Luca Gallelli

Luca Gallelli was born in Naples on November 03 1973 and he graduated in Medicine and Surgery at the University of Reggio Calabria, Italy on 1997. In the same year he started the PhD program in Pharmacology and Toxycology (Chemiotherapy) at the Second University of Naples, Italy. During this period, he studied the lung function in vivo and in vitro models. He improved his learning (lung function in animal models and in cell culture (fibroblasts, bronchial epithelial cells, cancer cells) in London at the Department of Pharmacology King’s College London (directed by Prof C.P. Page), and at the Department of Pulmonary Pharmacology in Faculty of Medicine Paris Ouest, Francia (directed by Prof C. Advenier), In 2005 he obtained the degree as Specialist in Clinical Pharmacology at the School of Medicine University of Catanzaro. From 2007 to date, he works in Pharmacology at the University of Catanzaro, Italy, and his field of expertise are Clinical pharmacology, clinical toxicology, drug use

EDUCATION

degree in medicine and surgery,
PhD in Pharmacology and Toxicology (Chemotherapy) in Second University of Naples, Italy,
Specialist in Clinical Pharmacology, School of Medicine University of Catanzaro
Postgraduate Course in Quality Organization & Personnel Management in Public Health, acquired at the "Magna Graecia" University of Catanzaro
1st Level Theoretical and Practical Course in Oxygen Ozone therapy. Organized by the Italian Society of Oxygen Ozone Therapy

RESEARCH, TEACHING, or OTHER INTERESTS

Pharmacology (medical), General Medicine, Pharmacology, Toxicology and Pharmaceutics, Pharmacology

Scopus Publications

A Precision Medicine Model for Targeted Antibiotic Therapy in Urinary Tract Infections: A Valuable Tool to Reduce Hospitalization Stay and the Time to Switch to Oral Treatment
Tommaso Cai, Anna Brugnolli, Massimiliano Lanzafame, Fabiana Dellai, Carlo Tascini, Claudio Scarparo, Vito Racanelli, Orietta Massidda, Gernot Bonkat, Luca Gallelli,et al.
MDPI AG
Background/Objectives: The management of urinary tract infections (UTIs) has become an increasingly challenging medical intervention. This study explores whether adoption of a precision medicine model could improve the management of acute uncomplicated pyelonephritis (uAPN) or complicated UTIs (cUTIs) compared with the standard of care approach, in hospitalized patients. Methods: From January 2022 to March 2024, all patients affected by uAPN or cUTIs and attending our urological institution were randomized to receive the following: antibiotic treatment according to guidelines and recommendations (standard of care group) or antibiotic treatment according to the precision medical model (intervention group). The main outcome measures were the rates of clinical success and the length of hospitalization. The time until switching to oral treatment was regarded as a secondary outcome measure. Results: Eighty-three patients were enrolled in the standard of care group, while seventy-nine patients were enrolled in the intervention group. While the overall clinical success rate was similar in the two groups (75 vs. 72; p = 0.97), a statistically significant difference was observed between the two groups in terms of length of hospitalization (8 days vs. 5 days; p = 0.03) and time to switch to oral treatment (96 h vs. 72 h; p = 0.04). A statistically significant difference was found between the two groups regarding the need to change antimicrobial therapy during hospitalization [12 out of 80 vs. 6 out of 77; p = 0.04]. Conclusions: Adoption of the precision medicine model appears as a valuable means to improve the management of patients with uAPN and cUTIs. By reducing the period of hospitalization and the time to switch to oral treatment, the precision medicine model also improves antimicrobial stewardship in the management of UTIs.


miRNA Signatures in Alveolar Macrophages Related to Cigarette Smoke: Assessment and Bioinformatics Analysis
Davida Mirra, Renata Esposito, Giuseppe Spaziano, Concetta Rafaniello, Francesca Panico, Antonio Squillante, Maddalena Falciani, Diana Marisol Abrego-Guandique, Eleonora Caiazzo, Luca Gallelli,et al.
MDPI AG
Cigarette smoke (CS) is a driver of many respiratory diseases, including chronic obstructive pulmonary disease (COPD) and non-small cell lung cancer (NSCLC). Tobacco causes oxidative stress, impaired phagocytosis of alveolar macrophages (AMs), and alterations in gene expression in the lungs of smokers. MicroRNAs (miRNAs) are small non-coding RNAs that influence several regulatory pathways. Previously, we monitored the expressions of hsa-miR-223-5p, 16-5p, 20a-5p, -17-5p, 34a-5p, and 106a-5p in AMs derived from the bronchoalveolar lavage (BAL) of subjects with NSCLC, COPD, and smoker and non-smoker control groups. Here, we investigated the capability of CS conditionate media to modulate the abovementioned miRNAs in primary AMs obtained in the same 43 sex-matched subjects. The expressions of has-miR-34a-5p, 17-5p, 16-5p, 106a-5p, 223-5p, and 20a-5p were assessed before and after in vitro CS exposure by RT-PCR. In addition, a comprehensive bioinformatic analysis of miRNAs KEGGS and PPI linked to inflammation was performed. Distinct and common miRNA expression profiles were identified in response to CS, suggesting their possible role in smoking-related diseases. It is worth noting that, following exposure to CS, the expression levels of hsa-miR-34a-5p and 17-5p in both smokers and non-smokers, 106a-5p in non-smokers, and 20a-5p in smokers, shifted towards those found in individuals with COPD, suggesting them as a risk factor in developing this lung condition. Moreover, CS-focused sub-analysis identified miRNA which exhibited CS-dependent pattern and modulated mRNA involved in the immune system or AMs property regulation. In conclusion, our study uncovered miRNA signatures in AMs exposed to CS, indicating that CS might modify epigenetic patterns that contribute to macrophage activation and lung disease onset and progression.


Emerging biological treatments for asthma
Daniela Pastore, Chiara Lupia, Maria D’Amato, Andrea Bruni, Eugenio Garofalo, Federico Longhini, Luca Gallelli, Alessandro Vatrella, Girolamo Pelaia, and Corrado Pelaia
Informa UK Limited
INTRODUCTION Severe asthma is a chronic airway disease characterized by many pathomechanisms known as endotypes. Biological therapies targeting severe asthma endotypes have significantly improved the treatment of this disease, thus remarkably bettering patient quality of life. AREAS COVERED This review aims to describe current biological therapies for severe asthma, highlighting emerging ones. Several studies have confirmed the beneficial effects of currently available monoclonal antibodies targeting immunoglobulin E (IgE), interleukin-5 (IL-5) or its receptor, and interleukin-4 (IL-4)/interleukin-13 (IL-13) receptors (IL-4 R/IL-13 R). However, patients with T2-low asthma are not eligible for the above biological therapies. EXPERT OPINION New treatments are now moving toward targeting the upstream pathways of asthma pathogenesis, coordinated by innate cytokines such as alarmins. These key proinflammatory mediators orchestrate the activation of complex cellular networks including both innate and adaptive immune responses. Alarmins include thymic stromal lymphopoietin (TSLP), interleukin-25 (IL-25), and interleukin-33 (IL-33), which are released from injured airway epithelial cells. TSLP and the other alarmins are suitable targets of biological therapies which are effective for add-on treatment of type 2 asthma. Moreover, anti-alarmin monoclonal antibodies can be also beneficial for patients with T2-low, poorly controlled severe asthma.


Probiotics in the Management of Chronic Bacterial Prostatitis Patients: A Randomized, Double-Blind Trial to Evaluate a Possible Link Between Gut Microbiota Restoring and Symptom Relief
Cristina Vocca, Diana Marisol Abrego-Guandique, Erika Cione, Vincenzo Rania, Gianmarco Marcianò, Caterina Palleria, Luca Catarisano, Manuela Colosimo, Gregorio La Cava, Italo Michele Palumbo,et al.
MDPI AG
Several studies have suggested that probiotics could play a role in the management of patients with chronic bacterial prostatitis (CBP). In this randomized, placebo-controlled clinical study, we evaluated the efficacy and safety of consumption of probiotics containing human Lactobacillus casei DG® as an add-on treatment in patients with clinical recurrences of CBP, through gut microbiota modification analysis. Enrolled patients with CBP were randomized to receive for 3 months probiotics containing human Lactobacillus casei DG® or placebo following 1 month treatment with ciprofloxacin. During the enrollment and follow-ups, urological examinations analyzed symptoms and quality of life, while microbiological tests analyzed gut and seminal microbiota. During the study, the development of adverse drug reactions was evaluated through the Naranjo scale. Twenty-four patients with CBP were recruited and treated for 3 months with placebo (n. 12) or with Lactobacillus casei DG® (n. 12). Lactobacillus casei DG® induced a significantly (p < 0.01) faster recovery of symptoms than placebo (2 days vs. 8 days) and an increased time free from symptoms (86 days vs. 42 days) without the occurrence of adverse events. In the probiotic group, the appearance of Lactobacilli after 30 days (T1) was higher vs. the placebo group, and a significant reduction in Corynebacterium, Peptoniphilus, Pseudomonas, Veillonella, Staphylococcus, and Streptococcus was also observed. These preliminary data suggest that in patients with CBP, the use of Lactobacillus casei DG after an antimicrobial treatment improves the days free of symptoms and the quality of life, without the development of adverse drug reactions.


Racecadotril in the management of diarrhea: an underestimated therapeutic option?
M. Manfredi, Gianmarco Marcianò, S. Iuliano, Francesco Leo and L. Gallelli

Acute infectious diarrhea (AID) represents an important clinical entity both regarding morbidity and mortality rates, even in industrialized countries, and it leads to one of the major public health burdens, among gastroenterological diseases, with significant healthcare costs. Oral rehydration solution is the cornerstone of the therapy, but despite its proven efficacy in avoiding dehydration, it is still underused as it does not reduce the duration of diarrhea; hence, it is perceived as ineffective by caregivers. In this narrative review, we collected literature regarding the use of racecadotril, deeply discussing its role in the treatment of AID in both adults and children. Racecadotril has been studied in wide populations of patients, in many countries, and in different clinical settings. Its effectiveness in reducing the stool output and the duration of diarrhea has been proven, not only in the early phase of the disease. Racecadotril has been shown to increase the likelihood of home management of AID, to reduce hospitalizations and parenteral rehydration needs resulting in healthcare costs reduction. The current new formulations require only two-daily doses for adults and the pediatric syrup should simplify its use.


Prescribing Pattern and Safety Profile of Biological Agents for Psoriasis in Real-World Practice: A Four-Year Calabrian Pharmacovigilance Analysis
Caterina De Sarro, Francesca Bosco, Agnese Gagliardi, Lorenza Guarnieri, Stefano Ruga, Antonio Fabiano, Laura Costantino, Antonio Leo, Caterina Palleria, Chiara Verduci,et al.
MDPI AG
Background: The treatment of psoriasis has made considerable progress with biologicals, including tumor necrosis factor inhibitors, and recently, monoclonal antibodies inhibiting directly interleukin (IL) 17, IL-23, or both IL-12/23. Newer biologicals are directed to the interleukin pathway and appear to improve complete or near-complete clearance. The newer biologicals have also been shown to have an excellent safety profile. However, despite experience with patients having confirmed the results obtained in clinical trials, there are still few data on using the newer biologicals. Methods: The present active study aimed to prospectively evaluate safety profiles and persistence of some biologicals in a multicenter pharmacovigilance study, that enrolled 733 patients treated with a biologic drug in five Calabrian hospital units. Informative and treatment persistence evaluations with predictors for suspension and occurrence of adverse events (AEs) were executed. In particular, reasons for treatment discontinuation in our program take account of primary/secondary failure or development of an AE. Results: AEs occurred in 187/733 patients and serious AEs (SAEs) were identified in 5/733 patients. An number of 182/733 patients showed a primary/secondary inefficacy. The AEs and SAEs were described with adalimumab, infliximab, and etanercept but not with abatacept, brodalumab, tildrakizumab, golinumab, ixekizumab, guselkumab, risankizumab, secukinumab, and ustekinumab. Conclusions: Our analysis, although limited by a small sample size and a short-term follow-up period, offers suitable data on commonly used biological agents and their safety, interruption rate, and the attendance of SAEs. Real-world studies should be carried out to evaluate other safety interests.


Assessing Gender Differences in Neuropathic Pain Management: Findings from a Real-Life Clinical Cross-Sectional Observational Study
Gianmarco Marcianò, Antonio Siniscalchi, Gianfranco Di Gennaro, Vincenzo Rania, Cristina Vocca, Caterina Palleria, Luca Catarisano, Lucia Muraca, Rita Citraro, Maurizio Evangelista,et al.
MDPI AG
Introduction: Neuropathic pain is defined as pain induced by a lesion or disease of the somatosensory nervous system. Pharmacological and non-pharmacological treatments are frequently employed. In the current clinical investigation, we assessed the effects of sex on the safety and effectiveness of medications used to treat neuropathic pain. Methods: We conducted a prospective analysis between 1 February 2021 and 20 April 2024, involving patients with neuropathic pain referred to the Ambulatory of Pain Medicine of “Renato Dulbecco” University Hospital in Catanzaro (Calabria, Italy). Patients over 18 years old with signs of neuropathic pain (Douleur Neuropathique en 4 questionnaire ≥ 4) were included. Exclusion criteria comprised patients with Alzheimer’s disease; patients with nociplastic or nociceptive pain; and patients with neoplasms. Patients with fewer than two accesses to ambulatory care were excluded, as were those who did not sign the informed consent. Clinical data were collected from each enrolled patient and subsequently analyzed, considering clinical outcomes. Sex and gender differences in efficacy were estimated using multivariate linear modeling and propensity-score matching. Results: During the study, 531 patients were screened, and 174 were enrolled (33.5%, mean age 61.5 ± 13.1; 64 males and 110 females, mean age 60.6 ± 13.4 and 61.96 ± 13.0) in accordance with the inclusion and exclusion criteria. Only minor differences in treatment prescription were observed based on age, body mass index, and comorbidities. Smoking, sex, educational level, and body mass index did not induce a significant change in pain perception. Males required slightly higher, though not significantly, doses of drugs for pain control than females. The treatment was not significantly more effective for females than for males. Females did not exhibit a significantly lower number of adverse drug reactions compared to males. Conclusions: The current study found that there are no appreciable differences between the sexes when it comes to the treatment of neuropathic pain.


Escin’s Action on Bradykinin Pathway: Advantageous Clinical Properties for an Unknown Mechanism?
Gianmarco Marcianò, Cristina Vocca, Demirhan Dıraçoğlu, Rotinda Özdaş Sevgin, and Luca Gallelli
MDPI AG
Escin, extracted from horse chestnut (Aesculus hippocastanum) has anti-edema and anti-inflammatory effects. It is used to treat several clinical conditions, including venous insufficiency, pain, inflammation, and edema. Considering escin’s pharmacodynamic, the inhibition of the bradykinin pathway represents a particular effect, decreasing the local edema and conferring an advantage in comparison to other compounds. In this narrative review, we described the effects of escin considering its effects on bradykinin pathway.


The Prescription and Safety of Oral Antidiabetic Drugs in Outpatients with Type 2 Diabetes Mellitus: An Observational, Retrospective, Multicenter Study on the Role of Adherence in a Real-Life Primary Care Setting
Gianmarco Marcianò, Cristina Vocca, Alessandro Casarella, Luca Gallelli, Vincenzo Rania, Caterina De Sarro, Rita Citraro, Caterina Palleria, Rosa Candida Bianco, Iolanda Fera,et al.
MDPI AG
Introduction: Type 2 diabetes mellitus (T2DM) is a common disease burdened with significant morbidity and mortality. Despite the substantial number of new available drug treatments, adherence to therapy and adverse drug reactions (ADRs) are the major constraint in the management of this disease. We evaluated the use, the adherence, and the safety of antidiabetic drugs in patients with T2DM. Methods: We performed an observational, retrospective, multicenter study on medical records of outpatients referred to general practitioners in Catanzaro (Calabria, Italy). Drug adherence was measured considering the packages of antidiabetic drugs prescribed at the time of admission, after three months, and 1 year later. ADRs were evaluated using the Naranjo probability scale. Collected data were analyzed using the Statistical Package for the Social Sciences. Results: During the study, we evaluated 12,170 medical records of seven general practitioners. The most prescribed drug was metformin alone (28.4%) or with other oral antidiabetics (19.6%) and then insulin (n: 354; men 190, women 164). Logistic regression showed an association between T2DM less than or equal to 5 years and low adherence (p = 0.023). During the study, we recorded 26 ADRs that were correlated with sex (women) and insulin treatment. Conclusions: this real-life study shows that patients with T2DM have a high adherence, probably related to their having a low number of ADRs.


The diagnostic yield of the Meares & Stamey test can be significantly improved by symptom-based patient selection and the experience of the test performer
Tommaso Cai, Irene Tamanini, Katia Odorizzi, Luca Gallelli, Massimiliano Lanzafame, Sandra Mazzoli, Paolo Lanzafame, Orietta Massidda, Alessandro Palmieri, Florian M. E. Wagenlehner,et al.
Springer Science and Business Media LLC



MicroRNA Monitoring in Human Alveolar Macrophages from Patients with Smoking-Related Lung Diseases: A Preliminary Study
Davida Mirra, Renata Esposito, Giuseppe Spaziano, Liberata Sportiello, Francesca Panico, Antonio Squillante, Maddalena Falciani, Ida Cerqua, Luca Gallelli, Erika Cione,et al.
MDPI AG
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that is commonly considered to be a potent driver of non-small cell lung cancer (NSCLC) development and related mortality. A growing body of evidence supports a role of the immune system, mainly played by alveolar macrophages (AMs), in key axes regulating the development of COPD or NSCLC phenotypes in response to harmful agents. MicroRNAs (miRNAs) are small non-coding RNAs that influence most biological processes and interfere with several regulatory pathways. The purpose of this study was to assess miRNA expression patterns in patients with COPD, NSCLC, and ever- or never-smoker controls to explore their involvement in smoking-related diseases. Bronchoalveolar lavage (BAL) specimens were collected from a prospective cohort of 43 sex-matched subjects to determine the expressions of hsa-miR-223-5p, 16-5p, 20a-5p, -17-5p, 34a-5p and 106a-5p by RT-PCR. In addition, a bioinformatic analysis of miRNA target genes linked to cancer was performed. Distinct and common miRNA expression levels were identified in each pathological group, suggesting their possible role as an index of NSCLC or COPD microenvironment. Moreover, we identified miRNA targets linked to carcinogenesis using in silico analysis. In conclusion, this study identified miRNA signatures in AMs, allowing us to understand the molecular mechanisms underlying smoking-related conditions and potentially providing new insights for diagnosis or pharmacological treatment.


Icarifil^® in Association with Daily Use of Tadalafil (5 mg) versus Standard Tadalafil Daily Dose (5 mg) or Alone: Results from a Controlled, Randomized Clinical Trial
Tommaso Cai, Fabrizio Palumbo, Carlos Miacola, Carlo Ceruti, Michele Rizzo, Giovanni Liguori, Luca Gallelli, and Alessandro Palmieri
MDPI AG
Background: The management of erectile dysfunction (ED) shows several grey zones and new treatments are required to reduce the percentage of patients discontinuing treatment. Here, we aim to evaluate the role of a natural mixture named Icarifil® (L-Citrulline, L-Carnitine, Eruca vesicaria, Panax ginseng, Tribulus terrestris, Turnera diffusa, Taurine, Vitamin E, Zinc) in the management of patients with ED. Methods: From September 2022 to March 2023, all patients attending 3 urological institutions due to ED were randomized to receive the following for 3 months: Icarifil® 1 sachet every 24 h (Group 1) or Icarifil® 1 sachet + tadalafil 5 mg 1 tablet every 24 h (Group 2) or tadalafil 5 mg 1 tablet daily (Group 3). All patients underwent urologic visits and dedicated questionnaires (IIEF-5, SEP-2, SEP-3) at enrollment and at the follow-up evaluation (3 months). Patient-Reported Outcomes (PROs) at the follow-up evaluation were used. The primary endpoint was the difference in the questionnaires at the follow-up visit compared to the one at enrollment among the study groups. Results: In the per-protocol analysis, 52 patients in Group 1, 55 in Group 2 and 57 in Group 3 were analyzed. At the follow-up evaluation, IIEF-5 scores improved in all the 3 groups between enrollment and the follow-up evaluation, but a statistically significant difference was reported between Group 2 (+7.4) and Group 1 (+4.1) or Group 3 (+5.1), (p < 0.001; p < 0.001). Moreover, 47 patients (94.0%) in Group 2 showed an improvement in the SEP questionnaires, when compared with the baseline, while 29 in Group 1 (56.9%) and 42 in Group 3 (82.3%) showed a statistically significant difference (p = 0.004; p = 0.003) among the groups. The PRO analysis reported better efficacy and patient satisfaction in Group 2 when compared with Group 1 or Group 3. Conclusions: In conclusion, Icarifil® is able to improve penile erectile function in mild–moderate ED and significantly improve the clinical efficacy of daily used tadalafil 5 mg. Icarifil® could represent an interesting alternative treatment in patients experiencing adverse effects or with contraindications for chronic treatment with PDE5-is.


Deprescribing in Older Poly-Treated Patients Affected with Dementia
Pietro Gareri, Luca Gallelli, Ilaria Gareri, Vincenzo Rania, Caterina Palleria, and Giovambattista De Sarro
MDPI AG
Polypharmacy is an important issue in older patients affected by dementia because they are very vulnerable to the side effects of drugs’. Between October 2021 and September 2022, we randomly assessed 205 old-aged outpatients. The study was carried out in a Center for Dementia in collaboration with a university center. The primary outcomes were: (1) deprescribing inappropriate drugs through the Beers and STOPP&START criteria; (2) assessing duplicate drugs and the risk of iatrogenic damage due to drug–drug and drug–disease interactions. Overall, 69 men and 136 women (mean age 82.7 ± 7.4 years) were assessed. Of these, 91 patients were home care patients and 114 were outpatient. The average number of the drugs used in the sample was 9.4 drugs per patient; after the first visit and the consequent deprescribing process, the average dropped to 8.7 drugs per patient (p = 0.04). Overall, 74 potentially inappropriate drugs were used (36.1%). Of these, long half-life benzodiazepines (8.8%), non-steroidal anti-inflammatory drugs (3.4%), tricyclic antidepressants (3.4%), first-generation antihistamines (1.4%), anticholinergics (11.7%), antiplatelet drugs (i.e., ticlopidine) (1.4%), prokinetics in chronic use (1.4%), digoxin (>0.125 mg/day) (1.4%), antiarrhythmics (i.e., amiodarone) (0.97%), and α-blockers (1.9%) were included. The so-called “duplicate” drugs were overall 26 (12.7%). In total, ten potentially dangerous prescriptions were found for possible interactions (4.8%). We underline the importance of checking all the drugs taken periodically and discontinuing drugs with the lowest benefit-to-harm ratio and the lowest probability of adverse reactions due to withdrawal. Computer tools and adequately trained teams (doctors, nurses, and pharmacists) could identify, treat, and prevent possible drug interactions.


Circulating miRNAs as Novel Clinical Biomarkers in Temporal Lobe Epilepsy
Lorenza Guarnieri, Nicola Amodio, Francesca Bosco, Sara Carpi, Martina Tallarico, Luca Gallelli, Vincenzo Rania, Rita Citraro, Antonio Leo, and Giovambattista De Sarro
MDPI AG
Temporal lobe epilepsy (TLE) represents the most common form of refractory focal epilepsy. The identification of innovative clinical biomarkers capable of categorizing patients with TLE, allowing for improved treatment and outcomes, still represents an unmet need. Circulating microRNAs (c-miRNAs) are short non-coding RNAs detectable in body fluids, which play crucial roles in the regulation of gene expression. Their characteristics, including extracellular stability, detectability through non-invasive methods, and responsiveness to pathological changes and/or therapeutic interventions, make them promising candidate biomarkers in various disease settings. Recent research has investigated c-miRNAs in various bodily fluids, including serum, plasma, and cerebrospinal fluid, of TLE patients. Despite some discrepancies in methodologies, cohort composition, and normalization strategies, a common dysregulated signature of c-miRNAs has emerged across different studies, providing the basis for using c-miRNAs as novel biomarkers for TLE patient management.


Humoral and T-cell response to SARS-CoV-2 mRNA vaccine in multiple sclerosis patients: Correlations with DMTs and clinical variables
Stefania Barone, Camillo Palmieri, Luca Gallelli, Vincenzo Rania, Angelo Pascarella, Antonio Abatino, Pietro Antonio Bruno, Alessandro Casarella, Marilisa Pasquale, Lucia Manzo,et al.
Elsevier BV



Phytotherapy Might Have a Role in Reducing Unnecessary Prostate Biopsies: Results from an Exploratory, Randomized Controlled Trial of Two Different Phytotherapeutic Agents
Tommaso Cai, Irene Tamanini, Marco Puglisi, Leonardo Bizzotto, Michele Rizzo, Giovanni Liguori, Luca Gallelli, Alessandro Palmieri, and Truls E. Bjerklund Johansen
MDPI AG
Background: We aimed to evaluate the impact of two different phytotherapeutic agents on decision making regarding prostate biopsy for patients with higher-than-normal prostate-specific antigen (PSA) levels. Methods: From June 2022 to May 2023, all patients attending two urological institutions due to higher-than-normal PSA levels were randomized to receive either oral capsules of Curcuma Longa, Boswellia, Pinus pinaster and Urtica dioica (Group A) or Serenoa Repens 320 mg (Group B) for 3 months. At the follow-up visit after 3 months, all patients underwent PSA tests and multiparametric magnetic resonance imaging (mpMRI). Results: In the per-protocol analysis, data from 66 patients in Group A and 76 in Group B were analyzed. Fifty patients in Group A (75.7%) showed a significant reduction in total PSA compared to forty-nine in Group B (64.4%) (p < 0.001). Twenty-eight patients had PI-RADS III or higher in mpMRI: twelve in Group A and fourteen in Group B. Twenty-three patients (34.8%) in Group A and fifty-nine (77.6%) in Group B (p < 0.001) underwent prostate biopsy based on the mpMRI findings and PSA values. Three patients in Group A showed a significant reduction in total PSA values while having positive mpMRI findings (6%) compared with nine in Group B (19.5%) (p < 0.001). On the contrary, 7 patients in Group A did not show significant reduction in total PSA values and had negative mpMRI findings (43%) compared to 22 in Group B (81.4%) (p < 0.001). Conclusions: In conclusion, a three-month course of a combination of Curcuma Longa, Boswellia, Pinus pinaster and Urtica dioica seems to be an interesting tool to avoid unnecessary prostate biopsies among men with higher-than-normal PSA levels.


Acute effects of a chewable beetroot-based supplement on cognitive performance: a double-blind randomized placebo-controlled crossover clinical trial
Maria Grazia Vaccaro, Bernardo Innocenti, Erika Cione, Luca Gallelli, Giovambattista De Sarro, Diego A. Bonilla, and Roberto Cannataro
Springer Science and Business Media LLC
Abstract Background Dietary nitrate (NO3−) has been shown to be useful as an ergogenic aid with potential applications in health and disease (e.g., blood pressure control). However, there is no consensus about the effects of dietary NO3− or beetroot (BR) juice supplementation on cognitive function. Objective The aim of this study was to evaluate the effects of a single dose of a chewable BR-based supplement on cognitive performance. Methods A double-blind randomized placebo-controlled two-period crossover clinical trial was carried out based on the extension of the CONSORT guidelines for randomized crossover trials. A total of 44 participants (24 F; 20 M; 32.7 [12.5] years; 66.3 [9.0] kg; 170 [9.2] cm; 22.8 [1.4] kg/m2) were randomly allocated to receive first either four BR-based chewable tablets (BR-CT) containing 3 g of a Beta vulgaris extract (RedNite®) or four tablets of a placebo (maltodextrin). A 4-day washout period was used before crossover. Ninety minutes after ingestion of the treatments, a neuropsychological testing battery was administered in each period. The trial was registered at clinicaltrials.gov NCT05509075. Results Significant improvements with moderate effect size were found on memory consolidation at the short and long term only after BR-CT supplementation via the Rey Auditory Verbal Learning Test immediate (+ 20.69%) and delayed (+ 12.34%) recalls. Likewise, enhancement on both frontal lobe functions (+ 2.57%) and cognitive flexibility (+ 11.16%) were detected after BR-CT. There was no significant change (p < 0.05) on verbal memory of short-term digits, working memory and information processing speed. Mixed results were found on mood and anxiety through the Beck Depression Inventory-II (BDI-II) and the State-Trait Anxiety Inventory (STAI-Y1 and STAI-Y2); however, sequence and period effects were seen on STAI-Y2. Conclusions The acute administration of a chewable BR-based supplement improves certain aspects of cognitive function in healthy females and males, particularly memory capacity and frontal skills.


Cenobamate enhances the anticonvulsant effect of other antiseizure medications in the DBA/2 mouse model of reflex epilepsy
Antonio Leo, Francesca Bosco, Lorenza Guarnieri, Caterina De Sarro, Vincenzo Rania, Luca Gallelli, Rita Citraro, and Giovambattista De Sarro
Elsevier BV



Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”
Nicoletta Luxi, Chiara Bellitto, Francesco Ciccimarra, Emiliano Cappello, Luca L’Abbate, Marco Bonaso, Chiara Ajolfi, Paolo Baldo, Roberto Bonaiuti, Claudio Costantino,et al.
Frontiers Media SA
Introduction: In 2021, the European Medicines Agency supported the “Covid Vaccine Monitor (CVM),” an active surveillance project spanning 13 European countries aimed at monitoring the safety of COVID-19 vaccines in general and special populations (i.e., pregnant/breastfeeding women, children/adolescents, immunocompromised people, and people with a history of allergies or previous SARS-CoV-2 infection). Italy participated in this project as a large multidisciplinary network called the “ilmiovaccinoCOVID19 collaborating group.”Methods: The study aimed to describe the experience of the Italian network “ilmiovaccinoCOVID19 collaborating group” in the CVM context from June 2021 to February 2023. Comprising about 30 partners, the network aimed to facilitate vaccinee recruitment. Participants completed baseline and follow-up questionnaires within 48 h from vaccination over a 6-month period. Analyses focused on those who completed both the baseline and the first follow-up questionnaire (Q1), exploring temporal trends, vaccination campaign correlation, and loss to follow-up. Characteristics of recruited vaccinees and vaccinee-reported adverse drug reactions (ADRs) were compared with passive surveillance data in Italy.Results: From June 2021 to November 2022, 22,384,663 first doses and 38,207,452 booster doses of COVID-19 vaccines were administered in Italy. Simultaneously, the study enrolled 1,229 and 2,707 participants for the first and booster doses, respectively. Of these, 829 and 1,879 vaccinees, respectively, completed both baseline and at least Q1 and were included in the analyses, with a significant proportion of them (57.8%/34.3%) belonging to special cohorts. Most vaccinees included in the analyses were women. Comirnaty® (69%) and Spikevax® (29%) were the most frequently administered vaccines. ADR rates following Comirnaty® and Spikevax® were higher after the second dose, particularly following Spikevax®. Serious ADRs were infrequent. Differences were observed in ADR characteristics between CVM and Italian passive surveillance.Conclusion: This study confirmed the favorable safety profile of COVID-19 vaccines, with findings consistent with pivotal clinical trials of COVID-19 vaccines, although different proportions of serious ADRs compared to spontaneous reporting were observed. Continuous evaluation through cohort event monitoring studies provides real-time insights crucial for regulatory responses. Strengthening infrastructure and implementing early monitoring strategies are essential to enhance vaccine safety assessment and prepare for future pandemics.


The Risk of Drug Interactions in Older Primary Care Patients after Hospital Discharge: The Role of Drug Reconciliation
Cristina Vocca, Antonio Siniscalchi, Vincenzo Rania, Cecilia Galati, Gianmarco Marcianò, Caterina Palleria, Luca Catarisano, Ilaria Gareri, Marco Leuzzi, Lucia Muraca,et al.
MDPI AG
Introduction: Drug–drug interactions (DDIs) represent an important clinical problem, particularly in older patients, due to polytherapy, comorbidity, and physiological changes in pharmacodynamic and pharmacokinetic pathways. In this study, we investigated the association between drugs prescribed after discharge from the hospital or clinic and the risk of DDIs with drugs used daily by each patient. Methods: We performed an observational, retrospective, multicenter study on the medical records of outpatients referred to general practitioners. DDIs were measured using the drug interaction probability scale. Potential drug interactions were evaluated by clinical pharmacologists (physicians) and neurologists. Collected data were analyzed using the Statistical Package for the Social Sciences. Results: During the study, we evaluated 1772 medical records. We recorded the development of DDIs in 10.3% of patients; 11.6% of these patients required hospitalization. Logistic regression showed an association among DDIs, sex, and the number of drugs used (p = 0.023). Conclusions: This observational real-life study shows that the risk of DDIs is common in older patients. Physicians must pay more attention after hospital discharge, evaluating the treatment to reduce the risk of DDIs.


Can platelet-rich fibrin act as a natural carrier for antibiotics delivery? A proof-of-concept study for oral surgical procedures
Francesco Bennardo, Luca Gallelli, Caterina Palleria, Manuela Colosimo, Leonzio Fortunato, Giovambattista De Sarro, and Amerigo Giudice
Springer Science and Business Media LLC
Abstract Objectives Evaluate the role of platelet-rich fibrin (PRF) as a natural carrier for antibiotics delivery through the analysis of drug release and antimicrobial activity. Materials and methods PRF was prepared according to the L-PRF (leukocyte- and platelet-rich fibrin) protocol. One tube was used as control (without drug), while an increasing amount of gentamicin (0.25 mg, G1; 0.5 mg, G2; 0.75 mg, G3; 1 mg, G4), linezolid (0.5 mg, L1; 1 mg, L2; 1.5 mg, L3; 2 mg, L4), vancomycin (1.25 mg, V1; 2.5 mg, V2; 3.75 mg, V3; 5 mg, V4) was added to the other tubes. At different times the supernatant was collected and analyzed. Strains of E. coli, P. aeruginosa, S. mitis, H. influenzae, S. pneumoniae, S. aureus were used to assess the antimicrobial effect of PRF membranes prepared with the same antibiotics and compared to control PRF. Results Vancomycin interfered with PRF formation. Gentamicin and linezolid did not change the physical properties of PRF and were released from membranes in the time intervals examined. The inhibition area analysis showed that control PRF had slight antibacterial activity against all tested microorganisms. Gentamicin-PRF had a massive antibacterial activity against all tested microorganisms. Results were similar for linezolid-PRF, except for its antibacterial activity against E. coli and P. aeruginosa that was comparable to control PRF. Conclusions PRF loaded with antibiotics allowed the release of antimicrobial drugs in an effective concentration. Using PRF loaded with antibiotics after oral surgery may reduce the risk of post-operative infection, replace or enhance systemic antibiotic therapy while preserving the healing properties of PRF. Further studies are needed to prove that PRF loaded with antibiotics represents a topical antibiotic delivery tool for oral surgical procedures.


Ibuprofen in the Management of Viral Infections: The Lesson of COVID-19 for Its Use in a Clinical Setting
Gianmarco Marcianò, Lucia Muraca, Vincenzo Rania, and Luca Gallelli
Wiley
AbstractNonsteroidal anti‐inflammatory drugs (NSAIDs) are commonly used for the management of fever, pain, and inflammation. However, they have always been considered to have a double‐faced role, according to their capacity to manage inflammation but also their possible reduction of immune system response and diagnosis delay. This last point could favor a dramatic increase of viral infection diffusion, possibly leading to a more severe outcome. The advent of severe acute respiratory syndrome coronavirus 2 excluded the use of NSAIDs, particularly ibuprofen, and then indicated this drug as the better NSAID to manage infected outpatients and prevent complications. Several authors described the role of NSAIDs and ibuprofen in preventing cytokine storm and modulating the immune system. However, the development of both adverse drug reactions (i.e., gastrointestinal, renal, hepatic, and cardiovascular) and drug interaction recalled the necessity of prescribing the better NSAID for each patient. In this narrative review, we describe the role of NSAIDs, particularly of ibuprofen, in the management of viral symptoms, suggesting that the NSAID may be chosen considering the characteristics of the patient, the comorbidity, and the polytherapy.


An In Vivo Electroencephalographic Analysis of the Effect of Riluzole against Limbic and Absence Seizure and Comparison with Glutamate Antagonists
Rita Citraro, Francesca Bosco, Gianfranco Di Gennaro, Martina Tallarico, Lorenza Guarnieri, Luca Gallelli, Vincenzo Rania, Antonio Siniscalchi, Giovambattista De Sarro, and Antonio Leo
MDPI AG
Background: Riluzole (RLZ) has demonstrated neuroprotective effects in several neurological disorders. These neuroprotective effects seem to be mainly due to its ability to inhibit the excitatory glutamatergic neurotransmission, acting on different targets located both at the presynaptic and postsynaptic levels. Methods: In the present study, we evaluated the effects of Riluzole (RLZ) against limbic seizures, induced by AMPA, kainate, and NMDA receptor agonists in Sprague–Dawley rats, and in a well-validated genetic model of absence epilepsy, the WAG/Rij rat. Furthermore, in this latter model, we also studied the effect of RLZ in co-administration with the competitive NMDA receptor antagonist, CPP, or the non-competitive AMPA receptor antagonist, THIQ-10c, on spike-wave discharges (SWDs) in WAG/Rij rats, to understand the potential involvement of AMPA and NMDA receptors in the anti-absence effect of RLZ. Results: In Sprague–Dawley rats, RLZ pretreatment significantly reduced the limbic seizure severity induced by glutamatergic agonists, suggesting an antagonism of RLZ mainly on NMDA rather than non-NMDA receptors. RLZ also reduced SWD parameters in WAG/Rij rats. Interestingly, the co-administration of RLZ with CPP did not increase the anti-absence activity of RLZ in this model, advocating a competitive effect on the NMDA receptor. In contrast, the co-administration of RLZ with THIQ-10c induced an additive effect against absence seizure in WAG/Rij rats. Conclusions: these results suggest that the antiepileptic effects of RLZ, in both seizure models, can be mainly due to the antagonism of the NMDA glutamatergic receptors.


Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
Fariba Ahmadizar, Nicoletta Luxi, Monika Raethke, Sandor Schmikli, Fabio Riefolo, Putri Widi Saraswati, Camelia Bucsa, Alhadi Osman, Megan Liddiard, Francisco Batel Maques,et al.
Springer Science and Business Media LLC



Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use
Tommaso Cai, Luca Gallelli, Paolo Verze, Andrea Salonia, and Alessandro Palmieri
Springer Science and Business Media LLC
A eutectic mixture of prilocaine/lidocaine spray (Fortacin™, Recordati, Milan, Italy) has been approved for the management of patients affected by life-long premature ejaculation (PE), but to date, there is a lack of dose- or time-finding studies in the literature that indicate the best method of intake to optimize treatment outcomes. In this multicentre, randomized, two-phase study, we aimed to compare, in terms of treatment effectiveness (primary objective) and safety (secondary objective), different treatment regimens (various doses and times of drug delivery) of Fortacin™ in 91 patients affected with lifelong PE who were recruited at four different centres and randomized (1:1:1 ratio) into three different groups. The study included two phases: during the first phase (focused on time-finding), the same drug dose (three sprays) was taken at different intervals before intercourse (5, 15, 30 min). In the second phase (focused on dose finding), different drug doses (1, 3, 5 sprays) were taken at the same interval before intercourse (5 min). The main outcome measure instruments were self-measured intravaginal ejaculation latency time (sm-IELT), the premature ejaculation diagnostic tool (PEDT), and the International Index of Erectile Function-5 (IIEF-5). Furthermore, patients were asked to report any side effects that appeared during the study period. Our main study findings showed that the treatment regimen with three sprays of Fortacin™ administered 5 min before sexual intercourse showed the best results in terms of ejaculation time and control (Phase I, IELT 221 ± 3.4, PEDT 7.7 ± 0.3; Phase II, IELT 213 ± 4.9, PEDT 7.8 ± 0.4) with a safety profile that was identical to other treatment regimens. Based on these data, patients who are prescribed Fortacin™ should stick to this regimen to optimize treatment results.

GRANT DETAILS

2017 RY Gold Zyp During the Italian Award of Innovation
IPA Adrion 2024

RESEARCH OUTPUTS (PATENTS, SOFTWARE, PUBLICATIONS, PRODUCTS)

1 Gallelli L, Cione E, Aiello F. Preparato per uso topico a base di 2-(3,4-diidrossifenil) -5,7-diidrossi-4-oxo-4H-cromen-3-1 oleato, in associazione con acido ialuronico per l’uso nel trattamento di ulcere e ferite cutanee e relativo metodo di produzione. BREVETTO INDUSTRIALE. n 102017000111372 17/12/2019.
2 Microbiota Quantity Test deposito di utilità presso UIMB del 15/06/2017. 202017000066854.
3 Gallelli L, Cione E, Caroleo MC, Cannataro R. Uso di microRNA come biomarcatori per la diagnosi e/o il follow-up del danno polmonare nei soggetti esposti ad inquinanti ambientali. Number 102017000034619 18/10/2017; International Patent 2/03/2018, PCT/IB2018/052176
4 G-Screen. Dispositivo medicale per la valutazione quali-quantitativa del latte materno durante l’allattamento. Number 102016000115242 27/07/2017.
5 Paolino FM, Romano F, Gallelli L, Dominijanni A. Metodo di preparazione di sangue periferico per l’ottenimento di un preparato con alte concentrazioni di fattori di crescita. Number: 102016000011829 04/02/2016.