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This was supported by reduction in phosphate excretion. Benefits were also seen in PTH levels which remained stable in the phosphate binder group more so in the calcium acetate group compared to an increase in levels seen in the placebo group.

However, the same study demonstrated increases in calcification scores in the active treatment phosphate binder group than with placebo — it was most pronounced in the calcium acetate group but was still present in those taking non-calcium containing binders. It should be noted that those with a zero-calcification score at baseline, regardless of randomisation, remained unchanged as has been seen in previous studies.

Calcium carbonate was not included in this study so the effect of an even higher elemental calcium load is unknown — mean dose of calcium acetate in this study was 5. On this basis the grade of this guideline has changed from 2D to 2C.

This is still a relatively weak evidentiary base, due to the lack of prospective studies targeting higher calcium concentrations with the aim to improve clinical outcomes. Although the original guideline suggested maintaining serum calcium in the normal range, correction of hypocalcemia carries a risk of inducing a positive calcium balance, and persistently low calcium levels in subjects treated with cinacalcet in the EVOLVE study was not harmful [ 15 ].

Therefore, the KDIGO committee considered it reasonable to consider low serum calcium within an individualised perspective, refraining from a generalised suggestion as in the previous of the KDIGO guideline to maintain calcium in the normal range for all CKD patients as mild and asymptomatic hypocalcemia e. The previous Renal Association guideline [ 10 ] suggested that albumin-adjusted serum calcium levels are kept within the normal reference range for the laboratory used and ideally maintained between 2.

The strength of this guideline recommendation has been upgraded from a 2D to a 2C based on two randomised controlled trials published after the original document in The first by Spasovski et al. The second by Ok et al. Neither study had a comparator group using a 1. It is worth noting here the observations of a retrospective cohort study by Brunelli et al. Similarly, with higher dialysate calcium concentrations of 1.

It is reasonable that the choice of phosphate binder takes into account CKD stage, the presence of other components of CKD—MBD, concomitant therapies, and side-effect profile not graded. A significant proportion of the rationale regarding this updated recommendation was based on two studies that were designed to investigate the effect of phosphate reduction on both FGF and soluble Klotho levels in normophosphataemic CKD G3b-G4 patients.

The results of both of these trials indicated that phosphate binding therapy should not be initiated as a preventative measure due to potential increases in calcium balance [ 13 ] and arterial calcification [ 12 ]. Consequently, the decision to treat should be based only on progressively or persistently elevated serum phosphate levels.

This was included to recognise that calcium-free binders may also possess a potential for harm e. Calcium binders have historically been an appealing first choice; indeed, they were the main beneficiary of the flight from aluminium-based binders.

Part of their popularity also arose because they also address the secondary hypocalcaemia that can be seen with hyperphosphataemia in patients with chronic kidney disease. However, overuse of calcium binders typically leads to hypercalcaemia and accelerated vascular calcification and these are the main concerns with using calcium-containing phosphate binders, particularly when they are combined with vitamin D therapy.

However, this recommendation has never been tested in a clinical trial setting, and so there is little hard evidence to support this recommendation in clinical practice. The updated KDIGO guideline also makes a case for restricting calcium-based phosphate binders in pre-dialysis CKD and dialysis patients based on 2 randomised trials from the Di Iorio group and a meta-analyses of phosphate binder trials.

Two meta-analyses of phosphate binder trials in CKD have shown a higher mortality in patients taking calcium-based binders compared to non-calcium based binders. Jamal et al. Of note, more recent meta-analyses may be confounded with the potential effect of widespread use of cinacalcet. The main advantage of calcium-based binders is that they are inexpensive. The NICE guideline on hyperphosphataemia management suggests using a calcium-based binder as first line treatment in the management of hyperphosphataemia in adults with CKD 4—5 and on dialysis, and either combining with, or switching to, a non-calcium-based binder if hypercalcaemia develops, if serum parathyroid hormone levels are low or if hyperphosphataemia persists despite adherence to the maximum recommended or tolerated dose of calcium-based phosphate binder [ 14 ].

In that document, calcium acetate is the preferred calcium-based binder, sevelamer hydrochloride or lanthanum carbonate the preferred non-calcium based binders; an additional non-calcium containing binder, sucroferric oxyhydroxide was the subject of a NICE evidence summary in as it was not available when NICE published the guideline [ 25 ]. Previous UK Renal Association guidelines did not give specific recommendations on the choice of phosphate binder stating that there are insufficient data from randomised controlled trials that any specific oral phosphate binder impacts on individual patient outcome.

However, the guideline did acknowledge that, given the strong association between high-dose calcium supplementation and worse outcome even in the general population, it would be reasonable to minimise calcium exposure in CKD and dialysis patients. This group continues to endorse the view that the choice of oral phosphate binder is best taken by involving both the patient and multi-disciplinary team, taking into account palatability, tolerability, efficacy, side-effect profile and affordability.

It is reasonable to consider phosphate source e. Generally, it is well accepted that reducing phosphate intake, with or without the use of phosphate binders, helps to reduce phosphate load in people with CKD. Although studies to support this are limited and of poor quality, there is a growing evidence base around phosphate in food and it is relevant to refer to this when making dietary recommendations.

There are many difficulties when assessing the phosphate content of food. Food tables may under-estimate phosphate content and are updated infrequently so their validity may be questionable; the phosphate content of many processed foods i. In addition, bioavailability of phosphate varies depending on the food source and whether the phosphate is organic or inorganic. Lack of clarity around phosphate in food and its bioavailability can make dietary counselling difficult and complicated, contributing to issues with compliance.

Foods that have a high organic phosphate content are often high in protein too and care needs to be taken not to compromise protein intake; protein:phosphate ratio is useful to identify the better protein sources to promote. However, we suggest that patients with levels of intact PTH iPTH above the upper normal limit of the assay are first evaluated for hyperphosphataemia, hypocalcaemia, and vitamin D deficiency 2C. However, we suggest that patients with levels of intact PTH progressively rising or persistently above the upper normal limit for the assay be evaluated for modifiable factors, including hyperphosphataemia, hypocalcaemia, high phosphate intake, and vitamin D deficiency 2C.

The former showed a significant reduction in PTH values with vitamin D supplementation, with no difference between the high- or low-dose groups reinforcing the original statement from regarding correction of vitamin D deficiency; recommendation 3. Modest increases in PTH may actually represent an appropriate adaptive response to declining kidney function, due to its phosphaturic effects and increasing bone resistance to PTH [ 30 ], hence the optimal PTH level remains unknown.

It is reasonable to reserve the use of calcitriol and vitamin D analogs for patients with CKD G4—G5 with severe and progressive hyperparathyroidism Not Graded. Both studies showed that episodes of hypercalcaemia were more frequent in the Paricalcitol group compared with the placebo group. Thus, lowering serum PTH failed to demonstrate improvements in clinically relevant outcomes but showed increased risk of hypercalcemia.

Accordingly, routine use of calcitriol or its analogs in CKD Stages 3a—5 is no longer recommended. Previous UK recommendations were in concordance with the original KDIGO guideline from and suggest that treatment is considered if PTH levels are persistently above the upper reference limit for the assay in patients with CKD 3b—5 and above 9 times the upper limit of normal for patients on dialysis, suggesting that treatment is modified in order to keep PTH levels between 2 and 9 times the upper limit of normal in dialysis patients.

It is reasonable that the initial drug selection for the treatment of elevated PTH be based on serum calcium and phosphorus levels and other aspects of CKD—MBD not graded. It is reasonable that calcium or non-calcium-based phosphate binder dosage be adjusted so that treatments to control PTH do not compromise levels of phosphorus and calcium not graded. We recommend that, in patients with hypercalcemia, calcitriol or another vitamin D sterol be reduced or stopped 1B. We suggest that, in patients with hyperphosphatemia, calcitriol or another vitamin D sterol be reduced or stopped 2D.

We suggest that, in patients with hypocalcemia, calcimimetics be reduced or stopped depending on severity, concomitant medications, and clinical signs and symptoms 2D. Recommendation 4. Nevertheless, KDIGO explicitly endorses the presence of clinical equipoise in its narrative and the need for further research. It should be noted that while calcimimetic therapy now appears first in the list of all acceptable treatment options, the KDIGO Work Group emphasises that calcimimetics, calcitriol, or vitamin D analogues are all acceptable first-line options, and there are no data to support clinical superiority of any one agent.

In addition, the updated recommendation has removed specific statements for dosage adjustment of phosphate binder, calcitriol or other vitamin D analogues to manage levels of phosphate, PTH and calcium. The recommendation is that individual treatment choice should continue to be guided by considerations of concomitant therapies as well as calcium and phosphate levels.

As such, the principal underlying this recommendation remains appropriate for UK practice. The group also notes that the UK NICE guidance [ 14 ], as well as the previous technology appraisal guidance from reviewed in [ 33 ], both of which provide more specific guidance in recommending the use of calcimimetics in the treatment of refractory SHPT in patients with end-stage renal disease. With respect to the latter, this group agreed that there are many instances when the risks of surgery are considered to outweigh the benefits, which are not simply limited to peri-operative risk and may include number of other patient related biopsychosocial factors.

Whilst parathyroidectomy remains an important and very effective treatment option in the management of SHPT, as with other sections within this commentary, we believe that decisions around medical and surgical options for the treatment of SHPT should be individualised and holistic.

Although this largely unchanged recommendation continues to emphasise the lack of definitive clinical trial evidence on the efficacy of antiresorptive medications in patients with CKD-MBD, the growing clinical experience with these agents in patients with CKD would appear to have addressed, at least in part, some of the concerns raised in the KDIGO Guideline.

The updated guideline recommendation remains broad in its treatment approach and does not support prioritising one agent over another. Treatment choices for patients with CKD at risk for fracture should consider treatment of underlying biochemical abnormalities, in addition to treatment with an antiresorptive medication.

Clinicians are also asked to consider whether the type of renal osteodystrophy diagnosed by bone biopsy will inform treatment decisions, as well as to take into account the course of kidney function decline. The narrative to this recommendation further implies the need for individualised treatment strategy.

The suggested approach, perhaps more pragmatic given available evidence, is applicable in the UK. However, there may be some ambiguity facing implementation of the guideline update in clinical practice because of both the inherent challenges in using biomarkers to predict underlying bone histology, and the present practical constraints in performing bone biopsies in the UK.

These deficiencies are likely to impede on the selection of an appropriate pharmacological treatment for this population. As detailed above in the new aforementioned Recommendation 3. To date, there are no prospective studies addressing the ability of DXA to predict fractures in transplant recipients.

One hundred sixty-one Lumbar spine and total-hip BMD results were expressed as T-scores and categorised as normal, osteopaenic or osteoporotic A total of 46 incident fractures were recorded in 53 patients. Multivariate models were not provided for the lumbar spine BMD T-score results; however, unadjusted analyses suggested that spine BMD provided less fracture prediction compared with total hip BMD.

Although this DXA study in kidney transplant recipients was not eligible for the evidence-based review due to its retrospective design, the Work Group concluded that the findings were consistent with the other studies in CKD G3a to G5D as described earlier. It is reasonable to consider a bone biopsy to guide treatment, specifically before the use of bisphosphonates due to the high incidence of adynamic bone disease not graded.

Consistent with the new pragmatic bone biopsy recommendation, recommendation 5. This updated recommendation maintains the prior broad suggestion to consider available therapies to prioritise treatment of underlying abnormalities in calcium, phosphate, PTH and vitamin D levels. The guideline update also asks the clinician to consider bone biopsy if results will assist therapeutic decisions.

This is in keeping with the recommendation for the non-transplant population, and thus faces the same challenges in implementation as described under guideline recommendation 4. This guideline update also reiterates the recommendation in that there are insufficient data to guide treatment after the first 12 months after kidney transplantation.

In the updated KDIGO guidelines the work group recognise the higher calcium requirements of the growing skeleton and recommend that when considering phosphate binder treatment or use of vitamin D analogues, the serum calcium levels are maintained in the age-appropriate normal range. This is reflected in the updated guidelines 4. The updated evidence review identified a prospective cohort study in children and adolescents with CKD stages 2—5 and dialysis that showed lower serum calcium levels were independently associated with lower tibial cortical volumetric bone mineral density BMD Z-scores [ 35 ].

Only two randomised controlled trials have examined phosphate lowering therapy in children with CKD or on dialysis; due to the small patient numbers and short follow-up both studies were excluded from the evidence review for the guideline update.

The first RCT examined biochemical end-points only and showed equivalent phosphate control with calcium acetate and sevelamer hydrochloride in an 8-week cross-over trial [ 37 ]. In the second, 29 children were randomised to different combinations of phosphate binders and vitamin D analogues: bone biopsies suggested that the sevelamer group had reduced bone formation at 8-month follow-up, but numbers were too small for comparison [ 38 ].

Although this study did not meet the criteria for recommendation for treatment, it highlights the need for additional studies in children. Given the association of high PTH levels with reduced bone mineralisation and vascular calcification, children are likely to need calcitriol or other active vitamin D analog therapy. A recent Cochrane review has examined vitamin D therapy for bone disease in children with CKD stages 2—5 and on dialysis [ 40 ].

Bone disease, as assessed by changes in PTH levels, was improved by all vitamin D preparations regardless of preparation or route or frequency of administration. High PTH levels were independently associated with reduced tibial cortical BMD Z-scores and are associated with coronary artery calcification in children on dialysis [ 41 ].

The NICE guideline on the management of hyperphosphataemia in adults with CKD [ 14 ] offers similar advice on phosphate binder treatment in children. Kidney Int Suppl. Article Google Scholar. Diagnostic usefulness of bone mineral density and biochemical markers of bone turnover in predicting fracture in CKD stage 5D patients—a single-center cohort study.

Nephrol Dial Transplant. Comparison of fracture risk prediction among individuals with reduced and normal kidney function. Clin J Am Soc Nephrol. Bone mineral density predicts fractures in chronic kidney disease. J Bone Miner Res. Bone mineral density and fracture risk in older individuals with CKD. Kidney Int. PTH--a particularly tricky hormone: why measure it at all in kidney patients?

Diagnostic accuracy of bone turnover markers and bone histology in patients with CKD treated by dialysis. Am J Kidney Dis. UK Renal Association. Google Scholar. CKD-mineral and bone disorder and risk of death and cardiovascular hospitalization in patients on hemodialysis. Effects of phosphate binders in moderate CKD.

J Am Soc Nephrol. Oral calcium carbonate affects calcium but not phosphorus balance in stage 3—4 chronic kidney disease. National Institute for Health and Care Excellence. Chronic kidney disease stage 4 or 5 : management of hyperphosphataemia. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med. Improvement of bone and mineral parameters related to adynamic bone disease by diminishing dialysate calcium. Reduction of dialysate calcium level reduces progression of coronary artery calcification and improves low bone turnover in patients on hemodialysis.

Facility dialysate calcium practices and clinical outcomes among patients receiving hemodialysis: a retrospective observational study. Impact of dialysate calcium concentration on clinical outcomes in incident hemodialysis patients.

Medicine Baltimore. National Kidney Foundation. Sevelamer versus calcium carbonate in incident hemodialysis patients: results of an open-label month randomized clinical trial. Mortality in kidney disease patients treated with phosphate binders: a randomized study. Effect of calcium-based versus non-calcium-based phosphate binders on mortality in patients with chronic kidney disease: an updated systematic review and meta-analysis.

Sevelamer versus calcium-based binders for treatment of hyperphosphatemia in CKD: a meta-analysis of randomized controlled trials. Hyperphosphataemia in adults with chronic kidney disease on dialysis: sucroferric oxyhydroxide. Evidence summary ESNM Effects of long-term cholecalciferol supplementation on mineral metabolism and calciotropic hormones in chronic kidney disease.

Kidney Blood Press Res. Cardiovascular effects of sevelamer in stage 3 CKD. Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD. Effect of rosuvastatin and sevelamer on the progression of coronary artery calcification in chronic kidney disease: a pilot study.

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No self respect anywhere thats for sure! It's a very lucky time for you, dear. Be more generous to others, and others will treat you likewise. Higher education, religious activities, political interests, and cultural pursuits take on a more social atmosphere this month. Romance, marriage, or any cooperative venture in a foreign country or featuring someone of another culture is stimulated.

Issues connected with a second marriage, or a court decision may arise. I mean seriously what kind of women will show there tits for a string of beads. Heck some don't even really want the beads, they just walk around naked. The only way i could tolerate it at all was because i was drunk, and yea i got beads, but they were from my hubby. Now that i don't drink anymore it is definately no where i would want to go!

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Light travels about , miles per second, or about 6 trillion miles 10 trillion km a year. In a bizarre display of basketball diplomacy, Rodman went on the record to offer highest praise for Kim Thursday, telling reporters, I love him. Rodman stood up to give a speech to the basketball crowd, at one point telling Kim, You have a friend for life. Rodman traveled to Pyongyang with members of the Harlem Globetrotters and a Vice magazine camera crew for an upcoming HBO documentary series.

The government has totally failed to provide security to common people in this country, Hyder Zaidi said. Schools tend to store different bits of student information in different databases, often with different operating systems. Critics said Obama should have held meaningful talks with congressional leaders long before Fridays last-minute meeting at the White House, which failed to prevent the automatic cuts written into law during a previous budget crisis in Asked if there would be a gap between the end of production by the Chalk River reactor and the supplies from the other sources, Oliver said he did not think so, since the technology was proven and what remained was commercialization.

Cardinal Daniel DiNardo, archbishop of Galveston-Houston in Texas, noted more than half the cardinal electors had been named since the now retired Pope Benedict was chosen in and had to find out how this most secretive of elections is conducted. If you agree to separate your debt in a divorce, its separate. Many are ditching their landline in favor of a mobile phone.

Schools do not need parental consent to share student records with any school official who has a legitimate educational interest, according to the Department of Education. But his numbers remained solid against lefthanded hitters, who batted just.

Personal attacks, especially on other participants, are not permitted. We reserve the right to permanently block any user who violates these terms and conditions. Comments that are very long, have multiple paragraph breaks, or include coding may not be posted. Although Diaz has mashed lefthanded pitching in his career, there are some concerns about where he would fit into the Phillies outfield.

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