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  1. Article ; Online: CYP3A4*22

    Skryabin, Valentin Yurievich / Franck, Johan / Lauschke, Volker Martin / Zastrozhin, Mikhail Sergeevich / Shipitsyn, Valery Valerievich / Bryun, Evgeny Alekseevich / Sychev, Dmitry Alekseevich

    Nordic journal of psychiatry

    2022  , Page(s) 1–4

    Abstract: Background: Diazepam is one of the most commonly prescribed pharmaceuticals for the treatment of alcohol withdrawal syndrome (AWS). However, diazepam sometimes is ineffective, and some patients experience dose-dependent adverse drug reactions (ADR). ... ...

    Abstract Background: Diazepam is one of the most commonly prescribed pharmaceuticals for the treatment of alcohol withdrawal syndrome (AWS). However, diazepam sometimes is ineffective, and some patients experience dose-dependent adverse drug reactions (ADR). Previous studies have shown that diazepam metabolism involves the CYP3A4 and CYP3A5 isoenzymes, whose activity is highly variable between individuals, which may contribute to differences in clinical response.
    Purpose: The study aimed to investigate the effects of the genetic polymorphisms
    Materials and methods: One hundred male AWS patients received 30 mg/day diazepam by intramuscular injections for 5 days. Genotyping for
    Results: Patients who carry
    Conclusion: These results suggest that genotyping for common CYP3A variants might have the potential to guide benzodiazepine withdrawal treatment.
    Language English
    Publishing date 2022-04-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 1104974-1
    ISSN 1502-4725 ; 0803-9488 ; 0029-1455
    ISSN (online) 1502-4725
    ISSN 0803-9488 ; 0029-1455
    DOI 10.1080/08039488.2022.2065531
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Pharmacogenomics of statins: lipid response and other outcomes in Brazilian cohorts.

    Dagli-Hernandez, Carolina / Zhou, Yitian / Lauschke, Volker Martin / Genvigir, Fabiana Dalla Vecchia / Hirata, Thiago Dominguez Crespo / Hirata, Mario Hiroyuki / Hirata, Rosario Dominguez Crespo

    Pharmacological reports : PR

    2021  Volume 74, Issue 1, Page(s) 47–66

    Abstract: Statins are inhibitors of 3-hydroxy-3-methylglutaryl-CoA reductase, a key enzyme in cholesterol biosynthesis, that are highly effective in reducing plasma low-density lipoprotein (LDL) cholesterol and decreasing the risk of cardiovascular events. In ... ...

    Abstract Statins are inhibitors of 3-hydroxy-3-methylglutaryl-CoA reductase, a key enzyme in cholesterol biosynthesis, that are highly effective in reducing plasma low-density lipoprotein (LDL) cholesterol and decreasing the risk of cardiovascular events. In recent years, a multitude of variants in genes involved in pharmacokinetics (PK) and pharmacodynamics (PD) have been suggested to influence the cholesterol-lowering response. However, the vast majority of studies have analyzed the pharmacogenetic associations in populations in Europe and the USA, whereas data in other populations, including Brazil, are mostly lacking. This narrative review provides an update of clinical studies on statin pharmacogenomics in Brazilian cohorts exploring lipid-lowering response, adverse events and pleiotropic effects. We find that variants in drug transporter genes (SLCO1B1 and ABCB1) positively impacted atorvastatin and simvastatin response, whereas variants in genes of drug metabolizing enzymes (CYP3A5) decreased response. Furthermore, multiple associations of variants in PD genes (HMGCR, LDLR and APOB) with statin response were identified. Few studies have explored statin-related adverse events, and only ABCB1 but not SLCO1B1 variants were robustly associated with increased risk in Brazil. Statin-related pleiotropic effects were shown to be influenced by variants in PD (LDLR, NR1H2) and antioxidant enzyme (NOS3, SOD2, MTHFR, SELENOP) genes. The findings of these studies indicate that statin pharmacogenomic associations are distinctly different in Brazil compared to other populations. This review also discusses the clinical implications of pharmacogenetic studies and the rising importance of investigating rare variants to explore their association with statin response.
    MeSH term(s) Brazil ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/classification ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology ; Lipid Metabolism Disorders/drug therapy ; Lipid Metabolism Disorders/ethnology ; Lipid Metabolism Disorders/genetics ; Pharmacogenetics ; Pharmacogenomic Variants
    Chemical Substances Hydroxymethylglutaryl-CoA Reductase Inhibitors
    Language English
    Publishing date 2021-08-17
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2186248-5
    ISSN 1734-1140
    ISSN 1734-1140
    DOI 10.1007/s43440-021-00319-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Cardiovascular Pharmacogenomics: An Update on Clinical Studies of Antithrombotic Drugs in Brazilian Patients.

    Hirata, Thiago Dominguez Crespo / Dagli-Hernandez, Carolina / Genvigir, Fabiana Dalla Vecchia / Lauschke, Volker Martin / Zhou, Yitian / Hirata, Mario Hiroyuki / Hirata, Rosario Dominguez Crespo

    Molecular diagnosis & therapy

    2021  Volume 25, Issue 6, Page(s) 735–755

    Abstract: Anticoagulant and antiplatelet drugs effectively prevent thrombotic events in patients with cardiovascular diseases, ischemic stroke, peripheral vascular diseases, and other thromboembolic diseases. However, genetic and non-genetic factors affect the ... ...

    Abstract Anticoagulant and antiplatelet drugs effectively prevent thrombotic events in patients with cardiovascular diseases, ischemic stroke, peripheral vascular diseases, and other thromboembolic diseases. However, genetic and non-genetic factors affect the response to antithrombotic therapy and can increase the risk of adverse events. This narrative review discusses pharmacogenomic studies on antithrombotic drugs commonly prescribed in Brazil. Multiple Brazilian studies assessed the impact of pharmacokinetic (PK) and pharmacodynamic (PD) gene variants on warfarin response. The reduced function alleles CYP2C9*2 and CYP2C9*3, and VKORC1 rs9923231 (c.-1639G>A) are associated with increased sensitivity to warfarin and a low dose requirement to prevent bleeding episodes, whereas CYP4F2 rs2108622 (p.Val433Met) carriers have higher dose requirements (warfarin resistance). These deleterious variants and non-genetic factors (age, gender, body weight, co-administered drugs, food interactions, and others) account for up to 63% of the warfarin dose variability. Few pharmacogenomics studies have explored antiplatelet drugs in Brazilian cohorts, finding associations between CYP2C19*2, PON1 rs662 and ABCC3 rs757421 genotypes and platelet responsiveness or clopidogrel PK in subjects with coronary artery disease (CAD) or acute coronary syndrome (ACS), whereas ITGB3 contributes to aspirin PK but not platelet responsiveness in diabetic patients. Brazilian guidelines on anticoagulants and antiplatelets recommend the use of a platelet aggregation test or genotyping only in selected cases of ACS subjects without ST-segment elevation taking clopidogrel, and also suggest CYP2C9 and VKORC1 genotyping before starting warfarin therapy to assess the risk of bleeding episodes or warfarin resistance.
    MeSH term(s) Anticoagulants/adverse effects ; Aryldialkylphosphatase/genetics ; Brazil ; Clopidogrel ; Cytochrome P-450 CYP2C9/genetics ; Fibrinolytic Agents ; Genotype ; Humans ; Metabolism, Inborn Errors ; Pharmacogenetics ; Platelet Aggregation Inhibitors/adverse effects ; Vitamin K Epoxide Reductases/genetics ; Warfarin/adverse effects
    Chemical Substances Anticoagulants ; Fibrinolytic Agents ; Platelet Aggregation Inhibitors ; Warfarin (5Q7ZVV76EI) ; Clopidogrel (A74586SNO7) ; Cytochrome P-450 CYP2C9 (EC 1.14.13.-) ; VKORC1 protein, human (EC 1.17.4.4) ; Vitamin K Epoxide Reductases (EC 1.17.4.4) ; Aryldialkylphosphatase (EC 3.1.8.1) ; PON1 protein, human (EC 3.1.8.1)
    Language English
    Publishing date 2021-08-06
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 2232796-4
    ISSN 1179-2000 ; 1177-1062
    ISSN (online) 1179-2000
    ISSN 1177-1062
    DOI 10.1007/s40291-021-00549-z
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  4. Article ; Online: Immunogenicity after 6 months of BNT162b2 vaccination in frail or disabled nursing home residents: The COVID-A Study.

    Salmerón Ríos, Sergio / Cortés Zamora, Elisa Belén / Avendaño Céspedes, Almudena / Romero Rizos, Luis / Sánchez-Jurado, Pedro Manuel / Sánchez-Nievas, Ginés / Mas Romero, Marta / Tabernero Sahuquillo, María Teresa / Blas Señalada, José Joaquín / Murillo Romero, Antonio / García Nogueras, Inmaculada / Estrella Cazalla, Juan de Dios / Andrés-Pretel, Fernando / Lauschke, Volker Martin / Stebbing, Justin / Abizanda, Pedro

    Journal of the American Geriatrics Society

    2021  Volume 70, Issue 3, Page(s) 650–658

    Abstract: Background: There is incomplete information regarding evolution of antibody titers against SARS-CoV-2 after a two-dose strategy vaccination with BNT162b2 in older adults in long-term care facilities (LTCFs) with frailty, disability, or cognitive ... ...

    Abstract Background: There is incomplete information regarding evolution of antibody titers against SARS-CoV-2 after a two-dose strategy vaccination with BNT162b2 in older adults in long-term care facilities (LTCFs) with frailty, disability, or cognitive impairment. We aimed to determine IgG antibody titer loss in older adults in LTCFs.
    Methods: This is a multicenter longitudinal cohort study including 127 residents (90 females and 37 males) with a mean age of 82.7 years (range 65-99) with different frailty and disability profiles in two LTCFs in Albacete, Spain. Residents received two doses of BNT162b2 as per label, and antibody levels were determined 1 and 6 months after the second dose. Age, sex, previous history of coronavirus disease 2019 (COVID-19), comorbidity (Charlson Index), performance in activities of daily living (Barthel Index), frailty (FRAIL instrument), and cognitive status were assessed.
    Results: The mean antibody titers 1 and 6 months after the second vaccine dose were 32,145 AU/ml (SD 41,206) and 6182 AU/ml (SD 13,316), respectively. Across all participants, the median antibody titer loss measured 77.6% (interquartile range [IQR] 23.8%). Notably, the decline of titers in individuals with pre-vaccination COVID-19 infection was significantly lower than in those without a history of SARS-CoV-2 infection (72.2% vs. 85.3%; p < 0.001). The median titer decrease per follow-up day was 0.47% (IQR 0.14%) and only pre-vaccination COVID-19 was associated with lower rate of antibody decline at 6 months (hazard ratio 0.17; 95% confidence interval 0.07-0.41; p < 0.001). Frailty, disability, older age, cognitive impairment, or comorbidity were not associated with the extent of antibody loss.
    Conclusions: Older adults in LTCFs experience a rapid loss of antibodies over the first 6 months after the second dose of BNT162b2 vaccine. Only pre-vaccination COVID-19 is associated with a slower rate of antibody decrease. Our data support immunization with a third dose in this vulnerable, high-risk population.
    MeSH term(s) Aged ; Aged, 80 and over ; Antibody Formation ; BNT162 Vaccine/administration & dosage ; BNT162 Vaccine/immunology ; COVID-19/immunology ; COVID-19/prevention & control ; Disabled Persons ; Female ; Frail Elderly ; Humans ; Longitudinal Studies ; Male ; Nursing Homes ; SARS-CoV-2 ; Spain
    Chemical Substances BNT162 Vaccine (N38TVC63NU)
    Language English
    Publishing date 2021-12-17
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 80363-7
    ISSN 1532-5415 ; 0002-8614
    ISSN (online) 1532-5415
    ISSN 0002-8614
    DOI 10.1111/jgs.17620
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  5. Article ; Online: Immunogenicity of the BNT162b2 vaccine in frail or disabled nursing home residents: COVID-A study.

    Salmerón Ríos, Sergio / Mas Romero, Marta / Cortés Zamora, Elisa Belén / Tabernero Sahuquillo, María Teresa / Romero Rizos, Luis / Sánchez-Jurado, Pedro Manuel / Sánchez-Nievas, Ginés / Señalada, José Joaquín Blas / García Nogueras, Inmaculada / Estrella Cazalla, Juan de Dios / Andrés-Pretel, Fernando / Murillo Romero, Antonio / Lauschke, Volker Martin / Stebbing, Justin / Abizanda, Pedro

    Journal of the American Geriatrics Society

    2021  Volume 69, Issue 6, Page(s) 1441–1447

    Abstract: Background/objectives: The safety and immunogenicity of the BNT162b2 coronavirus disease 2019 (COVID-19) vaccine in older adults with different frailty and disability profiles have not been well determined. Our objective was to analyze immunogenicity of ...

    Abstract Background/objectives: The safety and immunogenicity of the BNT162b2 coronavirus disease 2019 (COVID-19) vaccine in older adults with different frailty and disability profiles have not been well determined. Our objective was to analyze immunogenicity of the BNT162b2 mRNA COVID-19 vaccine in older adults across frailty and disability profiles.
    Design: Multicenter longitudinal cohort study.
    Setting and participants: A total of 134 residents aged ≥65 years with different frailty and disability profiles in five long-term care facilities (LTCFs) in Albacete, Spain.
    Intervention and measurements: Residents were administered two vaccine doses as per the label, and antibody levels were determined 21.9 days (SD 9.3) after both the first and second dose. Functional variables were assessed using activities of daily living (Barthel Index), and frailty status was determined with the FRAIL instrument. Cognitive status and comorbidity were also evaluated.
    Results: Mean age was 82.9 years (range 65-99), and 71.6% were female. The mean antibody titers in residents with and without previous COVID-19 infection were 49,878 AU/ml and 15,274 AU/ml, respectively (mean difference 34,604; 95% confidence interval [CI]: 27,699-41,509). No severe adverse reactions were observed, after either vaccine dose. Those with prevaccination COVID-19 had an increased antibody level after the vaccine (B = 31,337; 95% CI: 22,725-39,950; p < 0.001). Frailty, disability, older age, sex, cognitive impairment, or comorbidities were not associated with different antibody titers.
    Conclusions: The BNT162b2 mRNA COVID-19 vaccine in older adults is safe and produces immunogenicity, independently of the frailty and disability profiles. Older adults in LTCFs should receive a COVID-19 vaccine.
    MeSH term(s) Activities of Daily Living ; Aged ; Aged, 80 and over ; Antibody Formation ; COVID-19/prevention & control ; COVID-19 Serological Testing ; COVID-19 Vaccines/immunology ; COVID-19 Vaccines/therapeutic use ; Comorbidity ; Disabled Persons ; Female ; Frail Elderly ; Health Status Indicators ; Humans ; Longitudinal Studies ; Male ; Nursing Homes ; SARS-CoV-2 ; Spain
    Chemical Substances COVID-19 Vaccines ; BNT162 vaccine (N38TVC63NU)
    Language English
    Publishing date 2021-04-02
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 80363-7
    ISSN 1532-5415 ; 0002-8614
    ISSN (online) 1532-5415
    ISSN 0002-8614
    DOI 10.1111/jgs.17153
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  6. Article ; Online: Baricitinib reduces 30-day mortality in older adults with moderate-to-severe COVID-19 pneumonia.

    Abizanda, Pedro / Calbo Mayo, Juan María / Mas Romero, Marta / Cortés Zamora, Elisa Belén / Tabernero Sahuquillo, María Teresa / Romero Rizos, Luis / Sánchez-Jurado, Pedro Manuel / Sánchez-Nievas, Ginés / Campayo Escolano, Carlos / Ochoa Serrano, Alba / Sánchez-Flor Alfaro, Victoria / López Bru, Rita / Gómez Ballesteros, Cristina / Caldevilla Bernardo, David / Callejas González, Francisco Javier / Andrés-Pretel, Fernando / Lauschke, Volker Martin / Stebbing, Justin

    Journal of the American Geriatrics Society

    2021  Volume 69, Issue 10, Page(s) 2752–2758

    Abstract: Background: Older adults are at the highest risk of severe disease and death due to COVID-19. Randomized data have shown that baricitinib improves outcomes in these patients, but focused stratified analyses of geriatric cohorts are lacking. Our ... ...

    Abstract Background: Older adults are at the highest risk of severe disease and death due to COVID-19. Randomized data have shown that baricitinib improves outcomes in these patients, but focused stratified analyses of geriatric cohorts are lacking. Our objective was to analyze the efficacy of baricitinib in older adults with COVID-19 moderate-to-severe pneumonia.
    Methods: This is a propensity score [PS]-matched retrospective cohort study. Patients from the COVID-AGE and Alba-Score cohorts, hospitalized for moderate-to-severe COVID-19 pneumonia, were categorized in two age brackets of age <70 years old (86 with baricitinib and 86 PS-matched controls) or ≥70 years old (78 on baricitinib and 78 PS-matched controls). Thirty-day mortality rates were analyzed with Kaplan-Meier and Cox proportional hazard models.
    Results: Mean age was 79.1 for those ≥70 years and 58.9 for those <70. Exactly 29.6% were female. Treatment with baricitinib resulted in a significant reduction in death from any cause by 48% in patients aged 70 or older, an 18.5% reduction in 30-day absolute mortality risk (n/N: 16/78 [20.5%] baricitinib, 30/78 [38.5%] in PS-matched controls, p < 0.001) and a lower 30-day adjusted fatality rate (HR 0.21; 95% CI 0.09-0.47; p < 0.001). Beneficial effects on mortality were also observed in the age group <70 (8.1% reduction in 30-day absolute mortality risk; HR 0.14; 95% CI 0.03-0.64; p = 0.011).
    Conclusions: Baricitinib is associated with an absolute mortality risk reduction of 18.5% in adults older than 70 years hospitalized with COVID-19 pneumonia.
    MeSH term(s) Age Factors ; Aged ; Aged, 80 and over ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Azetidines/administration & dosage ; Azetidines/adverse effects ; COVID-19/mortality ; COVID-19/physiopathology ; Female ; Hospital Mortality ; Humans ; Janus Kinase Inhibitors/administration & dosage ; Janus Kinase Inhibitors/adverse effects ; Male ; Mortality ; Outcome and Process Assessment, Health Care ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/drug therapy ; Purines/administration & dosage ; Purines/adverse effects ; Pyrazoles/administration & dosage ; Pyrazoles/adverse effects ; SARS-CoV-2/isolation & purification ; Severity of Illness Index ; Spain/epidemiology ; Sulfonamides/administration & dosage ; Sulfonamides/adverse effects ; COVID-19 Drug Treatment
    Chemical Substances Antiviral Agents ; Azetidines ; Janus Kinase Inhibitors ; Purines ; Pyrazoles ; Sulfonamides ; baricitinib (ISP4442I3Y)
    Language English
    Publishing date 2021-07-09
    Publishing country United States
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 80363-7
    ISSN 1532-5415 ; 0002-8614
    ISSN (online) 1532-5415
    ISSN 0002-8614
    DOI 10.1111/jgs.17357
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