Pierluigi Navarra

A phase III, randomized, double blind, controlled trial to evaluate the efficacy and safety of a fixed combination of intramuscular diclofenac 75 mg + thiocolchicoside 4 mg, compared to diclofenac 75 mg monotherapy and placebo, in the treatment of acute low back pain

Cosimo Costantino, Theodoros Kormas, Avraam Ploumis, Panagiotis K. Karampinas et autres

BACKGROUND: This study aimed to demonstrate the superiority of diclofenac sodium 75 mg/thiocolchicoside 4 mg/4 mL fixed-dose combination (FDC) for intramuscular (IM) injection vs. diclofenac 75 mg alone or placebo in relieving pain in patients suffering from low back pain (LBP). METHODS: …

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Ri-Medi: a pilot implementation of a medication review and deprescribing service in primary care for elderly patients with polypharmacy in Rome.

Silvia Alessio, Alessandro Cesare Rosa, Michela Servadio, Cinzia Dello Russo et autres

'Ri-Medi' is a pilot project implementation of a medication review and deprescribing (MRDP) service in the primary care setting, involving two health districts of the Local Health Authority Roma 1 (Rome, Italy). General practitioners (GPs) are supported in this activity by a …

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Author’s reply to comments to: Italian Medicines Agency’s reform and time until pricing and reimbursement decisions: a time-to-event analysis

Gian Marco Raspolini, Bruno Federico, Mario Cesare Nurchis, Gianfranco Damiani et autres

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CGRP, VIP and PACAP plasmatic levels in migraine patients before and after anti-CGRP(R) monoclonal antibodies treatment

Davide Chiasserini, Alessia Bellotti, Alfredo Megaro, Giuseppe Tringali et autres

Aim Calcitonin gene-related peptide (CGRP), vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase-activating peptide (PACAP) play a crucial role in migraine pathophysiology. In recent years, anti-CGRP(R) monoclonal antibodies (mAbs) have emerged as the first targeted and highly effective therapy for migraine. This …

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Retinal Pigment Epithelium Cell Line ARPE-19 Exposed to M1 Microglia Releases Proinflammatory Cytokines and Reactive Oxygen Species Through MAP-Kinase Pathway

Michela Pizzoferrato, Benedetto Falsini, Giuseppe Tringali, Pierluigi Navarra et autres

Background: The retinal pigment epithelium (RPE) plays a pivotal role in the visual process by maintaining the blood–retina barrier, protecting the retina from oxidative stress, and regulating immune responses. Consequently, dysfunction or degeneration of the RPE is implicated in a broad spectrum …

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Italian Medicines Agency’s reform and time until pricing and reimbursement decisions: a time-to-event analysis

Gian Marco Raspolini, Bruno Federico, Mario Cesare Nurchis, Gianfranco Damiani et autres

Introduction: The duration of pricing and reimbursement (P&R) negotiations is a key performance indicator for medicines agencies in universal health coverage systems. In early 2024, the Italian Medicines Agency (AIFA) underwent a major reform, including the merging of the previous Scientific-Technical Committee …

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Tumor growth inhibitory activity of the P2X7 receptor antagonist AZ10606120 in two cell lines of human glioblastoma

Michela Graziano, Silvia Bono, Michela Pizzoferrato, Chiara Ferraro et autres

Glioblastoma multiforme (GBM) is among the most aggressive and lethal primary brain tumors. P2X7 is a purinergic receptor overexpressed in GBM, whose activation can promote tumor growth. Two major splice variants of the P2X7 receptor, isoforms A and B, are expressed in …

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Impact of ECOG performance status 2 participants on outcomes of pivotal cancer clinical trials: a meta-analysis and meta-regression

G.M. Iannantuono, T. Giovagnoli, L. Mastrantoni, Bishal Gyawali et autres

BACKGROUND: Although patients with Eastern Cooperative Oncology Group performance status (PS) of 2 constitute a significant proportion of the cancer population, they are often excluded from pivotal clinical trials owing to presumed higher risks of treatment effect dilution, toxicity, and lower compliance. …

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Main factors associated with variability in the assessment of the objective response rate. A re‐analysis of the PHEREXA phase 3 clinical trial

Gennaro Daniele, Tommaso Giovagnoli, Pierluigi Navarra, Cinzia Dello Russo

AIM: Local investigators (LIs) overestimate the objective response rate (ORR) in comparison to Blinded Independent Central Reviewers (BICR) in oncology. In this study, we re-analysed data obtained in the PHEREXA trial (NCT01026142) with the following aims: i) to confirm at the single-patient …

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Mebendazole Shows Antiproliferative and Antimigratory Effects in Paediatric Low-Grade Glioma Models

Chiara Ferraro, Michela Pizzoferrato, Michela Graziano, Tiziana Servidei et autres

: These findings indicate that MBZ exerts potent antiproliferative and anti-migratory activity in pediatric glioma cell lines, supporting its potential as a repositioned therapeutic drug. However, no additional benefit was observed when combined with vinblastine, underscoring the importance of exploring MBZ as …

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A systematic review with meta-analysis on the efficacy of 0.01% atropine eyedrops in preventing myopia progression in worldwide children’s populations

Pierluigi Navarra, Luca Buzzonetti, Valentina Amico, Melina Crò et autres

Introduction: Atropine eyedrops have long been used off-label to prevent myopia progression in children, and many clinical trials have been published on this topic in the past 30 years. Trials initially tested doses ranging from 0.01% to 1%, but more recently, the …

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A Survey on the Off-Label Use of Atropine in the Treatment of Myopia in Italy

Luca Buzzonetti, Pierluigi Navarra

The so-called myopia epidemic is a matter of concern for public health worldwide. It is estimated that more than 30% of world population currently suffers from myopia and is expected to be 50% (i.e...

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