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  1. Article ; Online: Impact of Race on Classification of Atherosclerotic Risk Using a National Cardiovascular Risk Prediction Tool.

    Beaudoin, Jarett R / Curran, Jill / Alexander, G Caleb

    AJPM focus

    2024  Volume 3, Issue 2, Page(s) 100200

    Abstract: Introduction: The use of race in clinical risk prediction tools may exacerbate racial disparities in healthcare access and outcomes. This study quantified the number of individuals reclassified for primary prevention of cardiovascular disease owing to a ...

    Abstract Introduction: The use of race in clinical risk prediction tools may exacerbate racial disparities in healthcare access and outcomes. This study quantified the number of individuals reclassified for primary prevention of cardiovascular disease owing to a change in their race alone on the basis of a commonly used risk prediction tool.
    Methods: This is a cross-sectional analysis of individuals aged 40-75 years without a history of cardiovascular events, diabetes, or other high-risk features using the 2005-2018 National Health and Nutritional Examination Survey. Authors compared atherosclerotic cardiovascular disease risk scores using the American Heart Association/American College of Cardiology equation recommended for White individuals or individuals of other races with that recommended for Black individuals.
    Results: A total of 2,946 White individuals; 1,361 Black individuals; and 2,495 individuals of other races were included in the analysis. Using the American Heart Association/American College of Cardiology equation, the mean 10-year atherosclerotic cardiovascular disease risk was 5.80% (95% CI=5.54, 6.06) for White individuals, 7.04% (956% CI=6.69, 7.39) for Black individuals, and 4.93% (95% CI=4.61, 5.24) for individuals of other races. When using the American Heart Association/American College of Cardiology equation designated for the opposite race (White/other race versus Black), the mean atherosclerotic cardiovascular disease risk score increased by 1.02% (95% CI=0.90, 1.13) for White individuals, decreased by 1.82% (95% CI= -1.67, -1.96) for Black individuals, and increased by 0.98% (95% CI=0.85, 1.10) for individuals of other races. When using clinical atherosclerotic cardiovascular disease categories of <7.5%, 7.5%-10%, and >10%, 16.93% of all individuals were reclassified when using the American Heart Association/American College of Cardiology's equation designated for the opposite race.
    Conclusions: Changing race within a commonly used cardiovascular risk prediction tool results in significant changes in risk classification among eligible White and Black individuals in the U.S.
    Language English
    Publishing date 2024-02-02
    Publishing country United States
    Document type Journal Article
    ISSN 2773-0654
    ISSN (online) 2773-0654
    DOI 10.1016/j.focus.2024.100200
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Rejection of Aducanumab (Aduhelm) by the Health Care Community: Lessons Learned and the Path Ahead.

    Bauchner, Howard / Alexander, G Caleb

    Medical care

    2022  Volume 60, Issue 5, Page(s) 392–393

    MeSH term(s) Antibodies, Monoclonal, Humanized/therapeutic use ; Delivery of Health Care ; Humans ; United States ; United States Food and Drug Administration
    Chemical Substances Antibodies, Monoclonal, Humanized ; aducanumab (105J35OE21)
    Language English
    Publishing date 2022-03-28
    Publishing country United States
    Document type Editorial
    ZDB-ID 411646-x
    ISSN 1537-1948 ; 0025-7079
    ISSN (online) 1537-1948
    ISSN 0025-7079
    DOI 10.1097/MLR.0000000000001716
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Distribution of Abatement Funds Arising From US Opioid Litigation.

    Alexander, G Caleb / Mansour, Omar

    JAMA

    2022  Volume 328, Issue 19, Page(s) 1901–1902

    MeSH term(s) Humans ; Analgesics, Opioid/adverse effects ; Analgesics, Opioid/economics ; Opioid-Related Disorders/economics ; Opioid-Related Disorders/prevention & control ; Tobacco Industry ; United States ; Legislation, Drug/economics ; Compensation and Redress/legislation & jurisprudence ; Drug Industry/economics ; Drug Industry/legislation & jurisprudence
    Chemical Substances Analgesics, Opioid
    Language English
    Publishing date 2022-10-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2022.19667
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Cost-Effectiveness of Lecanemab for Individuals With Early-Stage Alzheimer Disease.

    Nguyen, Hai V / Mital, Shweta / Knopman, David S / Alexander, G Caleb

    Neurology

    2024  Volume 102, Issue 7, Page(s) e209218

    Abstract: Background and objectives: Little is known regarding the cost-effectiveness of lecanemab (Leqembi), a monoclonal antibody approved by the US Food and Drug Administration in January 2023 for the treatment of mild cognitive impairment (MCI) or mild ... ...

    Abstract Background and objectives: Little is known regarding the cost-effectiveness of lecanemab (Leqembi), a monoclonal antibody approved by the US Food and Drug Administration in January 2023 for the treatment of mild cognitive impairment (MCI) or mild dementia due to Alzheimer disease (AD). This study aims to quantify the cost-effectiveness of lecanemab and how it varies based on the accuracy of AD testing and individuals'
    Methods: Seven alternative test-treat-target strategies defined by combinations of testing approaches (PET, CSF, or plasma assay), treatment choices (standard of care [SoC] alone or lecanemab in addition to SoC), and targeting strategies (targeting
    Results: Among the 7 test-treat-target strategies, SoC alone was the optimal strategy from a cost-effectiveness perspective. Neither targeted lecanemab treatment nor treatment unrestricted by
    Discussion: Neither targeted lecanemab treatment nor treatment unrestricted by
    MeSH term(s) Humans ; Alzheimer Disease/diagnosis ; Alzheimer Disease/genetics ; Alzheimer Disease/drug therapy ; Cost-Benefit Analysis ; Apolipoprotein E4/genetics ; Dementia/diagnosis ; Cognitive Dysfunction/genetics ; Cognitive Dysfunction/diagnosis ; Antibodies, Monoclonal, Humanized
    Chemical Substances lecanemab (12PYH0FTU9) ; Apolipoprotein E4 ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2024-03-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207147-2
    ISSN 1526-632X ; 0028-3878
    ISSN (online) 1526-632X
    ISSN 0028-3878
    DOI 10.1212/WNL.0000000000209218
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: The Problem of Aducanumab for the Treatment of Alzheimer Disease.

    Alexander, G Caleb / Karlawish, Jason

    Annals of internal medicine

    2021  Volume 174, Issue 9, Page(s) 1303–1304

    MeSH term(s) Alzheimer Disease/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Drug Approval ; Humans ; United States ; United States Food and Drug Administration
    Chemical Substances Antibodies, Monoclonal, Humanized ; aducanumab (105J35OE21)
    Language English
    Publishing date 2021-06-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 336-0
    ISSN 1539-3704 ; 0003-4819
    ISSN (online) 1539-3704
    ISSN 0003-4819
    DOI 10.7326/M21-2603
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Opioid use disorder during pregnancy: long-term developmental outcomes.

    Alinsky, Rachel H / Alexander, G Caleb

    Developmental medicine and child neurology

    2021  Volume 63, Issue 9, Page(s) 1016

    MeSH term(s) Female ; Humans ; Opioid-Related Disorders/epidemiology ; Pregnancy ; Pregnancy Complications/drug therapy
    Language English
    Publishing date 2021-06-28
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 80369-8
    ISSN 1469-8749 ; 0012-1622
    ISSN (online) 1469-8749
    ISSN 0012-1622
    DOI 10.1111/dmcn.14972
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Real-world utilization of Arachis hypogaea for peanut allergy: Patient and provider perspective.

    Magnarelli, Aimee / Wood, Robert A / Curran, Jill / Alexander, G Caleb / Dantzer, Jennifer

    The journal of allergy and clinical immunology. In practice

    2023  Volume 11, Issue 10, Page(s) 3253–3256.e2

    MeSH term(s) Humans ; Arachis ; Peanut Hypersensitivity ; Genetic Variation
    Language English
    Publishing date 2023-06-15
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2023.06.017
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Assessment of the U.S. Food and Drug Administration's risk evaluation and mitigation strategy (REMS) for prasugrel (EFFIENT): A narrative review.

    Metkus, Thomas / Curran, Jill / Lin, Shanshan / Qato, Dima M / Alexander, G Caleb

    American heart journal plus : cardiology research and practice

    2024  Volume 38

    Abstract: Background: Prasugrel, first approved in 2009, was subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risk of bleeding associated with its use.: Methods: We performed a narrative review ... ...

    Abstract Background: Prasugrel, first approved in 2009, was subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risk of bleeding associated with its use.
    Methods: We performed a narrative review of FDA documents obtained through a Freedom of Information Act request. Document classification and primary evidence extraction was performed by three authors (TM, JC, and SL).
    Results: The prasugrel REMS consists of a medication guide and a communication plan. Assessment of the REMS was via patient and clinician surveys. 1560 patients were invited to participate and 212 individuals (13.6 %) completed the survey. Rates of awareness among respondents varied across key messages and were highest for those examining the risks of premature discontinuation (96 % and 88 % of respondents), while lower for those regarding the importance of perioperative discontinuation (66 %) and contraindications posed by a history of stroke (16 %) or transient ischemic attack (17 %). Of the 6000 clinicians invited to participate in the survey, 201 (3.4 %) agreed to take part. Four of 11 key risk messages did not meet prespecified acceptable levels of comprehension. No prespecified levels of patient or provider knowledge were required for the retirement of the REMS, which took place on March 23, 2012 based on the sponsor's request.
    Conclusions: The prasugrel REMS consisted of passive educational materials whose adequacy was evaluated using highly limited, one-time, cross-sectional surveys. Our assessment adds to evidence suggesting the importance of improving the quality and impact of the FDA's post-approval activities to maximize drug safety.
    Language English
    Publishing date 2024-01-08
    Publishing country United States
    Document type Journal Article
    ISSN 2666-6022
    ISSN (online) 2666-6022
    DOI 10.1016/j.ahjo.2024.100359
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Recreational and Medical Cannabis Legalization and Opioid Prescriptions and Mortality.

    Nguyen, Hai V / McGinty, Emma E / Mital, Shweta / Alexander, G Caleb

    JAMA health forum

    2024  Volume 5, Issue 1, Page(s) e234897

    Abstract: Importance: While some have argued that cannabis legalization has helped to reduce opioid-related morbidity and mortality in the US, evidence has been mixed. Moreover, existing studies did not account for biases that could arise when policy effects vary ...

    Abstract Importance: While some have argued that cannabis legalization has helped to reduce opioid-related morbidity and mortality in the US, evidence has been mixed. Moreover, existing studies did not account for biases that could arise when policy effects vary over time or across states or when multiple policies are assessed at the same time, as in the case of recreational and medical cannabis legalization.
    Objective: To quantify changes in opioid prescriptions and opioid overdose deaths associated with recreational and medical cannabis legalization in the US.
    Design, setting, and participants: This quasiexperimental, generalized difference-in-differences analysis used annual state-level data between January 2006 and December 2020 to compare states that legalized recreational or medical cannabis vs those that did not.
    Intervention: Recreational and medical cannabis law implementation (proxied by recreational and medical cannabis dispensary openings) between 2006 and 2020 across US states.
    Main outcomes and measures: Opioid prescription rates per 100 persons and opioid overdose deaths per 100 000 population based on data from the US Centers for Disease Control and Prevention.
    Results: Between 2006 and 2020, 13 states legalized recreational cannabis and 23 states legalized medical cannabis. There was no statistically significant association of recreational or medical cannabis laws with opioid prescriptions or overall opioid overdose mortality across the 15-year study period, although the results also suggested a potential reduction in synthetic opioid deaths associated with recreational cannabis laws (4.9 fewer deaths per 100 000 population; 95% CI, -9.49 to -0.30; P = .04). Sensitivity analyses excluding state economic indicators, accounting for additional opioid laws and using alternative ways to code treatment dates yielded substantively similar results, suggesting the absence of statistically significant associations between cannabis laws and the outcomes of interest during the full study period.
    Conclusions and relevance: The results of this study suggest that, after accounting for biases due to possible heterogeneous effects and simultaneous assessment of recreational and medical cannabis legalization, the implementation of recreational or medical cannabis laws was not associated with opioid prescriptions or opioid mortality, with the exception of a possible reduction in synthetic opioid deaths associated with recreational cannabis law implementation.
    MeSH term(s) Humans ; Analgesics, Opioid/adverse effects ; Legislation, Drug ; Medical Marijuana/adverse effects ; Medical Marijuana/therapeutic use ; Opiate Overdose/mortality ; Prescriptions ; Marijuana Use/adverse effects
    Chemical Substances Analgesics, Opioid ; Medical Marijuana
    Language English
    Publishing date 2024-01-05
    Publishing country United States
    Document type Journal Article
    ISSN 2689-0186
    ISSN (online) 2689-0186
    DOI 10.1001/jamahealthforum.2023.4897
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Reply to: The informed majority could help make research into Alzheimer's disease fairer and more efficient.

    DiStefano, Michael J / Alexander, G Caleb / Anderson, Gerard F

    Journal of the American Geriatrics Society

    2022  Volume 70, Issue 6, Page(s) 1883–1885

    MeSH term(s) Alzheimer Disease ; Humans ; Informed Consent ; Mental Competency
    Language English
    Publishing date 2022-03-28
    Publishing country United States
    Document type Letter ; Research Support, Non-U.S. Gov't ; Comment
    ZDB-ID 80363-7
    ISSN 1532-5415 ; 0002-8614
    ISSN (online) 1532-5415
    ISSN 0002-8614
    DOI 10.1111/jgs.17757
    Database MEDical Literature Analysis and Retrieval System OnLINE

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