Farmacovigilanza attiva sul ruolo dei farmaci antiangiogenetici nell’osteonecrosi dei mascellari

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[automatically translated] Pharmacovigilance active on the role of antiangiogenic drugs nell'osteonecrosi maxillary Ilaria Morreale1, Maria Meli1, Olga Of Fede2, Giuseppina Campisi2, Natale D'Alessandro1 1Centro consulting on adverse reactions to drugs in oncology Region of Sicily - Unit of Clinical Pharmacology and 2Gruppo Proma .B. (Prevention and Research sull'Osteonecrosi Maxillae by Bisphosphonates) - Sector of Oral Medicine "Valerio Margiotta" - AOUP "P. Giaccone "of Palermo Objectives The use of bisphosphonates (BP) in oncology as well as in osteoporosis has been definitely associated with a relatively rare but serious complications such as osteonecrosis of the jaw (ONJ). The pathogenesis dell'ONJ by BP is not yet fully defined, although it seems that there is an involvement of different local and systemic predisposing factors and mechanisms, including inhibition of bone turnover, and angiogenesis and, last but not least, the role of concomitant medications. Apart from BP, other defendants drugs to induce ONJ are the denosumab and, possibly, antiangiogenic agents, including Avastin and sunitinib. The antiangiogenic may also increase the frequency and severity of ONJ by BP, but this must be further investigated. Methods Our group is currently carrying out a project AIFA Pharmacovigilance Enable aimed to better define through prospective and retrospective studies of patients with cancer of the regions of Sicily, Val d'Aosta and Piedmont the actual risk of ONJ due to antiangiogenic agents. It is implemented an ADR ad hoc reporting approach for ONJ. Are conducted pharmacogenetic analyzes that explore the pharmacodynamic and pharmacokinetic properties of antiangiogenic pathway. Results Since 2005 the Sicily Region has included in the National Network of Pharmacovigilance ONJ 198 reports, of which 135 in oncology, osteoporosis and 1 in 62 for POEMS syndrome. For ONJ in oncology, in 125 of them zoledronic acid has been listed as suspected drug (in 99 cases alone, 26 with other BP or other drugs), in 4 was suspected bevacizumab (in 1 case from only), in the 3 Sunitinib (in 1 case alone), in a thalidomide 1 and the Everolimus (each in combination). For ONJ in osteoporosis, in 43 of them it has been suspected alendronate (in 38 alone and in 5 with other BP). POEMS in the only drug suspect was Rituximab. Conclusions The project will create a rich database from which to draw more comprehensive information on dell'ONJ risk factors. It should be emphasized that the number of drugs responsible for bone toxicity is growing and it will be important to determine whether, in addition to glucocorticoids, the antineoplastic chemotherapy and antiangiogenic to, agents such as PPI, SSRIs, aromatase inhibitors, glitazones and others may have a co-responsibility in the onset of ONJ.
Original languageItalian
Number of pages1
Publication statusPublished - 2013

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