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Start Over Author "Davidson, Michael H." Publication Type Newspapers
1,525 results on '"Davidson, Michael H."'

3. Obicetrapib on top of maximally tolerated lipid‐modifying therapies in participants with or at high risk for atherosclerotic cardiovascular disease: rationale and designs of BROADWAY and BROOKLYN

Author

Nicholls, Stephen J., Nelson, Adam J., Ditmarsch, Marc, Kastelein, John J.P., Ballantyne, Christie M., Ray, Kausik K., Navar, Ann Marie, Nissen, Steven E., Golberg, Anne C., Brunham, Liam R., Curcio, Danielle, Wuerdeman, Erin, Neild, Annie, Kling, Douglas, Hsieh, Andrew, Dicklin, Mary R., Ference, Brian A., Laufs, Ulrich, Banach, Maciej, Mehran, Roxana, Catapano, Alberico L., and Davidson, Michael H.

Published
2024
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8. History of Lipidology

Author

Gotto, Antonio, Jr., Davidson, Michael H., Toth, Peter P., Series Editor, Davidson, Michael H., editor, and Maki, Kevin C., editor

Published
2021
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10. Guiding Dyslipidemia Treatment: A Population Pharmacokinetic–Pharmacodynamic Framework for Obicetrapib.

Author

Dunn, Allison, Ditmarsch, Marc, Kastelein, John J. P., Kling, Douglas, Neild, Annie, Davidson, Michael H., and Gobburu, Joga

Subjects
DRUG therapy for hyperlipidemia, HIGH density lipoproteins, ANTILIPEMIC agents, CARDIOVASCULAR diseases, RESEARCH funding, STRUCTURAL models, BODY weight, RESEARCH evaluation, GLYCOPROTEINS, DESCRIPTIVE statistics, DECISION making, BIOTRANSFORMATION (Metabolism), LOW density lipoproteins, DRUG development, ALLOMETRY, PHARMACODYNAMICS, CHEMICAL inhibitors
Abstract

Obicetrapib is a selective inhibitor of cholesteryl ester transfer protein that is currently in phase 3 of development for the treatment of dyslipidemia as adjunct therapy. The purpose of this study was to comprehensively characterize the pharmacokinetic (PK) and pharmacodynamic (PD) disposition of obicetrapib. Data from 7 clinical trials conducted in healthy adults and those with varying degrees of dyslipidemia were included for model development. The structural model that best described obicetrapib PK was a 3‐compartment model with 4‐compartment transit absorption and first‐order elimination. Body weight was the only covariate found to significantly explain observed variability and was therefore included using allometric scaling on all disposition parameters. For a typical patient weighing 75 kg, the estimated apparent total body clearance and apparent volume of distribution of the central compartment was 0.81 L/h and 36.1 L, respectively. The final PK model parameters were estimated with good precision and were ultimately leveraged to sequentially inform 2 turnover models that describe obicetrapib's effect on low‐density lipoprotein cholesterol (LDL‐C) and high‐density lipoprotein cholesterol (HDL‐C) concentrations. The maximum stimulatory effect of obicetrapib on LDL‐C loss was estimated to be 1.046, while the maximum inhibitory effect of obicetrapib on HDL‐C loss was 0.691. This corresponds to a predicted typical maximum percent change from baseline LDL‐C and HDL‐C of 51.1% and 224%, respectively. The final sequential model described obicetrapib PKPD well and was ultimately able to both demonstrate evidence of internal consistency and support decision‐making throughout the development lifecycle. [ABSTRACT FROM AUTHOR]

Published
2024
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13. CETP and SGLT2 inhibitor combination therapy increases glycemic control: a 2x2 factorial Mendelian randomization analysis.

Author

Khomtchouk, Bohdan B., Sun, Patrick, Maggio, Zane A., Ditmarsch, Marc, Kastelein, John J. P., and Davidson, Michael H.

Subjects
GLYCEMIC control, INSULIN, SODIUM-glucose cotransporter 2 inhibitors, CHOLESTERYL ester transfer protein, PEPTIDE receptors, ORAL drug administration, GLYCOSYLATED hemoglobin, GESTATIONAL diabetes, INSULIN sensitivity
Abstract

Introduction: Cholesteryl ester transfer protein (CETP) inhibitors, initially developed for treating hyperlipidemia, have shown promise in reducing the risk of new-onset diabetes during clinical trials. This positions CETP inhibitors as potential candidates for repurposing in metabolic disease treatment. Given their oral administration, they could complement existing oral medications like sodium-glucose cotransporter 2 (SGLT2) inhibitors, potentially delaying the need for injectable therapies such as insulin. Methods: We conducted a 2x2 factorial Mendelian Randomization analysis involving 233,765 participants from the UK Biobank. This study aimed to evaluate whether simultaneous genetic inhibition of CETP and SGLT2 enhances glycemic control compared to inhibiting each separately. Results: Our findings indicate that dual genetic inhibition of CETP and SGLT2 significantly reduces glycated hemoglobin levels compared to controls and single-agent inhibition. Additionally, the combined inhibition is linked to a lower incidence of diabetes compared to both the control group and SGLT2 inhibition alone. Discussion: These results suggest that combining CETP and SGLT2 inhibitor therapies may offer superior glycemic control over SGLT2 inhibitors alone. Future clinical trials should investigate the potential of repurposing CETP inhibitors for metabolic disease treatment, providing an oral therapeutic option that could benefit high-risk patients before they require injectable therapies like insulin or glucagon-like peptide-1 (GLP-1) receptor agonists. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Management of Dyslipidemia and Prevention of Cardiovascular Disease Algorithm – 2020 Executive Summary

Author

Handelsman, Yehuda, Jellinger, Paul S., Guerin, Chris K., Bloomgarden, Zachary T., Brinton, Eliot A., Budoff, Matthew J., Davidson, Michael H., Einhorn, Daniel, Fazio, Sergio, Fonseca, Vivian A., Garber, Alan J., Grunberger, George, Krauss, Ronald M., Mechanick, Jeffrey I., Rosenblit, Paul D., Smith, Donald A., and Wyne, Kathleen L.

Published
2020
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26. Inhibition of oxidized low-density lipoprotein with orticumab inhibits coronary inflammation and reduces residual inflammatory risk in psoriasis: a pilot randomized, double-blind placebo-controlled trial.

Author

Farina, Christopher J, Davidson, Michael H, Shah, Prediman K, Stark, Charles, Lu, Wenqi, Shirodaria, Cheerag, Wright, Timothy, Antoniades, Charalambos A, Nilsson, Jan, and Mehta, Nehal N

Subjects
*ATHEROSCLEROTIC plaque, *ATP-binding cassette transporters, *LIPOPROTEIN A, *INFLAMMATION, *DISEASE risk factors
Abstract

A pilot randomized, double-blind placebo-controlled trial was conducted to assess the effects of orticumab, a monoclonal antibody that targets oxidized low-density lipoprotein (oxLDL), on coronary inflammation in patients with psoriasis. The study found that treatment with orticumab reduced the Fat Attenuation Index (FAI) score, a measure of coronary inflammation, in patients with high levels of inflammation but had no effect in those with low levels of inflammation. The study suggests that targeting oxLDL with orticumab may reduce coronary inflammation and potentially lower the risk of fatal cardiac events in patients with elevated inflammation. However, further research is needed to fully understand the mechanisms and clinical implications of this treatment. [Extracted from the article]

Published
2024
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28. American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease

Author

Jellinger, Paul S., Handelsman, Yehuda, Rosenblit, Paul D., Bloomgarden, Zachary T., Fonseca, Vivian A., Garber, Alan J., Grunberger, George, Guerin, Chris K., Bell, David S.H., Mechanick, Jeffrey I., Pessah-Pollack, Rachel, Wyne, Kathleen, Smith, Donald, Brinton, Eliot A., Fazio, Sergio, Davidson, Michael, Davidson, Michael H., Smith, Donald A., Bush, Michael, and Zangeneh, Farhad

Published
2017
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30. CETP and SGLT2 inhibitor combination therapy improves glycemic control

Author

Khomtchouk, Bohdan B., Sun, Patrick, Ditmarsch, Marc, Kastelein, John J.P., and Davidson, Michael H.

Subjects
Article
Abstract

IMPORTANCE: Cholesteryl ester transfer protein (CETP) inhibition has been associated with decreased risk of new-onset diabetes in past clinical trials exploring their efficacy in cardiovascular disease and can potentially be repurposed to treat metabolic disease. Notably, as an oral drug it can potentially be used to supplement existing oral drugs such as sodium-glucose cotransporter 2 (SGLT2) inhibitors before patients are required to take injectable drugs such as insulin. OBJECTIVE: To identify whether CETP inhibitors could be used as an oral add-on to SGLT2 inhibition to improve glycemic control. DESIGN, SETTING, AND PARTICIPANTS: 2×2 factorial Mendelian Randomization (MR) is performed on the general population of UK Biobank participants with European ancestry. EXPOSURES: Previously constructed genetic scores for CETP and SGLT2 function are combined in a 2×2 factorial framework to characterize the associations between joint CETP and SGLT2 inhibition compared to either alone. MAIN OUTCOMES AND MEASURES: Glycated hemoglobin and type-2 diabetes incidence. RESULTS: Data on 233,765 UK Biobank participants suggests that individuals with genetic inhibition of both CETP and SGLT2 have significantly lower glycated hemoglobin levels (mmol/mol) than control (Effect size: −0.136; 95% CI: −0.190 to −0.081; p-value: 1.09E-06), SGLT2 inhibition alone (Effect size: −0.082; 95% CI: −0.140 to −0.024; p-value: 0.00558), and CETP inhibition alone (Effect size: −0.08479; 95% CI: −0.136 to −0.033; p-value: 0.00118). Furthermore, joint CETP and SGLT2 inhibition is associated with decreased incidence of diabetes (log-odds ratio) compared to control (Effect size: −0.068; 95% CI: −0.115 to −0.021; p-value: 4.44E-03) and SGLT2 inhibition alone (Effect size: −0.062; 95% CI: −0.112 to −0.012; p-value: 0.0149). CONCLUSIONS AND RELEVANCE: Our results suggest that CETP and SGLT2 inhibitor therapy may improve glycemic control over SGLT2 inhibitors alone. Future clinical trials can explore whether CETP inhibitors can be repurposed to treat metabolic disease and provide an oral therapeutic option to benefit high-risk patients before escalation to injectable drugs such as insulin or glucagon-like peptide 1 (GLP1) receptor agonists.

Published
2023

38. Genetic Testing for Hypertriglyceridemia in Academic Lipid Clinics: Implications for Precision Medicine—Brief Report

Author

Deshotels, Matthew R., primary, Hadley, Trevor D., additional, Roth, Mendel, additional, Agha, Ali M., additional, Pulipati, Vishnu Priya, additional, Nugent, Anne K., additional, Virani, Salim S., additional, Nambi, Vijay, additional, Moriarty, Patrick M., additional, Davidson, Michael H., additional, and Ballantyne, Christie M., additional

Published
2022
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