Financiado en parte por Fukuda Denshi
A randomised, factorial trial to reduce arterial stiffness independently of blood pressure: Proof of concept? The VaSera trial testing dietary nitrate and spironolactone
Mills CE, Govoni V, Faconti L, Casagrande ML, Morant SV, Crickmore H, Iqbal F, Maskell P, Masani A, Nanino E, Webb AJ, Cruickshank JK
British journal of clinical pharmacology · 26 citas
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Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiado por la industria
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- British Heart Foundation
- Universidad u hospital
- King's College London
- Empresa
- Fukuda Denshi
Según 4 financiadores declarados.
Publicación
- Publicado
- 2019-12-13 · Br J Clin Pharmacol · vol. 86 · número 5 · págs. 891–902
- Editorial
- Wiley
- Citado
- 39 citas · más que el 92% de estudios similares · 2.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 54 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Cardiovascular Health and Disease Prevention · Nitric Oxide and Endothelin Effects · Blood Pressure and Hypertension Studies
- Palabras clave
- Doxazosin, Blood pressure, Spironolactone, Arterial stiffness, Placebo, Cardiology, Internal medicine, Medicine, Heart failure
- MeSH
- humans, beta vulgaris, diabetes mellitus, type 2, nitrates, spironolactone, double-blind method, blood pressure, dietary supplements, adult, aged, middle aged, female, male, vascular stiffness, pulse wave analysis
12 autores
- Charlotte Elizabeth Mills🇬🇧🇫🇷🇧🇪St Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; Unité de Nutrition Humaine; King's College School; Nutrition Sciences (Belgium); University of Reading
- V. Govoni🇬🇧St Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
- Luca Faconti🇬🇧St Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; British Heart Foundation
- M. Casagrande🇬🇧St Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
- S. V. Morant🇬🇧University of Dundee
- Hannah Crickmore🇬🇧King's College London; King's College School
- Fahad Mujtaba Iqbal🇬🇧King's College London; King's College School
- Perry Maskell🇬🇧University of Dundee
- Alisha Masani🇬🇧University of Dundee
- Elisa Nanino🇬🇧St Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
- David J. Webb🇬🇧St Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; British Heart Foundation
- J. CRUICKSHANK🇬🇧 · autor de correspondenciaSt Thomas' Hospital; King's College London; Guy's and St Thomas' NHS Foundation Trust; King's College School
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
To test if spironolactone or dietary nitrate from beetroot juice could reduce arterial stiffness as aortic pulse wave velocity (PWVart), a potential treatment target, independently of blood pressure.
Methods
Daily spironolactone (≤50 mg) vs doxazosin (control ≤16 mg) and 70 mL beetroot juice (Beet-It ≤11 mmol nitrate) vs nitrate-depleted juice (placebo; 0 mmol nitrate) were tested in people at risk or with type-2 diabetes using a double-blind, 6-month factorial trial. Vascular indices (baseline, 12, 24 weeks) were cardiac-ankle vascular index (CAVI), a nominally pressure-independent stiffness measure (primary outcome), PWVart secondary, central systolic pressure and augmentation. Analysis was intention-to-treat, adjusted for systolic pressure differences between trial arms.
Results
Spironolactone did not reduce stiffness, with evidence for reduced CAVI on doxazosin rather than spironolactone (mean difference [95% confidence interval]; 0.25 [-0.3, 0.5] units, P = .080), firmer for PWVart (0.37 [0.01, 0.7] m/s, P = .045). There was no difference in systolic pressure reduction between spironolactone and doxazosin (0.7 [-4.8, 3.3] mmHg, P = .7). Circulating nitrate and nitrite increased on active vs placebo juice, with central systolic pressure lowered -2.6 [-4.5, - 0.8] mmHg, P = .007 more on the active juice, but did not reduce CAVI, PWVart or peripheral pressure. Change in nitrate and nitrite concentrations were 1.5-fold [1.1-2.2] and 2.2-fold [1.3, 3.6] higher on spironolactone than on doxazosin respectively; both P < .05.
Conclusion
Contrary to our hypothesis, in at-risk/type 2 diabetes patients, spironolactone did not reduce arterial stiffness, rather PWVart was lower on doxazosin. Dietary nitrate elevated plasma nitrite, selectively lowering central systolic pressure, observed previously for nitrite.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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