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Chronobiology International
The Journal of Biological and Medical Rhythm Research
Volume 38, 2021 - Issue 1
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Guidelines for the design and conduct of human clinical trials on ingestion-time differences – chronopharmacology and chronotherapy – of hypertension medications

Ramón C. Hermidaa Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo, Vigo, Spain;b Department of Biomedical Engineering, Cockrell School of Engineering, the University of Texas at Austin, Austin, Texas, USACorrespondence[email protected]
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Michael H. Smolenskyb Department of Biomedical Engineering, Cockrell School of Engineering, the University of Texas at Austin, Austin, Texas, USA;c Division of Cardiology, McGovern School of Medicine, the University of Texas at Houston, Houston, Texas, USA
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Horia Baland Department of Internal Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania
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Richard J. Castriottae Department of Medicine; Division of Pulmonary, Critical Care and Sleep Medicine; Keck School of Medicine, University of Southern California, Los Angeles, California, USA
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Juan J. Crespoa Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo, Vigo, Spain;f Centro de Salud de Bembrive, Estructura de Xestión Integrada de Vigo, Servicio Galego de Saúde (SERGAS), Vigo, Spain
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Yaron Dagang Applied Chronobiology Research Center, Tel-Hai Academic College, Israel; Human Biology Department, Haifa University, Israel;h Sleep and Fatigue Institute, Assuta Medical Center, Israel
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Sherine El-Toukhyi Intramural Research Program, National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, Maryland, USA
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José R. Fernándeza Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo, Vigo, Spain
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Garret A. FitzGeraldj Institute for Translational Medicine and Therapeutics, Smilow Center for Translational Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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Akio Fujimurak Department of Clinical Pharmacology, Jichi Medical University, Tochigi, Japan;l Department of Internal Medicine, Shin-Kaminokawa Hospital, Tochigi, Japan
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Yong-Jian Gengm Department of Internal Medicine, McGovern School of Medicine, University of Texas Health Science Center at Houston, Houston, Texas, USA
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Ramón G. Hermida-Ayalan Chief Pharmacology Officer, Circadian Ambulatory Technology & Diagnostics (CAT&D), Santiago de Compostela, Spain
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Antonio P. Machadoo President, Update em Medicina, Lisboa, Portugal
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Luiz Menna-Barretop Escola de Artes, Ciências e Humanidades, Grupo Multidisciplinar de Desenvolvimento e Ritmos Biológicos (GMDRB), Universidade de São Paulo, São Paulo, Brazil
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Artemio Mojóna Bioengineering & Chronobiology Laboratories; Atlantic Research Center for Information and Communication Technologies (atlanTTic), University of Vigo, Vigo, Spain
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Alfonso Oteroq Servicio de Nefrología, Complejo Hospitalario Universitario de Ourense, Estructura de Xestión Integrada de Ourense, Verín e O Barco de Valdeorras, Servicio Galego de Saúde (SERGAS), Ourense, Spain
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R. Daniel Rudicr Department of Pharmacology & Toxicology, Augusta University, Augusta, Georgia, USA
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Eva Schernhammers Department of Epidemiology, Harvard T.H Chan School of Public Health, Boston, Massachusetts, USA;t Department of Epidemiology, Center for Public Health, Medical University of Vienna, Vienna, Austria;u Channing Division of Network Medicine, Harvard Medical School, Boston, Massachusetts, USA
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Carsten Skarkej Institute for Translational Medicine and Therapeutics, Smilow Center for Translational Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
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Tomoko Y. Steenv Department of Microbiology and Immunology, School of Medicine, Georgetown University, Washington, DC, USA
,
Martin E. Youngw Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA
&
Xiaoyun Zhaox Respiratory and Critical Care Medicine Department, Sleep Medicine Center, Tianjin Chest Hospital, Tianjin, China
 show all
Pages 1-26 | Received 30 Oct 2020, Accepted 01 Nov 2020, Published online: 20 Dec 2020

Citations (18)

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Read on this site (5)

Ramón C. Hermida, Michael H. Smolensky, Artemio Mojón & José R. Fernández. (2023) Critical appraisal of recent translational chronopharmacology and chronotherapeutic reviews, meta-analyses, and pragmatic patient trials discloses significant deficiencies of design and conduct and suspect findings. Chronobiology International 40:8, pages 1146-1167.
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Tami A. Martino & Brian P. Delisle. (2023) Cardiovascular research and the arrival of circadian medicine. Chronobiology International 40:1, pages 1-3.
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Ramón C. Hermida, Artemio Mojón, José R. Fernández, Ramón G. Hermida-Ayala, Juan J. Crespo, María T. Ríos, Manuel Domínguez-Sardiña, Alfonso Otero & Michael H. Smolensky. (2023) Elevated asleep blood pressure and non-dipper 24h patterning best predict risk for heart failure that can be averted by bedtime hypertension chronotherapy: A review of the published literature. Chronobiology International 40:1, pages 63-82.
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Ramón G. Hermida-Ayala, Artemio Mojón, José R. Fernández, Michael H. Smolensky & Ramón C. Hermida. (2022) Ingestion-time differences in the pharmacodynamics of dual-combination hypertension therapies: Systematic review and meta-analysis of published human trials. Chronobiology International 39:4, pages 493-512.
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Ramón C. Hermida, Ramón G. Hermida-Ayala, Artemio Mojón, Michael H. Smolensky & José R. Fernández. (2021) Systematic review and quality evaluation of published human ingestion-time trials of blood pressure-lowering medications and their combinations. Chronobiology International 38:10, pages 1460-1476.
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Articles from other publishers (13)

José R. Fernández, Artemio Mojón, Michael H. Smolensky & Ramón C. Hermida. (2024) Impact of hypertension treatment-time on cardiovascular outcomes: erroneous trial selection leading to suspect findings. Journal of Hypertension 42:1, pages 190-191.
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Molly Crandall, Inna Rabinovich-Nikitin & Lorrie A. Kirshenbaum. 2023. Biology of Women’s Heart Health. Biology of Women’s Heart Health 205 217 .
Jian L. Yeo, Gaurav S. Gulsin, Emer M. Brady, Abhishek Dattani, Joanna M. Bilak, Anna-Marie Marsh, Manjit Sian, Lavanya Athithan, Kelly S. Parke, Joanne Wormleighton, Matthew P. M. Graham-Brown, Anvesha Singh, J. Ranjit Arnold, Claire Lawson, Melanie J. Davies, Hui Xue, Peter Kellman & Gerry P. McCann. (2022) Association of ambulatory blood pressure with coronary microvascular and cardiac dysfunction in asymptomatic type 2 diabetes. Cardiovascular Diabetology 21:1.
Crossref
Chau Le Bao Ho & Christopher M. Reid. (2022) Update on trials examining effects of night-time blood pressure lowering drug treatment on prevention of cardiovascular disease. Exploration of Medicine 2:3, pages 461-467.
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Thomas Marjot, David W. Ray & Jeremy W. Tomlinson. (2022) Is it time for chronopharmacology in NASH?. Journal of Hepatology 76:5, pages 1215-1224.
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Jing Zhao, Yuanyuan Zeng, Jieqiong Weng, Jingfang Zhang, Tingting Yao, Mengfei Yuan & Xiaoxu Shen. (2022) Evening versus morning administration of drug therapy for hypertension: A meta-analysis of randomized controlled trials. European Journal of Integrative Medicine 50, pages 102111.
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S. V. Opolskaya, V. V. Skibitsky, A. V. Fendrikova, T. B. Zabolotskich & A. V. Skibitsky .. (2021) Cardioprotective potential of chronopharmacotherapy in patients with arterial hypertension who had a transient ischemic attack. Kardiologiia 61:11, pages 33-41.
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Michael H. Smolensky & Ramón C. Hermida. (2021) Commentary on Bowles and Shea: Further perspectives and clinical implications of ingestion-time differences in the efficacy of blood pressure-lowering medications. Sleep Medicine Reviews 59, pages 101540.
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Giuseppe Maiolino, Valeria Bisogni, Davide Soranna, Martino F. Pengo, Giacomo Pucci, Roberto Vettor, Cristiano Fava, Gian Luca Colussi, Grzegorz Bilo, Carolina Lombardi, Gianfranco Parati, Gian Paolo Rossi & Alessandro Silvani. (2021) Effects of insomnia and restless legs syndrome on sleep arterial blood pressure: A systematic review and meta-analysis. Sleep Medicine Reviews 59, pages 101497.
Crossref
Ramón C. Hermida, Artemio Mojón, Ramón G. Hermida-Ayala, Michael H. Smolensky & José R. Fernández. (2021) Extent of asleep blood pressure reduction by hypertension medications is ingestion-time dependent: Systematic review and meta-analysis of published human trials. Sleep Medicine Reviews 59, pages 101454.
Crossref
Ramón C. Hermida, Artemio MojónMichael H. SmolenskyJosé R. Fernández. (2021) Lowering Nighttime Blood Pressure With Bedtime Dosing of Antihypertensive Medications: Controversies in Hypertension—Pro Side of the Argument. Hypertension 78:3, pages 879-893.
Crossref
Tomáš Baka, Peter Stanko & Fedor Šimko. (2021) Hypertension chronotherapy: does dosing antihypertensive medication at bedtime determine cardiovascular prognosis?. Klinická farmakologie a farmacie 35:2, pages 74-77.
Crossref
Yong-Jian Geng, Rosalinda Madonna, Ramon C. Hermida & Michael H. Smolensky. (2021) Pharmacogenomics and circadian rhythms as mediators of cardiovascular drug-drug interactions. Current Research in Pharmacology and Drug Discovery 2, pages 100025.
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