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  1. Article: Response to: "Challenges in DPYD Test Implementation in Patients Treated with Fluoropyirimidines, is DPYD Genotype Arriving on Time?" [Response to Letter].

    Montrasio, Cristina / Cheli, Stefania / Clementi, Emilio

    Pharmacogenomics and personalized medicine

    2024  Volume 17, Page(s) 51–52

    Language English
    Publishing date 2024-01-30
    Publishing country New Zealand
    Document type Journal Article ; Comment
    ZDB-ID 2508173-1
    ISSN 1178-7066
    ISSN 1178-7066
    DOI 10.2147/PGPM.S456240
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Pharmacogenetic Practice of Anticancer Drugs: Multiple Approaches for an Accurate and Comprehensive Genotyping.

    Montrasio, Cristina / Cheli, Stefania / Clementi, Emilio

    Pharmacogenomics and personalized medicine

    2023  Volume 16, Page(s) 739–746

    Abstract: The application of pharmacogenetics in oncology is part of the routine clinical practice. In particular, genotyping of dihydropyrimidine dehydrogenase (DPYD) and UDP-glucuronosyltransferase (UGT1A1) is crucial to manage the treatment of patients taking ... ...

    Abstract The application of pharmacogenetics in oncology is part of the routine clinical practice. In particular, genotyping of dihydropyrimidine dehydrogenase (DPYD) and UDP-glucuronosyltransferase (UGT1A1) is crucial to manage the treatment of patients taking fluoropyrimidines and irinotecan. The unique approach of our laboratory to the pharmacogenetic diagnostic service in oncology is to combine two real-time PCR methods, LightSNiP assay (TIB MOLBIOL), and more recently FRET (Fluorescent Resonance Energy Transfer) probes technology (Nuclear Laser Medicine), plus TaqMan assay (Thermo Fisher) for the confirmation of the presence of variant alleles on DNA from a second extraction. We found that both the FRET and LightSNiP assays, where detection occurs by melting curve analysis, offer an advantage over the competing TaqMan technology. Whereas unexpected genetic variants may be missed using a mutation-specific TaqMan assay, the information thus obtained can be useful to adjust the therapy in case of unexpected post-treatment toxicity. The combination of TaqMan and FRET assays helped us to achieve more accurate genotyping and a correct result for the patient. The added value of the DPYD FRET assay is the possibility of detecting, with the same amplification profile of the polymorphisms detailed in the guidelines, also the c.2194G>A (*6 rs1801160), cited in the recommendations as a variant to be investigated in case of severe toxicity. Regarding the UGT1A1 (TA)n promoter polymorphism (rs3064744), the distinctive and positive feature of the FRET assay is to allow clearly identifying all those potential variant alleles, including the (TA)5 and (TA)8 alleles, that are frequent in African Americans. Our clinical practice emphasizes the importance of not only rapid and easy-to-use assays, such as the new FRET ones, but also of accurate and comprehensive genotyping for good pharmacogenetic diagnostic activity.
    Language English
    Publishing date 2023-07-27
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2508173-1
    ISSN 1178-7066
    ISSN 1178-7066
    DOI 10.2147/PGPM.S412430
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System.

    Battini, Vera / Carnovale, Carla / Clementi, Emilio / Sessa, Maurizio

    Expert opinion on drug safety

    2023  Volume 22, Issue 11, Page(s) 1105–1112

    Abstract: Background: In this study, we fill this gap in knowledge by updating the safety profile of ubrogepant and rimegepant via disproportionality analysis in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), a US-based database ... ...

    Abstract Background: In this study, we fill this gap in knowledge by updating the safety profile of ubrogepant and rimegepant via disproportionality analysis in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), a US-based database registering spontaneous reports.
    Research design and methods: ASCII files of quarterly extraction of FAERS data were downloaded from the FDA website up to the 3
    Results: In total, 2010 and 3691 individual case safety reports (ICSRs) recorded in FAERS reported ubrogepant and rimegepant, respectively, as suspect drugs. Ten disproportionality signals for ubrogepant and 25 disproportionality signals for rimegepant were identified; these were mostly related to psychiatric, neurological, gastrointestinal, skin, vascular, and infectious type of adverse events.
    Conclusions: New safety aspects related to the treatment of ubrogepant and rimegepant using disproportionality analysis from spontaneous reporting databases were identified. Further studies are needed to confirm these findings.
    MeSH term(s) United States ; Humans ; Adverse Drug Reaction Reporting Systems ; United States Food and Drug Administration ; Piperidines ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/etiology ; Pharmacovigilance
    Chemical Substances rimegepant sulfate (1383NM3Q0H) ; ubrogepant (AD0O8X2QJR) ; Piperidines
    Language English
    Publishing date 2023-06-12
    Publishing country England
    Document type Journal Article
    ZDB-ID 2088728-0
    ISSN 1744-764X ; 1474-0338
    ISSN (online) 1744-764X
    ISSN 1474-0338
    DOI 10.1080/14740338.2023.2223958
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Comparing major and mild cognitive impairment risks in older type-2 diabetic patients: a Danish register-based study on dipeptidyl peptidase-4 inhibitors vs. glucagon-like peptide-1 analogues.

    Battini, Vera / Barbieri, Maria Antonietta / Carnovale, Carla / Spina, Edoardo / Clementi, Emilio / Sessa, Maurizio

    Journal of neurology

    2024  

    Abstract: Introduction: The prevalence of major and mild cognitive impairment (CI) in type-2 diabetes older patients is 15-25% and 30-60%, respectively, thus affecting quality of life and health outcomes. There is, therefore, the need of head-to-head studies ... ...

    Abstract Introduction: The prevalence of major and mild cognitive impairment (CI) in type-2 diabetes older patients is 15-25% and 30-60%, respectively, thus affecting quality of life and health outcomes. There is, therefore, the need of head-to-head studies aiming at identifying the optimal treatment for individuals with type-2 diabetes at increased risk of mild and major CI. This study focuses on the risk of developing mild and major CI in Danish patients treated with dipeptidyl peptidase-4 inhibitors (DPP-4i) and glucagon-like peptide-1 analogues (GLP-1a) using administrative and healthcare registers.
    Methods: An active comparator design with a 3-year follow-up period was used. The main outcome was the hospital admission with a diagnosis of mild CI or major CI. Multivariate Cox Regression analysis was performed using the high-dimensional propensity score to obtain adjusted Hazard Ratio (HR) estimates. Inverse probability of treatment weighting (IPTW) and marginal structured model were used to calculate risk differences while accounting for the variations of confounders throughout the follow-up period.
    Results: Our results show a significant higher risk of major CI between DPP-4i and GLP-1a in unadjusted [HR (95% CI) = 3.13 (2.45-4.00), p < 0.001] and adjusted analyses [HR (95% CI) = 1.58 (1.22-2.06), p = 0.001]. No statistically significant differences were observed for mild CI. IPTW resulted stable throughout the follow-up period. Marginal structure modeling (β (95% CI) = 0.022 (0.020-0.024), p < 0.001) resulted in a higher risk of major CI for DPP-4i when compared to GLP-1a.
    Discussion: DPP-4i was associated with an increased risk of developing major CI when compared to GLP-1a among older individuals with type-2 diabetes.
    Language English
    Publishing date 2024-03-22
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 187050-6
    ISSN 1432-1459 ; 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    ISSN (online) 1432-1459
    ISSN 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    DOI 10.1007/s00415-024-12300-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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  5. Article ; Online: Exploring the impact of co-exposure timing on drug-drug interactions in signal detection through spontaneous reporting system databases: a scoping review.

    Cocco, Marianna / Carnovale, Carla / Clementi, Emilio / Barbieri, Maria Antonietta / Battini, Vera / Sessa, Maurizio

    Expert review of clinical pharmacology

    2024  , Page(s) 1–13

    Abstract: Introduction: Drug-drug interactions (DDIs) are defined as the pharmacological effects produced by the concomitant administration of two or more drugs. To minimize false positive signals and ensure their validity when analyzing Spontaneous Reporting ... ...

    Abstract Introduction: Drug-drug interactions (DDIs) are defined as the pharmacological effects produced by the concomitant administration of two or more drugs. To minimize false positive signals and ensure their validity when analyzing Spontaneous Reporting System (SRS) databases, it has been suggested to incorporate key pharmacological principles, such as temporal plausibility.
    Areas covered: The scoping review of the literature was completed using MEDLINE from inception to March 2023. Included studies had to provide detailed methods for identifying DDIs in SRS databases. Any methodological approach and adverse event were accepted. Descriptive analyzes were excluded as we focused on automatic signal detection methods. The result is an overview of all the available methods for DDI signal detection in SRS databases, with a specific focus on the evaluation of the co-exposure time of the interacting drugs. It is worth noting that only a limited number of studies (
    Expert opinion: Current guidelines for signal validation focus on factors like the number of reports and temporal association, but they lack guidance on addressing overlapping drug administration times, highlighting a need for further research and method development.
    Language English
    Publishing date 2024-04-18
    Publishing country England
    Document type Journal Article ; Review
    ISSN 1751-2441
    ISSN (online) 1751-2441
    DOI 10.1080/17512433.2024.2343875
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. 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
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  7. 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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  8. Article: Updated Considerations for the Immunopharmacological Aspects of the "Talented mRNA Vaccines".

    Perrotta, Cristiana / Fenizia, Claudio / Carnovale, Carla / Pozzi, Marco / Trabattoni, Daria / Cervia, Davide / Clementi, Emilio

    Vaccines

    2023  Volume 11, Issue 9

    Abstract: Messenger RNA (mRNA) vaccines belong to a new class of medications, RNA therapeutics, including both coding and non-coding RNAs. The use of mRNA as a therapy is based on the biological role of mRNA itself, namely its translation into a functional protein. ...

    Abstract Messenger RNA (mRNA) vaccines belong to a new class of medications, RNA therapeutics, including both coding and non-coding RNAs. The use of mRNA as a therapy is based on the biological role of mRNA itself, namely its translation into a functional protein. The goal of mRNA vaccines is to produce a specific antigen in cells to elicit an immune response that might be prophylactic or therapeutic. The potential of mRNA as vaccine has been envisaged for years but its efficacy has been clearly demonstrated with the approval of COVID-19 vaccines in 2021. Since then, mRNA vaccines have been in the pipeline for diseases that are still untreatable. There are many advantages of mRNA vaccines over traditional vaccines, including easy and cost-effective production, high safety, and high-level antigen expression. However, the nature of mRNA itself and some technical issues pose challenges associated with the vaccines' development and use. Here we review the immunological and pharmacological features of mRNA vaccines by discussing their pharmacokinetics, mechanisms of action, and safety, with a particular attention on the advantages and challenges related to their administration. Furthermore, we present an overview of the areas of application and the clinical trials that utilize a mRNA vaccine as a treatment.
    Language English
    Publishing date 2023-09-12
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2703319-3
    ISSN 2076-393X
    ISSN 2076-393X
    DOI 10.3390/vaccines11091481
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Therapeutic Drug Monitoring of Anti-TNFα Inhibitors: A Matter of Cut-Off Ranges.

    Cheli, Stefania / Savino, Diego / Penagini, Francesca / Zuccotti, Gianvincenzo / Zuin, Giovanna / Clementi, Emilio / Cattaneo, Dario

    Pharmaceutics

    2023  Volume 15, Issue 7

    Abstract: Therapeutic drug monitoring (TDM) is a useful tool for optimising the use of anti-TNFα inhibitors in patients with inflammatory bowel diseases (IBDs). Recently, point-of-care methods for the quantification of drug levels and anti-drug antibodies (ADAs) ... ...

    Abstract Therapeutic drug monitoring (TDM) is a useful tool for optimising the use of anti-TNFα inhibitors in patients with inflammatory bowel diseases (IBDs). Recently, point-of-care methods for the quantification of drug levels and anti-drug antibodies (ADAs) have been developed to overcome the limitations of conventional enzyme-linked immunoabsorbent assays (ELISAs). Here, we evaluated the performance, interchangeability, and agreement between an automated ELISA-based immunoassay (CHORUS Promonitor) and the lateral flow assay (RIDA
    Language English
    Publishing date 2023-06-27
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2527217-2
    ISSN 1999-4923
    ISSN 1999-4923
    DOI 10.3390/pharmaceutics15071834
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  10. Article ; Online: Cryopreserved placental biopsies maintain mitochondrial activity for high-resolution respirometry.

    Giovarelli, Matteo / Serati, Anais / Zecchini, Silvia / Guelfi, Fabiola / Clementi, Emilio / Mandò, Chiara

    Molecular medicine (Cambridge, Mass.)

    2023  Volume 29, Issue 1, Page(s) 45

    Abstract: Background: High-resolution respirometry (HRR) of human biopsies can provide useful metabolic, diagnostic, and mechanistic insights for clinical research and comparative medical studies. Fresh tissues analysis offers the potential best condition, the ... ...

    Abstract Background: High-resolution respirometry (HRR) of human biopsies can provide useful metabolic, diagnostic, and mechanistic insights for clinical research and comparative medical studies. Fresh tissues analysis offers the potential best condition, the drawback being the need to use them shortly after dissection for mitochondrial respiratory experiments. The development of effective long-term storage protocols for biopsies that allow the assessment of key Electron Transport System (ETS) parameters at later stages is thus a major need.
    Methods: We optimised a cryopreservation protocol that preserves mitochondrial membranes intactness, otherwise affected by direct tissue freezing. The protocol is based on a gradual freezing step from on-ice to liquid nitrogen and - 80 °C storage using a specific DMSO-based buffer.
    Results: Placenta is a suitable tissue to design and test the effectiveness of long-term storage protocols being metabolically active foetal tissue with mitochondrial dysfunctions contributing to placental disease and gestational disorders. Here we designed and tested the effectiveness of the cryopreservation protocol using human placenta biopsies; we measured the ETS activity by HRR of placenta specimens comparing fresh, cryopreserved, and snap frozen conditions.
    Conclusions: By this protocol, Oxygen Consumption Rate (OCR) measurements of fresh and cryopreserved placental specimens are comparable whereas snap frozen procedure impairs mitochondrial activity.
    MeSH term(s) Female ; Humans ; Pregnancy ; Placenta/metabolism ; Cryopreservation/methods ; Mitochondria/metabolism ; Biopsy ; Freezing
    Language English
    Publishing date 2023-04-03
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1283676-x
    ISSN 1528-3658 ; 1076-1551
    ISSN (online) 1528-3658
    ISSN 1076-1551
    DOI 10.1186/s10020-023-00645-2
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