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  1. Article: Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (Zolgensma

    Ruggiero, Rosanna / Balzano, Nunzia / Nicoletti, Maria Maddalena / di Mauro, Gabriella / Fraenza, Federica / Campitiello, Maria Rosaria / Rossi, Francesco / Capuano, Annalisa

    Pharmaceuticals (Basel, Switzerland)

    2024  Volume 17, Issue 3

    Abstract: The recent introduction of the innovative therapy, onasemnogene abeparvovec ( ... ...

    Abstract The recent introduction of the innovative therapy, onasemnogene abeparvovec (Zolgensma
    Language English
    Publishing date 2024-03-19
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2193542-7
    ISSN 1424-8247
    ISSN 1424-8247
    DOI 10.3390/ph17030394
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis.

    Marrapodi, Maria Maddalena / Mascolo, Annamaria / di Mauro, Gabriella / Mondillo, Gianluca / Pota, Elvira / Rossi, Francesca

    Frontiers in pediatrics

    2022  Volume 10, Page(s) 929122

    Abstract: Background: Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that has proven efficacy in children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Despite its efficacy, it has also been associated with the development ... ...

    Abstract Background: Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that has proven efficacy in children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Despite its efficacy, it has also been associated with the development of potentially serious adverse events such as the cytokine release syndrome (CRS) and neurologic events. The present meta-analysis aimed to assess the safety profile of blinatumomab in terms of serious adverse events, CRS, and neurologic events (such as seizure and encephalopathy) in pediatric patients with B-cell ALL.
    Methods and findings: A systematic review was conducted in Pubmed up to December 10, 2021 to retain pediatric clinical trials on blinatumomab. A random effect meta-analysis approach was used. This study followed the PRISMA statement. Four out of the 255 initial references were selected, of which 2 were phase 1/2 clinical trials and 2 phase 3 clinical trials. Blinatumomab was associated with a lower risk of serious adverse events (Risk ratio RR, 0.56; 95% CI, 0.32-0.99), febrile neutropenia (RR, 0.13; 95% CI, 0.06-0.26), infection (RR, 0.40; 95% CI, 0.29-0.56), and grade ≥ 3 adverse events (RR, 0.79; 95% CI, 0.67-0.93) compared to chemotherapy. No difference in the risk of CRS (RR, 8.37; 95% CI, 0.27-260.97) and seizure (RR, 6.43; 95% CI, 0.79-53.08) was observed between groups, while for encephalopathy a higher risk was associated with blinatumomab compared to chemotherapy (RR, 8.90; 95% CI, 1.08-73.29).
    Conclusion: Our data support the good safety profile of bliantumomab in treating pediatric patients with B-ALL.
    Language English
    Publishing date 2022-07-22
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2711999-3
    ISSN 2296-2360
    ISSN 2296-2360
    DOI 10.3389/fped.2022.929122
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Sodium-glucose cotransporter-2 (SGLT2) inhibitors and the reporting of falls and fractures: an european pharmacovigilance analysis.

    Mascolo, Annamaria / Rafaniello, Concetta / di Mauro, Gabriella / Ruggiero, Donatella / Campitiello, Maria Rosaria / Donniacuo, Maria / Berrino, Pasquale Maria / Rossi, Francesco / Paolisso, Giuseppe / Capuano, Annalisa

    Frontiers in pharmacology

    2023  Volume 14, Page(s) 1245642

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2023-11-06
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2023.1245642
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Skin Toxicities Associated with Botulin Toxin Injection for Aesthetic Procedures: Data from the European Spontaneous Reporting System.

    Nicoletti, Maria Maddalena / Anatriello, Antonietta / Liguori, Valerio / Cantone, Andrea / di Mauro, Gabriella / Izzo, Imma / Lettera, Nicoletta / Della Ragione, Joao Marcos / Campitiello, Maria Rosaria / Cosenza, Vincenzo / Scavone, Cristina

    Pharmaceuticals (Basel, Switzerland)

    2023  Volume 16, Issue 11

    Abstract: Botulinum toxin is a protein deriving from the ... ...

    Abstract Botulinum toxin is a protein deriving from the bacteria
    Language English
    Publishing date 2023-11-15
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2193542-7
    ISSN 1424-8247
    ISSN 1424-8247
    DOI 10.3390/ph16111611
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  5. Article ; Online: Comparative study of polycyclic aromatic hydrocarbons (PAHs) in salt gland and liver of loggerhead turtle Caretta caretta (Linnaeus, Cheloniidae) stranded along the Mediterranean coast, Southern Italy.

    Arienzo, Michele / Toscanesi, Maria / Esposito, Mauro / Iaccarino, Doriana / Di Nocera, Fabio / Canzanella, Silvia / Ferrara, Luciano / Di Natale, Gabriella / Trifuoggi, Marco

    Ecotoxicology and environmental safety

    2023  Volume 263, Page(s) 115355

    Abstract: The levels of polycyclic aromatic hydrocarbons, PAHs, were determined in the liver and salt gland of 19 loggerhead turtles (Caretta caretta Linnaeus, Cheloniidae) stranded along the coasts of the south Tyrrhenian Sea, Italy, from 2019 to 2021. The 16 EPA' ...

    Abstract The levels of polycyclic aromatic hydrocarbons, PAHs, were determined in the liver and salt gland of 19 loggerhead turtles (Caretta caretta Linnaeus, Cheloniidae) stranded along the coasts of the south Tyrrhenian Sea, Italy, from 2019 to 2021. The 16 EPA's priority PAHs were determined by gas chromatography coupled with mass spectrometry (GC-MS). The average values of ΣPAHs in liver, 139 ± 55.0, were exceptionally high and up to one hundred times those of literature and appeared even more worrying in salt gland, 320 ± 97.6 ng/g, w.w. Naphthalene was the predominant contributor to PAHs richness and accounted for 90.0% and 93.7% of ΣPAHs in the two matrices, highlighting the petrogenic source of exposure. An overall higher bioaccumulation of NAP, more than two-fold, was detected in salt gland and especially in female and adults. Data of PAHs richness highlighted a potential risk of neoplastic disease development and that anthropogenic activities may seriously impair healthy state conditions of C. caretta. populations in south Tyrrhenian Sea.
    MeSH term(s) Female ; Animals ; Turtles ; Polycyclic Aromatic Hydrocarbons ; Salt Gland ; Liver ; Italy
    Chemical Substances Polycyclic Aromatic Hydrocarbons
    Language English
    Publishing date 2023-08-21
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 436536-7
    ISSN 1090-2414 ; 0147-6513
    ISSN (online) 1090-2414
    ISSN 0147-6513
    DOI 10.1016/j.ecoenv.2023.115355
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1418: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
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  6. Article ; Online: Cognitive impairment and type 2 diabetes mellitus: Focus of SGLT2 inhibitors treatment.

    Rizzo, Maria Rosaria / Di Meo, Irene / Polito, Rita / Auriemma, Maria Chiara / Gambardella, Antonio / di Mauro, Gabriella / Capuano, Annalisa / Paolisso, Giuseppe

    Pharmacological research

    2022  Volume 176, Page(s) 106062

    Abstract: Gliflozins are a novel class of oral anti-diabetic drugs, acting as inhibitors of sodium-glucose co-transporters (SGLTs) through the proximal convoluted tubules (PCT) and intestinal epithelium. The sodium-glucose co-transporters 2 (SGLT2) are mainly ... ...

    Abstract Gliflozins are a novel class of oral anti-diabetic drugs, acting as inhibitors of sodium-glucose co-transporters (SGLTs) through the proximal convoluted tubules (PCT) and intestinal epithelium. The sodium-glucose co-transporters 2 (SGLT2) are mainly expressed in S1 and S2 segments of the proximal convoluted tubule in the kidneys. Clinical guidelines recommend their use especially in Type 2 Diabetes mellitus (T2DM) patients with vascular complications and/or heart failure highlighting the importance of sodium-glucose co-transporter 2 inhibitors (SGLT2i) pleiotropic effects. Interestingly, cognitive decline is a widely recognized complication of T2DM and, in addition, to clarify its pathophysiology, there is an urgent need to understand how and if diabetes therapies can control diabetes-related cognitive dysfunction. At the time, although SGLT2 proteins are present in the Central Nervous System (CNS), the SGLT2i effects on cognitive impairments remain partly unknown. In pre-clinical studies, SGLT2i ameliorates cognitive dysfunction in obese and T2DM mice, reducing oxidative stress, neuroinflammation and improving neuronal plasticity and mitochondrial brain pathway. In addition, SGLT2i could bring back mTOR to a physiological state of activation, stopping neurodegenerative diseases' onset or progression. Instead, clinical studies on T2DM-related cognitive dysfunction treated by SGLT2i are much more limited. For these reasons, further studies are needed to better elucidate if SGLT2i therapy can affect T2DM-related cognitive decline. In this scenario, this review aims to summarize the state of knowledge on the role of SGLT2i in T2DM-related cognitive dysfunction and stimulate new clinical trials.
    MeSH term(s) Animals ; Brain/drug effects ; Brain/metabolism ; Cognitive Dysfunction/drug therapy ; Cognitive Dysfunction/etiology ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Humans ; Neuroprotective Agents/therapeutic use ; Sodium-Glucose Transporter 2/metabolism ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
    Chemical Substances Neuroprotective Agents ; Sodium-Glucose Transporter 2 ; Sodium-Glucose Transporter 2 Inhibitors
    Language English
    Publishing date 2022-01-10
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 1003347-6
    ISSN 1096-1186 ; 0031-6989 ; 1043-6618
    ISSN (online) 1096-1186
    ISSN 0031-6989 ; 1043-6618
    DOI 10.1016/j.phrs.2022.106062
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 721: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
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  7. Article ; Online: Author Correction: Periodontal evaluation of palatally impacted maxillary canines treated by closed approach with ultrasonic surgery and orthodontic treatment: a retrospective pilot study.

    Grenga, Camilla / Guarnieri, Rosanna / Grenga, Vittorio / Bovi, Mauro / Bertoldo, Serena / Galluccio, Gabriella / Di Giorgio, Roberto / Barbato, Ersilia

    Scientific reports

    2021  Volume 11, Issue 1, Page(s) 19866

    Language English
    Publishing date 2021-09-30
    Publishing country England
    Document type Published Erratum
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-021-99454-y
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  8. Article: European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events.

    di Mauro, Gabriella / Mascolo, Annamaria / Longo, Miriam / Maiorino, Maria Ida / Scappaticcio, Lorenzo / Bellastella, Giuseppe / Esposito, Katherine / Capuano, Annalisa

    Pharmaceuticals (Basel, Switzerland)

    2022  Volume 15, Issue 6

    Abstract: Few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European ... ...

    Abstract Few data have been published on the effects of impaired glucose metabolism induced by COVID-19 vaccines. We decided to perform a study to describe Individual Case Safety Reports (ICSRs) of impaired glucose metabolism events reported in the European database (Eudravigilance, EV). ICSRs were retrieved from the online website of Eudravigilance. The reporting odds ratios (ROR) were computed to assess the reporting frequency for COVID-19 mRNA vaccines compared to COVID-19 viral vector-based vaccines. A total of 3917 ICSRs with a COVID-19 vaccine suspected were retrieved, with a total of 4275 impaired glucose metabolism events. Overall, the most reported events were related to "high glucose levels" (2012; 47.06%). The mRNA vaccines were associated with an increased reporting frequency of "type 1 diabetes mellitus" (ROR 1.86; 95% CI 1.33-2.60), "type 2 diabetes mellitus" (ROR 1.58; 95% CI 1.03-2.42), "high glucose levels" (ROR 1.16; 95% CI 1.06-1.27), "diabetes mellitus inadequate control" (ROR 1.63; 95% CI 1.25-2.11), and "hypoglycemia" (ROR 1.62; 95% CI 1.41-1.86) compared to viral vector-based vaccines. mRNA COVID-19 vaccines were associated with an increased reporting frequency of alterations of glucose homeostasis compared to viral-vector COVID-19 vaccines. Clinicians should be aware of these events to better manage glycemic perturbations. Larger nationwide studies are warranted to verify these findings.
    Language English
    Publishing date 2022-05-27
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2193542-7
    ISSN 1424-8247
    ISSN 1424-8247
    DOI 10.3390/ph15060677
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  9. Article: The Reporting Frequency of Ketoacidosis Events with Dapagliflozin from the European Spontaneous Reporting System: The DAPA-KETO Study.

    di Mauro, Gabriella / Mascolo, Annamaria / Gaio, Mario / Rafaniello, Concetta / De Angelis, Antonella / Berrino, Liberato / Paolisso, Giuseppe / Rossi, Francesco / Capuano, Annalisa

    Pharmaceuticals (Basel, Switzerland)

    2022  Volume 15, Issue 3

    Abstract: Dapagliflozin was associated with an increased risk of diabetic ketoacidosis that has led to the European withdrawal of the authorization for the type 1 diabetes. However, it is still used for the treatment of type 2 diabetes. Therefore, we aim to ... ...

    Abstract Dapagliflozin was associated with an increased risk of diabetic ketoacidosis that has led to the European withdrawal of the authorization for the type 1 diabetes. However, it is still used for the treatment of type 2 diabetes. Therefore, we aim to evaluate the occurrence of dapagliflozin-induced ketoacidosis events by using the European spontaneous reporting system. The reporting odds ratios (ROR) were computed to assess the reporting frequency of ketoacidosis events for dapagliflozin compared to Dipeptidyl peptidase-4 (DPP-4) inhibitors, insulins, or all other Sodium-glucose cotransporter-2 (SGLT-2) inhibitors. A total of 2406 cases with dapagliflozin reported at least one event of ketoacidosis. The three most reported events were: diabetic ketoacidosis (1412; 55.39%), ketoacidosis (476; 18.67%), and euglycaemic diabetic ketoacidosis (296; 11.61%). Dapagliflozin was associated with the higher reporting frequency of ketoacidosis events compared to DPP-4 inhibitors (ROR 12.07, 95%CI 11.67-13.81) or insulins (ROR 7.59, 95%CI 7.13-7.89). A lower reporting frequency was instead observed compared to other SGLT2 inhibitors (ROR 0.91, 95%CI 0.87-0.96). Considering the higher reporting frequency of ketoacidosis observed with dapagliflozin then DPP-4 inhibitors or insulins, attention should be given to patients treated with this drug.
    Language English
    Publishing date 2022-02-25
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2193542-7
    ISSN 1424-8247
    ISSN 1424-8247
    DOI 10.3390/ph15030286
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  10. Article ; Online: Surveillance of adverse events following immunization related to human papillomavirus vaccines: 12 years of vaccinovigilance in Southern Italy.

    Scavone, Cristina / Di Mauro, Cristina / Brusco, Simona / Bertini, Michele / di Mauro, Gabriella / Rafaniello, Concetta / Sportiello, Liberata / Rossi, Francesco / Capuano, Annalisa

    Expert opinion on drug safety

    2019  Volume 18, Issue 5, Page(s) 427–433

    Abstract: ... ...

    Abstract Objectives
    MeSH term(s) Adolescent ; Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Child ; Female ; Humans ; Italy/epidemiology ; Male ; Papillomavirus Vaccines/administration & dosage ; Papillomavirus Vaccines/adverse effects ; Pharmacovigilance ; Vaccination/adverse effects ; Vaccination/methods
    Chemical Substances Papillomavirus Vaccines
    Language English
    Publishing date 2019-04-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 2088728-0
    ISSN 1744-764X ; 1474-0338
    ISSN (online) 1744-764X
    ISSN 1474-0338
    DOI 10.1080/14740338.2019.1598969
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 6096: Show issues Location:
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