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Elevated serum phosphorus and calcium are associated with arterial calcification and mortality in dialysis patients. Unlike calcium-based binders, sevelamer attenuates arterial calcification but it is unknown whether sevelamer affects mortality or morbidity. In a multicenter, randomized, open-label, parallel design trial we compared sevelamer and calcium-based binders on all-cause and cause-specific mortality (cardiovascular, infection, and other) in prevalent hemodialysis patients. A total of 2103 patients were initially randomized to treatment and 1068 patients completed the study. All-cause mortality rates and cause-specific mortality rates were not significantly different. There was a significant age interaction on the treatment effect. Only in patients over 65 years of age was there a significant effect of sevelamer in lowering the mortality rate. There was a suggestion that sevelamer was associated with lower overall, but not cardiovascular-linked, mortality in older patients. We suggest that further research is needed to confirm these findings.

ObjectivesThis study aimed to randomly compare in vivo coronal discoloration at 6 and 12 months after full pulpotomy in mature permanent molars using MTA, Biodentine, and TotalFill and to investigate the effect of variables such as remaining buccal wall thickness and time to achieve hemostasis.Materials and methodsOne hundred eight teeth that met the inclusion criteria received full pulpotomy and were randomly divided into 3 groups via a block randomization technique according to the calcium silicate cement (CSC): ProRoot WMTA, TotalFill, or Biodentine. Assessment of tooth color was carried out using a spectrophotometric device (VITA Easyshade Compact) after composite placement (T0), at 6- and 12-month follow-up. Buccal wall thickness and time to hemostasis were recorded. The primary outcome measure (color change ΔE) was calculated, and the results were analyzed by three-way ANOVA and crosstabulations in relation to material type and effect of variables.ResultsFour cases were excluded after pulpotomy failure; 81 teeth were evaluated at 6 months and 95 teeth at 12 months. All CSCs caused tooth discoloration (defined as ΔE > 3.7); MTA significantly caused the highest color change at 6- and 12-month follow-up (76% (19/25) and 87.5% (28/32), respectively) compared to Biodentine (41% (9/22), 48% (13/27)) and TotalFill (44% (15/34), 53% (19/53)) (p = 0.022, p = 0.002), while no significant difference was found between the Biodentine and TotalFill groups (p = 0.813, p = 0.8). Buccal wall thickness (above or below 2.7 mm) had a significant effect on the degree of discoloration (p = 0.004).ConclusionsThe 3 CSCs caused tooth discoloration based on the threshold of ΔE > 3; the remaining buccal wall thickness was a significant factor. The use of Biodentine and TotalFill instead of MTA is encouraged to minimize discoloration.Clinical relevanceWhile experimental studies report coronal discoloration after CSCs use, clinical data is lacking. This study assessed discoloration using a spectrophotometric device. The use of materials with lower discoloration potential in pulpotomy is encouraged.Trial registrationThe study was registered with clinical trial registration number: NCT04346849 on 14.4.2020.

We investigated the efficacy, safety and cost of lime wash of household walls plus treatment of sand fly breeding places with bleach (i.e. environmental management or EM), insecticide impregnated durable wall lining (DWL), and bed net impregnation with slow release insecticide (ITN) for sand fly control in the Indian sub-continent. This multi-country cluster randomized controlled trial had 24 clusters in each three sites with eight clusters per high, medium or low sand fly density stratum. Every cluster included 45-50 households. Five households from each cluster were randomly selected for entomological measurements including sand fly density and mortality at one, three, nine and twelve months post intervention. Household interviews were conducted for socioeconomic information and intervention acceptability assessment. Cost for each intervention was calculated. There was a control group without intervention. Sand fly mortality [mean and 95%CI] ranged from 84% (81%-87%) at one month to 74% (71%-78%) at 12 months for DWL, 75% (71%-79%) at one month to 49% (43%-55%) at twelve months for ITN, and 44% (34%-53%) at one month to 22% (14%-29%) at twelve months for EM. Adjusted intervention effect on sand fly density measured by incidence rate ratio ranged from 0.28 (0.23-0.34) at one month to 0.62 (0.51-0.75) at 12 months for DWL; 0.72 (0.62-0.85) at one month to 1.02 (0.86-1.22) at 12 months for ITN; and 0.89 (0.76-1.03) at one months to 1.49 (1.26-1.74) at 12 months for EM. Household acceptance of EM was 74% compared to 94% for both DWL and ITN. Operational cost per household in USD was about 5, 8, and 2 for EM, DWL and ITN, respectively. Minimal adverse reactions were reported for EM and ITN while 36% of households with DWL reported transient itching. DWL is the most effective, durable and acceptable control method followed by ITN. The Visceral Leishmaniasis (VL) Elimination Program in the Indian sub-continent should consider DWL and ITN for sand fly control in addition to IRS.

Background In the general population and in hemodialysis patients epicardial adipose tissue (EAT) has been associated with increased mortality and cardiovascular events. Weight loss and lipid lowering therapies reduced EAT in the general population. It is unknown whether sevelamer, a phosphate (Pi) binder that lowers cholesterol and reduces inflammation in dialysis patients also affects EAT progression. Methods Post-hoc analysis of a randomized trial of sevelamer (SVL) versus calcium-based Pi binders (CPiB) in incident hemodialysis patients. EAT was measured on cardiac computed tomography scans performed at enrollment, 6, 12 and 18 months from baseline. Results Of 109 patients, 54 received SVL and 55 CPiB; the median LDL change was −16.4 % (IQR: −67.5, 142.3 %) and 12.1 % (IQR: −51.9, 193.8 %) with SVL and CPiB respectively (p < 0.001). At baseline EAT correlated significantly with gender, body mass index and total coronary artery calcium score (all p < 0.02). At the end of follow-up, EAT progressed significantly from baseline in the CPiB treated patients but not in the SVL treated patients [median increase 9.1 % (p = 0.005) vs 3.9 % (p = 0.25)]. However, there was no significant difference in the degree of progression between treatment groups (p = 0.34). There was no correlation between LDL or CRP change and EAT change. There were insufficient events in either arm to assess the impact of EAT change on mortality. Conclusion EAT progression from baseline was significantly smaller with SVL than with CPiB, although the difference between treatments was not statistically significant, probably due to the small sample size. Change in serum lipids and markers of inflammation did not predict EAT progression.

Intramuscular acidosis is a contributing factor to fatigue during high-intensity exercise. Many nutritional strategies aiming to increase intra- and extracellular buffering capacity have been investigated. Among these, supplementation of beta-alanine (~3–6.4 g/day for 4 weeks or longer), the rate-limiting factor to the intramuscular synthesis of carnosine (i.e. an intracellular buffer), has been shown to result in positive effects on exercise performance in which acidosis is a contributing factor to fatigue. Furthermore, sodium bicarbonate, sodium citrate and sodium/calcium lactate supplementation have been employed in an attempt to increase the extracellular buffering capacity. Although all attempts have increased blood bicarbonate concentrations, evidence indicates that sodium bicarbonate (0.3 g/kg body mass) is the most effective in improving high-intensity exercise performance. The evidence supporting the ergogenic effects of sodium citrate and lactate remain weak. These nutritional strategies are not without side effects, as gastrointestinal distress is often associated with the effective doses of sodium bicarbonate, sodium citrate and calcium lactate. Similarly, paresthesia (i.e. tingling sensation of the skin) is currently the only known side effect associated with beta-alanine supplementation, and it is caused by the acute elevation in plasma beta-alanine concentration after a single dose of beta-alanine. Finally, the co-supplementation of beta-alanine and sodium bicarbonate may result in additive ergogenic gains during high-intensity exercise, although studies are required to investigate this combination in a wide range of sports.

Background Hyperphosphatemia in patients with chronic kidney disease (CKD) contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. Methods In this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR < 30 mL/min/1.73 m 2 and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH) levels. Results At 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs . 5.1 ± 1.4 mg/dL; p = 0.04). The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p < 0.001) and iPTH was significantly lower in the calcium acetate group compared to placebo (150 ± 157 vs. 351 ± 292 pg/mL respectively; p < 0.001). At 12 weeks, the proportions of subjects who had hypocalcemia were 5.4% and 19.5% for the calcium acetate and the placebo groups, respectively, while the proportions of those with hypercalcemia were 13.5% and 0%, respectively. Adverse events did not differ between the treatment groups. Conclusions In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period. Trial Registration www.clinicaltrials.gov NCT00211978 .

Key messages Particle sizes of E 551 products are in the micrometre range. The typical external diameters of the constituent particles (aggregates) are greater than 100 nm. E 551 does not break down under acidic conditions such as in the stomach, but may release dissolved silica in environments with higher pH such as the intestinal tract. E 551 is one of the toxicologically most intensively studied substances and has not shown any relevant systemic or local toxicity after oral exposure. Synthetic amorphous silica (SAS) meeting the specifications for use as a food additive (E 551) is and has always been produced by the same two production methods: the thermal and the wet processes, resulting in E 551 products consisting of particles typically in the micrometre size range. The constituent particles (aggregates) are typically larger than 100 nm and do not contain discernible primary particles. Particle sizes above 100 nm are necessary for E 551 to fulfil its technical function as spacer between food particles, thus avoiding the caking of food particles. Based on an in-depth review of the available toxicological information and intake data, it is concluded that the SAS products specified for use as food additive E 551 do not cause adverse effects in oral repeated-dose studies including doses that exceed current OECD guideline recommendations. In particular, there is no evidence for liver toxicity after oral intake. No adverse effects have been found in oral fertility and developmental toxicity studies, nor are there any indications from in vivo studies for an immunotoxic or neurotoxic effect. SAS is neither mutagenic nor genotoxic in vivo. In intact cells, a direct interaction of unlabelled and unmodified SAS with DNA was never found. Differences in the magnitude of biological responses between pyrogenic and precipitated silica described in some in vitro studies with murine macrophages at exaggerated exposure levels seem to be related to interactions with cell culture proteins and cell membranes. The in vivo studies do not indicate that there is a toxicologically relevant difference between SAS products after oral exposure. It is noted that any silicon dioxide product not meeting established specifications, and/or produced to provide new functionality in food, requires its own specific safety and risk assessment.

Hyperphosphatemia, which is nearly universal in kidney failure, is accompanied by low serum levels of vitamin D and hypocalcemia. Without treatment, severe secondary hyperparathyroidism occurs, which may result in painful fractures, brown tumors, and generalized osteopenia. This article reviews the rationale for treatment with oral phosphate binders, discusses evidence supporting the use of available agents, and suggests an approach for clinical practice. This article reviews the rationale for treatment with oral phosphate binders, discusses evidence supporting the use of available agents, and suggests an approach for clinical practice. Hyperphosphatemia, a nearly universal complication of kidney failure, is accompanied by hypocalcemia and low serum levels of vitamin D. Without treatment, these deficiencies usually lead to severe secondary hyperparathyroidism, which in turn leads to painful fractures, brown tumors, and generalized osteopenia. Dietary restriction of phosphate has long been the cornerstone of therapy, but this measure is usually not sufficient to control hyperphosphatemia. As a result, oral phosphate binders are used in over 90% of patients with kidney failure, at an annual cost of approximately $750 million (in U.S. dollars) worldwide. 1 Historically, treatment with oral phosphate binders was intended to prevent . . .

The aim of this study was to evaluate and compare the antimicrobial activity and cytocompatibility of six different pulp-capping materials: Dycal (Dentsply), Calcicur (Voco), Calcimol LC (Voco), TheraCal LC (Bisco), MTA Angelus (Angelus), and Biodentine (Septodont). To evaluate antimicrobial activity, materials were challenged in vitro with Streptococcus mutans, Streptococcus salivarius, and Streptococcus sanguis in the agar disc diffusion test. Cytocompatibility of the assayed materials towards rat MDPC-23 cells was evaluated at different times by both MTT and apoptosis assays. Results significantly differed among the different materials tested. Both bacterial growth inhibition halos and cytocompatibility performances were significantly different among materials with different composition. MTA-based products showed lower cytotoxicity and valuable antibacterial activity, different from calcium hydroxide-based materials, which exhibited not only higher antibacterial activity but also higher cytotoxicity.

As kidney disease progresses, phosphorus retention also increases, and phosphate binders are used to treat hyperphosphatemia. Clinicians prescribe phosphate binders thinking that reducing total body burden of phosphorus may decrease risks of mineral and bone disorder, fractures, cardiovascular disease, progression of kidney disease, and mortality. Recent meta-analyses suggest that sevelamer use results in lower mortality than use of calcium-containing phosphate binders. However, studies included in meta-analyses show significant heterogeneity, and exclusion or inclusion of specific studies alters results. Since no long-term studies have been conducted to determine whether treatment with any phosphate binder is better than placebo on any hard clinical endpoint (including mortality), it is unclear whether possible benefit with sevelamer represents net benefit of sevelamer, net harm with calcium-containing phosphate binders, or both. Although one meta-analysis suggested that calcium acetate may be more efficacious gram for gram than calcium carbonate as a binder, calcium acetate did not reduce hypercalcemia, and gastrointestinal intolerance was higher. Data are insufficient to determine whether calcium acetate provides lower risk of vascular calcification than calcium carbonate. Fears of lanthanum accumulation in the central nervous system or bone with long-term treatment do not appear to be warranted. Newer iron-containing phosphate binders have potential benefits, such as lower pill burden (sucroferric oxyhydroxide) and improved iron parameters (ferric citrate). The biggest challenge to phosphate binder efficacy is non-adherence. This article reviews the current knowledge regarding safety, effectiveness, and adherence with currently marketed phosphate binders and those in development.