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Efficacy and safety of an expanded dulaglutide dose range: A phase 2, placebo‐controlled trial in patients with type 2 diabetes using metformin

Autor: Lai S. Tham, Ying G. Li, Dagmar Bartaskova, Zvonko Milicevic, Brad Woodward, David A. Cox, Juan P. Frias, Alan G. Wynne, Beata Matyjaszek-Matuszek

Publikováno v: Diabetes, Obesity and Metabolism. 21:2048-2057

AIMS Dulaglutide, a once weekly GLP-1 receptor agonist, is approved at two doses (1.5 and 0.75 mg) for treatment of type 2 diabetes (T2D). Two higher doses of dulaglutide (3.0 and 4.5 mg) were evaluated for safety and efficacy to determine whether th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6bbb56e6e05c0c6bbde72032bfb9c14c
https://doi.org/10.1111/dom.13764

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Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11)

Autor: Zhuoxin Yu, Luis Nevárez Ruiz, M. Angelyn Bethel, Raleigh E. Malik, Zvonko Milicevic, Enzo Bonora, Ying G. Li, Juan P. Frias, David A. Cox

Publikováno v: Diabetes Care

OBJECTIVE To compare efficacy and safety of dulaglutide at doses of 3.0 and 4.5 mg versus 1.5 mg in patients with type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND METHODS Patients were randomly assigned to once-weekly dulag

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ad7a41393f7cc0eed8d6c9ebabee323
https://pubmed.ncbi.nlm.nih.gov/33397768

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Optimized Human Regular U-500 Insulin Treatment Improves β-Cell Function in Severely Insulin-Resistant Patients with Long-Standing Type 2 Diabetes and High Insulin Requirements

Autor: Andrea Mari, Ying G. Li, Julio Rosenstock, Xiaosu Ma, Jeffrey A. Jackson

Publikováno v: Endocrine Practice. 21:1344-1353

To assess β-cell function and insulin sensitivity following improvement in glycemic control in severely insulin-resistant patients with poorly controlled type 2 diabetes (T2D).A subset of patients in a 24-week, open-label, randomized trial comparing

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3c55dba69f35414000f8f17b8826e594
https://doi.org/10.4158/ep15898.or

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Relationship Between Exposure to Prasugrel Active Metabolite and Clinical Outcomes in the TRITON-TIMI 38 Substudy

Autor: Rebecca E. Wrishko, William L. Macias, C. Steven Ernest, Jeffrey S. Riesmeyer, Shashank Rohatagi, Daniel E. Salazar, David S. Small, Govinda Weerakkody, Junxiang Luo, Ying G. Li, Lan Ni

Publikováno v: The Journal of Clinical Pharmacology. 52:789-797

In TRITON-TIMI 38, levels of the prasugrel active metabolite (pras-AM) were measured in a population pharmacokinetic substudy that characterized the intrinsic and extrinsic factors influencing exposure. Higher exposure to the pras-AM was observed in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d4723bcd9625f4d3ec49cb6079898eb6
https://doi.org/10.1177/0091270011406280

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The Onset of Inhibition of Platelet Aggregation With Prasugrel Compared With Clopidogrel Loading Doses Using Gatekeeping Analysis of Integrated Clinical Pharmacology Data

Autor: Baojin Zhu, Mark B. Effron, Ying G. Li, Brian A. Baker, Debra L. Miller, Kenneth J. Winters, Joseph A. Jakubowski, Junxiang Luo, David S. Small, Pandurang M Kulkarni

Publikováno v: Journal of Cardiovascular Pharmacology. 57:317-324

The purpose of this analysis was to determine the time by which a prasugrel 60-mg loading dose (LD) achieved significantly greater inhibition of platelet aggregation (IPA) than the peak IPA after a clopidogrel 300-mg LD or 600-mg LD. Data were pooled

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a5f297a7997cf69880deb51dc7e8d264
https://doi.org/10.1097/fjc.0b013e3182073dfb

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Integrated Analysis of Pharmacokinetic Data Across Multiple Clinical Pharmacology Studies of Prasugrel, a New Thienopyridine Antiplatelet Agent

Autor: David S. Small, C. Steven Ernest, Kenneth J. Winters, Nagy A. Farid, Shashank Rohatagi, Christopher D. Payne, John H. April, Ying G. Li, Lan Ni

Publikováno v: The Journal of Clinical Pharmacology. 51:321-332

An integrated analysis of pharmacokinetic (PK) parameter estimates for prasugrel, from 16 phase I clinical pharmacology studies, consolidated exposure estimates from 506 healthy male and female participants and evaluated the effect of specific intrin

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e24550552c1ffae106f418e69ddb77e8
https://doi.org/10.1177/0091270010367429

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Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy chinese and white volunteers: An open-label trial

Autor: Fanni Natanegara, Mei Teng Loh, Eunice Yuen, Daniel E. Salazar, Ronan M. Kelly, Molly Tomlin, Christopher D. Payne, Prajakti A. Kothare, D. Richard Lachno, Joseph A. Jakubowski, Kenneth J. Winters, Ying G. Li, Lan Ni, David S. Small, Nagy A. Farid

Publikováno v: Clinical Therapeutics. 32:365-379

Prasugrel is an oral antiplatelet agent approved for the reduction of atherothrombotic cardiovascular events in patients presenting with acute coronary syndrome and undergoing percutaneous coronary intervention. Although the approved loading dose is

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a63aae8b7e34ac0c1675660fab79d4a4
https://doi.org/10.1016/j.clinthera.2010.02.015

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Population Pharmacokinetic Analyses to Evaluate the Influence of Intrinsic and Extrinsic Factors on Exposure of Prasugrel Active Metabolite in TRITON-TIMI 38

Autor: Ying G. Li, Lan Ni, Shashank Rohatagi, Jeffrey R. Riesmeyer, Eugene Braunwald, Elliott M. Antman, Rebecca E. Wrishko, C. Steven Ernest, William L. Macias, David S. Small, Daniel E. Salazar, Govinda Weerakkody, Stephen D. Wiviott

Publikováno v: The Journal of Clinical Pharmacology. 49:984-998

Serial pharmacokinetic (PK) sampling in 1159 patients from TRITON-TIMI 38 was undertaken. A multilinear regression model was used to quantitatively predict prasugrel's active metabolite (Pras-AM) concentrations from its 2 downstream inactive metaboli

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a0b74592487def5943f4cce943f73af5
https://doi.org/10.1177/0091270009337942

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Effect of ranitidine on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel

Autor: Nagy A. Farid, Kenneth J. Winters, David S. Small, C. Steven Ernest, Christopher D. Payne, Daniel E. Salazar, Ying G. Li

Publikováno v: Current Medical Research and Opinion. 24:2251-2257

Clopidogrel is an oral thienopyridine antiplatelet agent indicated for the treatment of atherothrombotic events in patients with acute coronary syndrome (ACS). Prasugrel, a novel oral thienopyridine, is under investigation for the reduction of athero

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::19869fc2ef2fb5053f2af86c63e50c3b
https://doi.org/10.1185/03007990802205985

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Effects of the Proton Pump Inhibitor Lansoprazole on the Pharmacokinetics and Pharmacodynamics of Prasugrel and Clopidogrel

Autor: David S. Small, Ying G. Li, Kenneth J. Winters, Nagy A. Farid, Daniel E. Salazar, Govinda Weerakkody, Christopher D. Payne, John T. Brandt

Publikováno v: The Journal of Clinical Pharmacology. 48:475-484

Prasugrel and clopidogrel, thienopyridine prodrugs, are each metabolized to an active metabolite that inhibits the platelet P2Y(12) ADP receptor. In this open-label, 4-period crossover study, the effects of the proton pump inhibitor lansoprazole on t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::06a6495789408db9d51a514a71784115
https://doi.org/10.1177/0091270008315310

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