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274 results on '"Terra, Steven G."'

4. Reductions in remnant cholesterol and VLDL cholesterol through inhibition of ANGPTL3 protein synthesis: an analysis from the TRANSLATE-TIMI 70 trial

Author

Zimerman, Andre, primary, Wiviott, Stephen D, additional, Park, Jeong-Gun, additional, Murphy, Sabina A, additional, Ran, Xinhui, additional, Bramson, Candace R, additional, Curto, Madelyn, additional, Ramos, Vesper, additional, Jevne, Alexandra, additional, Kuder, Julia F, additional, Verma, Subodh, additional, Wojakowski, Wojtek, additional, Terra, Steven G, additional, Sabatine, Marc S, additional, Bergmark, Brian A, additional, and Marston, Nicholas A, additional

Published
2024
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5. Hepatic Fat Changes with Antisense Oligonucleotide Therapy Targeting ANGPTL3

Author

Zimerman, Andre, primary, Wiviott, Stephen D., additional, Park, Jeong-Gun, additional, Murphy, Sabina A., additional, Ran, Xinhui, additional, Bramson, Candace R., additional, Curto, Madelyn, additional, Ramos, Vesper, additional, Jevne, Alexandra, additional, Kuder, Julia F., additional, Verma, Subodh, additional, Wojakowski, Wojtek, additional, Terra, Steven G., additional, Sabatine, Marc S., additional, Bergmark, Brian A., additional, and Marston, Nicholas A., additional

Published
2023
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12. Efficacy of Ertugliflozin on Heart Failure–Related Events in Patients With Type 2 Diabetes Mellitus and Established Atherosclerotic Cardiovascular Disease: Results of the VERTIS CV Trial

Author

Cosentino, Francesco, Cannon, Christopher P., Cherney, David Z.I., Masiukiewicz, Urszula, Pratley, Richard, Dagogo-Jack, Sam, Frederich, Robert, Charbonnel, Bernard, Mancuso, James, Shih, Weichung J., Terra, Steven G., Cater, Nilo B., Gantz, Ira, and McGuire, Darren K.

Published
2020
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15. HEPATIC FAT CHANGES AFTER AN ANTISENSE OLIGONUCLEOTIDE THERAPY TARGETING ANGPTL3: A TRANSLATE-TIMI 70 ANALYSIS

Author

Zimerman, André, primary, Wiviott, Stephen, additional, Park, Jeong-Gun, additional, Murphy, Sabina, additional, Ran, Xinhui, additional, Bramson, Candace, additional, Curto, Madelyn, additional, Ramos, Vesper, additional, Jevne, Alexandra, additional, Kuder, Julia, additional, Verma, Subodh, additional, Wojakowski, Wojciech, additional, Terra, Steven G., additional, Sabatine, Marc Steven, additional, Bergmark, Brian, additional, and Marston, Nicholas, additional

Published
2023
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19. Real-World Effectiveness of Nirmatrelvir/Ritonavir in Preventing Hospitalization Among Patients With COVID-19 at High Risk for Severe Disease in the United States: A Nationwide Population-Based Cohort Study

Author

Zhou, Xiaofeng, primary, Kelly, Scott P., additional, Liang, Caihua, additional, Li, Ling, additional, Shen, Rongjun, additional, Leister-Tebbe, Heidi K., additional, Terra, Steven G., additional, Gaffney, Michael, additional, and Russo, Leo, additional

Published
2022
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22. A multi‐purpose Japanese phase I study in the global development of vupanorsen: Randomized, placebo‐controlled, single‐ascending dose study in adults.

Author

Fukuhara, Kei, Furihata, Kenichi, Matsuoka, Nobushige, Itamura, Rio, Ramos, Vesper, Hagi, Toshiaki, Kalluru, Hindu, Bramson, Candace, Terra, Steven G., and Liu, Jing

Subjects
JAPANESE people, ADVERSE health care events, GALACTOSAMINE, MEDICAL equipment
Abstract

Vupanorsen (PF‐07285557) is a second‐generation tri‐N‐acetyl galactosamine (GalNAc3)‐antisense oligonucleotide targeted to angiopoietin‐like 3 (ANGPTL3) mRNA, shown to reduce lipids and apolipoproteins in subjects with dyslipidemia. To aid bringing innovative drugs to global patients efficiently, a multi‐purpose Japanese phase I study was conducted, with integrated development approaches agreed by the Pharmaceuticals and Medical Devices Agency (PMDA). This randomized, double‐blind, placebo‐controlled, single‐ascending dose (SAD) study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of vupanorsen administered subcutaneously to Japanese adults (20–65 years) with elevated triglycerides (TG). Participants were randomized (1:1:1) to vupanorsen (80:160 mg) or placebo (N = 4 each). Vupanorsen 160 mg was a first‐in‐human (FIH) dose level. Vupanorsen was well‐tolerated with no treatment‐related adverse events reported for either dose. Absorption into the systemic circulation was rapid with median time to maximum concentration (Tmax) of 3.5 and 2.0 h, for vupanorsen 80 and 160 mg, respectively. Following maximum concentration (Cmax), vupanorsen underwent multiphasic decline characterized by a relatively fast initial distribution phase followed by slower terminal elimination phase, with elimination half‐life (t1/2) of 397 and 499 h (80, 160 mg), respectively. Area under the concentration–time curve (AUC) and Cmax increased in a greater than dose‐proportional manner. Pharmacodynamic markers (ANGPTL3, TG, and other key lipids) were reduced with vupanorsen versus placebo. Vupanorsen was safe and well‐tolerated in healthy Japanese participants with elevated TG. This study provided FIH data for vupanorsen 160 mg. Moreover, the SAD study in Japanese participants fulfilled PMDA bridging requirements, and with the totality of global vupanorsen data, supported the PMDA waiver for a local phase II dose‐finding study. ClinicalTrials.gov: NCT04459767. [ABSTRACT FROM AUTHOR]

Published
2023
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23. Effect of Vupanorsen on Non–High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70

Author

Bergmark, Brian A., primary, Marston, Nicholas A., additional, Bramson, Candace R., additional, Curto, Madelyn, additional, Ramos, Vesper, additional, Jevne, Alexandra, additional, Kuder, Julia F., additional, Park, Jeong-Gun, additional, Murphy, Sabina A., additional, Verma, Subodh, additional, Wojakowski, Wojtek, additional, Terra, Steven G., additional, Sabatine, Marc S., additional, Wiviott, Stephen D., additional, Carbonneau, Diane, additional, Poulin-Robitaille, Raphael, additional, Wayne, Jeffrey, additional, Lee, Keung, additional, Mujica Trenche, Samuel, additional, Dzongowski, Petros, additional, Gaudet, Daniel, additional, Van, Joanna, additional, Ajani, Dilawar, additional, Bays, Harold, additional, O’Mahony, John, additional, Janas, Adam, additional, Scott, John, additional, Moustafa, Moustafa Ashraf, additional, Ransom, Thomas, additional, Benjamin, Sabrina, additional, Aggarwal, Naresh, additional, Bogdanski, Pawel, additional, Friars, Douglas, additional, Schlosser, Robert, additional, Okopien, Boguslaw, additional, Budhraja, Madhusudan, additional, Feld, Lawrence, additional, Klaff, Leslie, additional, Tellier, Guy, additional, Mazza, Giuseppe, additional, Wierzbicka, Iwona, additional, Jazwinska-Tarnawska, Ewa, additional, Boccalandro, Fernando, additional, Rosenstock, Julio, additional, Marquez, Elizabeth, additional, Barbel-Johnson, Kim, additional, Madziarska, Katarzyna, additional, Heaton, Kenneth, additional, Tardif, Jean-Claude, additional, Rubino, John, additional, Trevino, Miguel, additional, Moriarty, Katie, additional, Gupta, Anil, additional, Wojakowski, Wojciech, additional, Fidelholtz, James, additional, Gupta, Dinesh, additional, Alasaad, Hani, additional, Christensen, Shane, additional, Shah, Parag, additional, Li, Stephanie, additional, Sherman, Mark, additional, Frechette, Andre, additional, Arango, Cecilia, additional, Egan, Alan, additional, Srivastava, Sunny, additional, Bajaj, Archna, additional, Ince Jr, Carlos, additional, and Zurakowski, Aleksander, additional

Published
2022
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24. Bioequivalence of Ertugliflozin/Sitagliptin Fixed‐Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components

Author

Fediuk, Daryl J., Matschke, Kyle, Liang, Yali, Pelletier, Kathleen B., Wei, Hua, Shi, Haihong, Bass, Almasa, Hickman, Anne, Terra, Steven G., Zhou, Susan, Krishna, Rajesh, and Sahasrabudhe, Vaishali

Subjects
Adult, Male, bioequivalence, Cross-Over Studies, ertugliflozin, Sitagliptin Phosphate, Pharmaceutical Science, Original Manuscript, Articles, Fasting, Bridged Bicyclo Compounds, Heterocyclic, sitagliptin, Healthy Volunteers, fixed‐dose combination, Drug Combinations, Young Adult, Therapeutic Equivalency, Area Under Curve, Humans, Female, Pharmacology (medical), Tablets
Abstract

A fixed‐dose combination (FDC) tablet of ertugliflozin, a selective inhibitor of sodium‐glucose cotransporter 2, and sitagliptin, a dipeptidyl peptidase‐4 inhibitor, was developed for the treatment of patients with type 2 diabetes mellitus. Four studies were conducted under fasted conditions to demonstrate bioequivalence of ertugliflozin/sitagliptin FDC tablets and individual components at respective strengths when coadministered in healthy subjects. All studies had open‐label, randomized, 2‐period, 2‐sequence, single‐dose crossover designs. In each study 18 or 19 subjects were enrolled and received an ertugliflozin/sitagliptin FDC tablet (5 mg/50 mg, 5 mg/100 mg, 15 mg/50 mg, or 15 mg/100 mg) and corresponding strengths of ertugliflozin and sitagliptin coadministered as individual components. For both ertugliflozin and sitagliptin, the 90%CIs for the ratio (FDC:coadministration) of geometric means for area under the plasma concentration‐time profile from time 0 extrapolated to infinite time, and maximum observed plasma concentration, were within acceptance criteria for bioequivalence (80% to 125%). All adverse events were mild in intensity. The 4 studies demonstrated that each strength of FDC tablet is bioequivalent to the respective dose of coadministered individual components. This indicates that the known efficacy and tolerability of ertugliflozin and sitagliptin when coadministered can be translated to the use of a FDC formulation.

Published
2019

26. 10.1056/NEJMoa2004967

Author

Cannon, Christopher P., Pratley, Richard, Dagogo-Jack, Samuel, Mancuso, James, Huyck, Susan, Masiukiewicz, Urszula, Charbonnel, Bernard, Frederich, Robert, Gallo, Silvina, Cosentino, Francesco, Shih, Weichung J., Gantz, Ira, Terra, Steven G., Cherney, David Z.I., and McGuire, Darren K.

Subjects
n.a
Abstract

BACKGROUND The cardiovascular effects of ertugliflozin, an inhibitor of sodium–glucose cotransporter 2, have not been established. METHODS In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose groups pooled for analysis, the primary objective was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. RESULTS A total of 8246 patients underwent randomization and were followed for a mean of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients (11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97 ; 95.6% confidence interval [CI], 0.85 to 1.11 ; P

Published
2020

27. Novel Application of the Two‐Period Microtracer Approach to Determine Absolute Oral Bioavailability and Fraction Absorbed of Ertugliflozin

Author

Raje, Sangeeta, Callegari, Ernesto, Sahasrabudhe, Vaishali, Vaz, Alfin, Shi, Haihong, Fluhler, Eric, Woolf, Eric J., Schildknegt, Klaas, Matschke, Kyle, Alvey, Christine, Zhou, Susan, Papadopoulos, Dimitris, Fountaine, Robert, Saur, Didier, Terra, Steven G., Stevens, Lloyd, Gaunt, Daniel, and Cutler, David L.

Subjects
Adult, Male, Research, Chemistry, Pharmaceutical, Administration, Oral, Biological Availability, Articles, Middle Aged, Bridged Bicyclo Compounds, Heterocyclic, Article, Healthy Volunteers, Young Adult, Diabetes Mellitus, Type 2, Tandem Mass Spectrometry, Area Under Curve, Humans, Radioactive Tracers, Sodium-Glucose Transporter 2 Inhibitors, Chromatography, High Pressure Liquid
Abstract

Ertugliflozin, a sodium glucose cotransporter‐2 inhibitor, is approved in the United States for treatment of type 2 diabetes mellitus. A novel two‐period study design with 14C microtracer dosing in each period was used to determine absolute oral bioavailability (F) and fraction absorbed (Fa) of ertugliflozin. Eight healthy adult men received 100‐μg i.v. 14C‐ertugliflozin (400 nCi) dose 1 h after a 15‐mg oral unlabeled ertugliflozin dose (period 1), followed by 100 μg 14C‐ertugliflozin orally along with 15 mg oral unlabeled ertugliflozin (period 2). Unlabeled ertugliflozin plasma concentrations were determined using high‐performance liquid‐chromatography tandem mass spectrometry (HPLC‐MS/MS). 14C‐ertugliflozin plasma concentrations were determined using HPLC‐accelerator mass spectrometry (AMS) and 14C urine concentrations were determined using AMS. F ((area under the curve (AUC)p.o./14C‐AUCi.v.)*(14C‐Dosei.v./Dosep.o.)) and Fa ((14C_Total_Urinep.o./14C_Total_Urinei.v.)* (14C‐Dosei.v./14C‐Dosep.o.)) were estimated. Estimates of F and Fa were 105% and 111%, respectively. Oral absorption of ertugliflozin was complete under fasted conditions and F was ∼100%. Ertugliflozin was well tolerated.

Published
2018

28. Association of SGLT2 Inhibitors With Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes

Author

McGuire, Darren K., primary, Shih, Weichung J., additional, Cosentino, Francesco, additional, Charbonnel, Bernard, additional, Cherney, David Z. I., additional, Dagogo-Jack, Samuel, additional, Pratley, Richard, additional, Greenberg, Michelle, additional, Wang, Shuai, additional, Huyck, Susan, additional, Gantz, Ira, additional, Terra, Steven G., additional, Masiukiewicz, Urszula, additional, and Cannon, Christopher P., additional

Published
2021
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33. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes

Author

Cannon, Christopher P., primary, Pratley, Richard, additional, Dagogo-Jack, Samuel, additional, Mancuso, James, additional, Huyck, Susan, additional, Masiukiewicz, Urszula, additional, Charbonnel, Bernard, additional, Frederich, Robert, additional, Gallo, Silvina, additional, Cosentino, Francesco, additional, Shih, Weichung J., additional, Gantz, Ira, additional, Terra, Steven G., additional, Cherney, David Z.I., additional, and McGuire, Darren K., additional

Published
2020
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34. Efficacy and safety of ertugliflozin in older patients with type 2 diabetes: A pooled analysis of phase III studies

Author

Pratley, Richard, primary, Dagogo‐Jack, Samuel, additional, Charbonnel, Bernard, additional, Patel, Shrita, additional, Hickman, Anne, additional, Liu, Jie, additional, Tarasenko, Lisa, additional, Pong, Annpey, additional, Ellison, Misoo C., additional, Huyck, Susan, additional, Gantz, Ira, additional, and Terra, Steven G., additional

Published
2020
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39. 453_Supplementary_Fig1 – Supplemental material for Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies

Author

Liu, Jie, Tarasenko, Lisa, Terra, Steven G, Huyck, Susan, Wu, Larry, Annpey Pong, Calle, Roberto A, Gallo, Silvina, Darekar, Amanda, and Mancuso, James P

Subjects
FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Cardiology, 110323 Surgery, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, 453_Supplementary_Fig1 for Efficacy of ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies by Jie Liu, Lisa Tarasenko, Steven G Terra, Susan Huyck, Larry Wu, Annpey Pong, Roberto A Calle, Silvina Gallo, Amanda Darekar and James P Mancuso in Diabetes & Vascular Disease Research

Published
2019
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44. Bioequivalence of Ertugliflozin/Metformin Fixed‐Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components

Author

Dawra, Vikas Kumar, primary, Liang, Yali, additional, Wei, Hua, additional, Pelletier, Kathleen, additional, Shi, Haihong, additional, Hickman, Anne, additional, Bass, Almasa, additional, Terra, Steven G., additional, Zhou, Susan, additional, Krishna, Rajesh, additional, and Sahasrabudhe, Vaishali, additional

Published
2019
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48. 1197-P: Two-Year Effects of Ertugliflozin on Renal Function

Author

CHERNEY, DAVID, primary, HEERSPINK, HIDDO L., additional, FREDERICH, ROBERT, additional, MALDONADO, MARIO, additional, PONG, ANNPEY, additional, XU, ZHI JIN, additional, LIU, JIE, additional, MANCUSO, JAMES P., additional, GANTZ, IRA, additional, and TERRA, STEVEN G., additional

Published
2019
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50. Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia

Author

Ji, Linong, primary, Liu, Yanmei, additional, Miao, Heng, additional, Xie, Yongli, additional, Yang, Ming, additional, Wang, Wei, additional, Mu, Yuting, additional, Yan, Ping, additional, Pan, Sharon, additional, Lauring, Brett, additional, Liu, Shu, additional, Huyck, Susan, additional, Qiu, Yanping, additional, and Terra, Steven G., additional

Published
2019
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