Bone Guidelines Part 2 management of ESRD, and the ... · The Role of Calcium-Based Phosphate Binders for Attainment of K/DOQI™ Bone Guidelines 13 Cardiovascular Calciﬁcation

The Role of Calcium-Based Phosphate Binders for Attainment of K/DOQI™ Bone Guidelines 1

Renal Dietitians on the Front Line: The Role of Calcium-Based Phosphate Binders for Attainment of K/DOQI™ Bone Guidelines Part 2

Table of Contents

Introduction and Overview . .. . .. . .. . .. . .. . .. . .. .3Bone and Mineral Metabolism: Fighting the Battle, Winning the War . . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. .5Cardiovascular Calcification in Dialysis Patients and Potential Risks of Treatment With Calcium-Containing Phosphate Binders . .. . .. . .. . .. . .. . .. . .. . .. . .. . ..13Posttest Questions . .. . .. . .. . .. . .. . .. . .. . .. . .. . ..22Post Program Self-Assessment .. . .. . .. . .. . .. . .. . ..23Additional Reading.. . .. . .. . .. . .. . . Inside back cover

OverviewRenal dietitians and nurses are often on the front lines of treating hyperphosphatemia and work as a team to effectively manage patients with end-stage renal dis-ease. This condition is not only a major factor in the development of secondary hyperparathyroidism and renal osteodystrophy, but is also independently associ-ated with an increased risk of death. The mechanism whereby hyperphosphatemia increases mortality risk is unknown, but it may promote cardiovascular calci-fication. The current recommendation is that dialysis patients be treated to maintain serum phosphorus and calcium-phosphorus product in the normal range. As dietary restriction of phosphorus and conventional dialysis do not adequately control serum phosphorus in the majority of patients, the use of dietary phos-phate binders is often unavoidable. The most com-monly used phosphate binders worldwide are calcium acetate in the United States and calcium carbonate in Europe. Although calcium-based binders are clinically efficacious and cost-effective, their long-term safety has recently become the subject of intense debate.The objective of this 2 part accredited CD series is to critically examine these issues and provide rational guidelines for the use of calcium-based phosphate bind-

ers in patients with end-stage renal disease in the con-text of the recently published K/DOQI™ guidelines for bone and mineral metabolism in patients with chronic kidney disease. In addition, we will examine the role of renal dietitians and nurses as clinical partners in the management of ESRD, and the importance of patient-focused care in the treatment paradigm.

Intended AudienceThis activity will be of interest to renal dietitians, nurses, and technicians, who treat patient with end-stage renal disease.

Learning ObjectivesUpon completion of this activity, participants should be able to:

1. Describe patient types that are appropriate for therapy with calcium-based phosphate binders.

2. Correlate the role of dietary restriction of phosphorus in the treatment of patients with ESRD and the balance between diet and drug therapy.

3. Describe the risk factors for cardiac calcifica-tion in patients with ESRD, and discuss the issues surrounding the use of calcium-based phosphate binders in this patient population.

4. Review and discuss current studies of cal-cium acetate and Sevelamer hydrochloride and their impact on patient care.

5. Review current K/DOQI™ bone guidelines and describe the clinical role of the renal dietitian in attaining these guidelines.

This program is sponsored by The American Academy of CME, Inc.

This program is supported by an unrestricted educational grant from Nabi Biopharmaceuticals.

2 Renal Dietitians on the Front Line, Part 2

Introduction and OverviewCathi J. Martin, RD, CSR, LDN Regional Renal Dietitian, Renal Care Group of Springfield, Nashville, TN

Bone and Mineral Metabolism: Fighting the Battle, Winning the WarJennifer Kurzawa, RD Renal Osteodystrophy Manager, Gambro Healthcare, Old Bridge, NJCardiovascular Calcification in Dialysis Patients and Potential Risks of Treatment With Calcium-Containing Phosphate BindersCharles R. Nolan, MDProfessor of Medicine and SurgeryUniversity of Texas Health Sciences Center at San AntonioOrgan Transplant Program, San Antonio, TX

Conflict of Interest DisclosureDr. Nolan has received financial support and has par-ticipated in a Consultant/Speaker’s Bureau/Advisory Board for Nabi Biopharmaceuticals.Dr. Nolan does not intend to discuss any non-FDA-approved or investigational use of any product/device. Ms. Kurzawa does not have any relevant financial rela-tionships with any commercial interests.Ms. Kurzawa does not intend to discuss any non-FDA-approved or investigational use of any product/device. Ms. Martin has received financial support and has par-ticipated in a Consultant/Speaker’s Bureau/Advisory Board for Shire Pharmaceuticals, Amgen, and Abbott Laboratories.Ms. Martin does not intend to discuss any non-FDA-approved or investigational use of any product/device. This activity has been peer-reviewed for fair balance.

AccreditationRegistered dietitians (RD) and registered dietetic tech-nicians (DTR) will receive 1.0 Continuing Professional Education Units (CPEUs) for completion of this pro-gram. Continuing Professional Education Provider Accreditation does not constitute endorsement by CDR of a provider, program, or materials.The American Academy of CME, Inc. (Academy) is accredited as a provider of continuing nursing educa-tion by the American Nurses Credentialing Center’s Commission on Accreditation. The Academy designated this educational activity for 1.3 contact hours. Participants must register, listen to the lecture, and complete and submit the program eval-uation form in order to receive credit. A CE certificate will be issued within 6 to 8 weeks following receipt of your materials.It is the policy of the American Academy of CME, Inc. to ensure balance, independence, objectivity, and sci-entific rigor in all sponsored educational activities. Any and all financial relationships between faculty and the commercial supporters of the CME activity and prod-ucts being discussed are to be disclosed by the faculty to the attendees at the time of the activity. Discussion of any non-FDA-approved product or device shall also be made known to the audience.

Directions for Program Completion

1. Listen to the audio CD and read accompany-ing guide.

2. Circle the Posttest answers on page 23.

3. Complete the Post Program Self-Assesment on pages 23–24. Complete all other requested information on the form, detach, fax or stamp, and mail (address and fax num-ber on form).

Release Date: February 1, 2006Expiration Date: February 1, 2008


Introduction and Overview


K/DOQI™ is a trademark of the National Kidney Foundation, Inc.

K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(2 suppl 1):S1–S266. Used with permission.

Block GA, Hulbert-Shearon TE, Levin NW, et al. Association of serum phosphorus and calcium x phos-phate product with mortality risk in chronic hemo-dialysis patients: a national study. Am J Kidney Dis. 1998;Apr:31(4):607–17.Block GA, Klassen PS, Lazarus JM, et al. Mineral metab-olism, mortality, and morbidity in maintenance hemodi-alysis. J Am Soc Nephrol. 2004;Aug;15(8):2208–18.Block GA, Port FK. Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis. 2000;35(6):1226–37.Used with permission.


Malluche H, Faugere MC. Renal bone disease 1990: an unmet challenge for the nephrologist. Kidney Int. 1990;38:193–211.Malluche HH, Monier-Faugere MC. Risk of ady-namic bone disease in dialyzed patients. Kidney Int.1992;42(suppl 38):S62–S67. Moe SM. Current issues in the management of second-ary hyperparathyroidism and bone disease. Perit Dial Int. 2001;21:S241-S246.Used with permission.

Bone and Mineral Metabolism: Fighting the Battle, Winning the War









Cardiovascular Calcification in Dialysis Patients and Potential Risks of Treatment With Calcium-Containing Phosphate Binders

National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Am J Kidney Dis. 2003;42(Suppl. 3):S1-S202. Used with permission.


Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000;342:1478–1483. Used with permission.

Blacher J, Guerin AP, Pannier B, et al . Arterial cal-cifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertens. 2001;38:938–942. Used with permission.

Blacher J, Guerin AP, Pannier B, et al . Arterial calcifica-tions, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertens. 2001;38:938–942.



Chertow GM, Burke SK, Raggi P, et al. Sevelamer atten-uates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:245–252. Used with permission.




Nolan CR, Qunibi WY. [Letter to the Editor] Calcium on trial: beyond a reasonable doubt? Kidney Int. 2003;63:383. Used with permission.

Chertow GM, Burke SK, Raggi P, et al. Sevelamer attenu-ates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:245–252.Chertow GM, Dillon GM, Burke SK, et al. A random-ized trial of sevelamer hydrochloride (Renagel) with and without supplemental calcium. Strategies for the con-trol of hyperphosphatemia and hyperparathyroidism in hemodialysis patients. Clin Nephrol. 1999;51:18–26.Mai ML, Emmett M, et al. Calcium acetate, an effective phosphorus binder in patients with renal failure. Kidney Int. 1989;36:690–5.Sheikh M, Santa Ana C, Nicar M, et al. Gastrointestinal absorption of calcium from milk and calcium salts. N Engl J Med. 1987;317:532-6.Used with permission.


Achenbach S, Ropers D, Pohle K, et al. Influence of Lipid-Lowering Therapy on the Progression of Coronary Artery Calcification. Circulation. 2002;106:1077–82.Used with permission.


Callister, TQ, Raggi, P, Cooil, B, et al. Effect of HMG-CoA reductase inhibitors on coronary artery disease as assessed by electron-beam computed tomography. N Engl J Med. 1998;339:1972–8. Used with permission.


Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadav-eric transplant. N Engl J Med. 1999;341:1725–30. Used with permission.

Wanner C, Krane V, Marz W, et al. Atorvastatin in patient with type 2 diabetes mellitus undergoing hemo-dialysis. N Engl J Med. 2005;353:238–48. Used with permission.


Meier-Kriesche HU, Schold JD, Srinivas TR, et al. Kidney transplantation halts cardiovascular disease progression in patients with end-stage renal disease. Am J Transplant. 2004;Oct;4(10):1662–8. Used with permission.


Posttest Questions

1. Renal dietitians are the only members of the healthcare team who should be involved in bone and mineral metabolism management.a. Trueb. False

2. Common patient barriers to management of bone and mineral metabolism include: a. Comprehension.b. Compliance.c. Finances.d. Overall health.e. All of the above.

3. What is the K/DOQI target for calcium x phos-phorus product?a. < 35 mg2/dl2b. < 45mg2/dl2c. < 55mg2/dl2d. < 65mg2/dl2e. < 75mg2/dl2

4. What factors affect serum calcium levels?a. Dialysate calcium concentrationb. Dietary sources of calciumc. Vitamin D sterolsd. Use of calcium-based phosphate bindere. All of the above

5. The most important consideration in choosing a phosphate binder regimen is what the patient is most likely to follow.a. Trueb. False

6. Which of the following statement(s) regarding the pathogenesis of cardiovascular disease in chronic kidney disease is correct?a. In the setting of uremia, formation of bone

with deposition of hydroxyapatite may take place in arterial walls.

b. Although cause and effect has not been estab-lished, observational studies have shown that the administered dose of calcium-containing phosphate binders correlates with the extent of calcification in coronary arteries and periph-eral arteries.

c. Although the exact mechanism is unknown, treatment with Sevelamer leads to less cardio-vascular calcification compared to treatment with calcium-based phosphate binders.

d. Numerous traditional and nontraditional (dialysis-related) risk factors may be involved in the pathogenesis of cardiovascular disease in patients with chronic kidney disease.

e. All of the above. 7. Which of the following statements is most

accurate?a. Treatment with HMG-CoA reductase inhibitors

(statins) such as atorvastatin has been shown to reduce all-cause and cardiovascular mortality in dialysis patients.

b. Treatment with Sevelamer and avoidance of calcium-containing phosphate binders has been shown to significantly reduce mortality in all patients with end-stage renal disease on main-tenance hemodialysis.

c. Cardiovascular mortality in dialysis patients is no higher than in the general population.

d. Successful renal transplantation is the only ther-apy for end-stage renal disease, and, has been proven to significantly reduce all-cause and car-diovascular mortality.

22 Renal Dietitians on the Front Line

Post Program Self-Assessment

Renal Dietitians on the Front Line: The Role of Calcium-based Phosphate Binders for Attainment of K/DOQI™ Bone Guidelines Module 2 (05-AM-63-C-M-001-2)

Answer Sheet

1. A B 5. A B

2. A B C D E 6. A B C D E

3. A B C D E 7. A B C D

4. A B C D E

To aid us in evaluating the effectiveness of this activity, please complete and return this questionnaire at the end of the activity. If you wish to receive CE credits, you must return this completed form.

Send completed forms to:

American Academy of CME, Inc. 186 Tamarack Circle Skillman, NJ 08558 or fax to (609) 921-6428

Please check your professional title:

❏ Dietitian ❏ Physician ❏ Nurse/Nurse practitioner ❏ Pharmacist/PharmD ❏ Other: _________________________________

Please evaluate or answer the following:

Did the program meet your expectations? ❏ yes ❏ no

Were the course materials effective? ❏ yes ❏ no

Were the presentations free of commercial bias? ❏ yes ❏ no If no, why not? ________________________________

Objectives: Upon completion of this activity, were you able to:Describe patient types that are appropriate for therapy with calcium-based phosphate binders. ❏ yes ❏ no Correlate the role of dietary restriction of phosphorus in the treatment of patients with ESRD and the balance between diet and drug therapy. ❏ yes ❏ noDescribe the risk factors for cardiac calcification in patients with ESRD, and discuss the issues surrounding the use of calcium-based phosphate binders in this patient population. ❏ yes ❏ noReview and discuss current studies of calcium acetate and Sevelamer hydrochloride and their impact on patient care. ❏ yes ❏ noReview current K/DOQI™ bone guidelines, and describe the clinical role of the renal dietitian in attaining these guidelines. ❏ yes ❏ no

Using the following scale, please rate each presenter by checking the appropriate box. (1=Poor 2=Fair 3=Satisfactory 4=Good 5=Excellent)

Cathi J. Martin, RD, CSR, LDNValue of topic ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5Quality of presentation ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5

Jennifer Kurzawa, RDValue of topic ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5Quality of presentation ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5

Charles R. Nolan, MDValue of topic ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5Quality of presentation ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5

Rate the overall clinical relevance of today's program to your practice needs: ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5

Please complete other side ☛

Det

ach

form

her

e

The Role of Calcium-based Phosphate Binders for Attainment of K/DOQI™ Bone Guidelines 23

What one new thing did you learn from this program? ________________________________________________ __________________________________________________________________________________________

How will you modify your practice performance as a result of completing this program? ______________________ __________________________________________________________________________________________

What recommendations do you suggest to improve this program? _______________________________________ __________________________________________________________________________________________

What topics would you like to see in future presentations? _____________________________________________ __________________________________________________________________________________________

Please indicate how often you utilize the following formats to receive continuing professional education:Live symposia/conferences ❏ Frequently ❏ Occasionally ❏ Seldom ❏ NeverPrint materials/home study courses ❏ Frequently ❏ Occasionally ❏ Seldom ❏ NeverWeb-based CME ❏ Frequently ❏ Occasionally ❏ Seldom ❏ NeverCD-ROM ❏ Frequently ❏ Occasionally ❏ Seldom ❏ NeverOther: _____________________ ❏ Frequently ❏ Occasionally ❏ Seldom ❏ Never

Occasionally, AACME will be seeking information regarding future needs and outcomes measurements. May we contact you via e-mail for this purpose? ❏ yes ❏ no If yes, please include your e-mail address here: ______________________________________________________

In order to receive your CME/CE certificate, you must complete this portion and sign.

Time spent on this activity: Hours________ (Max: 1 hr RD/1.3 Nurse)

Print Name: _______________________________________________________________________________

Address: __________________________________________________________________________________

City: ________________________________ State: _____ Zip: __________________________________

E-mail: ______________________________ Last 4 digits of Social Security number ______________________

Signature: _________________________________________________________________________________

Thank you.

24 Renal Dietitians on the Front Line

Additional ReadingAchenbach S, Ropers D, Pohle K, Leber A, Thilo C, Knez A, et al. Influence of lipid-lowering therapy on the progression of coronary artery calcification: a prospective evaluation. Circulation. 2002;106(9):1077–1082.

Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardio-vascular risk in end-stage renal disease. Hypertens. 2001;38(4):938–942.

Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis. 1998;31(4): 607–617.

Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004;15(8):2208–2218.Block GA, Port FK. Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis. 2000;35(6):1226–1237.

Callister TQ, Raggi P, Cooil B, Lippolis NJ, Russo DJ. Effect of HMG-CoA reductase inhibitors on coronary artery disease as assessed by electron-beam computed tomography. N Engl J Med. 1998;339(27):1972–1978.

Chertow GM, Burke SK, Raggi P; Treat to Goal Working Group. Sevelamer attenuates the progression of coro-nary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62(1):245–252.

Chertow GM, Dillon M, Burke SK, Steg M, Bleyer AJ, Garrett BN, et al. A randomized trial of sevelamer hydro-chloride (Renagel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients. Clin Nephrol. 1999;51(1):18–26.

Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider D, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000;342(20):1478–1483.

Mai ML, Emmett M, Sheikh MS, Santa Ana CA, Schiller L, Fordtran JS. Calcium acetate, an effective phos-phorus binder in patients with renal failure. Kidney Int. 1989;36(4):690–695.Malluche H, Faugere MC. Renal bone disease 1990: an unmet challenge for the nephrologist. Kidney Int. 1990;38(2):193–211.Malluche HH, Monier-Faugere MC. Risk of adynamic bone disease in dialyzed patients. Kidney Int.1992;42(suppl 38):S62–S67.

Meier-Kriesche HU, Schold JD, Srinivas TR, Reed A, Kaplan B. Kidney transplantation halts cardiovascular disease progression in patients with end-stage renal disease. Am J Transplant. 2004;4(10):1662–1668.Moe SM. Current issues in the management of secondary hyperparathyroidism and bone disease. Perit Dial Int. 2001;21(suppl 3):S241-S246.National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(suppl 3):S1–S202.National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, clas-sification, and stratification. Am J Kidney Dis. 2002;39(2 suppl 1):S1–S266.Nolan CR, Qunibi WY. [Letter to the Editor] Calcium on trial: beyond a reasonable doubt? Kidney Int. 2003;63:383.

Sheikh MS, Santa Ana CA, Nicar MJ, Schiller LR, Fordtran JS. Gastrointestinal absorption of calcium from milk and calcium salts. N Engl J Med. 1987;317(9):532-536.

Wanner C, Krane V, Marz W, Olschewski M, Mann JF, Ruf G, et al, for the German Diabetes and Dialysis Study Investigators. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med. 2005;353(3):238–248.

Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999;341(23):1725–1730.

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Bone Guidelines Part 2 management of ESRD, and the ... · The Role of Calcium-Based Phosphate Binders for Attainment of K/DOQI™ Bone Guidelines 13 Cardiovascular Calciﬁcation