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Christine Taylor Brew, James F Blake, Anita Mistry, Fengling Liu, Diana Carreno, Deidre Madsen, YongQi Mu, Martha Mayo, Wilhelm Stahl, David Matthews, Derek Maclean, Steve Harrison
PURPOSE: Polymeric drugs, including patiromer (Veltassa®), bind target molecules or ions in the gut, allowing fecal elimination. Non-absorbed insoluble polymers, like patiromer, avoid common systemic drug-drug interactions (DDIs). However, the potential for DDI via polymer binding to orally administered drugs during transit of the gastrointestinal tract remains. Here we elucidate the properties correlated with drug-patiromer binding using quantitative structure-property relationship (QSPR) models...
March 8, 2018: Pharmaceutical Research
Jay Ian Lakkis, Matthew R Weir
PURPOSE OF REVIEW: Hyperkalemia develops in a patient with systemic arterial hypertension (HTN) if one or more risk factors are present, namely chronic kidney disease (CKD) (especially severe stage 4-5 CKD), diabetes mellitus (DM), heart failure (HF), or pharmacological therapies that interfere with potassium homeostasis, mainly through renin-angiotensin-aldosterone inhibition (RAASi). Hyperkalemia is a considerable reason of morbidity (emergency department (ED) visits and hospitalizations) and portends a higher mortality risk in patients at risk; for instance, hyperkalemia increases the risk of mortality within 1 day of a hyperkalemic event...
March 1, 2018: Current Cardiology Reports
Eirini Palaka, Saoirse Leonard, Amy Buchanan-Hughes, Anna Bobrowska, Bryony Langford, Susan Grandy
BACKGROUND: Hyperkalaemia is a potentially life-threatening condition that can be managed with pharmacological and non-pharmacological approaches. With the recent development of new hyperkalaemia treatments, new information on safe and effective management of hyperkalaemia has emerged. OBJECTIVES: This systematic literature review (SLR) aimed to identify all relevant comparative and non-comparative clinical data on management of hyperkalaemia in adults. Our secondary aim was to assess the feasibility of quantitatively comparing randomised controlled trial (RCT) data on the novel treatment sodium zirconium cyclosilicate (ZS) and established pharmacological treatments for the non-emergency management of hyperkalaemia, such as the cation-exchangers sodium/calcium polystyrene sulphonate (SPS/CPS)...
January 30, 2018: International Journal of Clinical Practice
Juan Tamargo, Ricardo Caballero, Eva Delpón
Hyperkalemia (serum potassium > 5.5 mEq/L) is a common clinical problem in patients with chronic kidney disease, hypertension, diabetes, and heart failure. It can result from increased K+ intake, impaired distribution between intracellular and extracellular spaces, and most frequently, decreased renal excretion. Patients at the highest risk of hyperkalemia are treated with renin-angiotensin-aldosterone system inhibitors (RAASIs) as they improve cardiovascular and renal outcomes and are strongly recommended in clinical guidelines...
January 25, 2018: Cardiovascular Drugs and Therapy
Bertram Pitt, David A Bushinsky, Dalane W Kitzman, Frank Ruschitzka, Marco Metra, Gerasimos Filippatos, Patrick Rossignol, Charles Du Mond, Dahlia Garza, Lance Berman, Mitja Lainscak
AIMS: Hyperkalaemia risk precludes optimal renin-angiotensin-aldosterone system inhibitor use in patients with heart failure (HF), particularly those with chronic kidney disease (CKD). Patiromer is a sodium-free, non-absorbed potassium (K+ )-binding polymer approved for the treatment of hyperkalaemia. In PEARL-HF, patiromer 25.2 g (fixed dose) prevented hyperkalaemia in HF patients with or without CKD initiating spironolactone. The current study evaluated the effectiveness of a lower starting dose of patiromer (16...
January 25, 2018: ESC Heart Failure
(no author information available yet)
Hyperkalaemia is a potentially life-threatening condition, in which there is an abnormally high concentration of potassium ions in the blood.1,2 Cation-exchange resins (e.g. calcium or sodium polystyrene sulfonate) that bind potassium in the gastrointestinal tract to increase faecal elimination have been used as part of the management of hyperkalaemia but they have some serious adverse effects, including potentially fatal gastrointestinal necrosis.3,4 Patiromer (▼Veltassa - Vifor Fresenius) is a cation-exchange polymer that is licensed for the treatment of hyperkalaemia in adults and, unlike other exchange resins, its licence is not restricted to people with anuria, severe oliguria or those requiring or undergoing dialysis...
January 2018: Drug and Therapeutics Bulletin
Panagiotis I Georgianos, Rajiv Agarwal
Among patients with proteinuric chronic kidney disease (CKD), current guideline recommendations mandate the use of agents blocking the renin angiotensin aldosterone system (RAAS) as first-line antihypertensive therapy based on randomized trials demonstrating that RAAS inhibitors are superior to other antihypertensive drug classes in slowing nephropathy progression to end-stage renal disease. However, the opportunities for adequate RAAS blockade in CKD are often limited, and an important impediment is the risk of hyperkalemia, especially when RAAS inhibitors are used in maximal doses or are combined...
December 21, 2017: Kidney International
Matthew R Weir, David A Bushinsky, Wade W Benton, Steven D Woods, Martha R Mayo, Susan P Arthur, Bertram Pitt, George L Bakris
BACKGROUND: Older people are predisposed to hyperkalemia because of impaired renal function, comorbid conditions, and polypharmacy. Renin-angiotensin-aldosterone system inhibitors (RAASi), which are recommended to treat chronic kidney disease and heart failure augment the risk. Patiromer, a nonabsorbed potassium binder, was shown in the phase 3 OPAL-HK study to decrease serum potassium in patients with chronic kidney disease taking RAASi. We studied the efficacy and safety of patiromer in a prespecified subgroup of patients aged ≥65 years from OPAL-HK...
November 26, 2017: American Journal of Medicine
James P Davidson, Andrew J King, Padmapriya Kumaraswamy, Jeremy S Caldwell, Paul Korner, Robert C Blanks, Jeffrey W Jacobs
INTRODUCTION: Hyperkalemia is a common complication in patients with heart failure or chronic kidney disease, particularly those who are taking inhibitors of the renin-angiotensin-aldosterone system. RDX7675, the calcium salt of a reengineered polystyrene sulfonate-based resin, is a potassium binder that is being investigated as a novel treatment for hyperkalemia. This study evaluated the pharmacodynamic effects of RDX7675 in mice, compared to 2 current treatments, sodium polystyrene sulfonate (SPS) and patiromer...
January 1, 2017: Journal of Cardiovascular Pharmacology and Therapeutics
Pablo E Pergola, David M Spiegel, Suzette Warren, Jinwei Yuan, Matthew R Weir
BACKGROUND: Patiromer is a sodium-free, nonabsorbed, potassium binder approved for treatment of hyperkalemia. This open-label study compares the efficacy and safety of patiromer administered without food versus with food. METHODS: Adults with hyperkalemia (potassium ≥5.0 mEq/L) were randomized (1:1) to receive patiromer once daily without food or with food for 4 weeks. The dosage was adjusted (maximum: 25.2 g/day) using a prespecified titration schedule to achieve and maintain potassium within a target range (3...
2017: American Journal of Nephrology
Rajeev Kumar, Leo Kanev, Steven D Woods, Melanie Brenner, Bernie Smith
Hyperkalemia is common among elderly patients and is associated with an increase in morbidity and mortality. Patients at highest risk for developing hyperkalemia are those with chronic kidney disease (CKD) and heart failure (HF), particularly those on guideline-recommended inhibitors of the renin-angiotensin-aldosterone system (RAAS). Hyperkalemia remains a challenge for clinicians practicing in the long-term care setting as they are often faced with the difficult decision of down-titrating or discontinuing RAAS inhibitors in response to hyperkalemia in the very patients who derive the greatest benefit from these agents...
February 2017: American Journal of Managed Care
Lawrence J Lesko, Elliot Offman, Christine Taylor Brew, Dahlia Garza, Wade Benton, Martha R Mayo, Alain Romero, Charles Du Mond, Matthew R Weir
INTRODUCTION: Patiromer is a potassium-binding polymer that is not systemically absorbed; however, it may bind coadministered oral drugs in the gastrointestinal tract, potentially reducing their absorption. METHODS: Twelve randomized, open-label, 3-period, 3-sequence crossover studies were conducted in healthy volunteers to evaluate the effect of patiromer (perpetrator drug) on absorption and single-dose pharmacokinetics (PK) of drugs (victims) that might be commonly used with patiromer...
September 2017: Journal of Cardiovascular Pharmacology and Therapeutics
Macaulay Amechi Chukwukadibia Onuigbo, Nneoma Agbasi, Fidelis Oguejiofor, Charles Odenigbo
Hyperkalemia is not uncommon in patients with end-stage renal disease (ESRD) on maintenance hemodialysis, often related to dietary indiscretion, following the prolonged inter-dialytic weekend interval in patients on thrice weekly hemodialysis treatments, and sometimes the adverse effects of medications such as RAAS blocking agents. Moreover, hyperkalemia following extended cardiac surgery can result from the use of high-potassium containing cardioplegic solutions used during cardiopulmonary bypass. Nevertheless, different from the foregoing, in the nephrology literature, there have been very rare reports of potentially life-threatening hyperkalemia following cardiac valve replacement procedure...
2017: Journal of Renal Injury Prevention
Zubaid Rafique, Matthew R Weir, Macaulay Onuigbo, Bertram Pitt, Richard Lafayette, Javed Butler, Maria Lopes, Carolyn Farnum, W Frank Peacock
Virtual panel meetings were conducted among 7 physicians, all of whom are independent experts, including 3 nephrologists, 2 cardiologists, and 2 emergency medicine physicians (the panel). The panel met with the purpose of discussing the current treatment landscape, treatment challenges, economic impact, and gaps in care for patients with hyperkalemia that is associated with heart failure and chronic kidney disease. The stated goal of the panel discussion was to develop practical solutions in the identification and management of hyperkalemia in this patient population...
April 2017: Journal of Managed Care & Specialty Pharmacy
Manuel Heras, María José Fernández-Reyes
Abnormalities in potassium concentrations are associated with morbidity and mortality. In recent years it has been considered that small variations in serum potassium concentrations within normal intervals may also be associated with mortality. Strategies for achieving normokalaemia include dietary measures, limiting the use of potassium retaining drugs, and use of conventional cation exchange resins (calcium/sodium polystyrene sulfonate) and/or the new non-absorbed cation exchange polymer (patiromer).
June 21, 2017: Medicina Clínica
Saibal Das, Jayanta Kumar Dey, Sumalya Sen, Rishav Mukherjee
BACKGROUND: Patients at the highest risk of hyperkalemia are those with chronic kidney disease (CKD) stages 3 and 4. OBJECTIVE: To evaluate the efficacy and safety of patiromer in hyperkalemia in patients with heart failure or CKD. METHODS: The Cochrane Renal Group's Specialized Register was searched through contact with the Trials' Search Coordinator. We aimed at including randomized controlled trials with patiromer in patients with developed or risks of developing hyperkalemia, comparing against an active comparator or placebo...
January 1, 2017: Journal of Pharmacy Practice
Mario V Beccari, Calvin J Meaney
INTRODUCTION: Hyperkalemia is a serious medical condition that often manifests in patients with chronic kidney disease and heart failure. Renin-angiotensin-aldosterone system inhibitors are known to improve outcomes in these disease states but can also cause drug-induced hyperkalemia. New therapeutic options exist for managing hyperkalemia in these patients which warrant evidence-based evaluation. AIM: The objective of this article was to review the efficacy and safety evidence for patiromer, sodium zirconium cyclosilicate (ZS9), and sodium polystyrene sulfonate (SPS) for the treatment of hyperkalemia...
2017: Core Evidence
Andrea C J Cowan, Elie G Gharib, Matthew A Weir
PURPOSE OF REVIEW: Patients with chronic kidney disease (CKD) have an increased risk of hyperkalemia that increases both short-term and long-term mortality. Historically, managing hyperkalemia has relied upon dietary modifications, augmentation of urinary potassium excretion and enhanced enteral potassium elimination. This review discusses current treatments and their limitations and summarizes the evidence supporting novel agents for potassium lowering in patients with CKD. RECENT FINDINGS: The introduction of two novel ion exchange resins represents the first new pharmacologic therapies for hyperkalemia in the last 50 years...
May 2017: Current Opinion in Nephrology and Hypertension
Matthew R Weir, Martha R Mayo, Dahlia Garza, Susan A Arthur, Lance Berman, David Bushinsky, Daniel J Wilson, Murray Epstein
OBJECTIVE: Recurrent hyperkalemia frequently limits use of renin-angiotensin-aldosterone system inhibitors (RAASi) in chronic kidney disease (CKD) patients with hypertension, diabetes, and/or heart failure. Patiromer is a sodium-free, nonabsorbed potassium (K)-binding polymer approved by the US Food and Drug Administration for the treatment of hyperkalemia. This post-hoc analysis of OPAL-HK examined the effectiveness and safety of patiromer in reducing serum K in hyperkalemic CKD patients on RAASi, with hypertension, receiving diuretic therapy versus those not on diuretics...
May 2017: Journal of Hypertension
Calvin J Meaney, Mario V Beccari, Yang Yang, Jiwei Zhao
OBJECTIVE: To compare and contrast the efficacy and safety of patiromer and sodium zirconium cyclosilicate (ZS-9) in the treatment of hyperkalemia. DESIGN: A systematic review and meta-analysis of phase II and III clinical trial data was completed. PATIENTS OR PARTICIPANTS: Eight studies (two phase II and four phase III trials with two subgroup analyses) were included in the qualitative analysis, and six studies (two phase II and four phase III trials) were included in the meta-analysis...
April 2017: Pharmacotherapy
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