Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.
Black or African American
antihypertensive agents
blood pressure
hypertension
renal denervation
Journal
Hypertension (Dallas, Tex. : 1979)
ISSN: 1524-4563
Titre abrégé: Hypertension
Pays: United States
ID NLM: 7906255
Informations de publication
Date de publication:
May 2024
May 2024
Historique:
medline:
19
4
2024
pubmed:
5
2
2024
entrez:
5
2
2024
Statut:
ppublish
Résumé
The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months ( Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.
Sections du résumé
BACKGROUND
UNASSIGNED
The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations.
METHODS
UNASSIGNED
The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans.
RESULTS
UNASSIGNED
Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (
CONCLUSIONS
UNASSIGNED
Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population.
REGISTRATION
UNASSIGNED
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.
Identifiants
pubmed: 38314554
doi: 10.1161/HYPERTENSIONAHA.123.22251
pmc: PMC11025607
doi:
Substances chimiques
Antihypertensive Agents
0
Banques de données
ClinicalTrials.gov
['NCT02439775']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1095-1105Références
Patient Prefer Adherence. 2020 Nov 23;14:2301-2313
pubmed: 33262580
Lancet. 2021 Sep 11;398(10304):957-980
pubmed: 34450083
Lancet. 2018 Jun 9;391(10137):2335-2345
pubmed: 29803590
Lancet. 2017 Nov 11;390(10108):2160-2170
pubmed: 28859944
Lancet. 2020 May 2;395(10234):1444-1451
pubmed: 32234534
J Clin Epidemiol. 2014 Mar;67(3):267-77
pubmed: 24275499
Hypertension. 2021 Dec;78(6):1719-1726
pubmed: 34365809
N Engl J Med. 2014 Apr 10;370(15):1393-401
pubmed: 24678939
Eur Heart J. 2015 Jan 21;36(4):219-27
pubmed: 25400162
JAMA. 2021 Mar 16;325(11):1049-1052
pubmed: 33616604
Circulation. 2020 Mar 3;141(9):e139-e596
pubmed: 31992061
J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823
pubmed: 37914510
Health Hum Rights. 2020 Dec;22(2):299-307
pubmed: 33390715
J Am Soc Hypertens. 2015 Oct;9(10):769-779
pubmed: 26362830
N Engl J Med. 2023 Feb 2;388(5):395-405
pubmed: 36342143
Lancet. 2021 Jun 26;397(10293):2476-2486
pubmed: 34010611
Lancet. 2015 May 16;385(9981):1957-65
pubmed: 25631070
Clin Res Cardiol. 2020 Mar;109(3):289-302
pubmed: 32034481
J Am Heart Assoc. 2021 Jun;10(11):e020997
pubmed: 34006116
Lancet. 2018 Jun 9;391(10137):2346-2355
pubmed: 29803589
Nat Rev Nephrol. 2020 Apr;16(4):223-237
pubmed: 32024986
Hypertension. 2010 Nov;56(5):780-800
pubmed: 20921433
Hypertens Res. 2022 Feb;45(2):221-231
pubmed: 34654905
N Engl J Med. 2018 Apr 05;378(14):1291-1301
pubmed: 29527973
Int J Environ Res Public Health. 2022 Jun 30;19(13):
pubmed: 35805680
Hypertension. 2018 Jun;71(6):1269-1324
pubmed: 29133354
Hypertension. 2020 Nov;76(5):1410-1417
pubmed: 32981360
Lancet. 2022 Dec 3;400(10367):1927-1937
pubmed: 36356632
Lancet. 2022 Apr 9;399(10333):1401-1410
pubmed: 35390320
JAMA. 2020 Sep 22;324(12):1190-1200
pubmed: 32902588