contacts, 16.2% homosexual males and 0.7% blood transfusion. Average CD4+ lymphocyte count at enrollment was 265 cells/mmc (SD ± 201). Average follow-up time is equal to 17.8 months (range 1–32). The risk of developing adverse reactions is significantly increased in female patients, older patients, hemophiliac subjects and in subjects with hepatitis. Patients treated with ritonavir, the association ritonavir-saquinavir HGC, stavudine and efavirenz have significantly increased incidence of adverse reactions in PI-containing regimens; conversely, saquinavir HGC, zidovudine and lamivudine use was associated with a lower risk of developing adverse reactions.
- Published
- 2001
21. Prevalence and risk factors for nosocomial infections in hospitals of the Veneto region, north-eastern Italy
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Ugo Fedeli, P. Mantoan, G. Pellizzer, Benedetta Allegranzi, P. Benedetti, Hugo Sax, L. Timillero, Elena Schievano, Paolo Spolaore, and Mario Saia
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Microbiology (medical) ,Adult ,Italy/epidemiology ,Male ,medicine.medical_specialty ,Pediatrics ,Staphylococcus aureus ,Multivariate analysis ,Adolescent ,medicine.medical_treatment ,Urinary system ,Enterococcus/isolation & purification ,Charlson index ,Cross Infection/epidemiology/microbiology ,Severity of Illness Index ,Pseudomonas aeruginosa/isolation & purification ,Risk Factors ,Intensive care ,Severity of illness ,Prevalence ,Medicine ,Intubation ,Humans ,ddc:610 ,Child ,Aged ,Aged, 80 and over ,Cross Infection ,Analysis of Variance ,business.industry ,Infant ,General Medicine ,Middle Aged ,Anti-Bacterial Agents ,Long-term care ,Anti-Bacterial Agents/therapeutic use ,Infectious Diseases ,Italy ,Staphylococcus aureus/isolation & purification ,Child, Preschool ,Emergency medicine ,Pseudomonas aeruginosa ,Female ,business ,Hospital Units ,Central venous catheter ,Enterococcus - Abstract
OBJECTIVE: The study aimed to assess prevalence and risk factors for nosocomial infection (NI) in 21 hospitals of the Veneto Region (Italy). METHODS: In May 2003, a one-week-period prevalence study of NI was carried out in 21 hospitals, representing 63% of all hospital beds for acute patients of the Veneto Region. Intensive care units represented 84% of all intensive care beds of the Region. Long term care, neonatal intensive care, burn, psychiatric and dermatology units were excluded. RESULTS: Overall, 6,352 patients were surveyed. The prevalence of NI was 7.6% (range 2.6%-17.7%), while 6.9% of patients (range 2.6%-15.5%) were affected by at least one NI. The prevalence of patients with NI in medical, surgical and intensive care areas was 6.6%, 5.0% and 25.8%, respectively. The sites most frequently affected were the following: urinary tract (28.4%), surgical site (20.3%), blood stream (19.3%), pulmonary and lower respiratory tract (17.6%). At multivariate analysis risk factors independently associated to NI were: Charlson index score >1, severity of underlying disease, exposure to antibiotics, surgical intervention, trauma at admission, presence of central venous catheter >24 h, urinary catheter, intubation, tracheostomy, and duration since admission >15 days. CONCLUSION: The study provided baseline data of NI in the Veneto Region hospitals. It showed that NI are frequent, and display a wide inter-hospital variability of rates. The highest prevalence has been reported in intensive care units. The unusual high frequency of blood stream infections and the relatively lower prevalence rate of surgical site infections highlighted the limits of prevalence studies.
- Published
- 2008
22. Regional and systemic prophylaxis with teicoplanin in total knee arthroplasty: a tissue penetration study
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Lia Timillero, Andrea Novelli, Fausto de Lalla, Nicola Marzano, Luca Lazzarini, R. Viola, and Stefania Fallani
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Bone and Bones ,Subcutaneous Tissue ,medicine ,Humans ,Surgical Wound Infection ,Orthopedics and Sports Medicine ,Antibiotic prophylaxis ,Vein ,Adverse effect ,Arthroplasty, Replacement, Knee ,Infusions, Intravenous ,Aged ,Skin ,Tourniquet ,business.industry ,Teicoplanin ,Foot ,Synovial Membrane ,Soft tissue ,Antibiotic Prophylaxis ,Arthroplasty ,Surgery ,Anti-Bacterial Agents ,Forearm ,medicine.anatomical_structure ,Anesthesia ,Injections, Intravenous ,Female ,business ,Subcutaneous tissue ,medicine.drug - Abstract
Five patients undergoing total knee arthroplasty (TKA) received 800 mg intravenous teicoplanin systemically 2.5 hours before surgery and 15 patients received 200 mg teicoplanin into a foot vein in the leg to be treated. Samples of bone, synovia, subcutaneous tissue, and skin were collected at 20, 40, and 60 minutes after tourniquet inflation and at the end of surgery. None of the study subjects experienced adverse effects, adverse events, or infections during the postoperative and follow-up period. Mean teicoplanin concentration in the collected tissue ranged from 1.52 to 5.81 mg/L after regional prophylaxis and from 0.9 to 2.94 mg/L after systemic prophylaxis. Bone and soft tissue penetration of teicoplanin after regional prophylaxis with 200 mg is at least comparable with that achieved after systemic prophylaxis with 800 mg. Regional prophylaxis in TKA appears to be safe and valuable. Higher dosages of teicoplanin seem to be needed to ensure coverage against coagulase negative staphylococci.
- Published
- 2003
23. [Causality relationship of drug adverse reactions: experience in the use of HIV-protease inhibitors]
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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, and T, Quirino
- Subjects
Adult ,Male ,Humans ,Female ,HIV Protease Inhibitors ,Prospective Studies ,Middle Aged - Abstract
To establish the exact cause and effect relationship between protease inhibitors (PIs) and adverse events.Prospective, cohort, multicenter study on HIV-positive patients who are beginning treatment with a PI. Causal relationships are evaluated using the RUCAM algorithm.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.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.
- Published
- 2001
24. Incidence of adverse reactions in HIV patients treated with protease inhibitors: a cohort study. Coordinamento Italiano Studio Allergia e Infezione da HIV (CISAI) Group
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P, Bonfanti, L, Valsecchi, F, Parazzini, S, Carradori, L, Pusterla, P, Fortuna, L, Timillero, F, Alessi, G, Ghiselli, A, Gabbuti, E, Di Cintio, C, Martinelli, I, Faggion, S, Landonio, and T, Quirino
- Subjects
Adult ,Male ,Nelfinavir ,Ritonavir ,Incidence ,Indinavir ,HIV Protease Inhibitors ,Middle Aged ,Cohort Studies ,Italy ,Risk Factors ,HIV Seropositivity ,Multivariate Analysis ,Confidence Intervals ,Adverse Drug Reaction Reporting Systems ,Humans ,Female ,Prospective Studies ,Drug Monitoring ,Saquinavir ,Follow-Up Studies - Abstract
To assess the probability that protease inhibitor (PI) therapy might be discontinued because of adverse events (AE) and to evaluate the incidence rate of adverse reactions during PI treatment.A prospective cohort, multicenter study on HIV-positive patients starting treatment with at least one PI.Ten departments of infectious diseases in Northern Italy.A total of 1207 patients who started PI therapy in September 1997 and were consecutively observed up to April 1999.Adverse reactions following initiation of PI therapy, and time to therapy discontinuation due to AE.During the study period, 35.9% patients presented adverse reactions of any grade, whereas 9.7% presented at least one serious AE. After 12 months of treatment, the percentage of patients who had interrupted treatment was 36% of ritonavir-treated patients, 14.2% of those treated with indinavir, 13.6% of ritonavir-saquinavir hard gel capsules (HGC)-treated patients, and 8.5% and 2.1%, respectively, for those treated with nelfinavir and saquinavir HGC. Women and patients with hepatitis experienced a significantly greater number of adverse events compared with other categories. Gastrointestinal events were more frequently observed in patients treated with either ritonavir alone or in combination with saquinavir HGC, as well as in patients receiving nelfinavir, although in this group serious events were rare. Here again, neurologic, metabolic, and hepatic toxicity occurred more frequently in ritonavir and ritonavir-saquinavir HGC treated patients. Allergic reactions were more often observed in patients receiving nelfinavir. Indinavir-treated patients presented the highest incidence of renal toxicity.Ritonavir is the drug associated with the largest number of reactions, which appear during the first few months of treatment. Saquinavir HGC and nelfinavir are the best tolerated drugs in a clinical setting.
- Published
- 2000
25. 093 OUTPATIENT PARENTERAL ANTIBIOTIC THERAPY FOR INFECTIVE ENDOCARDITIS. SINGLE-CENTRE EXPERIENCE
- Author
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Carlotto, A., primary, Ferretto, R., additional, Timillero, L., additional, Rossi, L., additional, Esposito, S., additional, and Marranconi, F., additional
- Published
- 2009
- Full Text
- View/download PDF
26. 093 OUTPATIENT PARENTERAL ANTIBIOTIC THERAPY FOR INFECTIVE ENDOCARDITIS. SINGLE-CENTRE EXPERIENCE
- Author
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L. Rossi, L. Timillero, F. Marranconi, R. Ferretto, A. Carlotto, and Silvano Esposito
- Subjects
Microbiology (medical) ,medicine.medical_specialty ,business.industry ,Parenteral antibiotic ,General Medicine ,medicine.disease ,HACEK endocarditis ,Single centre ,Infectious Diseases ,Infective endocarditis ,medicine ,Pharmacology (medical) ,Intensive care medicine ,business - Published
- 2009
27. Incidence of adverse reactions in HIV patients treated with protease inhibitors: A cohort study
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Silvia Carradori, Canio Martinelli, Alessi F, Ivano Faggion, Laura Valsecchi, Paolo Bonfanti, Simona Landonio, Tiziana Quirino, Fortuna P, Andrea Gabbuti, Luigi Pusterla, Fabio Parazzini, Ghiselli G, Di Cintio E, Timillero L, Bonfanti, P, Valsecchi, L, Parazzini, F, Carradori, S, Pusterla, L, Fortuna, P, Timillero, L, Alessi, F, Ghiselli, G, Gabbuti, A, Di Cintio, E, Martinelli, C, Faggion, I, Landonio, S, and Quirino, T
- Subjects
medicine.medical_specialty ,viruses ,Gastroenterology ,Pharmacotherapy ,immune system diseases ,Indinavir ,Internal medicine ,medicine ,Pharmacology (medical) ,Prospective cohort study ,Adverse effect ,Surveillance ,business.industry ,Incidence (epidemiology) ,virus diseases ,Adverse reaction ,biochemical phenomena, metabolism, and nutrition ,Antiretroviral therapy ,Discontinuation ,Infectious Diseases ,Nelfinavir ,Protease inhibitor ,Immunology ,Ritonavir ,business ,Saquinavir ,medicine.drug - Abstract
Objective: To assess the probability that protease inhibitor (PI) therapy might be discontinued because of adverse events (AE) and to evaluate the incidence rate of adverse reactions during PI treatment. Design: A prospective cohort, multicenter study on HIV-positive patients starting treatment with at least one PI. Setting: Ten departments of infectious diseases in Northern Italy. Patients: A total of 1207 patients who started PI therapy in September 1997 and were consecutively observed up to April 1999. Main Outcome Measures: Adverse reactions following initiation of PI therapy, and time to therapy discontinuation due to AE. Results: During the study period, 35.9% patients presented adverse reactions of any grade, whereas 9.7% presented at least one serious AE. After 12 months of treatment, the percentage of patients who had interrupted treatment was 36% of ritonavir-treated patients, 14.2% of those treated with indinavir, 13.6% of ritonavir-saquinavir hard gel capsules (HGC)-treated patients, and 8.5% and 2.1%, respectively, for those treated with nelfinavir and saquinavir HGC. Women and patients with hepatitis experienced a significantly greater number of adverse events compared with other categories. Gastrointestinal events were more frequently observed in patients treated with either ritonavir alone or in combination with saquinavir HGC, as well as in patients receiving nelfinavir, although in this group serious events were rare. Here again, neurologic, metabolic, and hepatic toxicity occurred more frequently in ritonavir and ritonavirsaquinavir HGC treated patients. Allergic reactions were more often observed in patients receiving nelfinavir. Indinavir-treated patients presented the highest incidence of renal toxicity. Conclusion: Ritonavir is the drug associated with the largest number of reactions, which appear during the first few months of treatment. Saquinavir HGC and nelfinavir are the best tolerated drugs in a clinical setting.
28. Cause and effect relationship of drug adverse events: Our experience using protease inhibitors of HIV | Relazione di causalità delle reazioni avverse a farmaci: Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV
- Author
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Bonfanti, P., Valsecchi, L., fabio parazzini, Carradori, S., Pusterla, L., Fortuna, P., Timillero, L., Alessi, F., Ghiselli, G., Gabbuti, A., Ricci, E., Martinelli, C., Faggion, I., Landonio, S., Quirino, T., 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, and Quirino, T
- Subjects
Pharmacovigilance ,HIV ,Cohort study - 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.
29. Cause and effect relationship of drug adverse events: Our experience using protease inhibitors of HIV,Relazione di causalità delle reazioni avverse a farmaci: Un'esperienza nell'utilizzo degli inibitori della proteasi di HIV
- Author
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Paolo Bonfanti, 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., and Quirino, T.
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