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1. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

3. Cardiovascular Risk After Adjuvant Trastuzumab in Early Breast Cancer: An Italian Population-Based Cohort Study

Author

Franchi, M, Trama, A, Merlo, I, Minicozzi, P, Tarantini, L, Garau, D, Kirchmayer, U, Di Martino, M, Romero, M, De Carlo, I, Scondotto, S, Apolone, G, Corrao, G, Franchi M., Trama A., Merlo I., Minicozzi P., Tarantini L., Garau D., Kirchmayer U., Di Martino M., Romero M., De Carlo I., Scondotto S., Apolone G., Corrao G., Franchi, M, Trama, A, Merlo, I, Minicozzi, P, Tarantini, L, Garau, D, Kirchmayer, U, Di Martino, M, Romero, M, De Carlo, I, Scondotto, S, Apolone, G, Corrao, G, Franchi M., Trama A., Merlo I., Minicozzi P., Tarantini L., Garau D., Kirchmayer U., Di Martino M., Romero M., De Carlo I., Scondotto S., Apolone G., and Corrao G.

Abstract

Background: Although trastuzumab (T) represents the standard of care for the adjuvant treatment of HER2-positive early-stage breast cancer, contrasting results are available about the cardiac toxicity associated to its use. We conducted a multiregional population-based cohort investigation aimed to assess both the short- and long-term cardiovascular (CV) outcomes in women with early breast cancer treated with T-based or standard adjuvant chemotherapy (CT). Materials and Methods: We used health care use databases of six Italian regions, overall accounting for 42% of the Italian population. The study cohort was made by all women surgically treated for breast cancer who started a first-line adjuvant T-based or CT treatment. Patients treated with T were 1:2 matched to those treated with CT based on date of treatment start, age, and presence of CV risk factors. Short- and long-term CV outcomes (heart failure and cardiomyopathy) were measured, respectively, after 1 year and at the end of follow-up. Results: Among 28,599 women who met the inclusion criteria, 6,208 T users were matched to 12,416 CT users. After a mean follow-up of 5.88 years, short- and long-term cumulative CV risk were 0.8% and 2.6% in patients treated with T and 0.2% and 2.8% in those treated with CT, respectively. Adjusted hazard ratios were 4.6 (95% confidence interval [CI], 2.6–8.0) for short-term and 1.2 (95% CI, 0.9–1.6) for long-term CV risk. Discussion: In our large real-world investigation, T-associated cardiotoxicity was limited to the treatment period. The addition of T to adjuvant CT did not result in long-term worsening of CV events. Implications for Practice: Adjuvant trastuzumab-based chemotherapy represents the backbone therapy in patients with HER2-positive early breast cancer. Although well tolerated, cardiovascular events can manifest during or after therapy because of treatment-related toxicities. In this wide multicenter and unselected cohort, long-term symptomatic cardiotoxicity was l

Published
2020

4. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

Author

Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P. M., Fantini M. P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Luxi N., Giovanazzi A., Capuano A., Crisafulli S., Cutroneo P.M., Fantini M.P., Ferrajolo C., Moretti U., Poluzzi E., Raschi E., Ravaldi C., Reno C., Tuccori M., Vannacci A., Zanoni G., Trifiro G., Luxi, N., Giovanazzi, A., Capuano, A., Crisafulli, S., Cutroneo, P. M., Fantini, M. P., Ferrajolo, C., Moretti, U., Poluzzi, E., Raschi, E., Ravaldi, C., Reno, C., Tuccori, M., Vannacci, A., Zanoni, G., Trifiro, G., Petrelli G., Girotti S., Arzenton E., Magro L., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Spina E., Minore C., Costantino C., Conforto A., Vitale F., Morreale I., Marsala L., Farinella D., Bavetta S., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Pappalardo F., Bonaiuti R., Lombardi N., Crescioli G., Tessari R., Zandona E., Marchiori F., Chiamulera C., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Rafaniello C., Pagliaro C., Mercaldo M., Fucile A., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Leopardi E., Fava G., Giuffrida S., Amato V., Gambera M., and Montresor V.

Subjects
Allergy, IMPACT, COVID-19 Vaccine, Breastfeeding, Review Article, Toxicology, Settore MED/42 - Igiene Generale E Applicata, CLINICAL CHARACTERISTICS, Pregnancy, Pharmacology (medical), Pregnancy Complications, Infectious, Child, OUTCOMES, education.field_of_study, CANCER, Vaccination, Europe, CORONAVIRUS DISEASE 2019, CLINICAL CHARACTERISTICS, CANCER, RECIPIENTS, SEVERITY, OUTCOMES, IMPACT, RATES, Breast Feeding, Child, Preschool, Practice Guidelines as Topic, Female, 2019-nCoV Vaccine mRNA-1273, Human, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, BNT162 Vaccine, COVID-19, ChAdOx1 nCoV-19, Humans, Infant, SARS-CoV-2, Hypersensitivity, Immunocompromised Host, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Population, MEDLINE, CORONAVIRUS DISEASE 2019, medicine, RATES, education, Pharmacology, business.industry, medicine.disease, Vaccine efficacy, RECIPIENTS, SEVERITY, Family medicine, Pregnancy Complications, Infectiou, business
Abstract

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit–risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-021-01131-6.

Published
2021

5. Risk of hospitalization for heart failure in patients with type 2 diabetes newly treated with DPP-4 inhibitors or other oral glucose-lowering medications: a retrospective registry study on 127,555 patients from the Nationwide OsMed Health-DB Database

Author

Fadini, Gian Paolo, Avogaro, Angelo, Degli Esposti, Luca, Russo, Pierluigi, Saragoni, Stefania, Buda, Stefano, Rosano, Giuseppe, Pecorelli, Sergio, Pani, Luca, Martinetti, S., Mero, P., Raeli, L., Migliazza, S., Dellagiovanna, M., Cerra, C., Gambera, M., Piccinelli, R., Zambetti, M., Atzeni, F., Valsecchi, V., DeLuca, P., Scopinaro, E., Moltoni, D., Pini, E., Leoni, O., Oria, C., Papagni, M., Nosetti, G., Caldiroli, E., Moser, V., Roni, R., Polverino, A., Bovo, C., Mezzalira, L., Andretta, M., Trentin, L., Palcic, S., Pettinelli, A., Arbo, A., Bertola, A., Capparoni, G., Cattaruzzi, C., Marcuzzo, L., Rosa, F.V., Basso, B., Saglietto, M., Delucis, S., Prioli, M., Filippi, R., Coccini, A., Ghia, M., Sanfelici, F., Radici, S., Scanavacca, P., Campi, A., Bianchi, S., Verzola, A., Morini, M., Borsari, M., Danielli, A., Dal Maso, M., Marsiglia, B., Vujovic, B., Pisani, M., Bonini, P., Lena, F., Aletti, P., Marcobelli, A., Sagratella, S., Fratini, S., Bartolini, F., Riccioni, G., Meneghini, A., Di Turi, R., Fano, V., Blasi, A., Pagnozzi, E., Quintavalle, G., DʼAvenia, P., De Matthaeis, M.C., Ferrante, F., Crescenzi, S., Marziale, L., Venditti, P., Bianchi, C., Senesi, I., Baci, R., De Carlo, I., Lavalle, A., Trofa, G., Marcello, G., Pagliaro, C., Troncone, C., Farina, G., Tari, M.G., Motola, G., De Luca, F., Saltarelli, M.L., Granieri, C., Vulnera, M., Palumbo, L., La Viola, F., Florio, L., De Francesco, A.E., Costantino, D., De Francesco, A.E., Rapisarda, F., Lazzaro, P.L., Pastorello, M., Parlli, M., Visconti, M., Uomo, I., Sanna, P., and Lombardo, F.

Published
2015
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6. Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project

Author

Franchi, M, Vener, C, Garau, D, Kirchmayer, U, Di Martino, M, Romero, M, De Carlo, I, Scondotto, S, Stival, C, Della Porta, M, Passamonti, F, Corrao, G, Franchi, Matteo, Vener, Claudia, Garau, Donatella, Kirchmayer, Ursula, Di Martino, Mirko, Romero, Marilena, De Carlo, Ilenia, Scondotto, Salvatore, Stival, Chiara, Della Porta, Matteo Giovanni, Passamonti, Francesco, Corrao, Giovanni, Franchi, M, Vener, C, Garau, D, Kirchmayer, U, Di Martino, M, Romero, M, De Carlo, I, Scondotto, S, Stival, C, Della Porta, M, Passamonti, F, Corrao, G, Franchi, Matteo, Vener, Claudia, Garau, Donatella, Kirchmayer, Ursula, Di Martino, Mirko, Romero, Marilena, De Carlo, Ilenia, Scondotto, Salvatore, Stival, Chiara, Della Porta, Matteo Giovanni, Passamonti, Francesco, and Corrao, Giovanni

Abstract

Introduction: Randomized clinical trials showed that bortezomib, in addition to conventional chemotherapy, improves survival and disease progression in multiple myeloma (MM) patients not eligible for stem cell transplantation. The aim of this retrospective population-based cohort study is the evaluation of both clinical and economic profile of bortezomib-based versus conventional chemotherapy in daily clinical practice.Methods: Healthcare utilization databases of six Italian regions were used to identify adult patients with non-transplant MM, who started a first-line therapy with bortezomib-based or conventional chemotherapy. Patients were matched by propensity score and were followed from treatment start until death, lost to follow-up or study end-point. Overall survival (OS) and restricted mean survival time (RMST) were estimated using the Kaplan-Meier method. Association between first-line treatment and risk of death was estimated by a conditional Cox proportional regression model. Average mean cumulative costs were estimated and compared between groups.Results: In the period 2010-2016, 3509 non-transplant MM patients met the inclusion criteria, of which 1157 treated with bortezomib-based therapy were matched to 1826 treated with conventional chemotherapy. Median OS and RMST were 33.9 and 27.9 months, and 42.9 and 38.4 months, respectively, in the two treatment arms. Overall, these values corresponded to a HR of death of 0.79 (95% CI 0.71-0.89) over a time horizon of 84 months. Average cumulative cost were 83,839 euro and 54,499 euro, respectively, corresponding to an incremental cost-effectiveness ratio of 54,333 euro per year of life gained, a cost coherent with the willingness-to-pay thresholds frequently adopted from Western countries.Conclusions: These data suggested that, in a large cohort of non-transplant MM patients treated outside the experimental setting, first-line treatment with bortezomib-based therapy was associated with a favourable effectiveness

Published
2021

7. Non-adherence to Mediterranean diet and synergy with lifestyle habits in the occurrence of breast cancer: a case-control study in Italy.

Author

LA TORRE, G., DE CARLO, I., SESTILI, C., COCCHIARA, R. A., LIA, L., DI BELLA, O., CIANFANELLI, S., D’EGIDIO, V., MANCINO, M., PALMERI, V., DE LUCA, A., FRUSONE, F., ACETI, V., AMABILE, M. I., CARDI, M., BACKHAUS, I., MANNOCCI, A., and MONTI, M.

Abstract

OBJECTIVE: The aim of this study was to assess the synergistic effect of non-adherence to the Mediterranean Diet (MD) and lifestyle habits on the occurrence of breast cancer (BC). PATIENTS AND METHODS: A case-control study was carried out from September 2018 to February 2019 at the Teaching Hospital “Umberto I” in Rome. A Food Frequency Questionnaire was used for assessing the level of adherence to MD, the IPAQ Questionnaire to measure physical activity, and AUDIT-C to estimate alcohol consumption. The possible interaction between risk factors was tested using the synergism index. RESULTS: A total of 94 cases and 88 controls were enrolled (median age 55.8 for cases and 57.9 for controls). The MD Score over 6 was associated with low odds of having breast cancer (OR = 0.29; 95% CI: 0.12-0.69). There is a clear indication for the additivity and synergism between non-adherence to MD and many risk factors on the occurrence of BC: current smoker (S = 2.02; 95% CI 0.62-8.07), physical inactivity (S = 2.14; 95% CI 0.71 2-8.28) and alcohol consumption (S = 3.02; 95% CI 0.91-12.95). CONCLUSIONS: Primary prevention of BC can benefit from intervention targeting nutritional and lifestyle factors that act synergistically. [ABSTRACT FROM AUTHOR]

Published
2021

8. Advanced Age and Medication Prescription: More Years, Less Medications? A Nationwide Report From the Italian Medicines Agency

Author

Martinetti, S., Mero, P., Raeli, L., Migliazza, S., Dellagiovanna, M., Cerra, C., Gambera, M., Piccinelli, R., Zambetti, M., Atzeni, F., Valsecchi, V., DeLuca, P., Scopinaro, E., Moltoni, D., Pini, E., Leoni, O., Oria, C., Papagni, M., Nosetti, G., Caldiroli, E., Moser, V., Roni, R., Polverino, A., Bovo, C., Mezzalira, L., Andretta, M., Trentin, L., Palcic, S., Pettinelli, A., Arbo, A., Bertola, A., Capparoni, G., Cattaruzzi, C., Marcuzzo, L., Rosa, F.V., Basso, B., Saglietto, M., Delucis, S., Prioli, M., Filippi, R., Coccini, A., Ghia, M., Sanfelici, F., Radici, S., Scanavacca, P., Campi, A., Bianchi, S., Verzola, A., Morini, M., Borsari, M., Danielli, A., Dal Maso, M., Marsiglia, B., Vujovic, B., Pisani, M., Bonini, P., Lena, F., Aletti, P., Marcobelli, A., Sagratella, S., Fratini, S., Bartolini, F., Riccioni, G., Meneghini, A., Di Turi, R., Fano, V., Blasi, A., Pagnozzi, E., Quintavalle, G., D'Avenia, P., De Matthaeis, M.C., Ferrante, F., Crescenzi, S., Marziale, L., Venditti, P., Bianchi, C., Senesi, I., Baci, R., De Carlo, I., Lavalle, A., Trofa, G., Marcello, G., Pagliaro, C., Troncone, C., Farina, G., Tari, M.G., Motola, G., De Luca, F., Saltarelli, M.L., Granieri, C., Vulnera, M., Palumbo, L., La Viola, F., Florio, L., De Francesco, A.E., Costantino, D., Rapisarda, F., Lazzaro, P.L., Pastorello, M., Parelli, M., Visconti, M., Uomo, I., Sanna, P., Lombardo, F., Onder, Graziano, Marengoni, Alessandra, Russo, Pierluigi, Degli Esposti, Luca, Fini, Massimo, Monaco, Alessandro, Bonassi, Stefano, Palmer, Katie, Marrocco, Walter, Pozzi, Giuseppe, Sangiorgi, Diego, Buda, Stefano, Marchionni, Niccolò, Mammarella, Federica, Bernabei, Roberto, Pani, Luca, and Pecorelli, Sergio

Published
2016
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9. Risk of hospitalization for heart failure in patients with type 2 diabetes newly treated with DPP-4 inhibitors or other oral glucose-lowering medications: A retrospective registry study on 127,555 patients from the Nationwide OsMed Health-DB Database

Author

Fadini, G. P., Avogaro, A., Degli Esposti, L., Russo, P., Saragoni, S., Buda, S., Rosano, G., Pecorelli, S., Pani, L., Martinetti, S., Mero, P., Raeli, L., Migliazza, S., Dellagiovanna, M., Cerra, C., Gambera, M., Piccinelli, R., Zambetti, M., Atzeni, F., Valsecchi, V., Deluca, P., Scopinaro, E., Moltoni, D., Pini, E., Leoni, O., Oria, C., Papagni, M., Nosetti, G., Caldiroli, E., Moser, V., Roni, R., Polverino, A., Bovo, C., Mezzalira, L., Andretta, M., Trentin, L., Palcic, S., Pettinelli, A., Arbo, A., Bertola, A., Capparoni, G., Cattaruzzi, C., Marcuzzo, L., Rosa, F. V., Basso, B., Saglietto, M., Delucis, S., Prioli, M., Filippi, R., Coccini, A., Ghia, M., Sanfelici, F., Radici, S., Scanavacca, P., Campi, A., Bianchi, S., Verzola, A., Morini, M., Borsari, M., Danielli, A., Dal Maso, M., Marsiglia, B., Vujovic, B., Pisani, M., Bonini, P., Lena, F., Aletti, P., Marcobelli, A., Sagratella, S., Fratini, S., Bartolini, F., Riccioni, G., Meneghini, A., Di Turi, R., Fano, V., Blasi, A., Pagnozzi, E., Quintavalle, G., D'Avenia, P., De Matthaeis, M. C., Ferrante, F., Crescenzi, S., Marziale, L., Venditti, P., Bianchi, C., Senesi, I., Baci, R., De Carlo, I., Lavalle, A., Trofa, G., Marcello, G., Pagliaro, C., Troncone, C., Farina, G., Tari, M. G., Motola, G., De Luca, F., Saltarelli, M. L., Granieri, C., Vulnera, M., Palumbo, L., La Viola, F., Florio, L., De Francesco, A. E., Costantino, D., Rapisarda, F., Lazzaro, P. L., Pastorello, M., Parlli, M., Visconti, M., Uomo, I., Sanna, P., and Lombardo, F.

Subjects
Adult, Male, medicine.medical_specialty, Epidemiology, Population, Administration, Oral, Medications, Heart failure, Type 2 diabetes, Lower risk, Diabetes, Incretin, Cardiology and Cardiovascular Medicine, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, education, Aged, Retrospective Studies, education.field_of_study, Analysis of Variance, Dipeptidyl-Peptidase IV Inhibitors, business.industry, Hazard ratio, Absolute risk reduction, Retrospective cohort study, Middle Aged, medicine.disease, Hospitalization, Endocrinology, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, Italy, Propensity score matching, Female, business, Diabetic Angiopathies
Abstract

Aims Oral glucose-lowering medications are associated with excess risk of heart failure (HF). Given the absence of comparative data among drug classes, we performed a retrospective study in 32 Health Services of 16 Italian regions accounting for a population of 18 million individuals, to assess the association between HF risk and use of sulphonylureas, DPP-4i, and glitazones. Methods and results We extracted data on patients with type 2 diabetes who initiated treatment with DPP-4i, thiazolidinediones, or sulphonylureas alone or in combination with metformin during an accrual time of 2 years. The endpoint was hospitalization for HF (HHF) occurring after the first 6 months of therapy, and the observation was extended for up to 4 years. A total of 127 555 patients were included, of whom 14.3% were on DPP-4i, 72.5% on sulphonylurea, 13.2% on thiazolidinediones, with average 70.7% being on metformin as combination therapy. Patients in the three groups differed significantly for baseline characteristics: age, sex, Charlson index, concurrent medications, and previous cardiovascular events. During an average 2.6-year follow-up, after adjusting for measured confounders, use of DPP-4i was associated with a reduced risk of HHF compared with sulphonylureas [hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.62–0.97; P = 0.026]. After propensity matching, the analysis was restricted to 39 465 patients, and the use of DPP-4i was still associated with a lower risk of HHF (HR 0.70; 95% CI 0.52–0.94; P = 0.018). Conclusion In a very large observational study, the use of DPP-4i was associated with a reduced risk of HHF when compared with sulphonylureas.

Published
2015

10. Advanced Age and Medication Prescription: More Years, Less Medications? A Nationwide Report From the Italian Medicines Agency

Author

Onder, Graziano, primary, Marengoni, Alessandra, additional, Russo, Pierluigi, additional, Degli Esposti, Luca, additional, Fini, Massimo, additional, Monaco, Alessandro, additional, Bonassi, Stefano, additional, Palmer, Katie, additional, Marrocco, Walter, additional, Pozzi, Giuseppe, additional, Sangiorgi, Diego, additional, Buda, Stefano, additional, Marchionni, Niccolò, additional, Mammarella, Federica, additional, Bernabei, Roberto, additional, Pani, Luca, additional, Pecorelli, Sergio, additional, Martinetti, S., additional, Mero, P., additional, Raeli, L., additional, Migliazza, S., additional, Dellagiovanna, M., additional, Cerra, C., additional, Gambera, M., additional, Piccinelli, R., additional, Zambetti, M., additional, Atzeni, F., additional, Valsecchi, V., additional, DeLuca, P., additional, Scopinaro, E., additional, Moltoni, D., additional, Pini, E., additional, Leoni, O., additional, Oria, C., additional, Papagni, M., additional, Nosetti, G., additional, Caldiroli, E., additional, Moser, V., additional, Roni, R., additional, Polverino, A., additional, Bovo, C., additional, Mezzalira, L., additional, Andretta, M., additional, Trentin, L., additional, Palcic, S., additional, Pettinelli, A., additional, Arbo, A., additional, Bertola, A., additional, Capparoni, G., additional, Cattaruzzi, C., additional, Marcuzzo, L., additional, Rosa, F.V., additional, Basso, B., additional, Saglietto, M., additional, Delucis, S., additional, Prioli, M., additional, Filippi, R., additional, Coccini, A., additional, Ghia, M., additional, Sanfelici, F., additional, Radici, S., additional, Scanavacca, P., additional, Campi, A., additional, Bianchi, S., additional, Verzola, A., additional, Morini, M., additional, Borsari, M., additional, Danielli, A., additional, Dal Maso, M., additional, Marsiglia, B., additional, Vujovic, B., additional, Pisani, M., additional, Bonini, P., additional, Lena, F., additional, Aletti, P., additional, Marcobelli, A., additional, Sagratella, S., additional, Fratini, S., additional, Bartolini, F., additional, Riccioni, G., additional, Meneghini, A., additional, Di Turi, R., additional, Fano, V., additional, Blasi, A., additional, Pagnozzi, E., additional, Quintavalle, G., additional, D'Avenia, P., additional, De Matthaeis, M.C., additional, Ferrante, F., additional, Crescenzi, S., additional, Marziale, L., additional, Venditti, P., additional, Bianchi, C., additional, Senesi, I., additional, Baci, R., additional, De Carlo, I., additional, Lavalle, A., additional, Trofa, G., additional, Marcello, G., additional, Pagliaro, C., additional, Troncone, C., additional, Farina, G., additional, Tari, M.G., additional, Motola, G., additional, De Luca, F., additional, Saltarelli, M.L., additional, Granieri, C., additional, Vulnera, M., additional, Palumbo, L., additional, La Viola, F., additional, Florio, L., additional, De Francesco, A.E., additional, Costantino, D., additional, Rapisarda, F., additional, Lazzaro, P.L., additional, Pastorello, M., additional, Parelli, M., additional, Visconti, M., additional, Uomo, I., additional, Sanna, P., additional, and Lombardo, F., additional

Published
2016
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12. Cardiovascular Risk After Adjuvant Trastuzumab in Early Breast Cancer: An Italian Population-Based Cohort Study

Author

Matteo Franchi, Mirko Di Martino, Donatella Garau, Giovanni Corrao, Ilenia De Carlo, Ursula Kirchmayer, Giovanni Apolone, Marilena Romero, Pamela Minicozzi, Luigi Tarantini, Salvatore Scondotto, Annalisa Trama, Ivan Merlo, Franchi, M, Trama, A, Merlo, I, Minicozzi, P, Tarantini, L, Garau, D, Kirchmayer, U, Di Martino, M, Romero, M, De Carlo, I, Scondotto, S, Apolone, G, and Corrao, G

Subjects
Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Population, Breast Neoplasms, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Risk Factors, Trastuzumab, Internal medicine, Breast Cancer, medicine, Humans, 030212 general & internal medicine, education, education.field_of_study, Cardiotoxicity, business.industry, Hazard ratio, Early breast cancer, Real world, medicine.disease, Confidence interval, Italy, Oncology, Cardiovascular Diseases, Chemotherapy, Adjuvant, Heart Disease Risk Factors, 030220 oncology & carcinogenesis, Cohort, Female, business, Cohort study, medicine.drug
Abstract

Background Although trastuzumab (T) represents the standard of care for the adjuvant treatment of HER2‐positive early‐stage breast cancer, contrasting results are available about the cardiac toxicity associated to its use. We conducted a multiregional population‐based cohort investigation aimed to assess both the short‐ and long‐term cardiovascular (CV) outcomes in women with early breast cancer treated with T‐based or standard adjuvant chemotherapy (CT). Materials and Methods We used health care use databases of six Italian regions, overall accounting for 42% of the Italian population. The study cohort was made by all women surgically treated for breast cancer who started a first‐line adjuvant T‐based or CT treatment. Patients treated with T were 1:2 matched to those treated with CT based on date of treatment start, age, and presence of CV risk factors. Short‐ and long‐term CV outcomes (heart failure and cardiomyopathy) were measured, respectively, after 1 year and at the end of follow‐up. Results Among 28,599 women who met the inclusion criteria, 6,208 T users were matched to 12,416 CT users. After a mean follow‐up of 5.88 years, short‐ and long‐term cumulative CV risk were 0.8% and 2.6% in patients treated with T and 0.2% and 2.8% in those treated with CT, respectively. Adjusted hazard ratios were 4.6 (95% confidence interval [CI], 2.6–8.0) for short‐term and 1.2 (95% CI, 0.9–1.6) for long‐term CV risk. Discussion In our large real‐world investigation, T‐associated cardiotoxicity was limited to the treatment period. The addition of T to adjuvant CT did not result in long‐term worsening of CV events. Implications for Practice Adjuvant trastuzumab‐based chemotherapy represents the backbone therapy in patients with HER2‐positive early breast cancer. Although well tolerated, cardiovascular events can manifest during or after therapy because of treatment‐related toxicities. In this wide multicenter and unselected cohort, long‐term symptomatic cardiotoxicity was low and limited to the treatment period. The findings suggest that developing tools that would be adequately able to predict cardiac toxicity at an early stage remains an important area in which additional research efforts are needed., With breast cancer patients experiencing longer survival, emphasizing their overall health through management of late and long‐term treatment effects is becoming increasingly important. This article reports a multiregional real‐world population‐based cohort investigation carried out to compare short‐term and long‐term cardiovascular risk of symptomatic cardiovascular events in women with localized breast cancer treated with trastuzumab‐based or standard adjuvant therapy in clinical practice.

Published
2020
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13. Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project

Author

Salvatore Scondotto, Mirko Di Martino, Marilena Romero, Donatella Garau, Ilenia De Carlo, Claudia Vener, Matteo Franchi, Matteo G. Della Porta, Giovanni Corrao, Francesco Passamonti, Ursula Kirchmayer, Chiara Stival, Franchi, M, Vener, C, Garau, D, Kirchmayer, U, Di Martino, M, Romero, M, De Carlo, I, Scondotto, S, Stival, C, Della Porta, M, Passamonti, F, and Corrao, G

Subjects
Oncology, medicine.medical_specialty, real-world, Cost effectiveness, cost-effectivene, effectiveness, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Medicine, 030212 general & internal medicine, cost-effectiveness, Multiple myeloma, Original Research, lcsh:RC633-647.5, business.industry, Bortezomib, Disease progression, bortezomib, multiple myeloma, Retrospective cohort study, lcsh:Diseases of the blood and blood-forming organs, Hematology, medicine.disease, 030220 oncology & carcinogenesis, Conventional chemotherapy, business, effectivene, medicine.drug
Abstract

Introduction: Randomized clinical trials showed that bortezomib, in addition to conventional chemotherapy, improves survival and disease progression in multiple myeloma (MM) patients not eligible for stem cell transplantation. The aim of this retrospective population-based cohort study is the evaluation of both clinical and economic profile of bortezomib-based versus conventional chemotherapy in daily clinical practice. Methods: Healthcare utilization databases of six Italian regions were used to identify adult patients with non-transplant MM, who started a first-line therapy with bortezomib-based or conventional chemotherapy. Patients were matched by propensity score and were followed from treatment start until death, lost to follow-up or study end-point. Overall survival (OS) and restricted mean survival time (RMST) were estimated using the Kaplan–Meier method. Association between first-line treatment and risk of death was estimated by a conditional Cox proportional regression model. Average mean cumulative costs were estimated and compared between groups. Results: In the period 2010–2016, 3509 non-transplant MM patients met the inclusion criteria, of which 1157 treated with bortezomib-based therapy were matched to 1826 treated with conventional chemotherapy. Median OS and RMST were 33.9 and 27.9 months, and 42.9 and 38.4 months, respectively, in the two treatment arms. Overall, these values corresponded to a HR of death of 0.79 (95% CI 0.71–0.89) over a time horizon of 84 months. Average cumulative cost were 83,839 € and 54,499 €, respectively, corresponding to an incremental cost-effectiveness ratio of 54,333 € per year of life gained, a cost coherent with the willingness-to-pay thresholds frequently adopted from Western countries. Conclusions: These data suggested that, in a large cohort of non-transplant MM patients treated outside the experimental setting, first-line treatment with bortezomib-based therapy was associated with a favourable effectiveness and cost-effectiveness profile.

Published
2021

14. Electrochemical rewiring through quantum conductance effects in single metallic memristive nanowires.

Author

Milano G, Raffone F, Bejtka K, De Carlo I, Fretto M, Pirri FC, Cicero G, Ricciardi C, and Valov I

Abstract

Memristive devices have been demonstrated to exhibit quantum conductance effects at room temperature. In these devices, a detailed understanding of the relationship between electrochemical processes and ionic dynamic underlying the formation of atomic-sized conductive filaments and corresponding electronic transport properties in the quantum regime still represents a challenge. In this work, we report on quantum conductance effects in single memristive Ag nanowires (NWs) through a combined experimental and simulation approach that combines advanced classical molecular dynamics (MD) algorithms and quantum transport simulations (DFT). This approach provides new insights on quantum conductance effects in memristive devices by unravelling the intrinsic relationship between electronic transport and atomic dynamic reconfiguration of the nanofilment, by shedding light on deviations from integer multiples of the fundamental quantum of conductance depending on peculiar dynamic trajectories of nanofilament reconfiguration and on conductance fluctuations relying on atomic rearrangement due to thermal fluctuations.

Published
2024
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15. Electrical and Thermal Conductivities of Single Cu x O Nanowires.

Author

De Carlo I, Baudino L, Klapetek P, Serrapede M, Michieletti F, De Leo N, Pirri F, Boarino L, Lamberti A, and Milano G

Abstract

Copper oxide nanowires (NWs) are promising elements for the realization of a wide range of devices for low-power electronics, gas sensors, and energy storage applications, due to their high aspect ratio, low environmental impact, and cost-effective manufacturing. Here, we report on the electrical and thermal properties of copper oxide NWs synthetized through thermal growth directly on copper foil. Structural characterization revealed that the growth process resulted in the formation of vertically aligned NWs on the Cu growth substrate, while the investigation of chemical composition revealed that the NWs were composed of CuO rather than Cu 2 O. The electrical characterization of single-NW-based devices, in which single NWs were contacted by Cu electrodes, revealed that the NWs were characterized by a conductivity of 7.6 × 10 -2 S∙cm -1 . The effect of the metal-insulator interface at the NW-electrode contact was analyzed by comparing characterizations in two-terminal and four-terminal configurations. The effective thermal conductivity of single CuO NWs placed on a substrate was measured using Scanning Thermal Microscopy (SThM), providing a value of 2.6 W∙m -1 ∙K -1 , and using a simple Finite Difference model, an estimate for the thermal conductivity of the nanowire itself was obtained as 3.1 W∙m -1 ∙K -1 . By shedding new light on the electrical and thermal properties of single CuO NWs, these results can be exploited for the rational design of a wide range of optoelectronic devices based on NWs.

Published
2023
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16. Vortex dynamics in NbTi films at high frequency and high DC magnetic fields.

Author

Ghigo G, Torsello D, Gozzelino L, Fracasso M, Bartoli M, Pira C, Ford D, Marconato G, Fretto M, De Carlo I, Pompeo N, and Silva E

Subjects
Electric Impedance, Magnetic Fields, Motion Pictures, Thioinosine
Abstract

We report on the characterization of NbTi films at [Formula: see text] 11 GHz and in DC magnetic fields up to 4 T, performed by means of the coplanar waveguide resonator technique, providing quantitative information about the penetration depth, the complex impedance, and the vortex-motion-induced complex resistivity. This kind of characterization is essential for the development of radiofrequency cavity technology. To access the vortex-pinning parameters, the complex impedance was analyzed within the formalism of the Campbell penetration depth. Measurements in this frequency range allowed us to determine the complete set of vortex-pinning parameters and the flux flow resistivity, both analyzed and discussed in the framework of high-frequency vortex dynamics models. The analysis also benefits from the comparison with results obtained by a dielectric-loaded resonator technique on similar samples and by other ancillary structural and electromagnetic characterization techniques that provide us with a comprehensive picture of the material. It turns out that the normalized flux flow resistivity follows remarkably well the trend predicted by the time dependent Ginzburg-Landau theory, while the pinning constant exhibits a decreasing trend with the field which points to a collective pinning regime., (© 2023. The Author(s).)

Published
2023
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17. Bortezomib-based therapy in non-transplant multiple myeloma patients: a retrospective cohort study from the FABIO project.

Author

Franchi M, Vener C, Garau D, Kirchmayer U, Di Martino M, Romero M, De Carlo I, Scondotto S, Stival C, Della Porta MG, Passamonti F, and Corrao G

Abstract

Introduction: Randomized clinical trials showed that bortezomib, in addition to conventional chemotherapy, improves survival and disease progression in multiple myeloma (MM) patients not eligible for stem cell transplantation. The aim of this retrospective population-based cohort study is the evaluation of both clinical and economic profile of bortezomib-based versus conventional chemotherapy in daily clinical practice., Methods: Healthcare utilization databases of six Italian regions were used to identify adult patients with non-transplant MM, who started a first-line therapy with bortezomib-based or conventional chemotherapy. Patients were matched by propensity score and were followed from treatment start until death, lost to follow-up or study end-point. Overall survival (OS) and restricted mean survival time (RMST) were estimated using the Kaplan-Meier method. Association between first-line treatment and risk of death was estimated by a conditional Cox proportional regression model. Average mean cumulative costs were estimated and compared between groups., Results: In the period 2010-2016, 3509 non-transplant MM patients met the inclusion criteria, of which 1157 treated with bortezomib-based therapy were matched to 1826 treated with conventional chemotherapy. Median OS and RMST were 33.9 and 27.9 months, and 42.9 and 38.4 months, respectively, in the two treatment arms. Overall, these values corresponded to a HR of death of 0.79 (95% CI 0.71-0.89) over a time horizon of 84 months. Average cumulative cost were 83,839 € and 54,499 €, respectively, corresponding to an incremental cost-effectiveness ratio of 54,333 € per year of life gained, a cost coherent with the willingness-to-pay thresholds frequently adopted from Western countries., Conclusions: These data suggested that, in a large cohort of non-transplant MM patients treated outside the experimental setting, first-line treatment with bortezomib-based therapy was associated with a favourable effectiveness and cost-effectiveness profile., Competing Interests: Conflict of interest statement: Giovanni Corrao received research support from the European Community (EC), the Italian Agency of Drugs (AIFA), and the Italian Ministry for University and Research (MIUR). He took part in a variety of projects that were funded by pharmaceutical companies (i.e. Novartis, GSK, Roche, AMGEN and BMS). He also received honoraria as a member of the advisory board to Roche. The other authors declare that they have no conflicts of interest to disclose., (© The Author(s), 2021.)

Published
2021
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18. Effectiveness and Costs Associated to Adding Cetuximab or Bevacizumab to Chemotherapy as Initial Treatment in Metastatic Colorectal Cancer: Results from the Observational FABIO Project.

Author

Franchi M, Garau D, Kirchmayer U, Di Martino M, Romero M, De Carlo I, Scondotto S, and Corrao G

Abstract

Evidence available on the effectiveness and costs of biological therapies for the initial treatment of metastatic colorectal cancer (mCRC) is scarce and contrasting. We conducted a population-based cohort investigation for assessing overall survival and costs associated with their use in a real-world setting. Healthcare utilization databases were used to select patients newly diagnosed with mCRC between 2010 and 2016. Those initially treated with biological therapy (bevacizumab or cetuximab) added to chemotherapy were propensity-score-matched to those treated with standard chemotherapy alone, and were followed up to June 30th, 2018. Kaplan-Meier survival estimates, restricted mean survival time (RMST) and cumulative costs were compared between the two treatment arms. The study cohort included 1896 mCRC patients treated with biological therapy matched to 5678 patients treated with chemotherapy alone. Median overall survival was 21.8 and 20.2 months, respectively. After 84 months of follow-up, RMSTs were 30.9 and 31.9 months ( p = 0.193), indicating no differences between the average survival time between treatment arms. Patients treated with biological therapy were associated with higher costs. Cumulative per capita costs were €59,663 and €44,399, respectively. In our study, first-line biological therapy did not improve long-term overall survival and was associated with higher costs as compared to standard chemotherapy.

Published
2020
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