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5. Integrated safety studies of the urate reabsorption inhibitor lesinurad in treatment of gout

Author

Terkeltaub, Robert, Saag, Kenneth G, Goldfarb, David S, Baumgartner, Scott, Schechter, Bruce M, Valiyil, Ritu, Jalal, Diana, Pillinger, Michael, and White, William B

Subjects
Kidney Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Cardiovascular Diseases, Clinical Trials, Phase III as Topic, Drug Therapy, Combination, Enzyme Inhibitors, Female, Gout, Gout Suppressants, Humans, Kidney Diseases, Male, Middle Aged, Randomized Controlled Trials as Topic, Thioglycolates, Treatment Outcome, Triazoles, Uric Acid, Xanthine Oxidase, Young Adult, gout, lesinurad, serum creatinine, treatment-emergent adverse events, xanthine oxidase inhibitor, combination therapy, renal adverse events, cardiovascular adverse events, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract

ObjectiveLesinurad (LESU) is a selective urate reabsorption inhibitor approved at 200 mg daily for use with a xanthine oxidase inhibitor (XOI) to treat hyperuricaemia in gout patients failing to achieve target serum urate on XOI. The aim of the study was to investigate the long-term safety of LESU + XOI therapy.MethodsSafety data were pooled from three 12-month phase III (core) trials evaluating LESU 200 and 400 mg/day combined with an XOI (LESU200+XOI and LESU400+XOI), and two 12-month extension studies using descriptive statistics. To adjust for treatment duration, treatment-emergent adverse events (TEAEs) were expressed as exposure-adjusted incidence rates (patients with events per 100 person-years).ResultsIn the core studies, exposure-adjusted incidence rates for total and total renal-related TEAEs were comparable for XOI alone and LESU200+XOI but higher with LESU400+XOI. Exposure-adjusted incidence rates for serum creatinine (sCr) elevations ⩾1.5×baseline were 2.9, 7.3 and 18.7, respectively. Resolution (sCr ⩽1.2×baseline) occurred in 75-90% of all events, with 66-75% occurring without any study medication interruption. Major adverse cardiovascular events were 3, 4 and 9 with XOI, LESU200+XOI and LESU400+XOI, respectively. Longer exposure in core+extension studies did not increase rates for any safety signals.ConclusionAt the approved dose of 200 mg once-daily combined with an XOI, LESU did not increase renal, cardiovascular or other adverse events compared with XOI alone, except for sCr elevations. With extended exposure in the core+extension studies, the safety profile was consistent with that observed in the core studies, and no new safety concerns were identified.

Published
2019

12. The Swago Creek Basin

Author

White, William B., Storrick, Gary D., Johnsson, Mark J., LaMoreaux, James W., Series editor, and White, William B., editor

Published
2018
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13. Karst Geomorphology

Author

White, William B., White, Elizabeth L., LaMoreaux, James W., Series editor, and White, William B., editor

Published
2018
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17. Henry R. Black, MD (1942-2024).

Author

White, William B.

Abstract

The article is an obituary for Dr. Henry R. Black, a renowned hypertension specialist, clinical trialist, professor, and medical educator. Dr. Black was born and raised in the Bronx and completed his medical education at Columbia University and the New York University School of Medicine. He had a successful career at Yale University, where he became an expert in clinical hypertension and cardiovascular prevention. Dr. Black also made significant contributions to the field through his involvement in research studies and professional organizations. He passed away in 2024, leaving behind a substantial legacy in the field of clinical hypertension. [Extracted from the article]

Published
2024
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22. Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium

Author

Sager, Philip T, Seltzer, Jonathan, Turner, J Rick, Anderson, Jeffrey L, Hiatt, William R, Kowey, Peter, Prochaska, Judith J, Stockbridge, Norman, and White, William B

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Patient Safety, Cardiovascular, Good Health and Well Being, Cardiovascular Agents, Cardiovascular Diseases, Clinical Trials as Topic, Congresses as Topic, Drug Approval, Humans, United States, United States Food and Drug Administration, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank cosponsored by the Cardiac Safety Research Consortium, the US Food and Drug Administration, and the American College of Cardiology, held at American College of Cardiology's Heart House, Washington, DC, on February 19, 2014. Studies to assess cardiovascular (CV) risk of a new drug are sometimes requested by regulators to resolve ambiguous safety signals seen during its development or among other members of its class. Think Tank participants thought that important considerations in undertaking such studies were as follows: (1) plausibility-how likely it is that a possible signal indicating risk is real, based on strength of evidence, and/or whether a plausible mechanism of action for potential CV harm has been identified; (2) relevance-what relative and absolute CV risk would need to be excluded to determine that the drug had an acceptable benefit-to-risk balance for its use in the intended patient population; and (3) how plausibility and relevance influence the timing and approach to further safety assessment.

Published
2015

29. Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension

Author

Parati, Gianfranco, Stergiou, George S., Bilo, Grzegorz, Kollias, Anastasios, Pengo, Martino, Ochoa, Juan Eugenio, Agarwal, Rajiv, Asayama, Kei, Asmar, Roland, Burnier, Michel, De La Sierra, Alejandro, Giannattasio, Cristina, Gosse, Philippe, Head, Geoffrey, Hoshide, Satoshi, Imai, Yutaka, Kario, Kazuomi, Li, Yan, Manios, Efstathios, Mant, Jonathan, McManus, Richard J., Mengden, Thomas, Mihailidou, Anastasia S., Muntner, Paul, Myers, Martin, Niiranen, Teemu, Ntineri, Angeliki, O’Brien, Eoin, Octavio, José Andres, Ohkubo, Takayoshi, Omboni, Stefano, Padfield, Paul, Palatini, Paolo, Pellegrini, Dario, Postel-Vinay, Nicolas, Ramirez, Agustin J., Sharman, James E., Shennan, Andrew, Silva, Egle, Topouchian, Jirar, Torlasco, Camilla, Wang, Ji Guang, Weber, Michael A., Whelton, Paul K., White, William B., and Mancia, Giuseppe

Published
2021
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31. Mineralogy of Mammoth Cave

Author

White, William B., LaMoreaux, James W., Series editor, Hobbs III, Horton H., editor, Olson, Rickard A, editor, Winkler, Elizabeth G, editor, and Culver, David C., editor

Published
2017
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48. Karst

Author

Jones, William K., primary and White, William B., additional

Published
2019
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49. Contributors

Author

Allred, Kevin, primary, am Ende, Barbara Anne, additional, Anthony, Darlene M., additional, Auler, Augusto S., additional, Bakalowicz, Michel, additional, Barnes, Craig M., additional, Barton, Hazel A., additional, Bar-Yosef, Ofer, additional, Bedos, Anne, additional, Bichuette, Maria E., additional, Boch, Ronny, additional, Bolger, Terry, additional, Brady, James E., additional, Brancelj, Anton, additional, Brucker, Roger W., additional, Bure, Codi M., additional, Chakrabarty, Prosanta, additional, Chen, Weihai, additional, Christman, Mary C., additional, Cigna, Arrigo A., additional, Clemmer, Gregg S., additional, Coke, James G., additional, Contos, Annalisa K., additional, Crothers, George, additional, Culver, David C., additional, Davis, Donald G., additional, Deharveng, Louis, additional, Delić, Teo, additional, Denniston, Rhawn F., additional, Dreybrodt, Wolfgang, additional, Droms, Yvonne, additional, Dublyansky, Yuri, additional, Dumnicka, Elzbieta, additional, Elliott, Lee F., additional, Engel, Annette Summers, additional, Fabel, Derek, additional, Faille, Arnaud, additional, Fenolio, Dante B., additional, Ferreira, Rodrigo Lopes, additional, Fišer, Žiga, additional, Fišer, Cene, additional, Fong, Daniel W., additional, Ford, Derek, additional, Fountain, Andrew G., additional, Fratesi, S. Beth, additional, Friedrich, Markus, additional, Frisia, Silvia, additional, Gabrovšek, Franci, additional, Galassi, Diana M.P., additional, Gibert, Janine, additional, Gluesenkamp, Andrew G., additional, Goldberg, Paul, additional, Gorički, Špela, additional, Granger, Darryl E., additional, Green, Ronald T., additional, Gulley, Jason D., additional, Häuselmann, Philipp, additional, Hays, Phillip D., additional, Heinerth, Jill, additional, Herman, Janet S., additional, Hervant, Frédéric, additional, Hill, Carol A., additional, Hobbs III, Horton H., additional, Holler, Cato, additional, Howarth, Francis G., additional, Hubbard, David A., additional, Humphreys, William F., additional, James, Julia M., additional, Jeannin, Pierre-Yves, additional, Jeffery, William R., additional, Jones, William K., additional, Kambesis, Patricia, additional, Katz, Brian G., additional, Kaufmann, Georg, additional, Kempe, Stephan, additional, Klimchouk, Alexander, additional, Knierim, Katherine J., additional, Konec, Marjeta, additional, Kowalko, Johanna E., additional, Krejca, Jean K., additional, Latella, Leonardo, additional, Loop, Caroline M., additional, Lučić, Ivo, additional, Lukić, Marko, additional, Lundberg, Joyce, additional, Ma, Li, additional, Macalady, Jennifer L., additional, Mainiero, Maurizio, additional, Malard, Florian, additional, Matthews, Peter, additional, Mead, Jim I., additional, Medville, Douglas M., additional, Mejía-Ortíz, Luis M., additional, Minton, Mark, additional, Moore, Marianne S., additional, Mulec, Janez, additional, Murphy, Phillip J., additional, Mylroie, John E., additional, Niemiller, Matthew L., additional, Onac, Bogdan P., additional, Palmer, Arthur N., additional, Parise, Mario, additional, Parker, Ceth W., additional, Pérez, María Alejandra, additional, Perșoiu, Aurel, additional, Pipan, Tanja, additional, Polyak, Victor J., additional, Prié, Vincent, additional, Reddell, James R., additional, Romanov, Douchko, additional, Ross, Cordelia, additional, Sasowsky, Ira D., additional, Sauro, Ugo, additional, Sauro, Francesco, additional, Schubert, Blaine W., additional, Schwartz, Benjamin, additional, Šebela, Stanka, additional, Shear, William A., additional, Shifflett, Thomas E., additional, Simon, Kevin S., additional, Sket, Boris, additional, Slay, Michael E., additional, Soares, Daphne, additional, Soares, Gustavo A., additional, Spötl, Christoph, additional, Springer, Gregory S., additional, Steward, Paul Jay, additional, Stone, Andrea, additional, Taylor, Steven J., additional, Trajano, Eleonora, additional, Trontelj, Peter, additional, Verovnik, Rudi, additional, Vesper, Dorothy J., additional, Waltham, Tony, additional, Watson, Patty Jo, additional, White, Elizabeth L., additional, White, William B., additional, Wiles, Mike, additional, William Steele, C., additional, Wilson, John M., additional, Worthington, Stephen R.H., additional, Yancey, Mary Elizabeth, additional, Yang, Jun-xing, additional, Zagmajster, Maja, additional, Zhang, Yuanhai, additional, Zhao, Yahui, additional, Zhu, Xuewen, additional, Zigler, Kirk S., additional, and Zupan Hajna, Nadja, additional

Published
2019
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