(by Francesco De Filippo) (ANSA) – TRIESTE, FEBRUARY 03 – It is the largest prospective randomized clinical trial of pharmacogenetics ever carried out, which involved 7 thousand patients from 7 European countries in order to demonstrate the clinical validity of the basis of a person’s genetic information. Put more simply, by knowing the genetic peculiarities of a patient, a therapy can be personalized, increasing its clinical validity, thus preventing adverse reactions. A principle demonstrates that the constitutive characteristics of genes are different for each patient leading to different side effects. The study, published today in the scientific journal The Lancet, was conceived at the CRO of Aviano whose Experimental and Clinical Pharmacology unit participated in the project.
After mapping each patient’s DNA, the researchers looked at 12 genes involved in adverse drug reactions, showing that 50 types of germline variants (polymorphisms) affect how the 39 selected drugs work. The study results found that patients prescribed a gene constitutive profile therapy experienced a significant reduction in serious side effects compared to patients prescribed a standard pharmaceutical dose.
In Aviano they treated 1,232 patients with the collaboration of the Ca’ Foncello (Treviso) and S.Filippo Neri (Rome) hospitals.
Funded by the Horizon 2020 programme, the project – ‘PREemptive Pharmacogenomic testing for Preventing Adverse drug Reactions (PREPARE) study’ – was coordinated by Henk-Jan Guchelaar of Leiden University Medical Center (LUMC). Giuseppe Toffoli, head of Experimental and Clinical Pharmacology at the CRO underlined that the study also aimed to establish the role of pharmacogenetics in preventing the toxic effects of drugs in oncology and, specifically, to establish the role of genetic variants affecting two genes: dihydropyrimidine dehydrogenase (DYPD) and uridine diphosphate glucuronosyltransferase (UGT). For Toffoli, the “twenty years of experience gained in the study of genetic variants, responsible for adverse drug reactions” in the sector he directs, were fundamental in the project. The work was attended by Erika Cecchin, belonging to the Experimental and Clinical Pharmacology and coordinator of the activities of the pharmacogenetic study, and the researchers Rossana Roncato (who dealt with the aspects of implementation and pharmacoeconomics) and Alessia Bignucolo (who participated in the enrollment of the patients and performed molecular tests). (HANDLE).
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