Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study
dc.contributor.author | Agarwal, Rajiv | |
dc.contributor.author | Rossignol, Patrick | |
dc.contributor.author | Garza, Dahlia | |
dc.contributor.author | Mayo, Martha R. | |
dc.contributor.author | Warren, Suzette | |
dc.contributor.author | Arthur, Susan | |
dc.contributor.author | Romero, Alain | |
dc.contributor.author | White, William B. | |
dc.contributor.author | Williams, Bryan | |
dc.contributor.department | Medicine, School of Medicine | en_US |
dc.date.accessioned | 2019-06-25T13:37:31Z | |
dc.date.available | 2019-06-25T13:37:31Z | |
dc.date.issued | 2018 | |
dc.description.abstract | BACKGROUND: While chronic kidney disease (CKD) is common in resistant hypertension (RHTN), prior studies -evaluating mineralocorticoid receptor antagonists excluded patients with reduced kidney function due to risk of hyperkalemia. AMBER (ClinicalTrials.gov identifier NCT03071263) will evaluate if the potassium-binding polymer patiromer used concomitantly with spironolactone in patients with RHTN and CKD prevents hyperkalemia and allows more persistent spironolactone use for hypertension management. METHODS: Randomized, double-blind, placebo-controlled parallel group 12-week study of patiromer and spironolactone versus placebo and spironolactone in patients with uncontrolled RHTN and CKD. RHTN is defined as unattended systolic automated office blood pressure (AOBP) of -135-160 mm Hg during screening despite taking ≥3 antihypertensives, including a diuretic, and an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker -(unless not tolerated or contraindicated). The CKD inclusion criterion is an estimated glomerular filtration rate (eGFR) of 25 to ≤45 mL/min/1.73 m2. Screening serum potassium must be 4.3-5.1 mEq/L. The primary efficacy endpoint is the between-group difference (spironolactone plus patiromer versus spironolactone plus placebo) in the proportion of patients remaining on spironolactone at Week 12. RESULTS: Baseline characteristics have been analyzed as of March 2018 for 146 (of a targeted 290) patients. Mean (SD) baseline age is 69.3 (10.9) years; 52.1% are male, 99.3% White, and 47.3% have diabetes. Mean (SD) baseline serum potassium is 4.68 (0.25) mEq/L, systolic AOBP is 144.3 (6.8) mm Hg, eGFR is 35.7 (7.7) mL/min/1.73 m2. CONCLUSION: AMBER will define the ability of patiromer to facilitate the use of spironolactone, an effective antihypertensive therapy for patients with RHTN and CKD. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Agarwal, R., Rossignol, P., Garza, D., Mayo, M. R., Warren, S., Arthur, S., … Williams, B. (2018). Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study. American journal of nephrology, 48(3), 172–180. doi:10.1159/000492622 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/19668 | |
dc.language.iso | en_US | en_US |
dc.publisher | Karger Publishers | en_US |
dc.relation.isversionof | 10.1159/000492622 | en_US |
dc.relation.journal | American Journal of Nephrology | en_US |
dc.rights | Publisher Policy | en_US |
dc.source | PMC | en_US |
dc.subject | Chronic kidney disease | en_US |
dc.subject | Hyperkalemia | en_US |
dc.subject | Patiromer | en_US |
dc.subject | Resistant hypertension | en_US |
dc.subject | Spironolactone | en_US |
dc.title | Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study | en_US |
dc.type | Article | en_US |
ul.alternative.fulltext | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214611/ | en_US |
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