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Item Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension(Wolters Kluwer, 2021) Parati, Gianfranco; Stergiou, George S.; Bilo, Grzegorz; Kollias, Anastasios; Pengo, Martino; Ochoa, Juan Eugenio; Agarwal, Rajiv; Asayama, Kei; Asmar, Roland; Burnier, Michel; De La Sierra, Alejandro; Giannattasio, Cristina; Gosse, Philippe; Head, Geoffrey; Hoshide, Satoshi; Imai, Yutaka; Kario, Kazuomi; Li, Yan; Manios, Efstathios; Mant, Jonathan; McManus, Richard J.; Mengden, Thomas; Mihailidou, Anastasia S.; Muntner, Paul; Myers, Martin; Niiranen, Teemu; Ntineri, Angeliki; O'Brien, Eoin; Octavio, José Andres; Ohkubo, Takayoshi; Omboni, Stefano; Padfield, Paul; Palatini, Paolo; Pellegrini, Dario; Postel-Vinay, Nicolas; Ramirez, Agustin J.; Sharman, James E.; Shennan, Andrew; Silva, Egle; Topouchian, Jirar; Torlasco, Camilla; Wang, Ji Guang; Weber, Michael A.; Whelton, Paul K.; White, William B.; Mancia, Giuseppe; Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension; Medicine, School of MedicineThe present paper provides an update of previous recommendations on Home Blood Pressure Monitoring from the European Society of Hypertension (ESH) Working Group on Blood Pressure Monitoring and Cardiovascular Variability sequentially published in years 2000, 2008 and 2010. This update has taken into account new evidence in this field, including a recent statement by the American Heart association, as well as technological developments, which have occurred over the past 20 years. The present document has been developed by the same ESH Working Group with inputs from an international team of experts, and has been endorsed by the ESH.Item Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension(Wolters Kluwer, 2021) Parati, Gianfranco; Stergiou, George S.; Bilo, Grzegorz; Kollias, Anastasios; Pengo, Martino; Ochoa, Juan Eugenio; Agarwal, Rajiv; Asayama, Kei; Asmar, Roland; Burnier, Michel; De La Sierra, Alejandro; Giannattasio, Cristina; Gosse, Philippe; Head, Geoffrey; Hoshide, Satoshi; Imai, Yutaka; Kario, Kazuomi; Li, Yan; Manios, Efstathios; Mant, Jonathan; McManus, Richard J.; Mengden, Thomas; Mihailidou, Anastasia S.; Muntner, Paul; Myers, Martin; Niiranen, Teemu; Ntineri, Angeliki; O'Brien, Eoin; Octavio, José Andres; Ohkubo, Takayoshi; Omboni, Stefano; Padfield, Paul; Palatini, Paolo; Pellegrini, Dario; Postel-Vinay, Nicolas; Ramirez, Agustin J.; Sharman, James E.; Shennan, Andrew; Silva, Egle; Topouchian, Jirar; Torlasco, Camilla; Wang, Ji Guang; Weber, Michael A.; Whelton, Paul K.; White, William B.; Mancia, Giuseppe; Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension; Medicine, School of MedicineThe present paper provides an update of previous recommendations on Home Blood Pressure Monitoring from the European Society of Hypertension (ESH) Working Group on Blood Pressure Monitoring and Cardiovascular Variability sequentially published in years 2000, 2008 and 2010. This update has taken into account new evidence in this field, including a recent statement by the American Heart association, as well as technological developments, which have occurred over the past 20 years. The present document has been developed by the same ESH Working Group with inputs from an international team of experts, and has been endorsed by the ESH.Item Patiromer and Spironolactone in Resistant Hypertension and Advanced CKD: Analysis of the Randomized AMBER Trial(American Society of Nephrology, 2021-01-15) Agarwal, Rajiv; Rossignol, Patrick; Budden, Jeffrey; Mayo, Martha R.; Arthur, Susan; Williams, Bryan; White, William B.; Medicine, School of MedicineBackground: Mineralocorticoid receptor antagonists reduce mortality in patients with heart failure with reduced ejection fraction and have become a standard of care in those with resistant hypertension (rHTN). Yet, their use is limited among patients with CKD, primarily due to hyperkalemia. Methods: AMBER was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that reported that the use of the potassium-binding drug patiromer allowed a more persistent use of spironolactone in patients with CKD and rHTN. In this report, we compare the safety and efficacy of patiromer in advanced CKD as a prespecified analysis. Results: Of the 295 patients randomized, 66 fell into the eGFR 25 to <30 subgroup. In this subgroup, persistent use of spironolactone was seen in 19 of 34 (56%) in the placebo group and 27 of 32 (84%) in the patiromer group (absolute difference 29%; P<0.02). In the eGFR 30-45 subgroup, persistent use of spironolactone was seen in 79 of 114 (69%) in the placebo group and 99 of 115 (86%) in the patiromer group (absolute difference 17%; P=0.003). There was no significant interaction between eGFR subgroups (P=0.46). Systolic BP reduction with spironolactone in the eGFR 25 to <30 subgroup was 6-7 mm Hg; in the eGFR 30-45 subgroup, it was 12-13 mm Hg. There was no significant interaction between eGFR subgroups on BP reduction (P=0.79). Similar proportions of patients reported adverse events (59% in the eGFR 25 to <30 subgroup; 53% in the eGFR 30-45 subgroup). Conclusions: Patiromer facilitates the use of spironolactone among patients with rHTN, and its efficacy and safety are comparable in those with eGFR 25 to <30 and 30-45 ml/min per 1.73 m2.Item Patiromer to Enable Spironolactone in Patients with Resistant Hypertension and CKD (AMBER): Results in the Prespecified Subgroup with Diabetes(Wolters Kluwer, 2021) Agarwal, Rajiv; Rossignol, Patrick; Mayo, Martha R.; Conrad, Ansgar; Arthur, Susan; Williams, Bryan; White, William B.; Medicine, School of MedicineItem Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study(Karger Publishers, 2018) Agarwal, Rajiv; Rossignol, Patrick; Garza, Dahlia; Mayo, Martha R.; Warren, Suzette; Arthur, Susan; Romero, Alain; White, William B.; Williams, Bryan; Medicine, School of MedicineBACKGROUND: 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.