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1. An evaluation of a supratherapeutic dose of inclisiran on cardiac repolarization in healthy volunteers: A phase I, randomized study

Author

David Kallend, Jay Mason, Patrick F. Smith, Michael J. Koren, Robert Stoekenbroek, YanLing He, and Peter Wijngaard

Subjects
Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270
Abstract

Abstract Inclisiran is a small interfering RNA molecule that has been shown to provide an effective and sustained reduction in low‐density lipoprotein cholesterol levels. This study aimed to determine whether a supratherapeutic dose of inclisiran affects cardiac repolarization and conduction in healthy volunteers. A phase I, randomized, double‐blind, double‐dummy, placebo‐ and positive‐controlled, three‐way crossover study was performed in 48 healthy volunteers. Volunteers were assigned to three treatments in a randomized sequence: a supratherapeutic dose of inclisiran sodium (900 mg), placebo, or moxifloxacin 400 mg as a positive control, with a minimum 7‐day washout period between treatments. Continuous electrocardiogram monitoring was performed from >60 min before dosing until 48 h after dosing. Pharmacokinetics, pharmacodynamics, and safety were also assessed. Inclisiran, at a supratherapeutic dose, did not show a clinically significant effect on the QT interval (Fridericia correction formula [QTcF]; maximal placebo‐ and baseline‐corrected change: 2.5 ms [90% confidence interval: 0.6, 4.5]) near the maximal plasma concentrations at 4 h. In addition, inclisiran did not show any effects on other electrocardiogram intervals or ST‐ and T‐wave morphology. The positive control, moxifloxacin, demonstrated the expected changes in QTcF interval, validating the adequate sensitivity of the study. A supratherapeutic dose of inclisiran sodium (900 mg) had no effect on the QTcF interval or other electrocardiogram parameters, providing additional insight and reassurance regarding the safety profile of inclisiran.

Published
2022
Full Text
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2. SYNTAX Score and Long-Term Outcomes

Author

Fumiaki Ikeno, Maria Mori Brooks, Kaori Nakagawa, Min-Kyu Kim, Hideaki Kaneda, Yoshiaki Mitsutake, Helen A. Vlachos, Leonard Schwartz, Robert L. Frye, Sheryl F. Kelsey, Katsuhisa Waseda, Mark A. Hlatky, Katherine M. Detre, Trevor J. Orchard, Stephen B. Thomas, Kim Sutton Tyrrell, Jamal S. Rana, Frani Averbach, Joan M. MacGregor, Scott M. O’Neal, Kathleen Pitluga, Veronica Sansing, Mary Tranchine, Sharon W. Crow, Marianne (Marnie) Bertolet, Regina Hardison, Kevin Kip, Manuel Lombardero, Jiang Lu, Sue Janiszewski, Darina Protivnak, Sarah Reiser, Stephen Barton, Ping Guo, Yulia Kushner, Owen Michael, Jeffrey P. Martin, Christopher Kania, Michael Kania, Jeffrey O’Donnell, Rae Ann Maxwell, Suzanne Goldberg, Yves Rosenberg, Patrice Desvigne-Nickens, Abby Ershow, David Gordon, Dina Paltoo, Teresa L.Z. Jones, Whady Hueb, José Ramires, Neuza Lopes, Bernardo Léo Wajchenberg, Eulogio E. Martinez, Sergio A. Oliveira, Expedito E. Ribeiro, Marcos Perin, Roberto Betti, George Steiner, Alan Barolet, Yolanda Groenewoud, Lisa Mighton, Kathy Camelon, Robert O’Rourke, Janet Blodgett, Edward Sako, Judith Nicastro, Robin Prescott, Charanjit Rihal, Frank Kennedy, Gregory Barsness, Amanda Basu, Alfredo Clavell, Robert Frye, David R. Holmes, Amir Lerman, Charles Mullaney, Guy Reeder, Robert Rizza, Hartzell Schaff, Steven Smith, Virend Somers, Thoralf Sundt, Henry Ting, R. Scott Wright, Pam Helgemoe, Diane Lesmeister, Deborah Rolbiecki, Luis Lepe-Montoya, Jorge Escobedo, Rafael Barraza, Rubén Baleón, Arturo Campos, Paula García, Carlos Lezama, Carlos Miramontes, Salvador Ocampo, Joaquín V. Peñafiel, Aquiles Valdespino, Raúl Verdín, Héctor Albarrán, Fernando Ayala, Eduardo Chávez, Héctor Murillo, Luisa Virginia Buitrón, Beatriz Rico-Verdin, Fabiola Angulo, Dale Adler, Austin Arthur Halle, Faramarz Ismail-Beigi, Suvinay Paranjape, Stacey Mazzurco, Karen Ridley, Kodangudi Ramanathan, Solomon Solomon, Barry Wall, Darryl Weinman, Tammy Touchstone, Lillie Douglas, Martial Bourassa, Jean-Claude Tardif, Jean-Louis Chiasson, Marc Andre Lavoie, Rémi Rabasa-Lhoret, Hélène Langelier, Suzy Foucher, Johanne Trudel, Scott Monrad, Vankeepuram Srinivas, Joel Zonszein, Jill Crandall, Helena Duffy, Eugen Vartolomei, Spencer King, Carl Jacobs, David Robertson, Marty Porter, Melanie Eley, Emmalee Nichols, Jennifer LaCorte, Melinda Mock, William Rogers, Fernando Ovalle, David Bell, Vijay K. Misra, William B. Hillegass, Raed Aqel, Penny Pierce, Melanie Smith, Leah Saag, Ashley Vaughn, Dwight Smith, Tiffany Grimes, Susan Rolli, Roberta Hill, Beth Dean Barrett, Clarinda Morehead, Ken Doss, Charles J. Davidson, Mark Molitch, Nirat Beohar, Elaine Massaro, Lynne Goodreau, Fabiola Arroyo, Petr Neužil, Lenka Pavlickova, Štĕpánka Stehlíková, Jaroslav Benedik, Liz Coling, Richard Davies, Christopher Glover, Michel LeMay, Thierry Mesana, Teik Chye Ooi, Mark Silverman, Alexander Sorisky, Colette Favreau, Susan McClinton, Melvin Weiss, Irene Weiss, Leo Saulle, Harichandra Kannam, Joanne C. Kurylas, Lorraine Vasi, John Douglas, Ziyad Ghazzal, Laurence Sperling, Priya Dayamani, Suzanne Gebhart, Sabreena Basu, Tarek Helmy, Vin Tangpricha, Pamela Hyde, Margaret Jenkins, Barbara P. Grant, Kenneth Kent, William Suddath, Michelle Magee, Patricia Julien-Williams, Vida Reed, Carine Nassar, Gilles Dagenais, Claude Garceau, Dominique Auger, Christopher Buller, Tom Elliott, Krishnan Ramanathan, Donald Ricci, Rebecca Fox, Daniela Kolesniak, Michael Attubato, Frederick Feit, Stephen Richardson, Ivan Pena Sing, James Slater, Angela Amendola, Bernardo Vargas, Nicholas Tsapatsaris, Bartholomew Woods, Gary Cushing, Martin Rutter, Premranjan Singh, Gail DesRochers, Gail Woodhead, Deborah Gannon, Nancy Shinopulos Campbell, Michael Ragosta, Ian Sarembock, Eric Powers, Eugene Barrett, Linda Jahn, Karen Murie, Gladwin Das, Gardar Sigurdsson, Carl White, John Bantle, J. Bruce Redmon, Christine Kwong, Jacqueline Tamis-Holland, Jeanine Albu, Judith S. Hochman, James Wilentz, Sylvaine Frances, Deborah Tormey, Carl Pepine, Karen Smith, Laurence Kennedy, Karen Brezner, Tempa Curry, Frank Bleyer, Stewart Albert, Arshag Mooradian, Sharon Plummer, Francisco Fuentes, Roberto Robles, Victor Lavis, Jaime Gomez, Cesar Iliescu, Carol Underwood, Maria Selin Fulton, Julie Gomez Ramirez, Jennifer Merta, Glenna Scott, Ashok Krishnaswami, Lynn Dowdell, Sarah Berkheimer, Adam Greenbaum, Fred Whitehouse, Raquel Pangilinan, Kelly Mann, Alice K. Jacobs, Elliot Sternthal, Susana Ebner, Zoran Nedeljkovic, Paula Beardsley, David Schneider, Richard Pratley, William Cefalu, Joel Schnure, Michaelanne Rowen, Linda Tilton, Alan Niederman, Cristina Mata, Terri Kellerman, John Farmer, Alan J. Garber, Neal Kleiman, Nancy Howard, Debra Nichols, Madonna Pool, Christopher Granger, Mark Feinglos, George Adams, Jennifer Green, Bernadette Druken, Dani Underwood, J. Lawrence Stafford, Thomas Donner, Warren Laskey, Dana Beach, John Lopez, Andrew Davis, David Faxon, Sirimon Reutrakul, Emily Bayer, Oscar Marroquin, Howard Cohen, Mary Korytkowski, Glory Koerbel, Lisa Baxendell, Debbie Rosenfelder, Louise DeRiso, Carole Farrell, Tina Vita, Janet McGill, Ronald Krone, Richard Bach, Carol Recklein, Kristin M. Luepke, Mary Jane Clifton, Michael E. Farkouh, Michael C. Kim, Donald A. Smith, Ida Guzman, Arlene Travis, James O’Keefe, Alan Forker, William Isley, Richard Moe, Paul Kennedy, Margaret Rosson, Aimee Long, Eric Bates, William Herman, Rodica Pop-Busui, Claire Duvernoy, Martin Stevens, Ann Luciano, Cheryl Majors, Sheldon H. Gottlieb, Annabelle Rodriguez, Melanie Herr, David Williams, Robert J. Smith, J. Dawn Abbott, Marc J. Laufgraben, Mary Grogan, Janice Muratori, Gabriel Habib, Marco Marcelli, Issam Mikati, Emilia Cordero, Gina Caldwell, David Schechter, Daniel Lorber, Phyllis August, Maisie Brown, Patricia Depree, Kurt Huber, Ursula Hanusch-Enserer, Nelly Jordanova, Dilek Cilesiz, Birgit Vogel, Ben McCallister, Michael Kleerekoper, Kelly Mandagere, Robert Urbanic, James Bengston, Bobby K. Kong, Andrew Pruitt, Jeffrey Sanfield, Carol Carulli, Ruth Churley-Strom, Raymond Magorien, Kwame Osei, Cecilia Casey Boyer, Richard Lee, Pasquale Palumbo, Joyce Wisbey, Edwin Alderman, Anne Schwarzkopf Michael Steffes, Maren Nowicki, Jean Bucksa, Bernard Chaitman, Jane Eckstein, Karen Stocke, Derek B. Boothroyd, Kathryn A. Melsop, Burton E. Sobel, Dagnija Neimane, Ami E. Iskandrian, Mary Beth Schaaf, Saul Genuth, Theresa Bongarno, Richard Nesto, Karen Hultberg, Helene Rosenhouse-Romeo, Georgia Pambianco, Michael Mock, Sheryl Kelsey, Trevor Orchard, Thomas Ryan, Harold Lebovitz, Robert Brown, Gottlieb Friesinger, Edward Horton, Jay Mason, Renu Virmani, Lawrence Wechsler, C. Noel Bairey-Merz, J. Ward Kennedy, Elliott Antman, John Colwell, Sarah Fowler, Curt Furberg, Lee Goldman, Bruce Jennings, and Scott Rankin

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Hazard ratio, Percutaneous coronary intervention, 030204 cardiovascular system & hematology, medicine.disease, Revascularization, humanities, Cardiac surgery, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Angioplasty, Conventional PCI, medicine, Cardiology, 030212 general & internal medicine, Myocardial infarction, Cardiology and Cardiovascular Medicine, business, Stroke
Abstract

Background The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease. Objectives This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. Methods Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years. Results A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p Conclusions Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305)

Published
2017

3. Alex Morgan. Jägerin der Zwischenwelt : Der geheimnisvolle Tunnel. Folge 1

Author

Jay Mason and Jay Mason

Subjects
Private investigators--Fiction, Good and evil--Fiction, College students--Fiction
Abstract

Als Alex eine E-Mail von einem gewissen c0nundrum bekommt, ist ihr Interesse geweckt. Woher weiß der geheimnisvolle Unbekannte von ihren Aktivitäten in der Zwischenwelt? Ist das vielleicht ein Scherz? Oder ist sein Hinweis zu der seltsamen Energie, die angeblich von ihrem College ausgeht, ernst gemeint? Alex begibt sich in das verzweigte unterirdische Tunnelsystem und begegnet dort einer Gruppe von Mädchen, die aus Unwissenheit einen alten Fluch heraufbeschworen haben... Die Serie: Alexandra'Alex'Morgan ist eine 19-jährige Studentin und Tochter zweier preisgekrönter Wissenschaftler. Was niemand ahnt: Nebenbei arbeitet Alex als paranormale Ermittlerin und löst mysteriöse Fälle. Zusammen mit ihrem besten Freund Rusty und dem geheimnisvollen Fremden c0nundrum kommt sie einer Verschwörung auf die Spur, die nicht nur ihr eigenes Leben, sondern auch das ihrer Familie in Gefahr bringt...

Published
2018

4. Alex Morgan. Jägerin der Zwischenwelt : Das Wesen aus der Dunkelheit. Folge 2

Author

Jay Mason and Jay Mason

Subjects
Private investigators--Fiction, Paranormal fiction, College students--Fiction
Abstract

Eines Nachts erwacht Alex und bemerkt seltsame Lichter, die über einem nahegelegenen Kornfeld kreisen. Sie ist sich sicher: Das hat mit den Aktivitäten im Hochsicherheitszentrum zu tun, in dem ihre Eltern arbeiten. Dann wird auch noch Rusty's jüngere Schwester Cat genau an dieser Stelle von einer abscheulichen Kreatur gejagt. Handelt es sich dabei um das sagenumwobene Howardsfield Monster? Oder gibt es eine natürliche Erklärung? Alex und Rusty beginnen zu ermitteln - aber dann kommt ihnen Joe Trend, der berühmte Schauspieler und selbst ernannte Ufologe, in die Quere... Die Serie: Alexandra'Alex'Morgan ist eine 19-jährige Studentin und Tochter zweier preisgekrönter Wissenschaftler. Was niemand ahnt: Nebenbei arbeitet Alex als paranormale Ermittlerin und löst mysteriöse Fälle. Zusammen mit ihrem besten Freund Rusty und dem geheimnisvollen Fremden c0nundrum kommt sie einer Verschwörung auf die Spur, die nicht nur ihr eigenes Leben, sondern auch das ihrer Familie in Gefahr bringt...

Published
2018

5. Alex Morgan. Jägerin der Zwischenwelt : Gefährliches Spiegelbild. Folge 3

Author

Jay Mason and Jay Mason

Subjects
Private investigators--Fiction, Paranormal fiction, College students--Fiction
Abstract

Alex bemerkt, dass sich ihre Mitschüler plötzlich sehr merkwürdig verhalten. Jeder, der in einen Spiegel schaut, wird paranoid und ist davon überzeugt, dass sein Spiegelbild versucht, ihn umzubringen. Bald schon zieht sich eine Spur der Verwüstung durch die gesamte Stadt - überall schlagen die Menschen Fensterscheiben ein und zerstören alle Spiegel. Als auch ihre Mutter infiziert wird, ist Alex überzeugt, dass die Ursache für das Chaos im Hochsicherheitszentrum zu suchen ist. Mit Hilfe von c0nundrum brechen Alex und ihre Freunde dort ein und entdecken ein schreckliches Geheimnis... Die Serie: Alexandra'Alex'Morgan ist eine 19-jährige Studentin und Tochter zweier preisgekrönter Wissenschaftler. Was niemand ahnt: Nebenbei arbeitet Alex als paranormale Ermittlerin und löst mysteriöse Fälle. Zusammen mit ihrem besten Freund Rusty und dem geheimnisvollen Fremden c0nundrum kommt sie einer Verschwörung auf die Spur, die nicht nur ihr eigenes Leben, sondern auch das ihrer Familie in Gefahr bringt...

Published
2018

6. The Howardsfield Horror : Alex Morgan. Paranormal Investigator. Episode 2

Author

Jay Mason and Jay Mason

Abstract

Alex is convinced the lights that have been hovering over the local cornfields are connected to the activities at the high security science Centre where her parents work. But then Rusty's younger sister, Cat, hopeful of seeing a UFO, is chased by a hideous creature. She claims that this is the monster from the local ghostly legend, the Howardsfield Horror. Alex and Rusty decide to investigate - until Joe Trend, the famous actor and amateur UFOlogist, gets in their way... The Series: Alexandra Morgan, known as Alex, is a 19-year-old college student and the daughter of two prize-winning scientists. What no one knows is that in her free time Alex is a paranormal investigator who takes on a variety of mysterious cases. Together with her best friend Rusty and an online associate known only as c0nundrum, she unravels a conspiracy that will put her own life and that of her family in danger...

Published
2018

7. The Clique : Alex Morgan. Paranormal Investigator. Episode 1

Author

Jay Mason and Jay Mason

Abstract

Alex is contacted by the enigmatic c0nundrum, who hires her to investigate a strange energy he senses emanating from her college. Her research leads her to a clique of popular girls, who are dabbling with ancient mystical forces deep underground in a forgotten mine. She races to stop them before an old evil is released... The Series: Alexandra Morgan, known as Alex, is a 19-year-old college student and the daughter of two prize-winning scientists. What no one knows is that in her free time Alex is a paranormal investigator who takes on a variety of mysterious cases. Together with her best friend Rusty and an online associate known only as c0nundrum, she unravels a conspiracy that will put her own life and that of her family in danger...

Published
2018

8. Strange Reflections : Alex Morgan. Paranormal Investigator. Episode 3

Author

Jay Mason and Jay Mason

Abstract

Alex notices that people start behaving oddly when they look into mirrors. They become paranoid and convinced that their mirror counterparts are trying to kill them. Soon students wreak havoc at the college and run amok through the town smashing windows. They attack anyone they believe may be working with their mirror selves. Even Alex's mother gets infected, confirming Alex's suspicion that the Centre is involved. With c0nundrum's help, Alex and her friends break into the Centre and discover the terrible secret at its heart... The Series: Alexandra Morgan, known as Alex, is a 19-year-old college student and the daughter of two prize-winning scientists. What no one knows is that in her free time Alex is a paranormal investigator who takes on a variety of mysterious cases. Together with her best friend Rusty and an online associate known only as c0nundrum, she unravels a conspiracy that will put her own life and that of her family in danger...

Published
2018

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