Chronotherapy
Studies have investigated whether hypertension therapy taken at bedtime results in improved cardiovascular disease (CVD) risk reduction compared with medication taken upon awakening. The Hygia Chronotherapy Trial, conducted in primary care, found that hypertensive patients taking ≥1 prescribed blood pressure (BP)-lowering medications at bedtime had improved ambulatory BP control compared with those who took their medications upon awakening, and they also had a reduced occurrence of major CVD events.[177]Hermida RC, Crespo JJ, Domínguez-Sardiña M, et al; Hygia Project Investigators. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial. Eur Heart J. 2020 Dec 21;41(48):4565-76.
https://academic.oup.com/eurheartj/article/41/48/4565/5602478
http://www.ncbi.nlm.nih.gov/pubmed/31641769?tool=bestpractice.com
However, excessive lowering of nocturnal BP with nighttime dosing may increase the potential risk of retinal, cerebral, and myocardial ischemia, and may lower medication adherence. The Treatment in Morning versus Evening (TIME) study compared evening and morning dosing of usual antihypertensive medication in participants followed up for a median of 5.2 years and found no difference between the groups for the primary composite outcome of vascular death or hospitalization for nonfatal myocardial infarction.[178]Mackenzie IS, Rogers A, Poulter NR, et al; TIME Study Group. Cardiovascular outcomes in adults with hypertension with evening versus morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial. Lancet. 2022 Oct 22;400(10361):1417-125.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01786-X/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/36240838?tool=bestpractice.com
One Cochrane review found very limited data to determine whether evening or morning dosing has more beneficial effects on cardiovascular outcomes or adverse events.[179]Wu C, Zhao P, Xu P, et al. Evening versus morning dosing regimen drug therapy for hypertension. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD004184.
http://www.ncbi.nlm.nih.gov/pubmed/38353289?tool=bestpractice.com
The 2023 European guidelines note that patients have a choice as to when to take hypertension therapy, but that adherence is generally better in the morning.[63]Mancia G, Kreutz R, Brunström M, et al. 2023 ESH guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Jun 21.
https://journals.lww.com/jhypertension/fulltext/9900/2023_esh_guidelines_for_the_management_of_arterial.271.aspx
http://www.ncbi.nlm.nih.gov/pubmed/37345492?tool=bestpractice.com
The 2024 ESC guidelines conclude that there is no reliable evidence to support bedtime dosing as a superior strategy and emphasize that patient choice and drug adherence should guide the timing of hypertension therapy.[1]McEvoy JW, McCarthy CP, Bruno RM, et al. 2024 ESC guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018.
https://academic.oup.com/eurheartj/article/45/38/3912/7741010?login=false
http://www.ncbi.nlm.nih.gov/pubmed/30165516?tool=bestpractice.com
Preliminary findings from the BedMed and BedMed Frail trials, presented at the 2024 ESC meeting, reported no significant benefit of bedtime dosing for cardiovascular outcomes. These findings have not yet been published in peer-reviewed journals.[1]McEvoy JW, McCarthy CP, Bruno RM, et al. 2024 ESC guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018.
https://academic.oup.com/eurheartj/article/45/38/3912/7741010?login=false
http://www.ncbi.nlm.nih.gov/pubmed/30165516?tool=bestpractice.com
Bedtime dosing may be considered in patients with documented high nighttime BP.
Renal sympathetic denervation
Activation of renal sympathetic nerves is a component of essential hypertension pathophysiology. Over the years, renal denervation studies have reported variable efficacy results; however, several randomized, sham-controlled trials have now shown BP lowering for both radiofrequency and ultrasound renal denervation in patients with mild-to-moderate, severe, and resistant hypertension.[180]Bhatt DL, Kandzari DE, O'Neill WW, et al; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401.
https://www.nejm.org/doi/10.1056/NEJMoa1402670
http://www.ncbi.nlm.nih.gov/pubmed/24678939?tool=bestpractice.com
[181]Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-55.
http://www.ncbi.nlm.nih.gov/pubmed/29803589?tool=bestpractice.com
[182]Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 0;391(10137):2335-45.
http://www.ncbi.nlm.nih.gov/pubmed/29803590?tool=bestpractice.com
[183]Oliveras A, Armario P, Clarà A, et al. Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial. J Hypertens. 2016 Sep;34(9):1863-71.
https://journals.lww.com/jhypertension/Fulltext/2016/09000/Spironolactone_versus_sympathetic_renal.26.aspx
http://www.ncbi.nlm.nih.gov/pubmed/27327441?tool=bestpractice.com
[184]Rosa J, Widimský P, Waldauf P, et al. Role of adding spironolactone and renal denervation in true resistant hypertension: one-year outcomes of randomized PRAGUE-15 study. Hypertension. 2015 Feb;67(2):397-403.
https://www.ahajournals.org/doi/full/10.1161/HYPERTENSIONAHA.115.06526
http://www.ncbi.nlm.nih.gov/pubmed/26693818?tool=bestpractice.com
[185]Fadl Elmula FEM, Feng YM, Jacobs L, et al. Sham or no sham control: that is the question in trials of renal denervation for resistant hypertension. A systematic meta-analysis. Blood Press. 2017 Aug;26(4):195-203.
https://www.tandfonline.com/doi/full/10.1080/08037051.2017.1311769
http://www.ncbi.nlm.nih.gov/pubmed/28443356?tool=bestpractice.com
[186]Azizi M, Schmieder RE, Mahfoud F, et al; RADIANCE-HTN Investigators. Six-month results of treatment-blinded medication titration for hypertension control following randomization to endovascular ultrasound renal denervation or a sham procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 May 28;139(22):2542-53.
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.040451
http://www.ncbi.nlm.nih.gov/pubmed/30880441?tool=bestpractice.com
[187]Böhm M, Kario K, Kandzari DE, et al; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-51.
http://www.ncbi.nlm.nih.gov/pubmed/32234534?tool=bestpractice.com
[188]Azizi M, Sanghvi K, Saxena M, et al. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-86.
http://www.ncbi.nlm.nih.gov/pubmed/34010611?tool=bestpractice.com
[189]Kandzari DE, Townsend RR, Bakris G, et al. Renal denervation in hypertension patients: proceedings from an expert consensus roundtable cosponsored by SCAI and NKF. Catheter Cardiovasc Interv. 2021 Sep;98(3):416-26.
https://onlinelibrary.wiley.com/doi/10.1002/ccd.29884
http://www.ncbi.nlm.nih.gov/pubmed/34343406?tool=bestpractice.com
[190]Pisano A, Iannone LF, Leo A, et al. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;(11):CD011499.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011499.pub3/full
http://www.ncbi.nlm.nih.gov/pubmed/34806762?tool=bestpractice.com
[191]Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-10.
http://www.ncbi.nlm.nih.gov/pubmed/35390320?tool=bestpractice.com
[192]Bhatt DL, Vaduganathan M, Kandzari DE, et al; SYMPLICITY HTN-3 Steering Committee Investigators. Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. Lancet. 2022 Oct 22;400(10361):1405-16.
http://www.ncbi.nlm.nih.gov/pubmed/36130612?tool=bestpractice.com
[193]Azizi M, Mahfoud F, Weber MA, et al; RADIANCE-HTN Investigators. Effects of renal denervation vs sham in resistant hypertension after medication escalation: prespecified analysis at 6 months of the RADIANCE-HTN TRIO randomized clinical trial. JAMA Cardiol. 2022 Dec 1;7(12):1244-52.
https://jamanetwork.com/journals/jamacardiology/fullarticle/2798468
http://www.ncbi.nlm.nih.gov/pubmed/36350593?tool=bestpractice.com
[194]Azizi M, Saxena M, Wang Y, et al. Endovascular ultrasound renal denervation to treat hypertension: the RADIANCE II randomized clinical trial. JAMA. 2023 Feb 28;329(8):651-61.
https://jamanetwork.com/journals/jama/fullarticle/2801849
http://www.ncbi.nlm.nih.gov/pubmed/36853250?tool=bestpractice.com
[195]Kirtane AJ, Sharp ASP, Mahfoud F, et al. Patient-level pooled analysis of ultrasound renal denervation in the sham-controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-73.
https://jamanetwork.com/journals/jamacardiology/fullarticle/2802098
http://www.ncbi.nlm.nih.gov/pubmed/36853627?tool=bestpractice.com
[196]Ahmad Y, Kane C, Arnold AD, et al. Randomized blinded placebo-controlled trials of renal sympathetic denervation for hypertension: a meta-analysis. Cardiovasc Revasc Med. 2022 Jan;34:112-8.
https://www.sciencedirect.com/science/article/pii/S1553838921000828?via%3Dihub
http://www.ncbi.nlm.nih.gov/pubmed/33551282?tool=bestpractice.com
[197]Yang X, Liu H, Chen S, et al. Intravascular renal denervation reduces ambulatory and office blood pressure in patients with essential hypertension: a meta-analysis of randomized sham-controlled trials. Kidney Blood Press Res. 2022;47(6):363-74.
https://karger.com/kbr/article/47/6/363/824494/Intravascular-Renal-Denervation-Reduces-Ambulatory
http://www.ncbi.nlm.nih.gov/pubmed/35385842?tool=bestpractice.com
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What are the effects of renal denervation for people with resistant hypertension?/cca.html?targetUrl=https://www.cochranelibrary.com/cca/doi/10.1002/cca.3935/fullShow me the answer In November 2023, the US Food and Drug Administration approved renal denervation as an adjunctive treatment for patients whose BP is inadequately controlled with lifestyle modifications and antihypertensive drugs.[198]Cluett JL, Blazek O, Brown AL, et al. Renal denervation for the treatment of hypertension: a scientific statement from the American Heart Association. Hypertension. 2024 Oct;81(10):e135-48.
https://www.ahajournals.org/doi/10.1161/HYP.0000000000000240
http://www.ncbi.nlm.nih.gov/pubmed/39101202?tool=bestpractice.com
The European guidelines now suggest that renal denervation may be considered as an adjunctive or alternative treatment option in patients with uncontrolled and resistant hypertension despite lifestyle and pharmacologic interventions, and may also be an option for those unable to tolerate long-term antihypertensive medication.[63]Mancia G, Kreutz R, Brunström M, et al. 2023 ESH guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Jun 21.
https://journals.lww.com/jhypertension/fulltext/9900/2023_esh_guidelines_for_the_management_of_arterial.271.aspx
http://www.ncbi.nlm.nih.gov/pubmed/37345492?tool=bestpractice.com
[199]Barbato E, Azizi M, Schmieder RE, et al. Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2023 Feb 15 [Epub ahead of print].
https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehad054/7036012
http://www.ncbi.nlm.nih.gov/pubmed/36790101?tool=bestpractice.com
Baroreflex activation therapy
Electrical stimulation of the carotid sinus baroreflex system, also known as baroreflex activation therapy (BAT), may decrease BP in patients with resistant hypertension. Electric stimulators directly activating afferent baroreflex nerves have previously failed in trials for technical reasons. However, a novel implantable device may overcome some of the previously experienced technical problems. The device stimulates the carotid sinus wall and has been shown to reduce BP in feasibility studies.[200]Heusser K, Tank J, Engeli S, et al. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. 2010 Mar;55(3):619-26.
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.109.140665
http://www.ncbi.nlm.nih.gov/pubmed/20101001?tool=bestpractice.com
[201]Illig KA, Levy M, Sanchez L, et al. An implantable carotid sinus stimulator for drug-resistant hypertension: surgical technique and short-term outcome from the multicenter phase II Rheos feasibility trial. J Vasc Surg. 2006 Dec;44(6):1213-8.
http://www.ncbi.nlm.nih.gov/pubmed/17145423?tool=bestpractice.com
[202]Scheffers IJ, Kroon AA, Schmidli J, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010 Oct 5;56(15):1254-8.
https://www.jacc.org/doi/10.1016/j.jacc.2010.03.089
http://www.ncbi.nlm.nih.gov/pubmed/20883933?tool=bestpractice.com
In the Rheos Pivotal trial, which assessed long-term BP control in resistant-hypertension patients receiving BAT, BP reduction was maintained over long-term follow-up of 22-53 months.[203]Bakris GL, Nadim MK, Haller H, et al. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens. 2012 Mar-Apr;6(2):152-8.
http://www.ncbi.nlm.nih.gov/pubmed/22341199?tool=bestpractice.com
L-arginine supplementation
Oral supplementation with L-arginine, an amino acid and a substrate of nitric oxide synthase, has been shown to significantly lower both systolic and diastolic BP.[204]Dong JY, Qin LQ, Zhang Z, et al. Effect of oral L-arginine supplementation on blood pressure: a meta-analysis of randomized, double-blind, placebo-controlled trials. Am Heart J. 2011 Dec;162(6):959-65.
http://www.ncbi.nlm.nih.gov/pubmed/22137067?tool=bestpractice.com
Vitamin C supplementation
Vitamin C supplementation has been shown to reduce systolic and diastolic BP in short-term trials. Long-term trials examining the effects of vitamin C supplementation on BP and clinical events are needed.[205]Juraschek SP, Guallar E, Appel LJ, et al. Effects of vitamin C supplementation on blood pressure: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2012 May;95(5):1079-88.
https://academic.oup.com/ajcn/article/95/5/1079/4576767
http://www.ncbi.nlm.nih.gov/pubmed/22492364?tool=bestpractice.com
[206]Guan Y, Dai P, Wang H. Effects of vitamin C supplementation on essential hypertension: a systematic review and meta-analysis. Medicine (Baltimore). 2020 Feb;99(8):e19274.
https://journals.lww.com/md-journal/Fulltext/2020/02210/Effects_of_vitamin_C_supplementation_on_essential.68.aspx
http://www.ncbi.nlm.nih.gov/pubmed/32080138?tool=bestpractice.com
Vitamin D supplementation
Data from cross-sectional studies report that low levels of 25-hydroxy vitamin D are associated with higher systolic BP and higher incidence of hypertension.[207]Tamez H, Thadhani RI. Vitamin D and hypertension: an update and review. Curr Opin Nephrol Hypertens. 2012 Sep;21(5):492-9.
http://www.ncbi.nlm.nih.gov/pubmed/22820371?tool=bestpractice.com
Large observational studies show a weaker, yet similar, association. This effect is thought to be partly mediated through regulation of the renin-angiotensin-aldosterone axis.[208]Tamez H, Kalim S, Thadhani RI. Does vitamin D modulate blood pressure? Curr Opin Nephrol Hypertens. 2013 Mar;22(2):204-9.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3984388
http://www.ncbi.nlm.nih.gov/pubmed/23299053?tool=bestpractice.com
Randomized controlled trials conflict with observational data, probably due to differences in populations studied, doses of vitamin D used, and unmeasured confounders. One systematic review found that in studies to date, vitamin D supplementation was ineffective for BP lowering.[209]Beveridge LA, Struthers AD, Khan F, et al; D-PRESSURE Collaboration. Effect of vitamin D supplementation on blood pressure: a systematic review and meta-analysis incorporating individual patient data. JAMA Intern Med. 2015 May;175(5):745-54.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2195120
http://www.ncbi.nlm.nih.gov/pubmed/25775274?tool=bestpractice.com
Large randomized trials focusing on patients with severe vitamin D deficiency and hypertension are needed before vitamin D can be recommended for the prevention or treatment of hypertension.
Calcium supplementation
Data indicate that increased calcium intake slightly reduces systolic and diastolic BP in people with normal BP, particularly young people. This could have implications for prevention and public health, but more and larger studies are needed.[210]Cormick G, Ciapponi A, Cafferata ML, et al. Calcium supplementation for prevention of primary hypertension. Cochrane Database Syst Rev. 2022 Jan 11;(1):CD010037.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010037.pub4/full
http://www.ncbi.nlm.nih.gov/pubmed/35014026?tool=bestpractice.com
Amiloride
In the PATHWAY-2 study of resistant hypertension, the potassium-sparing diuretic amiloride was shown to be as effective at reducing BP as spironolactone, suggesting it may be an alternative option for resistant hypertension.[211]Williams B, MacDonald TM, Morant SV, et al. Endocrine and haemodynamic changes in resistant hypertension, and blood pressure responses to spironolactone or amiloride: the PATHWAY-2 mechanisms substudies. Lancet Diabetes Endocrinol. 2018 Jun;6(6):464-75.
https://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30071-8/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/29655877?tool=bestpractice.com
Baxdrostat
In one phase 2 trial, baxdrostat, an aldosterone synthase inhibitor, was shown to reduce BP in patients with resistant hypertension over 12 weeks compared with placebo. Reductions were dose-related.[212]Freeman MW, Halvorsen YD, Marshall W, et al; BrigHTN Investigators. Phase 2 trial of baxdrostat for treatment-resistant hypertension. N Engl J Med. 2023 Feb 2;388(5):395-405.
http://www.ncbi.nlm.nih.gov/pubmed/36342143?tool=bestpractice.com
Lorundrostat
Lorundrostat is an aldosterone synthase inhibitor being investigated as a treatment for high BP. In one randomized controlled trial of adults with uncontrolled hypertension taking two or more antihypertensive drugs, use of lorundrostat decreased BP significantly more than placebo and was well tolerated.[213]Laffin LJ, Rodman D, Luther JM, et al. Aldosterone synthase inhibition with lorundrostat for uncontrolled hypertension: the target-HTN randomized clinical trial. JAMA. 2023 Sep 26;330(12):1140-50.
https://jamanetwork.com/journals/jama/fullarticle/2809625
http://www.ncbi.nlm.nih.gov/pubmed/37690061?tool=bestpractice.com
Further confirmatory studies are now needed.
Aprocitentan
Aprocitentan is a novel dual endothelin receptor antagonist that has been approved in the US for the treatment of hypertension in combination with other antihypertensive drugs, to lower BP in adult patients who are not adequately controlled on other drugs. In one phase 3, multicenter trial (PRECISION), aprocitentan reduced BP compared with placebo at 4 weeks of treatment.[214]Schlaich MP, Bellet M, Weber MA, et al; PRECISION investigators. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial. Lancet. 2022 Dec 3;400(10367):1927-37.
http://www.ncbi.nlm.nih.gov/pubmed/36356632?tool=bestpractice.com
Zilebesiran
Zilebesiran is an investigational RNA interference therapeutic agent that inhibits synthesis of hepatic angiotensinogen (the precursor of all angiotensin peptides). One phase 1 study, found that patients receiving zilebesiran had decreases in serum angiotensinogen and BP that were sustained for up to 24 weeks.[215]Desai AS, Webb DJ, Taubel J, et al. Zilebesiran, an RNA interference therapeutic agent for hypertension. N Engl J Med. 2023 Jul 20;389(3):228-38.
http://www.ncbi.nlm.nih.gov/pubmed/37467498?tool=bestpractice.com
One phase 2 study found that in adults with mild to moderate hypertension, zilebesiran given across a range of doses at 3- or 6-month intervals significantly decreased 24-hour mean ambulatory systolic BP at 6 months compared with placebo.[216]Bakris GL, Saxena M, Gupta A, et al. RNA interference with zilebesiran for mild to moderate hypertension: the KARDIA-1 randomized clinical trial. JAMA. 2024 Mar 5;331(9):740-9.
http://www.ncbi.nlm.nih.gov/pubmed/38363577?tool=bestpractice.com