Systematic review and quality evaluation of published human ingestion-time trials of blood pressure-lowering medications and their combinations

References

• Baraldo M. 2008. The influence of circadian rhythyms on the kinetics of drugs in humans. Expert Opin Drug Metab Toxicol. 4:175–192. doi:10.1517/17425255.4.2.175
   PubMed Web of Science ®Google Scholar
• Ben-Dov IZ, Kark JD, Ben-Ishay D, Mekler J, Ben-Arie L, Bursztyn M. 2007. Predictors of all-cause mortality in clinical ambulatory monitoring. Unique aspects of blood pressure during sleep. Hypertension. 49(6):1235–1241. doi:10.1161/HYPERTENSIONAHA.107.087262
   PubMed Web of Science ®Google Scholar
• Bicker J, Alves G, Falcao A, Fortuna A. 2020. Timing in drug absoption and disposition: the past, present, and future of chronopharmacokinetics. Br J Pharmacol. 177(10):2215–2239. doi:10.1111/bph.15017
   PubMed Web of Science ®Google Scholar
• Boggia J, Li Y, Thijs L, Hansen TW, Kikuya M, Björklund-Bodegård K, Richart T, Ohkubo T, Kuznetsova T, Torp-Pedersen CH, et al. 2007. Prognostic accuracy of day versus night ambulatory blood pressure: a cohort study. Lancet. 370(9594):1219–1229. doi:10.1016/S0140-6736(07)61538-4
   PubMed Web of Science ®Google Scholar
• Booth JN, Muntner P, Abdalla M, Diaz KM, Viera AJ, Reynolds K, Schwartz JE, Shimbo D. 2016. Differences in night-time and daytime ambulatory blood pressure when diurnal periods are defined by self-report, fixed times, and actigraphy: improving the detection of hypertension study. J Hypertens. 34(2):235–243. doi:10.1097/HJH.0000000000000791
   PubMed Web of Science ®Google Scholar
• Bowles NP, Thosar SS, Herzig MX, Shea SA. 2018. Chronotherapy for hypertension. Curr Hypertens Rep. 20:97. doi:10.1007/s11906-018-0897-4
   PubMed Web of Science ®Google Scholar
• Bruguerolle B. 1998. Chronopharmacokinetics. Current status. Clin Pharmacokinet. 35(2):83–94. doi:10.2165/00003088-199835020-00001
   PubMed Web of Science ®Google Scholar
• Crespo JJ, Piñeiro L, Otero A, Castiñeira C, Ríos MT, Regueiro A, Mojón A, Lorenzo S, Ayala DE, Hermida RC, on behalf of the Hygia Project Investigators. 2013. Administration-time-dependent effects of hypertension treatment on ambulatory blood pressure in patients with chronic kidney disease. Chronobiol Int. 30(1–2):159–175. doi:10.3109/07420528.2012.701459
   PubMed Web of Science ®Google Scholar
• De Giorgi A, Menegatti AM, Fabbian F, Portaluppi F, Manfredini R. 2013. Circadian rhythms and medical diseases: does it matter when drugs are taken? Eur J Intern Med. 24(8):698–706. doi:10.1016/j.ejim.2013.03.019
   PubMed Web of Science ®Google Scholar
• Dickman M. 2020. PURL: is it better to take that antihypertensive at night? J Fam Pract. 69(7):362–364. doi:10.12788/jfp.0046
   Web of Science ®Google Scholar
• Fabbian F, Smolensky MH, Tiseo R, Pala M, Manfredini R, Portaluppi F. 2013. Dipper and non-dipper blood pressure 24-hour patterns: circadian rhythm-dependent physiologic and pathophysiologic mechanisms. Chronobiol Int. 30(1–2):17–30. doi:10.3109/07420528.2012.715872
   PubMed Web of Science ®Google Scholar
• Fagard RH, Celis H, Thijs L, Staessen JA, Clement DL, De Buyzere ML, De Bacquer DA. 2008. Daytime and nighttime blood pressure as predictors of death and cause-specific cardiovascular events in hypertension. Hypertension. 51(1):55–61. doi:10.1161/HYPERTENSIONAHA.107.100727
   PubMed Web of Science ®Google Scholar
• Fernández JR, Mojón A, Hermida RC, for the Hygia Project Investigators. 2020. Chronotherapy of hypertension: advantages of 48-h ambulatory blood pressure monitoring assessments in MAPEC and Hygia Chronotherapy Trial. Chronobiol Int. 37(5):739–750. doi:10.1080/07420528.2020.1771355
   PubMed Web of Science ®Google Scholar
• Gupta R, Malik AH, Popli T, Ranchal P, Yandrapalli S, Aronow WS. 2020. Impact of bedtime dosing of antihypertensives compared to morning therapy: a meta-analysis of randomised controlled trials. Eur J Prev Cardiol: 204748732090361. Feb 3. Epub ahead of print. doi:10.1177/2047487320903611
   Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Fernández JR, Mojón A, Smolensky MH, Fabbian F, Portaluppi F. 2013a. Administration-time-differences in effects of hypertension medications on ambulatory blood pressure regulation. Chronobiol Int. 30(1–2):280–314. doi:10.3109/07420528.2012.709448
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Fontao MJ, Mojón A, Fernández JR. 2013b. Ambulatory blood pressure monitoring: importance of sampling rate and duration – 48 versus 24 hours – on the accurate assessment of cardiovascular risk. Chronobiol Int. 30(1–2):55–67. doi:10.3109/07420528.2012.701457
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Fernández JR. 2010. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 27(8):1629–1651. doi:10.3109/07420528.2010.510230
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Fernández JR. 2011. Decreasing sleep-time blood pressure determined by ambulatory monitoring reduces cardiovascular risk. J Am Coll Cardiol. 58(11):1165–1173. doi:10.1016/j.jacc.2011.04.043
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Fernández JR. 2012. Sleep-time blood pressure and the prognostic value of isolated-office and masked hypertension. Am J Hypertens. 25(3):297–305. doi:10.1038/ajh.2011.208
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Fernández JR. 2013c. Blunted sleep-time relative blood pressure decline increases cardiovascular risk independent of blood pressure level – the “normotensive non-dipper” paradox. Chronobiol Int. 30(1–2):87–98. doi:10.3109/07420528.2012.701127
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Fernández JR. 2016a. Sleep-time BP: prognostic marker of type 2 diabetes and therapeutic target for prevention. Diabetologia. 59(2):244–254. doi:10.1007/s00125-015-3748-8
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Fernández JR. 2017a. Sleep-time ambulatory BP is an independent prognostic marker of CKD. J Am Soc Nephrol. 28(9):2802–2811. doi:10.1681/ASN.2016111186
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Mojón A, Smolensky MH, Crespo JJ, Otero A, Domínguez-Sardiña M, Moyá A, Ríos MT, Castiñeira MC, et al. 2021a. Cardiovascular disease risk stratification by the Framingham Score is markedly improved by ambulatory compared to office blood pressure. Rev Esp Cardiol. Epub ahead of print. doi:10.1016/j.rec.2020.08.004
   Google Scholar
• Hermida RC, Ayala DE, Portaluppi F. 2007. Circadian variation of blood pressure: the basis for the chronotherapy of hypertension. Adv Drug Deliv Rev. 59(9–10):904–922. doi:10.1016/j.addr.2006.08.003
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Smolensky MH, Fernández JR, Mojón A, Portaluppi F. 2016b. Chronotherapy with conventional blood pressure medications improves management of hypertension and reduces cardiovascular and stroke risks. Hypertens Res. 39(5):277–292. doi:10.1007/s00125-015-3748-8
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Smolensky MH, Fernández JR, Mojón A, Portaluppi F. 2017b. Sleep-time blood pressure: unique sensitive prognostic marker of vascular risk and therapeutic target for prevention. Sleep Med Rev. 33:17–27. doi:10.1016/j.smrv.2016.04.001
   PubMed Web of Science ®Google Scholar
• Hermida RC, Calvo C, Ayala DE, Fernández JR, Ruilope LM, López JE. 2002. Evaluation of the extent and duration of the “ABPM effect” in hypertensive patients. J Am Coll Cardiol. 40(4):710–717. doi:10.1016/s0735-1097(02)02011-9
   PubMed Web of Science ®Google Scholar
• Hermida RC, Crespo JJ, Domínguez-Sardiña M, Otero A, Moyá A, Ríos MT, Sineiro E, Castiñeira MC, Callejas PA, Pousa L, et al. 2020a. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial. Eur Heart J. 41(48):4565–4576. doi:10.1093/eurheartj/ehz754
   PubMed Web of Science ®Google Scholar
• Hermida RC, Crespo JJ, Otero A, Domínguez-Sardiña M, Moyá A, Ríos MT, Castiñeira MC, Callejas PA, Pousa L, Sineiro E, et al. 2018. Asleep blood pressure: significant prognostic marker of vascular risk and therapeutic target for prevention. Eur Heart J. 39(47):4159–4171. doi:10.1093/eurheartj/ehy475
   PubMed Web of Science ®Google Scholar
• Hermida RC, Hermida-Ayala RG, Smolensky MH, Mojón A, Crespo JJ, Otero A, Ríos MT, Domínguez-Sardiña M, Fernández JR. 2020b. Does timing of antihypertensive medication dosing matter? Curr Cardiol Rep. 22(10):118. doi:10.1007/s11886-020-01353-7
   PubMed Web of Science ®Google Scholar
• Hermida RC, Hermida-Ayala RG, Smolensky MH, Mojón A, Fernández JR. 2020c. Chronopharmacology of hypertension medications: impact of ingestion-time on pharmacokinetics and pharmacodynamics. Exp Opin Drug Metab Toxicol. 16(12):1159–1173. doi:10.1080/17425255.2020.1825681
   PubMed Web of Science ®Google Scholar
• Hermida RC, Hermida-Ayala RG, Smolensky MH, Mojón A, Fernández JR. 2021b. Ingestion-time differences in the pharmacodynamics of hypertension medications: systematic review of human chronopharmacology trials. Adv Drug Deliv Rev. 170:200–213. doi:10.1016/j.addr.2021.01.013
   PubMed Web of Science ®Google Scholar
• Hermida RC, Mojón A, Fernández JR, Otero A, Crespo JJ, Domínguez-Sardiña M, Ríos MT, Smolensky MH. 2020d. Ambulatory blood pressure monitoring-based definition of true arterial hypertension. Minerva Med. 111:573–588. doi:10.23736/S0026-4806.20.06834-2
   PubMed Web of Science ®Google Scholar
• Hermida RC, Mojón A, Hermida-Ayala RG, Smolensky MH, Fernández JR. 2021c. Extent of asleep blood pressure reduction by hypertension medications is ingestion-time dependent: systematic review and meta-analysis of published human trials. Sleep Med Rev. 59:101454. In press. doi:10.1016/j.smrv.2021.101454.
   PubMed Web of Science ®Google Scholar
• Hermida RC, Mojón A, Smolensky MH, Fernández JR. 2021d. Should we lower sleep-time blood pressure with bedtime dosing of antihypertensive medications? Pro side of the argument. Hypertension. In press.
   PubMed Web of Science ®Google Scholar
• Hermida RC, Smolensky MH, Ayala DE, Portaluppi F, Crespo JJ, Fabbian F, Haus E, Manfredini R, Mojón A, Moyá A, et al. 2013d. 2013 ambulatory blood pressure monitoring recommendations for the diagnosis of adult hypertension, assessment of cardiovascular and other hypertension-associated risk, and attainment of therapeutic goals. Joint recommendations from the International Society for Chronobiology (ISC), American Association of Medical Chronobiology and Chronotherapeutics (AAMCC), Spanish Society of Applied Chronobiology, Chronotherapy, and Vascular Risk (SECAC), Spanish Society of Atherosclerosis (SEA), and Romanian Society of Internal Medicine (RSIM). Chronobiol Int. 30:355–410. doi:10.3109/07420528.2013.750490
   PubMed Web of Science ®Google Scholar
• Hermida RC, Smolensky MH, Balan H, Castriotta RJ, Crespo JJ, Dagan Y, El-Toukhy S, Fernández JR, FitzGerald GA, Fujimura A, et al. 2021e. Guidelines for the design and conduct of human clinical trials on ingestion-time differences – chronopharmacology and chronotherapy – of hypertension medications. Chronobiol Int. 38:1–26. doi:10.1080/07420528.2020.1850468
   PubMed Web of Science ®Google Scholar
• Hermida RC, Smolensky MH, Mojón A, Crespo JJ, Ríos MT, Domínguez-Sardiña M, Otero A, Fernández JR. 2020e. New perspectives on the definition, diagnosis, and treatment of true arterial hypertension. Expert Opin Pharmacother. 21:1167–1178. doi:10.1080/14656566.2020.1746274
   PubMed Web of Science ®Google Scholar
• Laffin LJ, Bakris GL. 2018. Has the sun set on nighttime dosing in uncomplicated hypertension? Hypertension. 72(4):836–838. doi:10.1161/HYPERTENSIONAHA.118.11207
   PubMed Web of Science ®Google Scholar
• Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D. 2009. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 151:W65–W94. doi:10.7326/0003-4819-151-4-200908180-00136
   PubMed Web of Science ®Google Scholar
• Martino TA, Tata N, Simpson JA, Vanderlaan R, Dawood F, Kabir MG, Khaper N, Cifelli C, Podobed P, Liu PP, et al. 2011. The primary benefits of angiotensin-converting enzyme inhibition on cardiac remodeling occur during sleep time in murine pressure overload hypertrophy. J Am Coll Cardiol. 57(20):2020–2028. doi:10.1016/j.jacc.2010.11.022
   PubMed Web of Science ®Google Scholar
• Minutolo R, Agarwal R, Borrelli S, Chiodini P, Bellizzi V, Nappi F, Cianciaruso B, Zamboni P, Conte G, Gabbai FB, et al. 2011. Prognostic role of ambulatory blood pressure measurement in patients with nondialysis chronic kidney disease. Arch Intern Med. 171(12):1090–1098. doi:10.1001/archinternmed.2011.230
   PubMedGoogle Scholar
• Moher D, Liberati A, Tetzlaff J, Altman DG. 2009. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 151(4):264–269. doi:10.7326/0003-4819-151-4-200908180-00135
   PubMed Web of Science ®Google Scholar
• Mojón A, Ayala DE, Piñeiro L, Otero A, Crespo JJ, Moyá A, Bóveda J, Pérez de Lis J, Fernández JR, Hermida RC, on behalf of the Hygia Project Investigators. 2013. Comparison of ambulatory blood pressure parameters of hypertensive patients with and without chronic kidney disease. Chronobiol Int. 30(1–2):145–158. doi:10.3109/07420528.2012.703083
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Excellence. 2019. Hypertension in adults: diagnosis and management. NICE guideline 136: methods, evidence and recommendations. London, UK: National Clinical Guidelines Centre. [accessed 2020 November 26]. https://www.nice.org.uk/guidance/ng136
   Google Scholar
• Ohkubo T, Hozawa A, Yamaguchi J, Kikuya M, Ohmori K, Michimata M, Matsubara M, Hashimoto J, Hoshi H, Araki T, et al. 2002. Prognostic significance of the nocturnal decline in blood pressure in individuals with and without high 24-h blood pressure: the Ohasama study. J Hypertens. 20:2183–2189. doi:10.1097/00004872-200211000-00017
   PubMed Web of Science ®Google Scholar
• Portaluppi F, Tiseo R, Smolensky MH, Hermida RC, Ayala DE, Fabbian F. 2012. Circadian rhythms and cardiovascular health. Sleep Med Rev. 16:151–166. doi:10.1016/j.smrv.2011.04.003
   PubMed Web of Science ®Google Scholar
• Poulter NR, Savoloulos C, Anjum A, Apostolopoulou M, Chapman N, Cross M, Falaschetti E, Fotiadis S, James RM, Kanellos I, et al. 2018. Randomized crossover trial of the impact of morning or evening dosing of antihypertensive agents on 24-hour ambulatory blood pressure – the HARMONY trial. Hypertension. 7(4):870–873. doi:10.1161/HYPERTENSIONAHA.118.11101
   Google Scholar
• Rabi DM, McBrien KA, Sapir-Pichhadze R, Nakhla M, Ahmed SB, Dumanski SM, Butalia S, Leung AA, Harris KC, Cloutier L, et al. 2020. Hypertension Canada’s 2020 comprehensive guidelines for the prevention, diagnosis, risk assessment, and treatment of hypertension in adults and children. Can J Cardiol. 36(5):596–624. doi:10.1016/j.cjca.2020.02.086
   PubMed Web of Science ®Google Scholar
• Rahman M, Greene T, Phillips RA, Agodoa LY, Bakris GL, Charleston J, Contreras G, Gabbai F, Hiremath L, Jamerson K, et al. 2013. A trial of 2 strategies to reduce nocturnal blood pressure in blacks with chronic kidney disease. Hypertension. 61(1):82–88. doi:10.1161/HYPERTENSIONAHA.112.200477
   PubMed Web of Science ®Google Scholar
• Roush GC, Fagard RH, Salles GF, Pierdomenico SD, Reboldi G, Verdecchia P, Eguchi K, Kario K, Hoshide S, Polonia J, et al. 2014a. Prognostic impact from clinic, daytime, and nighttime systolic blood pressure in 9 cohorts on 13,844 patients with hypertension. J Hypertens. 32(12):2332–2340. doi:10.1097/HJH.0000000000000355
   PubMed Web of Science ®Google Scholar
• Roush GC, Fapohunda J, Kostis JB. 2014b. Evening dosing of antihypertensive therapy to reduce cardiovascular events: a third type of evidence based on a systematic review and meta-analysis of randomized trials. J Clin Hypertens (Greenwich). 16(8):561–568. doi:10.1111/jch.12354
   PubMed Web of Science ®Google Scholar
• Salles GF, Reboldi G, Fagard RH, Cardoso C, Pierdomenico SD, Verdecchia P, Eguchi K, Kario K, Hoshide S, Polonia J, et al. 2016. Prognostic impact of the nocturnal blood pressure fall in hypertensive patients: the ambulatory blood pressure collaboration in patients with hypertension (ABC-H) meta-analysis. Hypertension. 67(4):693–700. doi:10.1161/HYPERTENSIONAHA.115.06981
   PubMed Web of Science ®Google Scholar
• Schillaci G, Battista F, Settimi L, Schillaci L, Pucci G. 2015. Antihypertensive drug treatment and circadian blood pressure rhythm: a review of the role of chronotherapy in hypertension. Curr Pharm Des. 21(6):756–772. doi:10.2174/1381612820666141024130013
   PubMed Web of Science ®Google Scholar
• Smolensky MH, Hermida RC, Castriotta RJ, Portaluppi F. 2007. Role of sleep-wake cycle on blood pressure circadian rhythms and hypertension. Sleep Med. 8(6):668–680. doi:10.1016/j.sleep.2006.11.011
   PubMed Web of Science ®Google Scholar
• Smolensky MH, Hermida RC, Geng YJ. 2021. Chronotherapy of cardiac and vascular disease: timing medications to circadian rhythms to optimize treatment effects and outcomes. Curr Opin Pharmacol. 57:41–48. doi:10.1016//j.coph.2020.10.014
   PubMed Web of Science ®Google Scholar
• Smolensky MH, Hermida RC, Portaluppi F. 2017. Circadian mechanisms of 24-hour blood pressure regulation and patterning. Sleep Med Rev. 33:4–16. doi:10.1016/j.smrv.2016.02.003
   PubMed Web of Science ®Google Scholar
• Sole MJ, Martino TA. 2009. Diurnal physiology: core principles with application to the pathogenesis, diagnosis, prevention, and treatment of myocardial hypertrophy and failure. J Appl Physiol. 107(4):1318–1327. doi:10.1152/japplphysiol.00426.2009
   PubMed Web of Science ®Google Scholar
• Stranges PM, Drew AM, Rafferty P, Shuster JE, Brooks AD. 2015. Treatment of hypertension with chronotherapy: is it time? Ann Pharmacother. 49(3):323–334. doi:10.1177/1060028014563535
   PubMed Web of Science ®Google Scholar
• Sun Y, Yu X, Liu J, Zhou N, Chen L, Zhao Y, Li X, Wang J, Cui L. 2016. Effect of bedtime administration of blood-pressure lowering agents on ambulatory blood pressure monitoring results: a meta-analysis. Cardiol J. 23(4):473–481. doi:10.5603/CJ.a2016.0027
   PubMed Web of Science ®Google Scholar
• Umemura S, Arima H, Arima S, Asayama K, Dohi Y, Hirooka Y, Horio T, Hoshide S, Ikeda S, Ishimitsu T, et al. 2019. The Japanese society of hypertension guidelines for the management of hypertension (JSH 2019). Hypertens Res. 42:1235–1481. doi:10.1038/s41440-019-0284-9
   PubMed Web of Science ®Google Scholar
• Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, et al. 2020. 2020 International Society of Hypertension global hypertension practice guidelines. Hypertension. 75(6):1334–1357. doi:10.1161/HYPERTENSIONAHA.120.15026
   PubMed Web of Science ®Google Scholar
• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Himmerfarb CD, DePalma SM, Gidding S, Jamerson KA, Jones DW, et al. 2018. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. J Am Coll Cardiol. 71(19):e127–e248. doi:10.1016/j.jacc.2017.11.006
   PubMed Web of Science ®Google Scholar
• Williams B, Mancia G, Spiering W, Rosei EA, Azizi M, Burnier M, Clement DL, Coca A, De Simone G, Dominiczak A, et al. 2018. 2018 ESC/ESH guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). Eur Heart J. 39:3021–3104. doi:10.1093/eaurheartj/ehy339
   PubMed Web of Science ®Google Scholar
• Zhao P, Xu P, Wan C, Wang Z 2011. Evening versus morning dosing regimen drug therapy for hypertension. Cochrane Database System Rev. 10(CD004184). doi:10.1002/14651858.CD004184.pub2
   Google Scholar