Endocrine and haemodynamic changes in resistant hypertension, and blood pressure responses to spironolactone or amiloride: the PATHWAY-2 mechanisms substudies
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BACKGROUND: In the PATHWAY-2 study of resistant hypertension, spironolactone reduced blood pressure substantially more than conventional antihypertensive drugs. We did three substudies to assess the mechanisms underlying this superiority and the pathogenesis of resistant hypertension. METHODS: PATHWAY-2 was a randomised, double-blind crossover trial done at 14 UK primary and secondary care sites in 314 patients with resistant hypertension. Patients were given 12 weeks of once daily treatment with each of placebo, spironolactone 25-50 mg, bisoprolol 5-10 mg, and doxazosin 4-8 mg and the change in home systolic blood pressure was assessed as the primary outcome. In our three substudies, we assessed plasma aldosterone, renin, and aldosterone-to-renin ratio (ARR) as predictors of home systolic blood pressure, and estimated prevalence of primary aldosteronism (substudy 1); assessed the effects of each drug in terms of thoracic fluid index, cardiac index, stroke index, and systemic vascular resistance at seven sites with haemodynamic monitoring facilities (substudy 2); and assessed the effect of amiloride 10-20 mg once daily on clinic systolic blood pressure during an optional 6-12 week open-label runout phase (substudy 3). The PATHWAY-2 trial is registered with EudraCT, number 2008-007149-30, and ClinicalTrials.gov, number NCT02369081. FINDINGS: =0·11, p=0·00024). 42 patients had low renin concentrations (predefined as the lowest tertile of plasma renin), of which 31 had a plasma aldosterone concentration greater than the mean value for all 126 patients (250 pmol/L). Thus, 31 (25% [95% CI 17-33]) of 126 patients were deemed to have inappropriately high aldosterone concentrations. Thoracic fluid content was reduced by 6·8% from baseline (95% CI 4·0 to 8·8; p<0·0001) with spironolactone, but not other treatments. Amiloride (10 mg once daily) reduced clinic systolic blood pressure by 20·4 mm Hg (95% CI 18·3-22·5), compared with a reduction of 18·3 mm Hg (16·2-20·5) with spironolactone (25 mg once daily). No serious adverse events were recorded, and adverse symptoms were not systematically recorded after the end of the double-blind treatment. Mean plasma potassium concentrations increased from 4·02 mmol/L (95% CI 3·95-4·08) on placebo to 4·50 (4·44-4·57) on amiloride (p<0·0001). INTERPRETATION: Our results suggest that resistant hypertension is commonly a salt-retaining state, most likely due to inappropriate aldosterone secretion. Mineralocorticoid receptor blockade by spironolactone overcomes the salt retention and resistance of hypertension to treatment. Amiloride seems to be as effective an antihypertensive as spironolactone, offering a substitute treatment for resistant hypertension. FUNDING: British Heart Foundation and UK National Institute for Health Research.
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The MR antagonist spironolactone is effective for treating patients with resistant hypertension who are usually overweight or obese and already on at least three antihypertensive drugs.
“The landmark PATHWAY-2 trial85,86 clearly established that the MR antagonist spironolactone is effective for treating patients with resistant hypertension who are usually overweight or obese and already on at least three antihypertensive drugs87.”
From Obesity, kidney dysfunction and hypertension: mechanistic links (2019) · cites this paper as [85]
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Human Urinary mRNA as a Biomarker of Cardiovascular Disease
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How common is primary aldosteronism?
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- Authors
- Williams, B., MacDonald, T. M., Morant, S. V., Webb, D. J., Sever, P., McInnes, G. T., Ford, I., Cruickshank, J. K., Caulfield, M. J., Padmanabhan, S., Mackenzie, I. S., Salsbury, J., Brown, M. J., Balakrishnan, K., Burton, T., Cannon, J., Collier, D., Coughlan, C., D'Souza, R., Enobakhare, E., Findlay, E., Gardiner-Hill, C., Gupta, P., Helmy, J., Helmy, C., Hobbs, L., Hobbs, R., Hood, S., Iles, R., Kean, S., Kwok, S., Lacy, P., MacIntyre, I., Mackay, J., Markandu, N., Martin, U., McCallum, L., McCann, G., McGinnis, A., Melville, V, Muir, S., Myint, K., Nazir, S., Palmer, J., Papworth, R., Rutkowski, K., Saxena, M., Schumann, A., Soran, H., Stanley, A., Thom, S., Webb, A., White, C., Wilson, R., & Zak, A.
- Affiliations
- National Institute for Health and Care Research (GB)
- University of Dundee (GB)
- The Queen's Medical Research Institute (GB)
- Imperial College London (GB)
- University of Glasgow (GB)
- King's College London (GB)
- Queen Mary University of London (GB)
- University of London (GB)
- Corresponding author
- Brown, Morris J
- Cannon, J
- D'Souza, R
- Helmy, J
- Hobbs, R
- Iles, R
- Mackay, J
- Markandu, N
- Palmer, J
- Papworth, R
- Wilson, R
- ORCID
- Williams, Bryan
- MacDonald, Thomas M
- Morant, Steve V
- Webb, David J
- Ford, Ian
- Cruickshank, J Kennedy
- Caulfield, Mark J
- Padmanabhan, Sandosh
- Mackenzie, Isla S
- Brown, Morris J
- Burton, T
- Collier, D
- Coughlan, C
- D'Souza, R
- Gupta, P
- Hobbs, R
- Iles, R
- Kean, S
- Kwok, S
- Lacy, P
- MacIntyre, I
- Martin, U
- McCallum, L
- McCann, G
- Papworth, R
- Schumann, A
- Soran, H
- Stanley, A
- Thom, S
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2018-06
- Volume
- 6
- Issue
- 6
- Pages
- 464-475
- ISSN
- 2213-8587 (ISSN-L)
- PMC
- PMC5966620
- OpenAlex
- W2796868581
- Cited by
- 347
- References
- 35
- Citations by year
- 2026: 39 · 2025: 42 · 2024: 29 · 2023: 48 · 2022: 42 · 2021: 40 · 2020: 48 · 2019: 36 · 2018: 14 · 2017: 3 · 2016: 1 · 2015: 4
- FWCI
- 27.46
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (publishedVersion, cc-by)
- Edinburgh Research Explorer (University of Edinburgh) (publishedVersion, cc-by)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- Research Portal (King's College London) (submittedVersion, cc-by)
- UCL Discovery (University College London) (submittedVersion)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion, cc-by)
- Funders
- National Institute for Health and Care Research
- British Heart Foundation (SP/08/002)
- NIHR Barts Biomedical Research Centre, Queen Mary University of London
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Renin-Angiotensin System Studies
- Keywords
- resistant hypertension, spironolactone, amiloride, aldosterone, renin, aldosterone-renin ratio, primary aldosteronism, hemodynamics, systemic vascular resistance, bisoprolol, doxazosin, blood pressure response, low-renin hypertension
- MeSH terms
- Aldosterone, Amiloride, Antihypertensive Agents, Blood Pressure, Female, Hemodynamics, Humans, Hypertension, Male, Middle Aged, Spironolactone, Randomized Controlled Trials as Topic, Doxazosin, Bisoprolol
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