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  1. Article ; Online: Variations in Use of Diabetes Drugs With Cardiovascular Benefits Among Medicaid Patients.

    Zhai, Mike Z / Avorn, Jerry / Liu, Jun / Kesselheim, Aaron S

    JAMA network open

    2022  Volume 5, Issue 11, Page(s) e2240117

    Abstract: Importance: Cardiovascular death remains the leading cause of mortality in patients with type 2 diabetes (T2D). A better understanding of the current use and adoption of glucose-lowering drugs with cardiovascular benefit can inform state policies to ... ...

    Abstract Importance: Cardiovascular death remains the leading cause of mortality in patients with type 2 diabetes (T2D). A better understanding of the current use and adoption of glucose-lowering drugs with cardiovascular benefit can inform state policies to ensure their appropriate use in patients with T2D.
    Objective: To characterize the use of glucose-lowering agents with known cardiovascular benefit over time and across states.
    Design, setting, and participants: This cross-sectional pharmacoepidemiological study of Medicaid prescription rates of glucose-lowering agents with known cardiovascular benefit vs those with less well-established cardiovascular benefit was conducted between 2014 and 2019. In 50 states and the District of Columbia, the study focused on nonmetformin, noninsulin glucose-lowering drugs divided into 3 cohorts: (1) sodium-glucose cotransporter 2 (SGLT2) inhibitors, (2) glucagon-like peptide 1 (GLP1) receptor agonists, and (3) all other classes of glucose-lowering drugs. Data were analyzed from January 2014 to December 2019.
    Main outcomes and measures: Number of days supplied of each cohort, use ratios between the aggregated days supplied of glucose-lowering agents with known cardiovascular benefit vs those with less well-established cardiovascular benefit, and the mean change in use ratios per quarter.
    Results: Across the 50 states and the District of Columbia, the use ratio of glucose-lowering agents with known cardiovascular benefit ranged from 1.58 to 0.14 (mean [SD], 0.48 [0.27]) in 2019. A lower use ratio was seen in states with a higher prevalence of diabetes (β = -0.049; 95% CI, -0.086 to -0.012; P = .01), a larger total population (β = -0.013; 95% CI, -0.023 to -0.003; P = .01), a greater number of Medicaid enrollees (β = -0.054; 95% CI, -0.096 to -0.014; P = .01), a greater proportion of people enrolled in Medicaid (β = -0.018; 95% CI, -0.030 to -0.007; P = .002), and a greater proportion of Medicaid patients enrolled in managed care organizations (β = -0.0032; 95% CI, -0.0051 to -0.0013; P = .002). Higher Medicaid expenditures per enrollee (β = 0.047; 95% CI, 0.007 to 0.089; P = .03) were associated with a higher use ratio of these agents. The relative use of glucose-lowering agents with known cardiovascular benefit by Medicaid enrollees increased 7.4% per year from 2014 to 2019, with wide variations across state Medicaid programs.
    Conclusions and relevance: In this cross-sectional study, glucose-lowering agents with cardiovascular benefit increased in use during the study period, but also demonstrated considerable variation among states in their relative use. Medicaid programs should try to clarify which factors may be contributing to relative underuse of these potentially life-saving drugs.
    MeSH term(s) United States/epidemiology ; Humans ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Diabetes Mellitus, Type 2/complications ; Sodium-Glucose Transporter 2 Inhibitors ; Cross-Sectional Studies ; Medicaid ; Hypoglycemic Agents/therapeutic use ; Glucose
    Chemical Substances Sodium-Glucose Transporter 2 Inhibitors ; Hypoglycemic Agents ; Glucose (IY9XDZ35W2)
    Language English
    Publishing date 2022-11-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2022.40117
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies.

    Zhai, Mike Z / Lye, Carolyn T / Kesselheim, Aaron S

    JAMA internal medicine

    2020  Volume 180, Issue 9, Page(s) 1145–1146

    MeSH term(s) Access to Information ; Antimalarials/pharmacology ; Betacoronavirus ; Chloroquine/pharmacology ; Coronavirus Infections/drug therapy ; Coronavirus Infections/epidemiology ; Drug Approval/legislation & jurisprudence ; Drug Repositioning/methods ; Drug Repositioning/standards ; Drug Repositioning/trends ; Evidence-Based Medicine ; Humans ; Hydroxychloroquine/pharmacology ; Pandemics ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/epidemiology ; Prior Authorization/legislation & jurisprudence ; Prior Authorization/trends
    Chemical Substances Antimalarials ; Hydroxychloroquine (4QWG6N8QKH) ; Chloroquine (886U3H6UFF)
    Keywords covid19
    Language English
    Publishing date 2020-05-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2699338-7
    ISSN 2168-6114 ; 2168-6106
    ISSN (online) 2168-6114
    ISSN 2168-6106
    DOI 10.1001/jamainternmed.2020.2402
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies

    Zhai, Mike Z / Lye, Carolyn T / Kesselheim, Aaron S

    JAMA Intern Med

    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #305888
    Database COVID19

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  4. Article ; Online: Why Are Biosimilars Not Living up to Their Promise in the US?

    Zhai, Mike Z / Sarpatwari, Ameet / Kesselheim, Aaron S

    AMA journal of ethics

    2019  Volume 21, Issue 8, Page(s) E668–678

    Abstract: Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments. An abbreviated approval pathway for biosimilars, near-identical versions of biologics made by different ...

    Abstract Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments. An abbreviated approval pathway for biosimilars, near-identical versions of biologics made by different manufacturers, was created by Congress in 2010 to stimulate competition in hopes of driving down costs and expanding access. However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market. Of the few biosimilars currently available to patients, overall utilization has been limited. This article examines the current landscape of the biosimilar market, characterizes tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars, and assesses ethical issues related to increasing the adoption of biosimilars.
    MeSH term(s) Biosimilar Pharmaceuticals/economics ; Biosimilar Pharmaceuticals/supply & distribution ; Drug Industry/legislation & jurisprudence ; Jurisprudence ; Patents as Topic/legislation & jurisprudence ; Prescription Drugs/economics ; United States ; United States Food and Drug Administration
    Chemical Substances Biosimilar Pharmaceuticals ; Prescription Drugs
    Language English
    Publishing date 2019-08-01
    Publishing country United States
    Document type Journal Article
    ISSN 2376-6980
    ISSN (online) 2376-6980
    DOI 10.1001/amajethics.2019.668
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies

    Zhai, Mike Z. / Lye, Carolyn T. / Kesselheim, Aaron S.

    JAMA Internal Medicine

    2020  Volume 180, Issue 9, Page(s) 1145

    Keywords Internal Medicine ; covid19
    Language English
    Publisher American Medical Association (AMA)
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2699338-7
    ISSN 2168-6114 ; 2168-6106
    ISSN (online) 2168-6114
    ISSN 2168-6106
    DOI 10.1001/jamainternmed.2020.2402
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Development of First-in-Class Dual Sirt2/HDAC6 Inhibitors as Molecular Tools for Dual Inhibition of Tubulin Deacetylation.

    Sinatra, Laura / Vogelmann, Anja / Friedrich, Florian / Tararina, Margarita A / Neuwirt, Emilia / Colcerasa, Arianna / König, Philipp / Toy, Lara / Yesiloglu, Talha Z / Hilscher, Sebastian / Gaitzsch, Lena / Papenkordt, Niklas / Zhai, Shiyang / Zhang, Lin / Romier, Christophe / Einsle, Oliver / Sippl, Wolfgang / Schutkowski, Mike / Gross, Olaf /
    Bendas, Gerd / Christianson, David W / Hansen, Finn K / Jung, Manfred / Schiedel, Matthias

    Journal of medicinal chemistry

    2023  Volume 66, Issue 21, Page(s) 14787–14814

    Abstract: Dysregulation of both tubulin deacetylases sirtuin 2 (Sirt2) and the histone deacetylase 6 (HDAC6) has been associated with the pathogenesis of cancer and neurodegeneration, thus making these two enzymes promising targets for pharmaceutical intervention. ...

    Abstract Dysregulation of both tubulin deacetylases sirtuin 2 (Sirt2) and the histone deacetylase 6 (HDAC6) has been associated with the pathogenesis of cancer and neurodegeneration, thus making these two enzymes promising targets for pharmaceutical intervention. Herein, we report the design, synthesis, and biological characterization of the first-in-class dual Sirt2/HDAC6 inhibitors as molecular tools for dual inhibition of tubulin deacetylation. Using biochemical
    MeSH term(s) Histone Deacetylase 6 ; Sirtuin 2/metabolism ; Tubulin/metabolism ; Histone Deacetylase Inhibitors/pharmacology ; Acetylation
    Chemical Substances Histone Deacetylase 6 (EC 3.5.1.98) ; Sirtuin 2 (EC 3.5.1.-) ; Tubulin ; Histone Deacetylase Inhibitors
    Language English
    Publishing date 2023-10-30
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 218133-2
    ISSN 1520-4804 ; 0022-2623
    ISSN (online) 1520-4804
    ISSN 0022-2623
    DOI 10.1021/acs.jmedchem.3c01385
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Non-alcoholic fatty liver disease and colorectal cancer survival.

    Wu, Kana / Zhai, Mike Z / Weltzien, Erin K / Cespedes Feliciano, Elizabeth M / Meyerhardt, Jeffrey A / Giovannucci, Edward / Caan, Bette J

    Cancer causes & control : CCC

    2018  Volume 30, Issue 2, Page(s) 165–168

    Abstract: Purpose: Liver diseases including non-alcoholic fatty liver disease (NAFLD) and ensuing alterations to the micro-environment may affect development of liver metastasis. Mirroring the rise in obesity rates, prevalence of NAFLD is increasing globally. Our ...

    Abstract Purpose: Liver diseases including non-alcoholic fatty liver disease (NAFLD) and ensuing alterations to the micro-environment may affect development of liver metastasis. Mirroring the rise in obesity rates, prevalence of NAFLD is increasing globally. Our objective was to examine the association between NAFLD and mortality in colorectal cancer patients.
    Methods: Colorectal Cancer-Sarcopenia and Near-term Survival (C-SCANS) is a retrospective cohort study which included 3,262 stage I-III patients, aged 18-80 years, and diagnosed between 2006 and 2011 at Kaiser Permanente Northern California. Cox proportional hazards regression was used to calculate multivariable adjusted hazard ratios (HR) and 95% confidence intervals (CI).
    Results: After up to 10 years of follow-up, 879 deaths, including 451 from CRC were identified. Cases diagnosed with NAFLD before and within 1 month after CRC diagnosis (pre-existing NAFLD; n = 83) had a HR of 1.64 (95% CI 1.06-2.54) for overall and a HR of 1.85 (95% CI 1.03-3.30) for CRC-specific mortality compared to those without NAFLD. Findings did not differ significantly by sex, stage, tumor location, and smoking status, and were also similar when restricted to obese patients only.
    Conclusions: Independent of body mass index and prognostic indicators, CRC patients with pre-existing NAFLD had a worse prognosis than those without NAFLD.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; California/epidemiology ; Colorectal Neoplasms/epidemiology ; Female ; Humans ; Male ; Middle Aged ; Non-alcoholic Fatty Liver Disease/epidemiology ; Obesity/epidemiology ; Prognosis ; Proportional Hazards Models ; Retrospective Studies ; Young Adult
    Language English
    Publishing date 2018-11-15
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1064022-8
    ISSN 1573-7225 ; 0957-5243
    ISSN (online) 1573-7225
    ISSN 0957-5243
    DOI 10.1007/s10552-018-1095-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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