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  1. Article: Sex and gender differences and pharmacovigilance: a knot still to be untied.

    Sportiello, Liberata / Capuano, Annalisa

    Frontiers in pharmacology

    2024  Volume 15, Page(s) 1397291

    Language English
    Publishing date 2024-04-17
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2024.1397291
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: It is the time to change the paradigms of pregnant and breastfeeding women in clinical research!

    Sportiello, Liberata / Capuano, Annalisa

    Frontiers in pharmacology

    2023  Volume 14, Page(s) 1113557

    Language English
    Publishing date 2023-02-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2587355-6
    ISSN 1663-9812
    ISSN 1663-9812
    DOI 10.3389/fphar.2023.1113557
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Editorial: Clinical prospective of SGLT2 inhibitors in atherosclerosis.

    Capuano, Annalisa / Clementi, Emilio / Paolisso, Giuseppe

    Frontiers in cardiovascular medicine

    2022  Volume 9, Page(s) 1040649

    Language English
    Publishing date 2022-11-11
    Publishing country Switzerland
    Document type Editorial
    ZDB-ID 2781496-8
    ISSN 2297-055X
    ISSN 2297-055X
    DOI 10.3389/fcvm.2022.1040649
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Editorial: Metabolic Related Cardiomyopathy in Hyperglycemic Patients.

    Capuano, Annalisa / Clementi, Emilio / Paolisso, Giuseppe

    Frontiers in cardiovascular medicine

    2022  Volume 8, Page(s) 826914

    Language English
    Publishing date 2022-01-13
    Publishing country Switzerland
    Document type Editorial
    ZDB-ID 2781496-8
    ISSN 2297-055X
    ISSN 2297-055X
    DOI 10.3389/fcvm.2021.826914
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: The Safety Profiles of Two First-Generation NTRK Inhibitors: Analysis of Individual Case Safety Reports from the FDA Adverse Event Reporting System (FAERS) Database.

    Liguori, Valerio / Gaio, Mario / Zinzi, Alessia / Cagnotta, Cecilia / Riccardi, Consiglia / Docimo, Giovanni / Capuano, Annalisa

    Biomedicines

    2023  Volume 11, Issue 9

    Abstract: The first-generation tropomyosin receptor kinase (TRK) inhibitors, larotrectinib and entrectinib, represent exciting new developments in cancer treatment that offer relevant, rapid, and long-lasting clinical benefits. Larotrectinib and entrectinib are ... ...

    Abstract The first-generation tropomyosin receptor kinase (TRK) inhibitors, larotrectinib and entrectinib, represent exciting new developments in cancer treatment that offer relevant, rapid, and long-lasting clinical benefits. Larotrectinib and entrectinib are recommended as first-line treatments for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive TRK gene fusions. In this study, using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database between 2019 and 2022, a retrospective analysis was conducted to evaluate the safety profiles of these drugs. During our study period, 807 individual case safety reports (ICSRs) related to larotrectinib or entrectinib were retrieved from the FAERS database, of which 48.7% referred to females and 24.7% referred to adult patients (18-64 years) with a median age of 61.0 years. A total of 1728 adverse drug reactions (ADRs) were identified. The most frequently reported ADRs were dizziness and pain, which belong to the System Organ Classes (SOCs) "nervous system disorders" and "general disorders and administration site conditions". Regarding all ADRs, the median time to onset was 37.0 days for larotrectinib and 12.0 days for entrectinib. No evident safety concerns emerged in the long-term safety profiles (>365 days). Only 18 ICSRs were related to pediatric populations (≤16 years), of which 94.0% of the ICSRs were related to larotrectinib. The median age was 10.5 years, while most patients were female (44.4%). Our results show favorable risk-benefit profiles for larotrectinib and entrectinib. Considering the increased use of neurotrophic tyrosine receptor kinase (NTRK) inhibitors, continuous safety monitoring of larotrectinib and entrectinib is required for the detection of possible new adverse drug reactions.
    Language English
    Publishing date 2023-09-15
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2720867-9
    ISSN 2227-9059
    ISSN 2227-9059
    DOI 10.3390/biomedicines11092538
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Vaccine Hesitancy Among Religious Groups: Reasons Underlying This Phenomenon and Communication Strategies to Rebuild Trust.

    Kibongani Volet, Annie / Scavone, Cristina / Catalán-Matamoros, Daniel / Capuano, Annalisa

    Frontiers in public health

    2022  Volume 10, Page(s) 824560

    MeSH term(s) Communication ; Trust ; Vaccination ; Vaccination Hesitancy ; Vaccines
    Chemical Substances Vaccines
    Language English
    Publishing date 2022-02-07
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2711781-9
    ISSN 2296-2565 ; 2296-2565
    ISSN (online) 2296-2565
    ISSN 2296-2565
    DOI 10.3389/fpubh.2022.824560
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Glucagon-like Peptide-1 Receptor Agonists and Suicidal Ideation: Analysis of Real-Word Data Collected in the European Pharmacovigilance Database.

    Ruggiero, Rosanna / Mascolo, Annamaria / Spezzaferri, Angela / Carpentieri, Claudia / Torella, Daniele / Sportiello, Liberata / Rossi, Francesco / Paolisso, Giuseppe / Capuano, Annalisa

    Pharmaceuticals (Basel, Switzerland)

    2024  Volume 17, Issue 2

    Abstract: Background: A potential risk of suicide associated with liraglutide or semaglutide treatments has recently emerged. Therefore, we decided to investigate the reporting probability of suicidal events among glucagon-like peptide-1 receptor agonists (GLP-1 ... ...

    Abstract Background: A potential risk of suicide associated with liraglutide or semaglutide treatments has recently emerged. Therefore, we decided to investigate the reporting probability of suicidal events among glucagon-like peptide-1 receptor agonists (GLP-1 RAs).
    Methods: A retrospective pharmacovigilance study of the European Pharmacovigilance database was conducted for the period from 1 January 2018 to 10 July 2023. Disproportionality analyses (reporting odds ratio, ROR) were performed to assess the reporting probability of suicidal events among GLP-1 RAs.
    Results: A total of 230 reports of suicidal events were identified. The most reported GLP-1 RA was liraglutide (38.3%), followed by semaglutide (36.5%) and dulaglutide (16.1%). The most reported events were suicidal ideation (65.3%) and suicide attempt (19.5%). Disproportionality analysis found a higher reporting probability of suicidal events for semaglutide than dulaglutide (ROR, 2.05; 95%CI, 1.40-3.01) and exenatide (ROR, 1.81; 95%CI, 1.08-3.05). In the same way, liraglutide was associated with a higher reporting probability of suicidal events than dulaglutide (ROR, 3.98; 95%CI, 2.73-5.82) and exenatide (ROR, 3.52; 95%CI, 2.10-5.92). On the contrary, a lower reporting probability was found for semaglutide than liraglutide (ROR, 0.51; 95%CI, 0.38-0.69).
    Conclusions: Suicidal events were mostly reported with semaglutide and liraglutide, which were also associated with significantly higher reporting probabilities compared to other GLP1 RAs. Although this study provides the reporting frequencies of suicide-related events with GLP-1 RAs, establishing causality requires further investigation, which will probably be addressed by the Pharmacovigilance Risk Assessment Committee of the European Medicine Agency in the future.
    Language English
    Publishing date 2024-01-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2193542-7
    ISSN 1424-8247
    ISSN 1424-8247
    DOI 10.3390/ph17020147
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Two years with GIOIA 'Effects of gliflozins and gliptins on markers of cardiovascular damage in type 2 diabetes': A prospective, multicentre, quasi-experimental study on sodium-glucose cotransporter 2 and dipeptidyl peptidase-4 inhibitors in diabetes clinical practice.

    Longo, Miriam / Caruso, Paola / Scappaticcio, Lorenzo / Maiorino, Maria Ida / Bellastella, Giuseppe / Capuano, Annalisa / Esposito, Katherine / Giugliano, Dario

    Diabetes, obesity & metabolism

    2024  Volume 26, Issue 4, Page(s) 1492–1501

    Abstract: Aim: To assess and compare the metabolic and vascular effectiveness of sodium-glucose cotransporter 2 inhibitors (SGLT-2i) and dipeptidyl peptidase-4 inhibitors (DPP-4i) in the clinical practice of patients with type 2 diabetes in Italy.: Materials ... ...

    Abstract Aim: To assess and compare the metabolic and vascular effectiveness of sodium-glucose cotransporter 2 inhibitors (SGLT-2i) and dipeptidyl peptidase-4 inhibitors (DPP-4i) in the clinical practice of patients with type 2 diabetes in Italy.
    Materials and methods: GIOIA is a 2-year prospective, multicentre, quasi-experimental study that enrolled patients with type 2 diabetes initiating SGLT-2i or DPP-4i for inadequate glycaemic control [glycated haemoglobin (HbA1c) >7%] between March 2018 and March 2021. The primary endpoints were changes in markers of organ damage [carotid intima-media thickness (CIMT), albuminuria, myocardial function] and HbA1c from baseline to year 2.
    Results: In total, 1150 patients were enrolled in the study (SGLT-2i n = 580, DPP-4i n = 570). Patients initiated on SGLT-2i were younger (about 6 years) and heavier (about 11 kg), had higher HbA1c level (1% more), more albuminuria and cardiovascular events (16% more) than patients initiated on DPP-4i. CIMT and echocardiographic parameters were not significantly different. Propensity score matching yielded two groups, each consisting of 155 patients with diabetes with similar baseline characteristics. Despite a significant similar reduction in HbA1c levels in both groups (-0.8%), more patients on SGLT-2i had regression of CIMT and albuminuria (22% and 10%, respectively, p < .001 vs. DPP-4i); more patients on DPP-4i had progression of CIMT and albuminuria (23% and 28%, respectively, p < .001 vs. SGLT-2i). Left ventricular ejection fraction improved slightly (3%, p = .043) on SGLT-2i only.
    Conclusions: In a real-world setting, both SGLT-2i and DPP-4i improve glycaemic control persisting after 2 years of treatment, with a robust effect on both CIMT and albuminuria regression for SGLT-2i as compared with DPP-4i in the propensity score matching.
    MeSH term(s) Humans ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/chemically induced ; Dipeptidyl-Peptidase IV Inhibitors/adverse effects ; Sodium-Glucose Transporter 2 Inhibitors/adverse effects ; Hypoglycemic Agents/therapeutic use ; Glycated Hemoglobin ; Prospective Studies ; Albuminuria/epidemiology ; Albuminuria/etiology ; Carotid Intima-Media Thickness ; Stroke Volume ; Ventricular Function, Left ; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases/therapeutic use ; Glucose/therapeutic use ; Sodium
    Chemical Substances Dipeptidyl-Peptidase IV Inhibitors ; Sodium-Glucose Transporter 2 Inhibitors ; Hypoglycemic Agents ; Glycated Hemoglobin ; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases (EC 3.4.14.-) ; Glucose (IY9XDZ35W2) ; Sodium (9NEZ333N27)
    Language English
    Publishing date 2024-01-17
    Publishing country England
    Document type Multicenter Study ; Journal Article
    ZDB-ID 1454944-x
    ISSN 1463-1326 ; 1462-8902
    ISSN (online) 1463-1326
    ISSN 1462-8902
    DOI 10.1111/dom.15451
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5442: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
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  9. Article: Cost-Effectiveness of Treatment Optimisation with Biomarkers for Immunotherapy in Solid Tumours: A Systematic Review.

    Mucherino, Sara / Lorenzoni, Valentina / Triulzi, Isotta / Del Re, Marzia / Orlando, Valentina / Capuano, Annalisa / Danesi, Romano / Turchetti, Giuseppe / Menditto, Enrica

    Cancers

    2024  Volume 16, Issue 5

    Abstract: This study investigated the health economic evaluations of predictive biomarker testing in solid tumours treated with immune checkpoint inhibitors (ICIs). Searching PubMed, EMBASE, and Web of Science from June 2010 to February 2022, 58 relevant articles ... ...

    Abstract This study investigated the health economic evaluations of predictive biomarker testing in solid tumours treated with immune checkpoint inhibitors (ICIs). Searching PubMed, EMBASE, and Web of Science from June 2010 to February 2022, 58 relevant articles were reviewed out of the 730 screened. The focus was predominantly on non-small cell lung cancer (NSCLC) (65%) and other solid tumours (40%). Among the NSCLC studies, 21 out of 35 demonstrated cost-effectiveness, notably for pembrolizumab as first-line treatment when preceded by PD-L1 assessment, cost-effective at a threshold of $100,000/QALY compared to the standard of care. However, for bladder, cervical, and triple-negative breast cancers (TNBCs), no economic evaluations met the affordability threshold of $100,000/QALY. Overall, the review highlights a certain degree of uncertainty about the cost-effectiveness of ICI. In particular, we found PD-L1 expression associated with ICI treatment to be a cost-effective strategy, particularly in NSCLC, urothelial, and renal cell carcinoma. The findings suggest the potential value of predictive biomarker testing, specifically with pembrolizumab in NSCLC, while indicating challenges in achieving cost-effectiveness for certain other solid tumours.
    Language English
    Publishing date 2024-02-29
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers16050995
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. 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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