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357 results on '"Pietronigro, A."'

53. Blockade of α4 integrins reduces leukocyte-endothelial interactions in cerebral vessels and improves memory in a mouse model of Alzheimer's disease

Author

Gabriela Constantin, Vittorina Della Bianca, Somayehsadat Ghasemi, Giulia Iannoto, Barbara Rossi, Rajasekar Nagarajan, Anna Slanzi, Eleonora Terrabuio, Gabriele Tosadori, Silvia Dusi, Elena Zenaro, Enrica Caterina Pietronigro, and Gennj Piacentino

Subjects
0301 basic medicine, Genetically modified mouse, Integrin alpha4, Tau protein, Integrin, lcsh:Medicine, Hyperphosphorylation, Mice, Transgenic, Plaque, Amyloid, tau Proteins, Inflammation, Cell Communication, Chronic inflammation, Alzheimer's disease, Microgliosis, Article, Mice, 03 medical and health sciences, 0302 clinical medicine, Alzheimer Disease, Memory, Leukocyte Trafficking, Leukocytes, Animals, Medicine, Endothelium, Cognitive decline, lcsh:Science, Maze Learning, Amyloid beta-Peptides, Multidisciplinary, biology, business.industry, lcsh:R, Antibodies, Monoclonal, Chronic inflammation, Alzheimer's disease, Immunohistochemistry, 3. Good health, Disease Models, Animal, Treatment Outcome, 030104 developmental biology, Gene Expression Regulation, biology.protein, Cancer research, lcsh:Q, medicine.symptom, business, Biomarkers, 030217 neurology & neurosurgery
Abstract

Alzheimer’s disease (AD) is a neurodegenerative disorder characterized by cognitive decline associated with the deposition of amyloid-β (Aβ) plaques, hyperphosphorylation of tau protein, and neuronal loss. Vascular inflammation and leukocyte trafficking may contribute to AD pathogenesis, and a better understanding of these inflammation mechanisms could therefore facilitate the development of new AD therapies. Here we show that T cells extravasate in the proximity of cerebral VCAM-1+ vessels in 3xTg-AD transgenic mice, which develop both Aβ and tau pathologies. The counter-ligand of VCAM-1 – α4β1 integrin, also known as very late antigen-4 (VLA-4) – was more abundant on circulating CD4+ T cells and was also expressed by a significant proportion of blood CD8+ T cells and neutrophils in AD mice. Intravital microscopy of the brain microcirculation revealed that α4 integrins control leukocyte–endothelial interactions in AD mice. Therapeutic targeting of VLA-4 using antibodies that specifically block α4 integrins improved the memory of 3xTg-AD mice compared to an isotype control. These antibodies also reduced neuropathological hallmarks of AD, including microgliosis, Aβ load and tau hyperphosphorylation. Our results demonstrate that α4 integrin-dependent leukocyte trafficking promotes cognitive impairment and AD neuropathology, suggesting that the blockade of α4 integrins may offer a new therapeutic strategy in AD.

Published
2019

54. Influenza Vaccination in Italian Healthcare Workers (2018–2019 Season): Strengths and Weaknesses. Results of a Cohort Study in Two Large Italian Hospitals

Author

Panatto, D., Lai, P. L., Mosca, S., Lecini, E., Orsi, A., Signori, A., Castaldi, S., Pariani, E., Pellegrinelli, L., Galli, C., Anselmi, G., Icardi, G., Sticchi, L., Zangrillo, F., Iovine, M., Marchini, F., Grammatico, F., Pennati, B. M., Zacconi, M., Tassinari, F., Arcuri, C., Canepa, P., Caligiuri, P., Rappazzo, E., Guarona, G., Barisione, G., Varesano, S., Cavazzana, L., Carnevali, D., Del Castillo, G., Forni, G., Gandolfi, C., Grimoldi, L., Magnoni, P., Mosillo, M., Pietronigro, A., Principi, N., Tiwana, N., Battistini, A., Di Bella, A. M., Guglielmi, B., Bellina, D., Talamini, A., Daturi, V., and Ziferro, R.

Subjects
0301 basic medicine, Influenza vaccine, Healthcare workers, Influenza, Influenza vaccination, Influenza vaccination coverage, Laboratory-confirmed influenza, 030106 microbiology, Immunology, lcsh:Medicine, laboratory-confirmed influenza, Article, 03 medical and health sciences, 0302 clinical medicine, Environmental health, Drug Discovery, Health care, Medicine, Pharmacology (medical), 030212 general & internal medicine, Pharmacology, influenza vaccination coverage, healthcare workers, business.industry, Proportional hazards model, lcsh:R, Confounding, virus diseases, Influenza a, influenza vaccination, 3. Good health, Vaccination, Infectious Diseases, influenza, business, Strengths and weaknesses, Cohort study
Abstract

Background: Annual vaccination is the most effective way to combat influenza. As influenza viruses evolve, seasonal vaccines are updated annually. Within the European project Development of Robust and Innovative Vaccine Effectiveness (DRIVE), a cohort study involving Italian healthcare workers (HCWs) was carried out during the 2018-2019 season. Two aims were defined: to measure influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza cases and to conduct an awareness-raising campaign to increase vaccination coverage. Methods: Each subject enrolled was followed up from enrollment to the end of the study. Each HCW who developed ILI was swabbed for laboratory confirmation of influenza. Influenza viruses were identified by molecular assays. A Cox regression analysis, crude and adjusted for confounding variables, was performed to estimate the IVE. Results: Among the 4483 HCWs enrolled, vaccination coverage was 32.5%, and 308 ILI cases were collected: 23.4% were positive for influenza (54.2% A(H1N1) pdm09, 45.8% A(H3N2)). No influenza B viruses were detected. No overall IVE was observed. Analyzing the subtypes of influenza A viruses, the IVE was estimated as 45% (95% CI: -59 to 81) for A(H1N1) pdm09. Conclusions: Vaccination coverage among HCWs increased. Study difficulties and the circulation of drifted variants of A(H3N2) could partly explain the observed IVE.

Published
2020

55. LFA-1 Controls Th1 and Th17 Motility Behavior in the Inflamed Central Nervous System

Author

Dusi, Silvia, primary, Angiari, Stefano, additional, Pietronigro, Enrica Caterina, additional, Lopez, Nicola, additional, Angelini, Gabriele, additional, Zenaro, Elena, additional, Della Bianca, Vittorina, additional, Tosadori, Gabriele, additional, Paris, Francesca, additional, Amoruso, Antonella, additional, Carlucci, Tommaso, additional, Constantin, Gabriela, additional, and Rossi, Barbara, additional

Published
2019
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56. [P1–205]: TREATMENT WITH CALCIUM DOBESILATE REDUCES NEUROINFLAMMATION AND IMPROVES COGNITION IN A MOUSE MODEL OF ALZHEIMER's DISEASE

Author

Michela Mirenda, Gennj Piacentino, Gabriela Constantin, Elena Zenaro, Vittorina Della Bianca, Lara Toffali, Enrica Caterina Pietronigro, Jacques Bauer, and Rajasekar Nagarajan

Subjects
Epidemiology, business.industry, Health Policy, Calcium dobesilate, Cognition, Disease, Psychiatry and Mental health, Cellular and Molecular Neuroscience, Developmental Neuroscience, Medicine, Neurology (clinical), Geriatrics and Gerontology, business, Neuroscience, Neuroinflammation, medicine.drug
Published
2017

57. [P2–063]: INHIBITION OF PROTEIN ARGININE DEIMINASES IMPROVES COGNITION AND REDUCES NEUROPATHOLOGICAL CHANGES IN MOUSE MODELS OF ALZHEIMER's DISEASE

Author

Enrica Caterina Pietronigro, Elena Zenaro, Paul M. Thompson, Vittorina Della Bianca, Marco Bonani, Giulia Iannoto, Rajasekar Nagarajan, and Gabriela Constantin

Subjects
Epidemiology, business.industry, Health Policy, Cognition, Disease, Psychiatry and Mental health, Cellular and Molecular Neuroscience, Developmental Neuroscience, Medicine, Neurology (clinical), Geriatrics and Gerontology, business, Neuroscience, Protein-Arginine Deiminases
Published
2017

58. [O1–14–01]: TIM‐1 CONTROLS NEUTROPHIL TRAFFICKING AND CONTRIBUTES TO THE INDUCTION OF COGNITIVE DECLINE AND NEUROPATHOLOGICAL CHANGES IN ANIMAL MODELS OF ALZHEIMER'S DISEASE

Author

Vittorina Della Bianca, Gabriela Constantin, Rajasekar Nagarajan, Enrica Caterina Pietronigro, Gennj Piacentino, Jessica Arioli, Stefano Angiari, Giulia Iannoto, Elena Zenaro, and Marco Bonani

Subjects
Epidemiology, business.industry, Health Policy, Disease, Psychiatry and Mental health, Cellular and Molecular Neuroscience, Developmental Neuroscience, Immunology, Medicine, Neurology (clinical), Geriatrics and Gerontology, Cognitive decline, business, Neuroscience
Published
2017

59. NETosis in Alzheimer’s Disease

Author

Vittorina Della Bianca, Elena Zenaro, Enrica Caterina Pietronigro, and Gabriela Constantin

Subjects
0301 basic medicine, Genetically modified mouse, Pathology, medicine.medical_specialty, Immunology, Integrin, neutrophil extracellular traps, Review, Blood–brain barrier, neuroinflammation, Pathogenesis, 03 medical and health sciences, neutrophils, Parenchyma, medicine, Immunology and Allergy, Neuroinflammation, biology, Neutrophil extracellular traps, blood-brain barrier, 030104 developmental biology, medicine.anatomical_structure, Neuroimmunology, Alzheimer’s disease, biology.protein
Abstract

Alzheimer’s disease (AD) is a neurodegenerative disorder characterized by the progressive deterioration of cognitive functions. Its neuropathological features include amyloid-β (Aβ) accumulation, the formation of neurofibrillary tangles and the loss of neurons and synapses. Neuro-inflammation is a well-established feature of AD pathogenesis and a better understanding of its mechanisms could facilitate the development of new therapeutic approaches. Recent studies in transgenic mouse models of AD have shown that neutrophils adhere to blood vessels and migrate inside the parenchyma. Moreover, studies in human AD subjects have also shown that neutrophils adhere and spread inside brain vessels and invade the parenchyma, suggesting these cells play a role in AD pathogenesis. Indeed, neutrophil depletion and the therapeutic inhibition of neutrophil trafficking, achieved by blocking LFA-1 integrin in AD mouse models, significantly reduced memory loss and the neuropathological features of AD. We observed that neutrophils release neutrophil extracellular traps (NETs) inside blood vessels and in the parenchyma of AD mice, potentially harming the blood–brain barrier BBB and neural cells. Furthermore, confocal microscopy confirmed the presence of NETs inside the cortical vessels and parenchyma of subjects with AD, providing more evidence that neutrophils and NETs play a role in AD-related tissue destruction. The discovery of NETs inside the AD brain suggests that these formations may exacerbate neuro-inflammatory processes, promoting vascular and parenchymal damage during AD. The inhibition of NET formation has achieved therapeutic benefits in several models of chronic inflammatory diseases, including autoimmune diseases affecting the brain. Therefore, the targeting of NETs may delay AD pathogenesis and offer a novel approach for the treatment of this increasingly prevalent disease.

Published
2017

60. TIM-1 Glycoprotein Binds the Adhesion Receptor P-Selectin and Mediates T Cell Trafficking during Inflammation and Autoimmunity

Author

Stefano Angiari, Gabriela Constantin, Sheng Xiao, Vittorina Della Bianca, Vijay K. Kuchroo, Enrica Caterina Pietronigro, Simona Budui, Barbara Rossi, Tiziano Donnarumma, Paul D. Rennert, Elena Zenaro, Carlo Laudanna, José M. Casasnovas, Lara Toffali, Gennj Piacentino, and Silvia Dusi

Subjects
Adoptive cell transfer, T cell immunoglobulin, Encephalomyelitis, Autoimmune, Experimental, Naive T cell, T cell, Immunology, autoimmune disease, Biology, Ligands, Article, Mice, Cell Movement, T-Lymphocyte Subsets, Leukocyte Trafficking, Hypersensitivity, medicine, Animals, Immunology and Allergy, Hepatitis A Virus Cellular Receptor 1, Receptor, Cells, Cultured, Cell Proliferation, Mice, Knockout, leukocyte trafficking, Membrane Glycoproteins, Cell growth, Experimental autoimmune encephalomyelitis, Brain, Membrane Proteins, Th1 Cells, medicine.disease, Adoptive Transfer, Molecular biology, Peptide Fragments, 3. Good health, Mice, Inbred C57BL, P-Selectin, Infectious Diseases, medicine.anatomical_structure, Selectins, mucin domain 1 (TIM-1), Myelin-Oligodendrocyte Glycoprotein, Selectin
Abstract

SummarySelectins play a central role in leukocyte trafficking by mediating tethering and rolling on vascular surfaces. Here we have reported that T cell immunoglobulin and mucin domain 1 (TIM-1) is a P-selectin ligand. We have shown that human and murine TIM-1 binds to P-selectin, and that TIM-1 mediates tethering and rolling of T helper 1 (Th1) and Th17, but not Th2 and regulatory T cells on P-selectin. Th1 and Th17 cells lacking the TIM-1 mucin domain showed reduced rolling in thrombin-activated mesenteric venules and inflamed brain microcirculation. Inhibition of TIM-1 had no effect on naive T cell homing, but it reduced T cell recruitment in a skin hypersensitivity model and blocked experimental autoimmune encephalomyelitis. Uniquely, the TIM-1 immunoglobulin variable domain was also required for P-selectin binding. Our data demonstrate that TIM-1 is a major P-selectin ligand with a specialized role in T cell trafficking during inflammatory responses and the induction of autoimmune disease.

Published
2014

61. Little red riding hood in the social forest. Online grooming as a public health issue: a narrative review.

Author

Forni, G., Pietronigro, A., Tiwana, N., Gandolfi, C. E., Del Castillo, G., Mosillo, M., and Pellai, A.

Subjects
PERSONAL grooming, MINORS, INTERNET, CHILD sexual abuse, SOCIAL media
Abstract

Copyright of Annali di Igiene, Medicina Preventiva e di Comunità is the property of Societa Editrice Universo s.r.l. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2020
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62. Neutrophils promote Alzheimer's disease-like pathology and cognitive decline via LFA-1 integrin

Author

Lucia Calciano, Giorgio Berton, Ermanna Turano, Elena Zenaro, Gabriela Constantin, Bruno Bonetti, Laura Marongiu, Alessio Montresor, Gabriele Tosadori, Tommaso Carlucci, Enrica Caterina Pietronigro, Barbara Rossi, Daniele Catalucci, Simona Budui, Silvia Dusi, Gennj Piacentino, Sara Nani, Vittorina Della Bianca, Stefano Angiari, Zenaro, E, Pietronigro, E, Bianca, V, Piacentino, G, Marongiu, L, Budui, S, Turano, E, Rossi, B, Angiari, S, Dusi, S, Montresor, A, Carlucci, T, Nani, S, Tosadori, G, Calciano, L, Catalucci, D, Berton, G, Bonetti, B, and Constantin, G

Subjects
Pathology, medicine.medical_specialty, Amyloid beta-Peptide, Neutrophils, Inflammation, Mice, Transgenic, Neuropathology, Extracellular Traps, General Biochemistry, Genetics and Molecular Biology, Cognition Disorder, Mice, Peptide Fragment, Alzheimer Disease, Cell Movement, medicine, Cell Adhesion, Animals, Humans, Lymphocyte function-associated antigen 1, Cognitive decline, Alzheimer's disease, inflammation, LFA-1 integrin, Neutrophil extravasation, Amyloid beta-Peptides, Animal, business.industry, Neutrophil, Interleukin-17, LFA-1 integrin, General Medicine, Neutrophil extracellular traps, Alzheimer's disease, medicine.disease, Extracellular Trap, Lymphocyte Function-Associated Antigen-1, Peptide Fragments, Mice, Inbred C57BL, Gliosis, inflammation, Immunology, medicine.symptom, business, Cognition Disorders, Human
Abstract

Inflammation is a pathological hallmark of Alzheimer's disease, and innate immune cells have been shown to contribute to disease pathogenesis. In two transgenic models of Alzheimer's disease (5xFAD and 3xTg-AD mice), neutrophils extravasated and were present in areas with amyloid-β (Aβ) deposits, where they released neutrophil extracellular traps (NETs) and IL-17. Aβ 42 peptide triggered the LFA-1 integrin high-affinity state and rapid neutrophil adhesion to integrin ligands. In vivo, LFA-1 integrin controlled neutrophil extravasation into the CNS and intraparenchymal motility. In transgenic Alzheimer's disease models, neutrophil depletion or inhibition of neutrophil trafficking via LFA-1 blockade reduced Alzheimer's disease-like neuropathology and improved memory in mice already showing cognitive dysfunction. Temporary depletion of neutrophils for 1 month at early stages of disease led to sustained improvements in memory. Transgenic Alzheimer's disease model mice lacking LFA-1 were protected from cognitive decline and had reduced gliosis. In humans with Alzheimer's disease, neutrophils adhered to and spread inside brain venules and were present in the parenchyma, along with NETs. Our results demonstrate that neutrophils contribute to Alzheimer's disease pathogenesis and cognitive impairment and suggest that the inhibition of neutrophil trafficking may be beneficial in Alzheimer's disease.

Published
2014

64. P3‐113: LFA‐1 Integrin Mediates Neutrophil Trafficking in the Brain And Contributes to Disease Pathology in Mouse Models of Alzheimer’s Disease

Author

Tommaso Carlucci, Gabriela Constantin, Elena Zenaro, Silvia Dusi, Carlo Laudanna, Enrica Caterina Pietronigro, Gennj Piacentino, and Vittorina Della Bianca

Subjects
Pathology, medicine.medical_specialty, biology, Epidemiology, business.industry, Health Policy, Integrin, Disease, Psychiatry and Mental health, Cellular and Molecular Neuroscience, Developmental Neuroscience, biology.protein, Medicine, Neurology (clinical), Geriatrics and Gerontology, business
Published
2016

65. P2‐126: Blockade of ALPHA4 Integrins Ameliorates Cognitive Dysfunction and Neuropathological Changes in Transgenic Animals with Alzheimer's‐Like Disease

Author

Enrica Caterina Pietronigro, Gabriela Constantin, Vittorina Della Bianca, Tommaso Carlucci, Gennj Piacentino, Silvia Dusi, and Elena Zenaro

Subjects
0301 basic medicine, biology, Epidemiology, business.industry, Health Policy, Transgene, Integrin, Cognition, Disease, Blockade, 03 medical and health sciences, Psychiatry and Mental health, Cellular and Molecular Neuroscience, 030104 developmental biology, Developmental Neuroscience, Immunology, biology.protein, Medicine, Neurology (clinical), Geriatrics and Gerontology, business, Neuroscience
Published
2016

66. Are all people with diabetes and cardiovascular risk factors or microvascular complications at very high risk? Findings from the Risk and Prevention Study

Author

Marzona, I., Avanzini, F., Lucisano, G., Tettamanti, M., Baviera, M., Nicolucci, A., Roncaglioni, M. C., Tombesi, M., Tognoni, G., Massa, E., Marrocco, W., Micalella, M., Caimi, V., Longoni, P., Franzosi, M. G., Monesi, L., Pangrazzi, I., Barlera, S., Milani, V., Nicolis, E., Casola, C., Clerici, F., Palumbo, A., Sgaroni, G., Marchioli, R., Silletta, M. G., Pioggiarella, R., Scarano, M., Marfisi, R. M., Flamminio, A., Macino, L., Ferri, B., Pera, C., Polidoro, A., Abbatino, D., Acquati, M., Addorisio, G., Adinolfi, D., Adreani, L., Agistri, M. R., Agneta, A., Agnolio, M. L., Agostini, N., Agostino, G., Airo, A., Alaimo, N., Albano, M., Albano, N., Alecci, G., Alemanno, S., Alexanian, A., Alfarano, M., Alfe, L., Alonzo, N., Alvino, S., Ancora, A., Andiloro, S., Andreatta, E., Angeli, S., Angiari, F., Angilletti, V., Annicchiarico, C., Anzivino, M., Aprea, R., Aprile, A., Aprile, E., Aprile, I., Aprile, L., Armellani, V., Arnetoli, M., Aronica, A., Autiero, V., Bacca, G., Baccalaro, A. M., Bacci, M., Baglio, G., Bagnani, M., Baiano, A., Baldari, A., Ballarini, L., Banchi, G., Bandera, R., Bandini, F., Baratella, M., Barbieri, A., Barbieri Vita, A., Bardi, M., Barlocchi, M., Baron, P., Bartoli, M., Basile, A., Basile, F., Basile, S., Battaggia, A., Battaglia, A., Bau, A., Beconcini, G., Beggio, R., Belfiore, P. A., Belicchi, M., Bellamoli, S., Bellini, C., Bellomo, M., Benetollo, C., Benetti, R., Beretta, E., Bertalero, P., Bertaso, F. G., Bertolani, U., Bettelli, G., Biagiotti, G., Bianchi, S., Bianco, G., Biccari, F., Bigioli, F., Bindi, M., Bisanti, G., Bitetti, E. M., Blasetti, M. P., Blesi, F., Boato, V., Boga, S., Boidi, E., Boldrin, G., Bollati, A., Bolzan, L., Bolzonella, S., Bonardi, P., Bonato, G. B., Bonci, M., Bonfitto, G., Bonincontro, E., Boninsegna, F., Bonissone, D., Bono, L., Bonollo, E., Borghi, M., Borioli, N., Borsatto, M., Bosco, T., Bosisio Pioltelli, M., Botarelli, C., Botassis, S., Bottini, F., Bottos, C., Bova, G., Bova, V., Bozzani, A., Bozzetto, R. M., Braga, V. T., Braglia, M., Bramati, E., Brazzoli, C., Breglia, G., Brescia, A., Briganti, D., Brigato, G., Brocchi, A., Brosio, F. A., Bruni, E., Buscaglia, E., Bussini, M. D., Bussotti, A., Buzzaccarini, F., Buzzatti, A., Caccamo, G., Cacciavillani, C., Caggiano, G., Calciano, F. P., Calderisi, M., Calienno, S., Caltagirone, P., Calzolari, I., Cammisa, M., Campanaro, M., Campanella, G. B., Campese, F., Canali, G., Candiani, D. E. L., Canepa, R., Canini, D., Canino, A., Cantoro, E. A., Capilupi, V., Capotosto, P., Cappelli, B., Capraro, G., Carafa, F. A., Carano, Q., Carcaterra, V., Carriero, D., Carrozzo, G., Cartanese, M., Casalena, M., Casarola, M., Caso, C., Casotto, M., Castaldi, F., Castegnaro, R., Castellani, G., Castri, S., Catalano, E., Catinello, N., Caturano, G., Cavallaro, R., Cavallo, A. M., Cavallo, G., Cavion, M. T., Cavirani, G., Cazzaniga, F., Cazzetta, D., Cecconi, V., Cefalo, A., Celebrano, M., Celora, A., Centonze, P., Cerati, D., Cesaretti, D., Checchia, G., Checchin, A., Cherubini, M., Chianese, L., Chiappa, A., Chiappa, M. V., Chiariello, G., Chiavini, G., Chicco, M., Chiumeo, F., Ciacciarelli, A., Ciaci, D., Ciancaglini, R., Cicale, C., Cicale, S., Cipolla, A., Ciruolo, A., Citeri, A. L., Citterio, G., Clerici, M., Coazzoli, E., Collecchia, G., Colletta, F., Colombo, I., Colorio, P., Coluccia, S., Comerio, M., Comoretto, P., Compagni, M., Conte, O., Contri, S., Contrisciani, A., Coppetti, T., Corasaniti, F., Corradi, M. T., Corsano, A., Corsini, A., Corti, N., Costantini, G., Costantino, A., Cotroneo, S., Cozzi, D., Cravello, M. G., Cristiano, E., Cucchi, R., Cusmai, L., D'Errico, G. B., D'Agostino, P., Dal Bianco, L., Dal Mutto, U., Dal Pozzo, G., Dallapiccola, P., Dallatorre, G., Dalle Molle, G., Dalloni, E., D'Aloiso, A., D'Amicis, G., Danese, R., Danieli, D., Danisi, G., D'Anna, M. A., Danti, G., D'Ascanio, S., Davidde, G., De Angeli, D., De Bastiani, R., De Battisti, A., De Bellis, A., De Berardinis, G., De Carlo, F., De Giorgi, D., De Gobbi, R., De Lorenzis, E., De Luca, P., De Martini, G., De Marzi, M., De Matteis, D., De Padova, S., De Polo, P., De Sabato, N., De Stefano, T., De Vita, M. T., De Vito, U., De Zolt, V., Debernardi, F., Del Carlo, A., Del Re, G., Del Zotti, F., D'Elia, R., Della Giovanna, P., Dell'Acqua, L., Dell'Orco, R. L., Demaria, G., Di Benedetto, M. G., Di Chiara, G., Di Corcia, V., Di Domizio, O., Di Donato, P., Di Donato, S., Di Fermo, G., Di Franco, M., Di Giovannantonio, G., Di Lascio, G., Di Lecce, G., Di Lorenzo, N., Di Maro, T., Di Mattia, Q., Di Michele, E., Di Modica, R. S., Di Murro, D., Di Noi, M. C., Di Paoli, V., Di Santi, M., Di Sanzo, A., Di Turi, C., Diazzi, A., Dileo, I., D'Ingianna, A. P., Dolci, A., Dona, G., Donato, C., Donato, P., Donini, A., Donna, M. E., Donvito, T. V., Esposito, L., Esposito, N., Evangelista, M., Faita, G., Falco, M., Falcone, D. A., Falorni, F., Fanciullacci, A., Fanton, L., Fasolo, L., Fassina, R., Fassone, A., Fatarella, P., Fedele, F., Fera, I., Fera, L., Ferioli, S., Ferlini, M. G., Ferlino, R., Ferrante, G., Ferrara, F. N., Ferrarese, M. F., Ferrari, G., Ferrari, O., Ferreri, A., Ferroni, M., Fezzi, G., Figaroli, C., Fina, M. G., Fioretta, A., Fiorucci, C., Firrincieli, R., Fischetti, M., Fischietti, G., Fiume, D. C., Flecchia, G., Forastiere, G., Fossati, B., Franceschi, P. L., Franchi, L., Franzoso, F., Frapporti, G., Frasca, G., Frisotti, A., Fumagalli, G., Fusco, D., Gabriele, P., Gabrieli, A., Gagliano, D., Galimberti, G., Galli, A., Gallicchio, N., Gallio, F., Gallipoli, T., Gallo, P., Galopin, T., Gambarelli, L., Garbin, A., Garozzo, G. M., Gasparri, R., Gastaldo, M., Gatti, E., Gazzaniga, P., Gennachi, N., Gentile, R. V., Germani, P., Gesualdi, F., Gherardi, E., Ghezzi, C., Ghidini, M. G., Ghionda, F., Giacci, L., Gialdini, D., Giampaolo, C., Giancane, R., Giannanti, A., Giannese, S., Giannini, L., Giaretta, M., Giaretta, R., Giavardi, L., Giordano, P., Giordano, E., Giordano, B., Gioria, G. M., Giugliano, R., Grassi, E. A., Greco, A., Greco, L., Grilletti, N., Grimaldi, N., Grisetti, G., Groppelli, G., Gualtieri, L., Guarducci, M., Guastella, G., Guerra, M., Guerrini, F., Guglielmini, A., Guido, A., Gulotta, P., Iacono, E., Iadarola, G., Ianiro, G., Iarussi, V., Ieluzzi, M. L., Ierardi, C., Ingaldi, F., Interlandi, S., Iocca, M., Iorno, A., Ioverno, E., Iurato, R., La Pace, L., La Piscopia, C., La Selva, R., Lafratta, M., Lamparelli, M., Lanaro, G., Lancerotto, R., Larcher, M., Lassandro, M., Lattuada, G., Laurino, P., Lefons, C., Legrottaglie, F., Lemma, A., Leone, D., Leone, F., Leso, A., Leuzzi, G., Levato, G., Libardi, L., Libralesso, N., Licini, P. I., Licursi, G., Lidonnici, F., Lillo, C., Liveri, L., Livio, A., Loiero, R. A., Loison, M., Lombardo, G., Lombardo, T., Lomunno, V., Lomuscio, S., Lonedo, A., Longo, E., Lora, L., Lotterio, A., Lucatello, L., Luongo, A., Lupoli, M., Macchia, C., Macri, G., Mafessanti, M., Maggialetti, V., Maggioni, A., Magnani, M., Maiellaro, G., Mancuso, A., Maniglio, A. R., Mannari, G. L., Manni, A., Manocchio, B., Mao, M., Marano, A., Maraone, E., Marascio, D., Marcheselli, P., Marchetto, B., Marchetto, S., Marchi, A., Marchi, G. L., Mariano, C., Marinacci, S., Marinelli, S., Marini, G., Marra, V. C., Marrali, F., Marseglia, C., Martello, G., Martino, C., Martino, G., Martino, M., Marulli, C. F., Maruzzi, G., Marzotti, A., Mascheroni, G., Mascolo, P., Masoch, G., Masone, R., Massa, L., Massafra, M., Massi, M., Massignani, D. M., Matarese, A. M., Matini, G., Mauro, R., Mazzi, M., Mazzillo, A., Mazzocato, E., Mazzoleni, N. S., Mazzone, A., Melacci, A., Mele, E., Meliota, P., Menaspa, S., Meneghello, F., Merola, G., Merone, L., Metrucci, A., Mezzina, V., Micchi, A., Michielon, A., Migliore, N., Minero, G., Minotta, F., Mirandola, C., Mistrorigo, S., Modafferi, L., Moitre, R., Mola, E., Monachese, C., Mongiardini, C., Montagna, F., Montani, M., Montemurno, I., Montolli, R., Montorsi, S., Montresor, M., Monzani, M. G., Morabito, F., Mori, G., Moro, A., Mosca, M. F., Motti, F., Muddolon, L., Mugnai, M., Muscas, F., Naimoli, F., Nanci, G., Nargi, E., Nasorri, R., Nastrini, G., Negossi, M., Negrini, A., Negroni, A., Neola, V., Niccolini, F., Niro, C. M., Nosengo, C., Novella, G., Nuti, C., Obici, F., Olita, C., Oliverio, S. S., Olivieri, I., Oriente, S., Orlando, G., Paci, C., Pagano, G., Pagliara, C., Paita, G., Paladini, G., Paladino, G., Palano, T., Palatella, A., Palermo, P., Palmisano, M., Pando, P., Panessa, P., Panigo, F., Panozzo, G., Panvini, F., Panzieri, F., Panzino, A., Panzitta, F., Paoli, N., Papagna, R., Papaleo, M. G., Papalia, G., Parisi, R., Parotti, N., Parravicini, D., Passarella, P., Pastore, G. A., Patafio, M., Pavone, P., Pedroli, W., Pedroni, M., Pelligra, G., Pellizzari, M., Penati, A., Perlot, M., Perrone, A., Perrone, G., Peruzzi, P., Peselli, C., Petracchini, L., Petrera, L., Petrone, S., Peverelli, C., Pianorsi, F., Piazza, G. P., Piazzolla, G., Picci, A., Pienabarca, G., Pietronigro, T. P., Pignocchino, P., Pilone, R., Pinto, D., Pirovano, E., Pirrotta, D., Pisante, V., Pitotto, P., Pittari, L., Piva, A., Pizzoglio, A., Plantera, O. R., Plebani, W., Plessi, S., Podrecca, D., Poerio, V., Poggiani, F., Pogliani, W., Poli, L., Poloni, F. G., Porcelli, R., Porto, S., Pranzo, L., Prevedello, C., Profeta, C., Profico, D., Punzi, A., Quaglia, G. M., Racano, M., Raccone, A., Radice, F., Raho, C. A., Raimondi, R., Raino, M., Ramponi, R., Ramunni, A., Ramunni, A. L., Ravasio, F., Ravera, M., Re Sarto, G., Rebustello, G., Regazzoli, S., Restelli, C., Rezzonico, M., Ricchiuto, F., Rigo, S., Rigon, G., Rigon, R., Rinaldi, O. V., Rinaldi, M., Risplendente, P. G., Rispoli, M., Riundi, R., Riva, M. G., Rizzi, A. L., Rizzi, D., Rizzo, L. D., Rocchi, L., Rondinone, B., Rosa, B., Rosati, F., Roselli, F., Rossetti, A., Rossetti, C., Rossi, R., Rossi, P. R., Rossi, A., Rossi, C. L., Rossitto, A., Ruffini, R., Ruffo, A., Ruggio, S., Ruo, M., Russo, B., Russo, L., Russo, R., Russo, S., Russo, U., Russo, V., Ruta, G., Sacchi, F., Sacco Botto, F., Saia, A., Salladini, G., Salmoiraghi, S., Saluzzo, F., Salvatore, C., Salvatori, E., Salvio, G., Sandri, P., Sandrini, T., Sangermano, V., Santoni, N., Saracino, A. D., Saracino, A., Sarasin, P., Sardo Infirri, C., Sarri, B., Sartori, G., Sartori, N., Sauro, C., Scaglioni, M., Scalfi, C., Scamardella, A. M., Scandale, G., Scandone, L., Scannavini, G., Scarati, R., Scardi, A., Scarpa, F. M., Scazzi, P., Schifone, A., Schiroso, G., Scigliano, G., Scilla, A., Sciortino, M., Scolaro, G., Scollo, E., Scorretti, G., Sellitti, R., Selmo, A., Selvaggio, G., Sempio, A., Seren, F., Serio, L., Serra, C., Serra, L., Siciliano, D., Sideri, A., Sighele, M., Signore, R., Siliberto, F., Silvestro, M., Simioni, G., Simmini, G., Simonato, L., Sinchetto, F., Sizzano, E., Smajato, G., Smaldone, M., Sola, G., Sordillo, L., Sovran, C. S., Spagnul, P., Spano, F., Sproviero, S., Squintani, A., Stella, L., Stilo, V., Stocchiero, B., Stornello, M. C., Stracka, G., Strada, S., Stranieri, G., Stucci, N., Stufano, N., Suppa, A., Susca, V. G., Sutti, M., Taddei, M., Tagliabue, E., Tagliente, G., Talato, F., Talerico, P., Talia, R., Taranto, R., Tartaglia, M., Tauro, N., Tedesco, A., Tieri, P., Tirelli, M., Tocci, L., Todesco, P., Tognolo, M., Tomba, A., Tonello, P., Tonon, R., Toscano, L., Tosi, A., Tosi, G., Toso, S., Travaglio, P., Tremul, L., Tresso, C., Triacchini, P., Triggiano, L., Trigilio, A., Trimeloni, J., Tripicchio, G., Tritto, G. S., Trono, F., Trotta, E., Trotta, G., Tubertini, A., Turri, C., Turri, L., Tuttolani, M. P., Urago, M., Ursini, G., Valcanover, F., Valente, L., Valenti, M., Valentini, F., Vallone, G., Valz, P., Valzano, L., Vanin, V., Vatteroni, M., Vegetti, L., Vendrame, D., Veramonti, I., Veronelli, G., Vesco, A., Vicariotto, G., Vignale, G., Villa, P. L., Vinciguerra, R., Visco, A., Visentin, G., Visona, E., Vitali, E., Vitali, S., Vitti, F., Volpone, D. A., Zambon, N., Zammarrelli, A., Zanaboni, A., Zane, D., Zanetti, B., Zanibellato, R., Zappetti, M., Zappone, P., Zerilli, G., Zirino, V., Zoccali, R., Zuin, F., Altomonte, M., Anelli, N., Angio, F., Annale, P., Antonacci, S., Anzilotta, R., Bano, F., Basadonna, O., Beduschi, L., Becagli, P., Bellotti, G., Blotta, C., Bruno, G., Cappuccini, A., Caramatti, S., Cariolato, M. P., Castellana, M., Castellani, L., Catania, R., Chielli, A., Chinellato, A., Ciaccia, A., Clerici, E., Cocci, A., Costanzo, G., D'Ercole, F., De Stefano, G., Dece, F., Di Cicco, N., Di Marco, A., Donati Sarti, C., Draghi, E., Dusi, G., Esposito, V., Ferraro, L., Ferretti, A., Ferri, E., Foggetti, L., Foglia, A., Fonzi, E., Frau, G., Fuoco, M. R., Furci, G., Gallo, L., Garra, V., Giannini, A., Gris, A., Iacovino, R., Interrigi, R., Joppi, R., Laner, B., La Fortezza, G., La Padula, A., Lista, M. R., Lupi, G., Maffei, D., Maggioni, G., Magnani, L., Marrazzo, E., Marcon, L., Marino, V., Maroni, A., Martinelli, C., Mastandrea, E., Mastropierro, F., Meo, A. T., Mero, P., Minesso, E., Moschetta, V., Mosele, E., Nanni, C., Negretti, A., Nistico, C., Orsini, A., Osti, M., Pacilli, M. C., Pennestre, C., Picerno, G., Piol, K., Pivano, L., Pizzuti, E., Poggi, L., Poidomani, I., Pozzetto, M., Presti, M. L., Ravani, R., Recalenda, V., Romagnuolo, F., Rossignoli, S., Rossin, E., Sabatella, C., Sacco, F., Sanita, F., Sansone, E., Servadei, F., Sisto, M. T., Sorio, A., Sorrentino, A., Spinelli, E., Spolaor, A., Squillacioti, A., Stella, P., Talerico, A., Todisco, C., Vadino, M., and Zuliani, C.

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Population, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Overweight, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Prediction model, Internal medicine, Diabetes mellitus, Internal Medicine, Diabetes Mellitus, Medicine, Humans, Multicenter Studies as Topic, Myocardial infarction, Risk factor, education, Stroke, Aged, Randomized Controlled Trials as Topic, education.field_of_study, Lifestyle habits, business.industry, Major cardiovascular events, Atrial fibrillation, General Medicine, Middle Aged, medicine.disease, Cardiovascular Diseases, Heart failure, Physical therapy, Female, medicine.symptom, business, Diabetic Angiopathies
Abstract

To verify whether it is possible, in people with diabetes mellitus (DM) considered at very high cardiovascular (CV) risk, stratify this risk better and identify significant modifiable risk factor (including lifestyle habits) to help patients and clinicians improve CV prevention. People with DM and microvascular diseases or one or more CV risk factors (hypertension, hyperlipidemia, smoking, poor dietary habits, overweight, physical inactivity) included in the Risk and Prevention study were selected. We considered the combined endpoint of non-fatal acute myocardial infarction and stroke and CV death. A multivariate Cox proportional analysis was carried out to identify relevant predictors. We also used the RECPAM method to identify subgroups of patients at higher risk. In our study, the rate of major CV events was lower than expected (5 % in 5 years). Predictors of CV events were age, male, sex, heart failure, previous atherosclerotic disease, atrial fibrillation, insulin treatment, high HbA1c, heart rate and other CV diseases while being physically active was protective. RECPAM analysis indicated that history of atherosclerotic diseases and a low BMI defined worse prognosis (HR 4.51 95 % CI 3.04–6.69). Among subjects with no previous atherosclerotic disease, men with HbA1c more than 8 % were at higher CV risk (HR 2.77; 95 % CI 1.86–4.14) with respect to women. In this population, the rate of major CV events was lower than expected. This prediction model could help clinicians identify people with DM at higher CV risk and support them in achieving goals of physical activity and HbA1c.

Published
2016

67. The differential effect of lenalidomide monotherapy in patients with relapsed or refractory transformed non-Hodgkin lymphoma of distinct histological origin

Author

Rena Buckstein, Annetti Ervin-Haynes, Craig B. Reeder, Thomas E. Witzig, Ju Li, Julie M. Vose, Dennis Pietronigro, Pier Luigi Zinzani, Myron S. Czuczman, and Jonathan Polikoff

Subjects
Oncology, medicine.medical_specialty, Pathology, business.industry, Follicular lymphoma, Histology, Hematology, medicine.disease, Lymphoma, Clinical trial, Leukemia, Refractory, Internal medicine, medicine, Adverse effect, business, Lenalidomide, medicine.drug
Abstract

Summary Transformed lymphoma (TL) represents a heterogeneous group of lymphomas with an aggressive course and poor prognosis. We assessed the clinical benefit of single-agent lenalidomide based on histological origin, including transformed follicular lymphoma (tFL) and transformed chronic lymphocytic leukaemia/small lymphocytic lymphoma (tCLL/SLL). Our analysis included 33 patients with TL. Patients received lenalidomide at a median dose of 25 mg/d. The overall response rate (ORR) was 46%, with a median response duration of 12·8 months after a median follow-up of 5·6 months. Median progression-free survival was 5·4 months. Among patients with tFL, ORR was 57%, with a median response duration of 12·8 months. None of the patients with tCLL/SLL responded to lenalidomide monotherapy. The most common grade 3/4 adverse events were reversible myelosuppression. Our results suggest that the original lymphoma histology (i.e. FL) in TL patients may potentially be associated with response to salvage lenalidomide monotherapy.

Published
2011

68. Lenalidomide Oral Monotherapy Produces Durable Responses in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Author

Kenichi Takeshita, Peter H. Wiernik, Craig Cole, Henry G. Kaplan, Timothy E. Moore, Glen Justice, Jerome B. Zeldis, Julie M. Vose, Annette Ervin-Haynes, Michael Voralia, Craig B. Reeder, Dennis Pietronigro, and Thomas E. Witzig

Subjects
Adult, Diarrhea, Male, Oncology, Cancer Research, medicine.medical_specialty, Neutropenia, Time Factors, Administration, Oral, Antineoplastic Agents, Kaplan-Meier Estimate, Drug Administration Schedule, Refractory, Recurrence, Internal medicine, medicine, Clinical endpoint, Indolent Non-Hodgkin Lymphoma, Humans, Lenalidomide, Fatigue, Aged, Aged, 80 and over, business.industry, Lymphoma, Non-Hodgkin, Cancer, Middle Aged, medicine.disease, Thalidomide, Lymphoma, Surgery, Non-Hodgkin's lymphoma, Clinical trial, Treatment Outcome, Drug Resistance, Neoplasm, Female, business, Constipation, medicine.drug
Abstract

Purpose Lenalidomide is a novel immunomodulatory agent with antiproliferative activities. Given its efficacy in a wide range of hematologic malignancies, we conducted a phase II trial (NHL-001) of single-agent lenalidomide in indolent non-Hodgkin's lymphoma (NHL). Patients and Methods Patients with relapsed/refractory indolent NHL were eligible, with no limit on the number of previous therapies. Oral lenalidomide 25 mg was self-administered once daily on days 1 to 21 of every 28-day cycle for up to 52 weeks as tolerated, or until disease progression. The primary end point was objective response rate (ORR), with secondary end points of duration of response (DR), progression-free survival (PFS), and safety. Results Forty-three enrolled patients were assessable for response and safety. Patients received a median of three prior systemic therapies (range, 1 to 17) and half were refractory to last therapy. ORR was 23% (10 of 43), including a 7% complete response (CR) or unconfirmed CR rate. Twenty-seven percent (six of 22) of patients with follicular lymphoma grade 1 or 2, and 22% (four of 18) with small lymphocytic lymphoma responded to therapy. Median DR was not reached, but was longer than 16.5 months with seven of 10 responses ongoing at 15 to 28 months. Median PFS for the whole group was 4.4 months (95% CI, 2.5 to 10.4 months). Adverse events were predictable and manageable; the most common grade 3 or 4 adverse events were neutropenia (30% and 16%, respectively) and thrombocytopenia (14% and 5%, respectively). Conclusion Oral lenalidomide monotherapy produces durable responses with manageable adverse events in patients with relapsed/refractory indolent NHL, warranting further investigation of treatment for indolent NHL.

Published
2009

69. Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma

Author

David S. Siegel, Robert Vescio, Donna E. Reece, Robert Knight, Jerome B. Zeldis, Nizar J. Bahlis, Steven Coutre, Dennis Pietronigro, Rafat Abonour, Shaji Kumar, Edward A. Stadtmauer, Paul G. Richardson, Ruben Niesvizky, Ralph V. Boccia, Jeffrey Matous, Melissa Alsina, Vincent Rajkumar, and Christine Chen

Subjects
Adult, Male, medicine.medical_specialty, Combination therapy, relapsed/refractory, Dexamethasone, combination therapy, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Adverse effect, Lenalidomide, Multiple myeloma, Aged, Aged, 80 and over, Haematological Malignancy, business.industry, lenalidomide plus dexamethasone, Hematology, Middle Aged, medicine.disease, Thalidomide, Discontinuation, Surgery, multiple myeloma, Treatment Outcome, Drug Resistance, Neoplasm, Expanded access, Female, business, medicine.drug
Abstract

Lenalidomide gained Food and Drug Administration (FDA) approval for treatment of patients with relapsed or refractory multiple myeloma (MM) in combination with dexamethasone in June 2006. In April 2005, the FDA and patient advocacy groups requested an expanded access programme to both provide lenalidomide to patients likely to benefit and obtain additional safety information. Relapsed/refractory MM patients received lenalidomide 25 mg/d (days 1-21) and dexamethasone 40 mg/d (days 1-4, 9-12, and 17-20 of cycles 1-4; days 1-4 only from cycle 5 onwards), in 4-week cycles until disease progression, study drug discontinuation, or lenalidomide approval. Of the 1438 patients enrolled, approximately 60% were male, median age was 64 years, and 61.7% had Durie-Salmon stage III disease. Median time on study was 15.4 weeks (range: 0.1-49.1) and median dose was 25 mg. The most common adverse events (AEs) were haematological (49%), gastrointestinal (59%), and fatigue (55%). The most common gradeor =3 AEs were haematological (45%), fatigue (10%), and pneumonia (7%). The most common serious AEs were pneumonia (8%), pyrexia (4%), and deep-vein thrombosis (3%). Primary cause of death was disease progression (10%). Safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in patients with relapsed/refractory MM.

Published
2009

71. TIM-1 CONTROLS NEUTROPHIL TRAFFICKING AND CONTRIBUTES TO THE INDUCTION OF COGNITIVE DECLINE AND NEUROPATHOLOGICAL CHANGES IN ANIMAL MODELS OF ALZHEIMER'S DISEASE

Author

Constantin, Gabriela, primary, Zenaro, Elena, additional, Angiari, Stefano, additional, Pietronigro, Enrica Caterina, additional, Della Bianca, Vittorina, additional, Nagarajan, Rajasekar, additional, Piacentino, Gennj, additional, Arioli, Jessica, additional, Iannoto, Giulia, additional, and Bonani, Marco, additional

Published
2017
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74. O1‐11‐04: Targeting leukocyte integrins has therapeutic effect in Alzheimer's‐like disease

Author

Gabriela Constantin, Enrica Caterina Pietronigro, Maria Giovanna Rossi, Elena Zenaro, Vittorina Della Bianca, Gennj Piacentino, and Carlo Laudanna

Subjects
Epidemiology, business.industry, Health Policy, Therapeutic effect, Disease, Leukocyte integrins, Psychiatry and Mental health, Cellular and Molecular Neuroscience, Developmental Neuroscience, Immunology, Medicine, Neurology (clinical), Geriatrics and Gerontology, business
Published
2015

75. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation

Author

Pier Luigi Zinzani, Ju Li, Thomas E. Witzig, Izidore S. Lossos, Craig B. Reeder, Myron S. Czuczman, Joseph Tuscano, Dennis Pietronigro, Thomas M. Habermann, Julie M. Vose, Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, and Witzig TE

Subjects
Adult, Male, Oncology, medicine.medical_specialty, autologous stem cell transplantation, lenalidomide, Angiogenesis Inhibitors, Aggressive Non-Hodgkin Lymphoma, Young Adult, Autologous stem-cell transplantation, Refractory, Recurrence, immune system diseases, Internal medicine, hemic and lymphatic diseases, Humans, Medicine, Aged, Retrospective Studies, Lenalidomide, business.industry, Lymphoma, Non-Hodgkin, non-Hodgkin lymphoma, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, medicine.disease, Combined Modality Therapy, Thalidomide, Surgery, Lymphoma, Transplantation, Treatment Outcome, Disease Progression, Drug Evaluation, Female, Mantle cell lymphoma, Stem cell, business, medicine.drug
Abstract

Patients with aggressive non-Hodgkin lymphoma (NHL) who relapse after autologous stem cell transplantation (ASCT) have a poor prognosis. Additional therapy is often poorly tolerated, and new treatment modalities are needed. This efficacy and safety study was a retrospective analysis of two phase II trials (NHL-002 and NHL-003) that studied single-agent lenalidomide in patients with relapsed/refractory aggressive NHL with prior (n = 87) compared with no prior ASCT (n = 179). The overall response rate in the ASCT group was 39% [14% complete response (CR)], including 29% in patients with diffuse large B-cell lymphoma, 63% in mantle cell lymphoma, and 60% in transformed lymphoma. The timing of transplant relative to receiving lenalidomide had no effect on outcomes. Median progression-free survival for the ASCT group was 3·7 months (16·9 months for patients in CR; 7·3 months for partial responders) at a median 12·5-month follow-up. Median response duration was 7·9 months. Regardless of prior ASCT, lenalidomide monotherapy was efficacious in heavily pretreated patients with aggressive, relapsed/refractory NHL, with a safety profile that was consistent with prior studies of single-agent lenalidomide.

Published
2013

76. Intratumoral injection of BCNU in ethanol (DTI-015) results in enhanced delivery to tumor – a pharmacokinetic study

Author

John M. Young, Daniel E. Hall, Brian D. Ross, Alnawaz Rehemtulla, Dennis Pietronigro, Kirk A. Frey, Julie Carter, Timothy J. Desmond, Daniel A. Hamstra, and Bradford A. Moffat

Subjects
Male, Cancer Research, medicine.medical_treatment, Cmax, Brain tumor, Injections, Intralesional, Pharmacology, Therapeutic index, Pharmacokinetics, Glioma, medicine, Animals, Humans, Tissue Distribution, Antineoplastic Agents, Alkylating, Saline, Injections, Intraventricular, Volume of distribution, Ethanol, Brain Neoplasms, Chemistry, medicine.disease, Carmustine, Magnetic Resonance Imaging, Rats, Neurology, Oncology, Area Under Curve, Anesthesia, Injections, Intravenous, Neurology (clinical), Perfusion, Half-Life
Abstract

Solvent facilitated perfusion (SFP) has been proposed as a technique to increase the delivery of chemotherapeutic agents to tumors. SFP entails direct injection of the agent into the tumor in a water-miscible organic solvent, and because the solvent moves easily through both aqueous solutions and cellular membranes it drives the penetration of the solubilized anticancer agent throughout the tumor. To test this hypothesis, we compared the pharmacokinetics (PK) of 14C-labeled 1,3-bis-chlorethyl-1-nitrosourea (BCNU) in intra-cerebral 9L rat gliomas after intravenous (IV) infusion in 90% saline--10% ethanol or direct intratumoral (IT) injection of 14C-BCNU in 100% ethanol (DTI-015). Treatment with DTI-015 yielded a peak radioactive count (Cmax) for the 14C label that was 100-1000 fold higher in the tumor than in all other tissues in addition to a concentration in the tumor that was 100-fold higher than that achieved following IV infusion of 14C-BCNU. Pathologic and auto-radiographic analysis of tissue sections following IT injection of 14C-BCNU in ethanol into either tumor or normal rat brain revealed both an enhanced local volume of distribution and an increased concentration of BCNU delivered to tumor compared to non-tumor bearing brain. To investigate the mechanism behind the SFP of BCNU to the tumor both dynamic contrast and perfusion MRI were performed on 9L tumors before and after treatment and demonstrated a decrease in tumor perfusion following IT injection of DTI-015. Finally, initial PK of patient blood samples following administration of DTI-015 into relapsed high-grade glioma indicated a 20-fold decrease in systemic exposure to BCNU compared to IV infusion of BCNU providing further evidence for the enhanced therapeutic ratio observed for DTI-015.

Published
2005

77. HCV and GBV-c/HGV infection in HIV positive patients in southern Italy

Author

RENDINA D, VIGORITA E, BONAVOLTA R, D'ONOFRIO M, IURA A, PIETRONIGRO MT, LACCETTI R, BONADIES G, LIUZZI G, FORMISANO, PIETRO, LACCETTI P, PORTELLA, GIUSEPPE, BORGIA, GUGLIELMO, Rendina, D, Vigorita, E, Bonavolta, R, D'Onofrio, M, Iura, A, Pietronigro, M. T, Laccetti, R, Bonadies, G, Liuzzi, G, Borgia, G, Formisano, Pietro, Laccetti, P, Portella, Giuseppe, Rendina, D., Vigorita, E., Bonavolta, R., D'Onofrio, M., Iura, A., M. T. T., Laccetti, R., Bonadies, G., Liuzzi, G., Borgia, G., Laccetti, Paolo, Pietronigro, Mt, and Borgia, Guglielmo

Subjects
Adult, Male, Chi-Square Distribution, Hepaciviru, Genotype, Hepatitis, Viral, Human, Reverse Transcriptase Polymerase Chain Reaction, Risk Factor, Immunoenzyme Technique, GB virus C, Hepatitis C, Italy, Prevalence, Female, HIV Infection, Flaviviridae Infection, Case-Control Studie, Substance Abuse, Intravenous, Human
Abstract

Flaviviridae-hepatitis C virus (HCV) and GB virus C/hepatitis G virus (GBV-C/HGV) - and human immunodeficiency virus (HIV) frequently show similar modes of transmission. HCV and GBV-C/HGV infection was assessed in 134 consecutive patients with evidence of HIV infection, living in Campania, Italy. Data obtained from this cohort were compared with those obtained from 252 age- and sex-matched HCV infected patients without evidence of HIV infection (HCV control group). Following enzymatic immunoassays, samples were tested for the presence of HCV-RNA by RT-PCR. The HCV-RNA positive sera were genotyped by LiPA procedure. The prevalence of HCV infection in HIV patients was 19.40% and the largest group of HIV-HCV co-infected patients (84.62%) was represented by intravenous drug users (IVDU). The distribution of HCV genotypes in HIV-HCV patients was different, compared to that observed in HCV control group. HCV genotypes 1a (50%) and 3a (23.08%) were more frequently detected in HIV-HCV patients, compared to HCV control group (5.16 and 5.56% for 1a and 3a, respectively). Conversely, HCV genotypes 1b (55.70%) and 2a/2c (30.26%) were more represented in HCV control group, compared to HIV-HCV patients (15.38 and 0% for 1b and 2a/2c, respectively). GBV-C/HGV seroprevalence was 41.04% in HIV patients and 6.54% in healthy control individuals. Differently from HCV, GBV-C/HGV infection did not correlate to a preferential risk behaviour in the HIV cohort. Comparative analysis of HCV and GBV-C/HGV infection indicates that the use of injecting drugs might play a key role in the epidemiology of HCV and, in particular, of 1a and 3a HCV genotypes, in HIV patients.

Published
2001

78. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma

Author

Jonathan Polikoff, H. Tilly, Rena Buckstein, Julie M. Vose, Craig B. Reeder, Dennis Pietronigro, Corinne Haioun, Thomas E. Witzig, Myron S. Czuczman, Annette Ervin-Haynes, Pier Luigi Zinzani, R. Bouabdallah, Pingshan Guo, Witzig T.E., Vose J.M., Zinzani P.L., Reeder C.B., Buckstein R., Polikoff J.A., Bouabdallah R., Haioun C., Tilly H., Guo P., Pietronigro D., Ervin-Haynes A.L., and Czuczman M.S.

Subjects
Adult, Male, medicine.medical_specialty, Antineoplastic Agents, Lymphoma, Mantle-Cell, Gastroenterology, Young Adult, Internal medicine, hemic and lymphatic diseases, medicine, Refractory Diffuse Large B-Cell Lymphoma, Humans, Progression-free survival, B-cell lymphoma, aggressive B-cell non-Hodgkin’s lymphoma, Lenalidomide, Lymphoma, Follicular, Aged, Aged, 80 and over, large cell lymphoma, business.industry, International Agencies, Hematology, Middle Aged, medicine.disease, Lymphoma, Non-Hodgkin's lymphoma, Surgery, Thalidomide, Survival Rate, Treatment Outcome, Oncology, Mantle cell lymphoma, Female, Lymphoma, Large B-Cell, Diffuse, Neoplasm Recurrence, Local, business, Diffuse large B-cell lymphoma, medicine.drug, Follow-Up Studies
Abstract

Background Lenalidomide is an immunomodulatory agent with antitumor activity in B-cell malignancies. This phase II trial aimed to demonstrate the safety and efficacy of lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular grade 3 lymphoma (FL-III), or transformed lymphoma (TL). Methods Patients received oral lenalidomide 25 mg on days 1–21 every 28 days as tolerated or until progression. The primary end point was overall response rate (ORR). Results Two hundred and seventeen patients enrolled and received lenalidomide. The ORR was 35% (77/217), with 13% (29/217) complete remission (CR), 22% (48/217) partial remission, and 21% (45/217) with stable disease. The ORR for DLBCL was 28% (30/108), 42% (24/57) for MCL, 42% (8/19) for FL-III, and 45% (15/33) for TL. Median progression-free survival for all 217 patients was 3.7 months [95% confidence interval (CI) 2.7–5.1]. For 77 responders, the median response duration lasted 10.6 months (95% CI 7.0–NR). Median response duration was not reached in 29 patients who achieved a CR and in responding patients with FL-III or MCL. The most common adverse event was myelosuppression with grade 4 neutropenia and thrombocytopenia in 17% and 6%, respectively. Conclusion Lenalidomide is well tolerated and produces durable responses in patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma.

Published
2011

79. The differential effect of lenalidomide monotherapy in patients with relapsed or refractory transformed non-Hodgkin lymphoma of distinct histological origin

Author

Myron S, Czuczman, Julie M, Vose, Thomas E, Witzig, Pier L, Zinzani, Rena, Buckstein, Jonathan, Polikoff, Ju, Li, Dennis, Pietronigro, Annetti, Ervin-Haynes, Craig B, Reeder, Czuczman M.S., Vose J.M., Witzig T.E., Zinzani P.L., Buckstein R., Polikoff J., Li J., Pietronigro D., Ervin-Haynes A., and Reeder C.B.

Subjects
Adult, Aged, 80 and over, Male, transformed chronic lymphocytic leukaemia, Lymphoma, Non-Hodgkin, MONOTHERAPY, Antineoplastic Agents, Kaplan-Meier Estimate, Middle Aged, Leukemia, Lymphocytic, Chronic, B-Cell, transformed follicular lymphoma, Thalidomide, Treatment Outcome, Recurrence, Humans, Female, transformed lymphoma, transformed small lymphocytic lymphoma, Lymphoma, Follicular, Lenalidomide, Aged, Follow-Up Studies
Abstract

Transformed lymphoma (TL) represents a heterogeneous group of lymphomas with an aggressive course and poor prognosis. We assessed the clinical benefit of single-agent lenalidomide based on histological origin, including transformed follicular lymphoma (tFL) and transformed chronic lymphocytic leukaemia/small lymphocytic lymphoma (tCLL/SLL). Our analysis included 33 patients with TL. Patients received lenalidomide at a median dose of 25 mg/d. The overall response rate (ORR) was 46%, with a median response duration of 12·8 months after a median follow-up of 5·6 months. Median progression-free survival was 5·4 months. Among patients with tFL, ORR was 57%, with a median response duration of 12·8 months. None of the patients with tCLL/SLL responded to lenalidomide monotherapy. The most common grade 3/4 adverse events were reversible myelosuppression. Our results suggest that the original lymphoma histology (i.e. FL) in TL patients may potentially be associated with response to salvage lenalidomide monotherapy.

Published
2011

80. [Untitled]

Author

Victor A. Levin, Donald D. Giannini, William J. Bodell, Saira Singh, and Dennis D. Pietronigro

Subjects
Cancer Research, Carmustine, Chemotherapy, business.industry, Cell growth, medicine.medical_treatment, Pharmacology, medicine.disease, Route of administration, Neurology, Oncology, Glioma, Anesthesia, Drug delivery, medicine, Neurology (clinical), Growth delay, business, Perfusion, medicine.drug
Abstract

Intratumoral (IT) administration of DTI-015 (BCNU in 100% ethanol) utilizes solvent facilitated perfusion for the treatment of tumors. RIF-1 tumors were treated by IT injection of either ethanol alone or 0.05–1.0 mg of DTI-015 or by iv injection of 0.5 mg of BCNU. Treatment with ethanol alone or iv injection of 0.5 mg of BCNU did not produce a significant growth delay. In contrast, IT administration of DTI-015 produced a significant growth delay at each of the treatment doses (p < 0.05 to p < 0.001). We have quantified the levels of N7-(2-hydroxyethyl) guanine (N7-HOEtG) in RIF-1 tumors 24 h following either IT treatment with 0.5 mg DTI-015 or ip administration of 0.5 mg BCNU. Levels of N7-HOEtG (μmol/mol DNA) were ≤0.08 for both untreated controls and following ip treatment with BCNU and 13.1 ± 5.6 following IT administration of DTI-015. The levels of N7-HOEtG detected in RIF-1 tumors following IT administration of DTI-015 were 164-fold higher than the level(s) of N7-HOEtG in the ip BCNU treated tumor samples. These studies demonstrate that IT administration of DTI-015 produces high levels of DNA adducts in the tumor which correspond to a significant increase in tumor growth delay compared to the same dose of BCNU administered systemically.

Published
2003

81. Stereotactic Injection of DTI-015 into Recurrent Malignant Gliomas: Phase I/II Trial

Author

Victor A. Levin, Emilio M. Nardone, Samuel J. Hassenbusch, Norman E. Leeds, and Dennis D. Pietronigro

Subjects
Adult, Male, Cancer Research, Maximum Tolerated Dose, Injections, Intralesional, GBM, lcsh:RC254-282, Stereotaxic Techniques, Glioma, Medicine, Humans, recurrent tumor, Adverse effect, stereotactic injection, Survival rate, Antineoplastic Agents, Alkylating, Aged, Carmustine, medicine.diagnostic_test, Ethanol, business.industry, Brain Neoplasms, Magnetic resonance imaging, clinical trial, malignant glioma, Middle Aged, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Magnetic Resonance Imaging, Survival Rate, Stereotaxic technique, Stereotactic injection, Female, Neoplasm Recurrence, Local, business, Nuclear medicine, Perfusion, medicine.drug, Research Article
Abstract

DTI-015 (BCNU in 100% ethanol) utilizes solvent facilitated perfusion for the intratumoral treatment of gliomas. The ethanol solvent vehicle facilitates a rapid and thorough saturation of the tumor with the dissolved anticancer agent BCNU. We conducted a phase I/II dose escalation study of DTI-015 in 40 heavily pretreated patients with inoperable recurrent malignant glioma. The study goals were to establish a maximally tolerated dose (MTD) for DTI-015 and assess its safety and activity. Patients received stereotactic intratumoral injection of DTI-015 under magnetic resonance imaging guidance. Dose escalation was performed in two phases. First, DTI-015 volume was escalated at a set BCNU concentration of 12.5 mg/ml; second, BCNU mg dose was escalated by increasing BCNU concentration to 30, 45, 60, and 75 mg/ml. A MTD of 5 ml and 240 mg was established. Twenty-five of 28 DTI-015 treatments (89%) using ≤MTD were administered safely without producing high-grade drug-related adverse events. Median survival for GBM patients administered DTI-015 at ≤MTD was 55 weeks. Magnetic resonance imaging demonstrated stable disease in 72% of evaluable patients with a median of 10.5 weeks. The results suggest that DTI-015 administered at ≤MTD is well tolerated and active in patients with inoperable recurrent GBM.

Published
2003
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84. O2‐06‐05: NEUTROPHILS INDUCE ALZHEIMER'S‐LIKE DISEASE VIA LFA‐1‐INTEGRIN AND NEUTROPHIL EXTRACELLULAR TRAPS

Author

Bruno Bonetti, Elena Zenaro, Carlo Laudanna, Alessio Montresor, Enrica Caterina Pietronigro, Ermanna Turano, Gennj Piacentino, Vittorina Della Bianca, and Gabriela Constantin

Subjects
Epidemiology, Integrin, Inflammation, law.invention, 03 medical and health sciences, Cellular and Molecular Neuroscience, 0302 clinical medicine, Developmental Neuroscience, Confocal microscopy, law, Parenchyma, Extracellular, medicine, 030304 developmental biology, 0303 health sciences, biology, Health Policy, Adhesion, Neutrophil extracellular traps, In vitro, 3. Good health, Cell biology, Psychiatry and Mental health, biology.protein, Neurology (clinical), Geriatrics and Gerontology, medicine.symptom, 030217 neurology & neurosurgery
Abstract

Methods: Confocal microscopy studies were performed to evaluate inflammation mechanisms. Intra-vital microscopy studies using two-photon microscopy were performed to visualize and analyze the movement of neutrophils inside brain vessels and in the parenchyma. In vitro rapid adhesion assays were performed on integrin ligands whereas and integrin affinity was measured using Image Stream technology. Neuropathological studies, fear conditioning and Y maze tests were performed to analyze the effect of inflammation mechanism inhibition on disease.

Published
2014

88. [Untitled]

Author

Giuseppe Portella, E. Vigorita, Guglielmo Borgia, Domenico Rendina, A. Iura, R. Bonavolta, M.T.T. Pietronigro, Pietro Formisano, R. Laccetti, P. Laccetti, G. Bonadies, M. D'Onofrio, and G. Liuzzi

Subjects
biology, Epidemiology, business.industry, Transmission (medicine), Hepacivirus, Hepatitis C virus, virus diseases, medicine.disease, biology.organism_classification, medicine.disease_cause, Virology, GB virus C, digestive system diseases, Flaviviridae, Acquired immunodeficiency syndrome (AIDS), Medicine, Viral disease, business, Sida
Abstract

Flaviviridae–hepatitis C virus (HCV) and GB virus C/hepatitis G virus (GBV-C/HGV) – and human immunodeficiency virus (HIV) frequently show similar modes of transmission. HCV and GBV-C/HGV infection was assessed in 134 consecutive patients with evidence of HIV infection, living in Campania, Italy. Data obtained from this cohort were compared with those obtained from 252 age- and sex-matched HCV infected patients without evidence of HIV infection (HCV control group). Following enzymatic immunoassays, samples were tested for the presence of HCV-RNA by RT-PCR. The HCV-RNA positive sera were genotyped by LiPA procedure. The prevalence of HCV infection in HIV patients was 19.40% and the largest group of HIV–HCV co-infected patients (84.62%) was represented by intravenous drug users (IVDU). The distribution of HCV genotypes in HIV–HCV patients was different, compared to that observed in HCV control group. HCV genotypes 1a (50%) and 3a (23.08%) were more frequently detected in HIV–HCV patients, compared to HCV control group (5.16 and 5.56% for 1a and 3a, respectively). Conversely, HCV genotypes 1b (55.70%) and 2a/2c (30.26%) were more represented in HCV control group, compared to HIV–HCV patients (15.38 and 0% for 1b and 2a/2c, respectively). GBV-C/HGV seroprevalence was 41.04% in HIV patients and 6.54% in healthy control individuals. Differently from HCV, GBV-C/HGV infection did not correlate to a preferential risk behaviour in the HIV cohort. Comparative analysis of HCV and GBV-C/HGV infection indicates that the use of injecting drugs might play a key role in the epidemiology of HCV and, in particular, of 1a and 3a HCV genotypes, in HIV patients.

Published
2001

89. Research Project Number 33: Investigating the Creative Process in a Microgravity Environment

Author

Frank Pietronigro

Subjects
Human spirit, Architectural engineering, Engineering, Reduced Gravity, Visual Arts and Performing Arts, business.industry, Process (engineering), media_common.quotation_subject, Space exploration, Computer Science Applications, Quality (business), business, Engineering (miscellaneous), Music, Simulation, media_common
Abstract

The author, an interdiscipli-nary artist, discusses his creation of art in a microgravity environ-ment as part of the 1998 NASA Student Reduced Gravity Flight Program. He discusses his three-dimensional “drift paintings” which floated in the air along with his body in microgravity. The au-thor posits that the transcendent quality of the creative process can help keep the human spirit alive during long-term space missions.

Published
2000

95. N-3 fatty acids in patients with multiple cardiovascular risk factors

Author

Roncaglioni, Maria Carla, Avanzini, Fausto, Barlera, Simona, Marzona, Irene, Milani, Valentina, Tombesi, Massimo, Caimi, Vittorio, Longoni, Paolo, Silletta, Maria Giuseppina, Tognoni, Gianni, Marchioli, Avanzini F, Roberto., Caimi, V, Longoni, P, Marchioli, R, Roncaglioni, Mc, Silletta, Mg, Tognoni, G, Tombesi, M, Barlera, S, Milani, V, Nicolis, Eb, Casola, C, Marzona, I, Massa, E, Marrocco, W, Micalella, M, Avanzini, F, Franzosi, Mg, Geraci, E, Giansiracusa, N, Rocchetti, L, Decarli, A, Satolli, R, Alli, C, Beghi, E, Bertele', V, Volpi, A, Baviera, M, Monesi, L, Pangrazzi, I, Nicolis, E, Clerici, F, Palumbo, A, Sgaroni, G, Pioggiarella, R, Scarano, M, Marfisi, Rm, Flamminio, A, Macino, L, Ferri, B, Pera, C, Polidoro, A, Abbatino, D, Acquati, M, Addorisio, G, Adinolfi, D, Adreani, L, Agistri, Mr, Agneta, A, Agnolio, Ml, Agostini, N, Agostino, G, Airò, A, Alaimo, N, Albano, M, Albano, N, Alecci, G, Alemanno, S, Alexanian, A, Alfarano, M, Alfè, L, Alonzo, N, Alvino, S, Ancora, A, Andiloro, S, Andreatta, E, Angeli, S, Angiari, F, Angilletti, V, Annicchiarico, C, Anzivino, M, Aprea, R, Aprile, A, Aprile, E, Aprile, I, Aprile, L, Armellani, V, Arnetoli, M, Aronica, A, Autiero, V, Bacca, G, Baccalaro, Am, Bacci, M, Baglio, G, Bagnani, M, Baiano, A, Baldari, A, Ballarini, L, Banchi, G, Bandera, R, Bandini, F, Baratella, M, Barbieri, A, Barbieri Vita, A, Bardi, M, Barlocchi, M, Baron, P, Bartoli, M, Basile, A, Basile, F, Basile, S, Battaggia, A, Battaglia, A, Baù, A, Beconcini, G, Beggio, R, Belfiore, Pa, Belicchi, M, Bellamoli, S, Bellini, C, Bellomo, M, Benetollo, C, Benetti, R, Beretta, E, Bertalero, P, Bertaso, Fg, Bertolani, U, Bettelli, G, Biagiotti, G, Bianchi, S, Bianco, G, Biccari, F, Bigioli, F, Bindi, M, Bisanti, G, Bitetti, Em, Blasetti, Mp, Blesi, F, Boato, V, Boga, S, Boidi, E, Boldrin, G, Bollati, A, Bolzan, L, Bolzonella, S, Bonardi, P, Bonato, Gb, Bonci, M, Bonfitto, G, Bonincontro, E, Boninsegna, F, Bonissone, D, Bono, L, Bonollo, E, Borghi, M, Borioli, N, Borsatto, M, Bosco, T, Bosisio Pioltelli, M, Botarelli, C, Botassis, S, Bottini, F, Bottos, C, Bova, G, Bova, V, Bozzani, A, Bozzetto, Rm, Braga, Vt, Braglia, M, Bramati, E, Brazzoli, C, Breglia, G, Brescia, A, Briganti, D, Brigato, G, Brocchi, A, Brosio, Fa, Bruni, E, Buscaglia, E, Bussini, Md, Bussotti, A, Buzzaccarini, F, Buzzatti, A, Caccamo, G, Cacciavillani, C, Caggiano, G, Calciano, Fp, Calderisi, M, Calienno, S, Caltagirone, P, Calzolari, I, Cammisa, M, Campanaro, M, Campanella, Gb, Campese, F, Canali, G, Candiani, De, Canepa, R, Canini, D, Canino, A, Cantoro, Ea, Capilupi, V, Capotosto, P, Cappelli, B, Capraro, G, Carafa, Fa, Carano, Q, Carcaterra, V, Carriero, D, Carrozzo, G, Cartanese, M, Casalena, M, Casarola, M, Caso, C, Casotto, M, Castaldi, F, Castegnaro, R, Castellani, G, Castri, S, Catalano, E, Catinello, N, Caturano, G, Cavallaro, R, Cavallo, Am, Cavallo, G, Cavion, Mt, Cavirani, G, Cazzaniga, F, Cazzetta, D, Cecconi, V, Cefalo, A, Celebrano, M, Celora, A, Centonze, P, Cerati, D, Cesaretti, D, Checchia, G, Checchin, A, Cherubini, M, Chianese, L, Chiappa, A, Chiappa, Mv, Chiariello, G, Chiavini, G, Chicco, M, Chiumeo, F, Ciacciarelli, A, Ciaci, D, Ciancaglini, R, Cicale, C, Cicale, S, Cipolla, A, Ciruolo, A, Citeri, Al, Citterio, G, Clerici, M, Coazzoli, E, Collecchia, G, Colletta, F, Colombo, I, Colorio, P, Coluccia, S, Comerio, M, Comoretto, P, Compagni, M, Conte, O, Contri, S, Contrisciani, A, Coppetti, T, Corasaniti, F, Corradi, Mt, Corsano, A, Corsini, A, Corti, N, Costantini, G, Costantino, A, Cotroneo, S, Cozzi, D, Cravello, Mg, Cristiano, E, Cucchi, R, Cusmai, L, D' Errico GB, D'Agostino, P, Dal Bianco, L, Dal Mutto, U, Dal Pozzo, G, Dallapiccola, P, Dallatorre, G, Dalle Molle, G, Dalloni, E, D'Aloiso, A, D'Amicis, G, Danese, R, Danieli, D, Danisi, G, D'Anna, Ma, Danti, G, D'Ascanio, S, Davidde, G, De Angeli, D, De Bastiani, R, De Battisti, A, De Bellis, A, De Berardinis, G, De Carlo, F, De Giorgi, D, De Gobbi, R, De Lorenzis, E, De Luca, P, De Martini, G, De Marzi, M, De Matteis, D, De Padova, S, De Polo, P, De Sabato, N, De Stefano, T, De Vita MT, De Vita, U, De Zolt, V, Debernardi, F, Del Carlo, A, Del Re, G, Del Zotti, F, D'Elia, R, Della Giovanna, P, Dell'Acqua, L, Dell'Orco, Rl, Demaria, G, Di Benedetto MG, Di Chiara, G, Di Corcia, V, Di Domizio, O, Di Donato, P, Di Donato, S, Di Fermo, G, Di Franco, M, Di Giovannantonio, G, Di Lascio, G, Di Lecce, G, Di Lorenzo, N, Di Maro, T, Di Mattia, Q, Di Michele, E, Di Modica RS, Di Murro, D, Di Noi MC, Di Paoli, V, Di Santi, M, Di Sanzo, A, Di Turi, C, Diazzi, A, Dileo, I, D'Ingianna, Ap, Dolci, A, Donà, G, Donato, C, Donato, P, Donini, A, Donna, Me, Donvito, Tv, Esposito, L, Esposito, N, Evangelista, M, Faita, G, Falco, M, Falcone, Da, Falorni, F, Fanciullacci, A, Fanton, L, Fasolo, L, Fassina, R, Fassone, A, Fatarella, P, Fedele, F, Fera, I, Fera, L, Ferioli, S, Ferlini, Mg, Ferlino, R, Ferrante, G, Ferrara, Fn, Ferrarese, Mf, Ferrari, G, Ferrari, O, Ferreri, A, Ferroni, M, Fezzi, G, Figaroli, C, Fina, Mg, Fioretta, A, Fiorucci, C, Firrincieli, R, Fischetti, M, Fischietti, G, Fiume, Dc, Flecchia, G, Forastiere, G, Fossati, B, Franceschi, Pl, Franchi, L, Franzoso, F, Frapporti, G, Frasca, G, Frisotti, A, Fumagalli, G, Fusco, D, Gabriele, P, Gabrieli, A, Gagliano, D, Galimberti, G, Galli, A, Gallicchio, N, Gallio, F, Gallipoli, T, Gallo, P, Galopin, T, Gambarelli, L, Garbin, A, Garozzo, Gm, Gasparri, R, Gastaldo, M, Gatti, E, Gazzaniga, P, Gennachi, N, Gentile, Rv, Germani, P, Gesualdi, F, Gherardi, E, Ghezzi, C, Ghidini, Mg, Ghionda, F, Giacci, L, Gialdini, D, Giampaolo, C, Giancane, R, Giannanti, A, Giannese, S, Giannini, L, Giaretta, M, Giaretta, R, Giavardi, L, Giordano, P, Giordano, E, Giordano, B, Gioria, Gm, Giugliano, R, Grassi, Ea, Greco, A, Greco, L, Grilletti, N, Grimaldi, N, Grisetti, G, Groppelli, G, Gualtieri, L, Guarducci, M, Guastella, G, Guerra, M, Guerrini, F, Guglielmini, A, Guido, A, Gulotta, P, Iacono, E, Iadarola, G, Ianiro, G, Iarussi, V, Ieluzzi, Ml, Ierardi, C, Ingaldi, F, Interlandi, S, Iocca, M, Iorno, A, Ioverno, E, Iurato, R, La Pace, L, La Piscopia, C, La Selva, R, Lafratta, M, Lamparelli, M, Lanaro, G, Lancerotto, R, Larcher, M, Lassandro, M, Lattuada, G, Laurino, P, Lefons, C, Legrottaglie, F, Lemma, A, Leone, D, Leone, F, Leso, A, Leuzzi, G, Levato, G, Libardi, L, Libralesso, N, Licini, Pi, Licursi, G, Lidonnici, F, Lillo, C, Liveri, L, Livio, A, Loiero, Ra, Loison, M, Lombardo, G, Lombardo, T, Lomunno, V, Lomuscio, S, Lonedo, A, Longo, E, Lora, L, Lotterio, A, Lucatello, L, Luongo, A, Lupoli, M, Macchia, C, Macri, G, Mafessanti, M, Maggialetti, V, Maggioni, A, Magnani, M, Maiellaro, G, Mancuso, A, Maniglio, Ar, Mannari, Gl, Manni, A, Manocchio, B, Mao, M, Maranò, A, Maraone, E, Marascio, D, Marcheselli, P, Marchetto, B, Marchetto, S, Marchi, A, Marchi, Gl, Mariano, C, Marinacci, S, Marinelli, S, Marini, G, Marra, Vc, Marrali, F, Marseglia, C, Martello, G, Martino, C, Martino, G, Martino, M, Marulli, Cf, Maruzzi, G, Marzotti, A, Mascheroni, G, Mascolo, P, Masoch, G, Masone, R, Massa, L, Massafra, M, Massi, M, Massignani, Dm, Matarese, Am, Matini, G, Mauro, R, Mazzi, M, Mazzillo, A, Mazzocato, E, Mazzoleni, Ns, Mazzone, A, Melacci, A, Mele, E, Meliota, P, Menaspà, S, Meneghello, F, Merola, G, Merone, L, Metrucci, A, Mezzina, V, Micchi, A, Michielon, A, Migliore, N, Minero, G, Minotta, F, Mirandola, C, Mistrorigo, S, Modafferi, L, Moitre, R, Mola, E, Monachese, C, Mongiardini, C, Montagna, F, Montani, M, Montemurno, I, Montolli, R, Montorsi, S, Montresor, M, Monzani, Mg, Morabito, F, Mori, G, Moro, A, Mosca, Mf, Motti, F, Muddolon, L, Mugnai, M, Muscas, F, Naimoli, F, Nanci, G, Nargi, E, Nasorri, R, Nastrini, G, Negossi, M, Negrini, A, Negroni, A, Neola, V, Niccolini, F, Niro, Cm, Nosengo, C, Novella, G, Nuti, C, Obici, F, Olita, C, Oliverio, Ss, Olivieri, I, Oriente, S, Orlando, G, Paci, C, Pagano, G, Pagliara, C, Paita, G, Paladini, G, Paladino, G, Palano, T, 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Subjects
Male, medicine.medical_specialty, General Practice, Kaplan-Meier Estimate, Placebo, Double-Blind Method, Risk Factors, Internal medicine, Fatty Acids, Omega-3, Clinical endpoint, medicine, Humans, Myocardial infarction, Treatment Failure, Aged, Proportional Hazards Models, chemistry.chemical_classification, Omega-3, business.industry, Proportional hazards model, Medicine (all), Hazard ratio, Fatty Acids, General Medicine, Middle Aged, medicine.disease, Hospitalization, Primary Prevention, chemistry, Cardiovascular Diseases, Heart failure, Cohort, Female, business, Polyunsaturated fatty acid
Abstract

Background Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients with a previous myocardial infarction or heart failure. We evaluated the potential benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction. Methods In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients who were followed by a network of 860 general practitioners in Italy. Eligible patients were men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty acids (1 g daily) or placebo (olive oil). The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke. At 1 year, after the event rate was found to be lower than anticipated, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes. Results Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and 6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%) had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58). The same null results were observed for all the secondary end points. Conclusions In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality and morbidity. (Funded by Societa Prodotti Antibiotici and others; ClinicalTrials.gov number, NCT00317707.).

Published
2013

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