Evidence in support of hyperkalaemia management strategies: A systematic literature review

Palaka, Eirini; Leonard, Saoirse; Buchanan-Hughes, Amy; Bobrowska, Anna; Langford, B.; Grandy, Susan

doi:10.1111/ijcp.13052

Cited by 20 publications

(26 citation statements)

References 73 publications

(177 reference statements)

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“…New potassium binders were developed, such as sodium zirconium cyclosilicate (ZS-9) and patiromer. Their safety and efficacy have been compared among them and/or with polysulfonate resins, but none of them were assessed with temporizing agents or other traditional therapies applied in order to decrease serum potassium levels 10,11,12. While Sterns et al .…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Varallo¹,

Trombotto

Lucchetta

et al. 2019

Pharm Pract (Granada)

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Background: Although the management of hyperkalemia follows expert guidelines, treatment approaches are based on traditionally accepted practice standards. New drugs have been assessed such as sodium zirconium cyclosilicate and patiromer; however, their safety and efficacy or effectiveness have not yet been compared to traditional pharmacotherapy. Objective: The present systematic review had the purpose to evaluate the efficacy, effectiveness, and safety of hyperkalemia pharmacotherapies. Methods: PubMed, LILACS, Cochrane Library, and ClinicalTrials were searched through November 2018. Clinical trial, cohort and case-control were searched. The risk of bias (RoB v2.0 and ROBINS-I) and quality of evidence (GRADE) at the level of outcomes were assessed. Results: Sixteen clinical trials and one retrospective cohort were identified regarding efficacy and safety of 24 different alternatives. The management of hyperkalemia remains empirical and off-label, since sodium zirconium cyclosilicate and patiromer are not available in several countries and further studies are required to assess efficacy, effectiveness and safety. Sodium or calcium polystyrene sulfonate (moderate confidence), sodium zirconium cyclosilicate (moderate confidence), and insulin plus dextrose (moderate confidence) showed superior efficacy to, respectively, placebo, no treatment, placebo, and dextrose. Other therapies (low confidence) showed similar efficacy compared to active or inactive alternatives. Most of the adverse events reported were nonspecific, so it was not possible to assign the cause and to classify as defined or probable. Conclusions: Comparative cohort and case-control studies are need to evaluate the safety and effectiveness of new and traditional pharmacotherapies to support the development of guidelines about acute and chronic hyperkalemia, with high-quality evidence.

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Section: Introductionmentioning

confidence: 99%

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Varallo¹,

Trombotto

Lucchetta

et al. 2019

Pharm Pract (Granada)

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“…1) polymer. PSS is an approved excipient by the Food and Drug Administration (FDA) [29][30][31][32][33]. In that work we demonstrate that the formation of the NPs is based on ionic a nity and critically dependent on the occurrence of aromatic-aromatic interactions between the drug and the polymer.…”

Section: Introductionmentioning

confidence: 78%

“…Based on previous investigations where our group demonstrated the synthesis of NPs comprising imipramine, amitriptyline, or cyclobenzaprine with the hydrophilic and aromatic polymer PSS [21], polymer already approved by the FDA for therapeutic applications [29,30,32,34,35], we postulate in this work a simple strategy to create NPs loaded with CQ.…”

Section: Elaboration and Characterization Of Cq/polymer Formulationsmentioning

confidence: 99%

The Critical Role of Aromatic-Aromatic Drug-Polymer Interactions to Provide Nanomedicines Containing Chloroquine: A Simple Proposal to Provide High Encapsulation, High Stability, and Prolonged Drug Release

Villamizar‐Sarmiento¹,

Moreno‐Villoslada²,

Oyarzún-Ampuero³

2020

Preprint

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Background: Chloroquine (CQ) is a drug commonly used to treat malaria. CQ has also gained interest for the treatment of other chronic diseases such as arthritis, lupus, cancer, diabetes, atherosclerosis, and dermatomyositis, among others. Since CQ is hydrophilic and low molecular-weight, attractive interactions with polymers in aqueous medium are weaker than with water, so that low encapsulation together with uncontrolled and fast release is observed. Importantly, a long-term administration of CQ is suggested, thus the development of formulations with controlled and prolonged release is desirable. Results: Here we propose the use of aromatic interactions between the cationic CQ and the FDA approved polymer poly(sodium 4-styrenesulfonate) (PSS) for the formation and stabilization of nanoparticles (NPs). The strategy consists on the simple mixture of two aqueous solutions containing the oppositelly charged molecules. UV-vis and NMR spectroscopy evidence intimate aromatic-aromatic interactions between CQ and PSS. CQ/PSS molar ratios from 0.2 to 0.5 allow obtaining NPs with spherical shape, size in the range of 170-410 nm, zeta potential from -18 to -45 mV, and particles number in the range of 0.9 - 6.6 x 1010 NPs/mL. Selected NPs (CQ/PSS molar ratio 0.4) are stable to wide variations in ionic strength (0-200 mM), pH (2-10) and temperature (20-50 °C). In addition, CQ/polymer 0.4 was also tested but with the absence of the aromatic group in the polymer, and providing smaller (70 nm), lower-concentrated (6.1 x 109 NPs/mL), and unstable particles, confirming the key role of the aromatic group. Furthermore, CQ/PSS NPs are stable during months and can be converted to a reconstitutable powder. Importantly, the selected NPs (CQ/PSS 0.4) show full drug association efficiency (100 %), very high drug loading (49 %), very high yield (89 %), and evidencing a drug entrapment/release governed by kinetic associations (≈99 %). Finally, release studies evidence a controlled and prolonged delivery. Conclusions: Considering the potential uses of CQ for chronic diseases, and the simplicity and efficiency of our proposal, it could be considered as a valuable alternative to developed nanomedicines. In addition, this strategy could be used for other drugs and polymers showing similar characteristics to CQ and PSS.

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“…The remainder of this month's issue of the journal contains additional reviews covering a variety of conditions and/or procedures, including the management of hyperkalaemia, the treatment of hypothyroidism, integrated left trial evaluation, the use of endobronchial ultrasound trans‐bronchial needle aspiration, and a discussion on exocrine pancreatic insufficiency . Next month we will resume our usual publication pattern to include single study reports.…”

mentioning

confidence: 99%

Perspectives, Commentaries, Consensus Reports, Grand Rounds, Meta-Analyses, Systematic Reviews, Narrative Reviews: Collecting useful information in one place

Citrome

2018

Int J Clin Pract

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Evidence in support of hyperkalaemia management strategies: A systematic literature review

Abstract: Despite hyperkalaemia being associated with several chronic diseases, there is a paucity of high-quality randomised evidence on long-established treatment options (SPS and CPS) and a limited evidence base for hyperkalaemia management with these agents.

Cited by 20 publications

References 73 publications

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review

The Critical Role of Aromatic-Aromatic Drug-Polymer Interactions to Provide Nanomedicines Containing Chloroquine: A Simple Proposal to Provide High Encapsulation, High Stability, and Prolonged Drug Release

Perspectives, Commentaries, Consensus Reports, Grand Rounds, Meta-Analyses, Systematic Reviews, Narrative Reviews: Collecting useful information in one place

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