Výsledky vyhledávání - "Alvin Estilo"

Evaluating the impact of a Risk Evaluation and Mitigation Strategy with tolvaptan to monitor liver safety in patients with autosomal dominant polycystic kidney disease

Autor: Alvin Estilo, LaRee Tracy, Carol Matthews, Michele Riggen, Annette Stemhagen, Timothy Wilt, Anatoliy Krakovich, Charlotte Jones-Burton, Vinu George, Robert McQuade, Mirza Rahman

Publikováno v: Clinical Kidney Journal. 15:1553-1561

Background On approval of JYNARQUE (tolvaptan) for use in patients with autosomal dominant polycystic kidney disease (ADPKD) at risk for rapid progression, the US Food and Drug Administration required a Risk Evaluation and Mitigation Strategy (REMS)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::26b2655b542db45c7b16c0e453f06c47
https://doi.org/10.1093/ckj/sfac076

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Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study

Autor: Linda McCormick, Mirza Rahman, Alvin Estilo

Publikováno v: Advances in Therapy

Introduction Hyponatremia is a common condition of varying etiology among hospitalized patients and is associated with adverse outcomes. Treatment to normalize serum sodium is advisable. Tolvaptan received European Union marketing authorization for h

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f950283b1c992d18b73f57bd5860fbf6
http://europepmc.org/articles/PMC8572184

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Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials

Autor: Denise Coffey, Ann Marie Stanley, Liliam Pineda-Salgado, Don C. Rockey, Meenal Patwardhan, Melissa Palmer, Raúl J. Andrade, Ritu Raheja, John Caminis, Sandzhar Abdullaev, Lara Dimick-Santos, David L. Bourdet, Paul H. Hayashi, Daniel Seekins, J. Hey-Hadavi, Haifa Tyler, Alvin Estilo

Publikováno v: Drug Safety

Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs),

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee031e6b817903ec93fa129cfbd98131
https://doi.org/10.1007/s40264-021-01051-5

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Clinical Pattern of Tolvaptan-Associated Liver Injury in Trial Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD): An Analysis of Pivotal Clinical Trials

Autor: David H. Alpers, James H. Lewis, Christine M. Hunt, James W. Freston, Vicente E. Torres, Hui Li, Wenchyi Wang, Molly E. Hoke, Sharin E. Roth, Lucas Westcott-Baker, Alvin Estilo

Publikováno v: American journal of kidney diseases : the official journal of the National Kidney Foundation.

Tolvaptan is associated with risk of drug-induced liver injury when used to treat autosomal dominant polycystic kidney disease (ADPKD). After this risk was described based on the clinical trials TEMPO 3:4 and TEMPO 4:4, additional data from the REPRI

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::43d6c18199374116e2b88ebeb5db7779
https://pubmed.ncbi.nlm.nih.gov/36191725

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A Post Hoc Analysis of Statin Use in Tolvaptan Autosomal Dominant Polycystic Kidney Disease Pivotal Trials

Autor: Olga Sergeyeva, Susan E. Shoaf, Alvin Estilo, John Ouyang, Deborah Leung, Hui Li

Publikováno v: Clinical Journal of the American Society of Nephrology. 15:643-650

Background and objectives Tolvaptan is approved to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. Because in vitro studies indicated that the tolvaptan oxobutyric acid me

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d2db2b7d73f1937c9f85b693463c1d35
https://doi.org/10.2215/cjn.08170719

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Using an Automated Algorithm to Identify Potential Drug-Induced Liver Injury Cases in a Pharmacovigilance Database

Autor: Liliam Pineda Salgado, Mirza Rahman, Michael Jan, Ritu Gupta, Vinu George, Alvin Estilo, Osman Turkoglu

Publikováno v: Advances in Therapy

Introduction Drug-induced liver injury (DILI) is the most frequent cause of acute liver failure in North America and Europe, but it is often missed because of unstandardized diagnostic methods and criteria. This study aimed to develop and validate an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4516793c7741c9352cf72b035ee9778
https://pubmed.ncbi.nlm.nih.gov/34319549

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Autor: Susan E, Shoaf, John, Ouyang, Olga, Sergeyeva, Alvin, Estilo, Hui, Li, Deborah, Leung

Publikováno v: Clin J Am Soc Nephrol

BACKGROUND AND OBJECTIVES: Tolvaptan is approved to slow kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD) at risk of rapid progression. Because in vitro studies indicated that the tolvaptan oxobutyric acid m

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::8a76c68a7444116ca13ecc0363ed0389
https://pubmed.ncbi.nlm.nih.gov/32241780

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