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Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).
Peacock, WF, Rafique, Z, Vishnevskiy, K, Michelson, E, Vishneva, E, Zvereva, T, Nahra, R, Li, D, Miller, J
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2020;(6):475-486
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Abstract
OBJECTIVES Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder currently approved in the United States and European Union for treatment of hyperkalemia. This pilot evaluation explored the efficacy of SZC with insulin and glucose as hyperkalemia treatment in the emergency department (ED). METHODS This exploratory, phase II, multicenter, randomized, double-blind, placebo-controlled study (NCT03337477) enrolled adult ED patients with blood potassium ≥ 5.8 mmol/L. Patients were randomized 1:1 to receive SZC 10 g or placebo, up to three times during a 10-hour period, with insulin and glucose. The primary efficacy outcome was the mean change in serum potassium (sK+ ) from baseline until 4 hours after start of dosing. RESULTS Overall, 70 patients were randomized (SZC n = 33, placebo n = 37), of whom 50.0% were male. Their mean (± standard deviation [±SD]) age was 59.0 (±13.8) years and mean initial sK+ was similar between groups (SZC 6.4 mmol/L, placebo 6.5 mmol/L). The least squares mean (±SD) sK+ change from baseline to 4 hours was -0.41 (±0.11) mmol/L and -0.27 (±0.10) mmol/L with SZC and placebo, respectively (difference = -0.13 mmol/L, 95% confidence interval [CI] = -0.44 to 0.17). A greater reduction in mean (±SD) sK+ from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (±0.12) versus -0.36 (±0.11) mmol/L (LSM difference = -0.35 mmol/L, 95% CI = -0.68 to -0.02), respectively. A numerically lower proportion of patients in the SZC group required additional potassium-lowering therapy due to hyperkalemia at 0 to 4 hours versus placebo (15.6% vs. 30.6%, respectively; odds ratio = 0.40, 95% CI = 0.09 to 1.77). Comparable proportions of patients experienced adverse events in both treatment groups at 0 to 24 hours. CONCLUSIONS This pilot study suggested that SZC with insulin and glucose may provide an incremental benefit in the emergency treatment of hyperkalemia over insulin and glucose alone.
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Maintenance of serum potassium with sodium zirconium cyclosilicate (ZS-9) in heart failure patients: results from a phase 3 randomized, double-blind, placebo-controlled trial.
Anker, SD, Kosiborod, M, Zannad, F, Piña, IL, McCullough, PA, Filippatos, G, van der Meer, P, Ponikowski, P, Rasmussen, HS, Lavin, PT, et al
European journal of heart failure. 2015;(10):1050-6
Abstract
AIMS: Hyperkalaemia in heart failure patients limits use of cardioprotective renin-angiotensin-aldosterone system inhibitors (RAASi). Sodium zirconium cyclosilicate (ZS-9) is a selective potassium ion trap, whose mechanism of action may allow for potassium binding in the upper gastrointestinal tract as early as the duodenum following oral administration. ZS-9 previously demonstrated the ability to reduce elevated potassium levels into the normal range, with a median time of normalization of 2.2 h and sustain normal potassium levels for 28 days in HARMONIZE--a Phase 3, double-blind, randomized, placebo-controlled trial. In the present study we evaluated management of serum potassium with daily ZS-9 over 28 days in heart failure patients from HARMONIZE, including those receiving RAASi therapies. METHODS AND RESULTS Heart failure patients with evidence of hyperkalaemia (serum potassium ≥5.1 mmol/L, n = 94) were treated with open-label ZS-9 for 48 h. Patients (n = 87; 60 receiving RAASi) who achieved normokalaemia (potassium 3.5-5.0 mmol/L) were randomized to daily ZS-9 (5, 10, or 15 g) or placebo for 28 days. Mean potassium and proportion of patients maintaining normokalaemia during days 8-29 post-randomization were evaluated. Despite RAASi doses being kept constant, patients on 5 g, 10 g, and 15 g ZS-9 maintained a lower potassium level (4.7 mmol/L, 4.5 mmol/L, and 4.4 mmol/L, respectively) than the placebo group (5.2 mmol/L; P<0.01 vs. each ZS-9 group); greater proportions of ZS-9 patients (83%, 89%, and 92%, respectively) maintained normokalaemia than placebo (40%; P < 0.01 vs. each ZS-9 group). The safety profile was consistent with previously reported overall study population. CONCLUSION Compared with placebo, all three ZS-9 doses lowered potassium and effectively maintained normokalaemia for 28 days in heart failure patients without adjusting concomitant RAASi, while maintaining a safety profile consistent with the overall study population.
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Response of human dental pulp capped with biodentine and mineral trioxide aggregate.
Nowicka, A, Lipski, M, Parafiniuk, M, Sporniak-Tutak, K, Lichota, D, Kosierkiewicz, A, Kaczmarek, W, Buczkowska-Radlińska, J
Journal of endodontics. 2013;(6):743-7
Abstract
INTRODUCTION Biodentine is a new bioactive cement that is similar to the widely used mineral trioxide aggregate (MTA). It has dentin-like mechanical properties, which may be considered a suitable material for clinical indications of dentin-pulp complex regeneration such as direct pulp capping. The purpose of the present study was to compare the response of the pulp-dentin complex in human teeth after direct capping with this new tricalcium silicate-based cement with that of MTA. METHODS Pulps in 28 caries-free maxillary and mandibular permanent intact human molars scheduled for extraction for orthodontic reasons were mechanically exposed and assigned to 1 of 2 experimental groups, Biodentine or MTA, and 1 control group. Assay of periapical response and clinical examination were performed. After 6 weeks, the teeth were extracted, stained with hematoxylin-eosin, and categorized by using a histologic scoring system. RESULTS The majority of specimens showed complete dentinal bridge formation and an absence of inflammatory pulp response. Layers of well-arranged odontoblast and odontoblast-like cells were found to form tubular dentin under the osteodentin. Statistical analysis showed no significant differences between the Biodentine and MTA experimental groups during the observation period. CONCLUSIONS Within the limitations of this study, Biodentine had a similar efficacy in the clinical setting and may be considered an interesting alternative to MTA in pulp-capping treatment during vital pulp therapy.
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Silicate-substituted calcium phosphate as a bone graft substitute in surgery for adolescent idiopathic scoliosis.
Lerner, T, Liljenqvist, U
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013;(Suppl 2):S185-94
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Abstract
STUDY DESIGN AND OBJECTIVE The purpose of this prospective clinical study is to evaluate the clinical and radiographic outcomes using a silicate-substituted calcium phosphate (Si-CaP) as a bone graft substitute in surgery for adolescent idiopathic scoliosis (AIS). In posterior corrective surgery for AIS, harvesting autologous bone from the iliac crest still represents the gold standard to augment the local bone graft though it is comparatively invasive and associated with donor site morbidity. Si-CaP enriched with bone marrow aspirate (BMA) might be an appropriate bone graft extender to overcome these difficulties. METHODS Eighteen female and three male patients with AIS who underwent corrective posterior instrumentation were observed clinically and radiographically for a minimum of 24 months. In all cases, 20-40 ml Si-CaP granules (ACTIFUSE) mixed with BMA from vertebral bodies was used to extend the local bone graft. Fusion was assessed by standardized conventional radiographs regarding loss of correction and implant failure. Clinical outcome was evaluated with use of the Scoliosis Research Society-22 patient Questionnaire (SRS-22) and a Visual Analog Scale (VAS) for back pain. RESULTS Cobb angle of major curves averaged 63° preoperatively, 22° after surgery, and 24° at final follow-up, with a maximum loss of correction of 7° recorded after 4 months. No adverse effects related to the study material had been observed. In all patients, there was no evidence of implant failure, and formation of an increasingly densifying 'fusion mass' was visible, as assessed by conventional radiography. VAS score for back pain averaged 1.7 before surgery, 2.3 at discharge, and 1.5 at final follow-up. Outcome assessment using the SRS-22 revealed a significantly enhanced overall health-related quality of life (84 vs. 74 % before surgery; P = 0.0005) due to a significant improvement of the domains 'self image' (77 vs. 59 %; P = 0.0002) and 'pain' (88 vs. 80 %; P = 0.02). Patients' management satisfaction averaged 93 %. CONCLUSIONS Si-CaP augmented with BMA from vertebral bodies seems to prove an effective, safe, and easy to handle bone graft extender in scoliosis surgery and thus a suitable alternative to bone harvesting procedures.
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Evaluation of fluoride varnish and its comparison with pumice prophylaxis using self-etching primer in orthodontic bonding--an in vivo study.
Grover, S, Sidhu, MS, Prabhakar, M, Jena, S, Soni, S
European journal of orthodontics. 2012;(2):198-201
Abstract
The aim of this study was to evaluate the use of fluoride varnish as a prophylaxis method with self etching primer (SEP) and its comparison with pumice before orthodontic bonding. Thirty seven orthodontic patients participated in a prospective clinical trial. A split mouth technique was used in each patient, one quadrant was assigned to fluoride varnish and the contralateral quadrant to pumice prophylaxis. A total of 684 teeth were bonded with SEP (Transbond plus; 3M Unitek) and monitored for 6 months for bond failures. A total of 42 (6.1%) failures were recorded, 9 (2.6%) in the pumice group and 33 (9.6%) in the fluoride varnish group. Chi-square analysis was used to compare the number of bracket failures between the pumice and fluoride varnish groups and the number of patients in each group experiencing at least one bond failure. Statistically significant differences were found both in total number of bond failures (P < 0.001) and in the number of patients with bond failures (P < 0.05) between both groups. A significantly lower and clinically acceptable bond failure rate was observed with Transbond Plus self etching primer after pumice prophylaxis.
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The outcome of composite bone graft substitute used to treat cavitary bone defects.
Siegel, HJ, Baird, RC, Hall, J, Lopez-Ben, R, Lander, PH
Orthopedics. 2008;(8):754
Abstract
Although autogenous bone graft remains the gold standard graft material, it is associated with an unacceptably high incidence of morbidity. Furthermore, operative time, blood loss, and length of hospitalization are often increased. In order for a graft substitute to replicate the optimal bone healing properties of autogenous graft, 3 essential elements must be present: scaffolding for osteoconduction, growth factors for osteoinduction, and progenitor cells for osteogenesis. A composite graft that combines a synthetic scaffold with osteoprogenitor cells from bone marrow aspirate (BMA) may potentially deliver the advantages of autogenous bone grafts without the procurement morbidity. Sixty consecutive patients with cavitary bone defects were treated with a composite of b-tricalcium phosphate (beta-TCP), Vitoss (Orthovita, Malvern, Pennsylvania), and BMA. The cavitary defects were measured on orthogonal views by experienced musculoskeletal radiologists. Radiographically, resorption and trabeculation increased steadily with time. This differential was slightly more noticeable in large defects with a central trabeculation occurring in advance of the peripheral region. The majority of patients progressed to unrestricted activities by 6 weeks and had returned to their usual activities by 12 weeks. No significant difference in graft incorporation rate was noted based on age, size of defect, or use of adjuvant local treatment. The use of a composite graft (ultraporous beta-TCP+BMA) in the treatment of cavitary lesions appears to be safe and effective.
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Effects of microhydrin supplementation on endurance performance and metabolism in well-trained cyclists.
Glazier, LR, Stellingwerff, T, Spriet, LL
International journal of sport nutrition and exercise metabolism. 2004;(5):560-73
Abstract
This study investigated whether the supplement Microhydrin (MH) contains silica hydride bonds (Si-H) and if Microhydrin supplementation increased performance or altered metabolism compared to placebo (PL) during prolonged endurance cycling. Seven endurance-trained male cyclists consumed 9.6 g of MH or PL over 48 h in a randomized, double-blind, crossover design. Subjects cycled at approximately 70% of their VO2peak, coupled with five 2-min bursts at 85% VO2peak to simulate hill climbs over 2 h. Subjects then completed a time trial, which required them to complete 7 kJ/kg body mass as quickly as possible. Infrared spectrometry analysis showed a complete absence of Si-H bonds in MH. There was no difference in time trial performance between the 2 trials (PL: 2257+/-120 s vs. MH: 2345+/-152 s). Measured oxygen uptake, respiratory exchange ratio, carbohydrate (MH: 2.99+/-0.13 g/min; PL: 2.83+/-0.17 g/min avg. over 2 h) and fat (MH: 0.341+/-0.06 g/min; PL: 0.361+/-0.07 g/min) oxidation rates and all blood parameters (lactate, glucose, and free fatty acids) were all unaffected by MH supplementation. The volume of expired CO2 and ventilation were significantly greater with MH supplementation (P < or = 0.05). The results indicate that oral Microhydrin supplementation does not enhance cycling time trial performance or alter metabolism during prolonged submaximal exercise in endurance-trained cyclists.
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Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth.
Agamy, HA, Bakry, NS, Mounir, MM, Avery, DR
Pediatric dentistry. 2004;(4):302-9
Abstract
PURPOSE The aim of this study was to use clinical, radiographic, and histologic examinations to compare the relative success of gray mineral trioxide aggregate (MTA), white MTA, and formocresol as pulp dressings in pulpotomized primary teeth. METHODS Twenty-four children, each with at least 3 primary molars requiring pulpotomy, were selected for this study's clinical and radiographic portion. An additional 15 carious primary teeth planned for serial extraction were selected for this study's histologic portion. All selected teeth were evenly divided into 3 test groups and treated with pulpotomies. Gray MTA was used as the pulp dressing for one third of the teeth, white MTA was the dressing for one third, and the remaining one third were treated with formocresol. The treated teeth selected for the clinical and radiographic evaluations were monitored periodically for 12 months. The treated teeth selected for histologic study were monitored periodically and extracted 6 months postoperatively. RESULTS Four children with 12 pulpotomized teeth failed to return for any follow-up evaluations in the clinical and radiographic study. Of the remaining 60 teeth in 20 patients, 1 tooth (gray MTA) exfoliated normally and 6 teeth (4 white MTA and 2 formocresol) failed due to abscesses. The remaining 53 teeth appeared to be clinically and radiographically successful 12 months postoperatively. Pulp canal obliteration was a radiographic finding in 11 teeth treated with gray MTA and 1 tooth treated with white MTA. In the histologic study, both types of MTA successfully induced thick dentin bridge formation at the amputation sites, while formocresol induced thin, poorly calcified dentin. Teeth treated with gray MTA demonstrated pulp architecture nearest to normal pulp by preserving the odontoblastic layer and delicate fibrocellular matrix, yet few inflammatory cells or isolated calcified bodies were seen. Teeth treated with white MTA showed a denser fibrotic pattern, with more isolated calcifications in the pulp tissue along with secondary dentin formation. CONCLUSIONS Gray MTA appears to be superior to white MTA and formocresol as a pulp dressing for pulpotomized primary teeth.