Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial

Agarwal, Rajiv; Rossignol, Patrick; Romero, Alain; Garza, Dahlia; Mayo, Martha; Warren, Suzette; Ma, Jun; White, William Β.; Williams, Bryan

doi:10.1016/s0140-6736(19)32135-x

Cited by 271 publications

(210 citation statements)

References 20 publications

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“…receiving patiromer compared to 60% receiving placebo at 12 weeks (P < 0.0001) [28]. Like all observational studies, the present study has several limitations.…”

Section: Discussionmentioning

confidence: 77%

Real-world management of hyperkalemia with patiromer among United States Veterans

Kövesdy

Gosmanova

Woods

et al. 2020

Postgraduate Medicine

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Objective: Patiromer is a sodium-free, non-absorbed, potassium (K + ) binder approved for the treatment of hyperkalemia (HK). Among US Veterans with HK, this retrospective, observational cohort study evaluated patiromer utilization, RAASi continuation, and K + concentration change following patiromer initiation. Methods: Using data from the Veterans Affairs Corporate Data Warehouse, Veterans with HK (K + ≥5.1 mmol/L) were included upon patiromer initiation (index date) during the study period (1/2016-8/2018). All patients had heart failure (HF), diabetes, or chronic kidney disease (CKD). Patients with end-stage renal disease were excluded. The following outcomes were assessed within 6-months post-patiromer initiation: patiromer utilization (using proportion of days covered); K + concentration change (pre-vs post-initiation); and RAASi continuation. Results: 288 Veterans with HK were included. Baseline characteristics were: median age 70 years, African-American race 24%, diabetes 83%, HF 32%, CKD 95%, and median K + concentration 5.7 mmol/L. At 1, 3, and 6 months post-index, the median patiromer PDC was 100%, 66%, and 44%, respectively. K + concentration reductions post-patiromer initiation were, on average, -1.0 mmol/L (P < 0.001). At 3-6 months, 71% of patiromer initiators had K + <5.1 mmol/L and 95% had K + <5.5 mmol/L. RAASi therapy was continued in >80%-90% of patiromer-treated patients. Conclusions: The real-world utilization results suggest patiromer is used for the chronic management of HK. Clinically relevant K + concentration reductions were observed at all study time points. The successful management of HK may have contributed to the observed high rate of RAASi therapy continuation. Further research is warranted to corroborate and extend these findings. ARTICLE HISTORY

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“…receiving patiromer compared to 60% receiving placebo at 12 weeks (P < 0.0001) [28]. Like all observational studies, the present study has several limitations.…”

Section: Discussionmentioning

confidence: 77%

Real-world management of hyperkalemia with patiromer among United States Veterans

Kövesdy

Gosmanova

Woods

et al. 2020

Postgraduate Medicine

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“…However, the long-term clinical benefits and harms of this strategy are not known. 87 Whether newer nonsteroidal mineralocorticoid receptor antagonists may provide benefit in diabetes and CKD with fewer side effects is an area of ongoing research. 86,88…”

Section: No Dosage Adjustment Necessary Poorly Removed By Hemodialysismentioning

confidence: 99%

KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease

Boer¹,

Caramori²,

Chan³

et al. 2020

Kidney International

822

549

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S20 Introduction S22 Summary of recommendation statements and practice points S30 Chapter 1: Comprehensive care in patients with diabetes and CKD S39 Chapter 2: Glycemic monitoring and targets in patients with diabetes and CKD S47 Chapter 3: Lifestyle interventions in patients with diabetes and CKD S58 Chapter 4: Antihyperglycemic therapies in patients with type 2 diabetes (T2D) and CKD S79 Chapter 5: Approaches to management of patients with diabetes and CKD S87 Methods for guideline development S96 Biographic and disclosure information S106 Acknowledgments S107 References The development and publication of this guideline were supported by KDIGO. The opinions or views expressed in this professional education supplement are those of the authors and do not necessarily reflect the opinions or recommendations of the International Society of Nephrology or Elsevier. Dosages, indications, and methods of use for products that are referred to in the supplement by the authors may reflect their clinical experience or may be derived from the professional literature or other clinical sources. Because of the differences between in vitro and in vivo systems and between laboratory animal models and clinical data in humans, in vitro and animal data may not necessarily correlate with clinical results.

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“…241 Results from the AMBER trial showed that in patients with resistant hypertension and advanced CKD (25 to # 45 ml/min per 1.73 m 2 ), concomitant use of patiromer, compared with placebo, resulted in a larger proportion of patients using spironolactone at 12 weeks. 242 RAAS inhibition clearly improves outcomes in patients with heart failure and reduced ejection fraction 238 and in patients with proteinuric kidney disease, including diabetes, 243 although its role in advanced CKD is less clear, based on evidence from a single trial of 224 participants with proteinuric CKD G4. 244 We regard it as critical to test whether such strategies to reduce the risk of hyperkalemia (e.g., examining existing or extended clinical indications for RAAS inhibition) improves patient-important outcomes ( Figure 6).…”

Section: Chronic Hyperkalemiamentioning

confidence: 99%

Potassium homeostasis and management of dyskalemia in kidney diseases: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

Clase

Carrero

Ellison

et al. 2020

Kidney International

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342

303

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Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial

Cited by 271 publications

References 20 publications

Real-world management of hyperkalemia with patiromer among United States Veterans

Real-world management of hyperkalemia with patiromer among United States Veterans

KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease

Potassium homeostasis and management of dyskalemia in kidney diseases: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

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