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Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study
J. Rosa, P. Widimský, P. Waldauf, T. Zelinka, O. Petrák, M. Táborský, M. Branny, P. Toušek, K. Čurila, L. Lambert, F. Bednář, R. Holaj, B. Štrauch, J. Václavík, E. Kociánová, I. Nykl, O. Jiravský, G. Rappová, T. Indra, Z. Krátká, J. Widimský,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
Grantová podpora
NV16-30345A
MZ0
CEP - Centrální evidence projektů
- MeSH
- ambulantní monitorování krevního tlaku MeSH
- antagonisté mineralokortikoidních receptorů terapeutické užití MeSH
- antihypertenziva terapeutické užití MeSH
- dospělí MeSH
- hypertenze terapie MeSH
- klinické křížové studie MeSH
- kombinovaná farmakoterapie MeSH
- koronární vazospasmus terapie MeSH
- krevní tlak MeSH
- ledviny inervace patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- prospektivní studie MeSH
- senioři MeSH
- spironolakton terapeutické užití MeSH
- sympatektomie * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
OBJECTIVES: The randomized, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data. METHODS: A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP of 159 ± 17 and 155 ± 17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients. Spironolactone addition, as crossover after 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients. RESULTS: Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P < 0.001) versus 14.1 mmHg (P < 0.001), whereas the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed nonsignificantly better efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001). CONCLUSION: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.
Citace poskytuje Crossref.org
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- $a Rosa, Ján $u a3rd Department of Medicine, Centre for Hypertension, General University Hospital and First Faculty of Medicine, Charles University bCardiocentre cDepartment of Anaesthesiology, University Hospital Královské Vinohrady and Third Faculty of Medicine, Charles University, Prague dDepartment of Internal Medicine I - Cardiology, Faculty of Medicine and Dentistry, University Hospital Olomouc and Palacký University, Olomouc eCardiocentre, Nemocnice Podlesí, Třinec fDepartment of Radiology gDepartment of Nephrology, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic.
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- $a OBJECTIVES: The randomized, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data. METHODS: A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP of 159 ± 17 and 155 ± 17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients. Spironolactone addition, as crossover after 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients. RESULTS: Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P < 0.001) versus 14.1 mmHg (P < 0.001), whereas the number of antihypertensive drugs did not differ significantly between groups. Crossover analysis showed nonsignificantly better efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001). CONCLUSION: In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.
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