Administered paricalcitol dose and survival in hemodialysis patients: A marginal structural model analysis

Several observational studies have indicated that vitamin D receptor activators (VDRA), including paricalcitol, are associated with greater survival in maintenance hemodialysis (MHD) patients. However, patients with higher serum parathyroid hormone, a surrogate of higher death risk, are usually given higher VDRA doses, which can lead to confounding by indication and attenuate the expected survival advantage of high VDRA doses.

[1]  K. Kalantar-Zadeh,et al.  Association of activated vitamin D treatment and mortality in chronic kidney disease. , 2008, Archives of internal medicine.

[2]  R. Light,et al.  Paricalcitol Reduces Albuminuria and Inflammation in Chronic Kidney Disease: A Randomized Double-Blind Pilot Trial , 2008, Hypertension.

[3]  J M Robins,et al.  Correction for non-compliance in equivalence trials. , 1998, Statistics in medicine.

[4]  P. Raggi,et al.  The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. , 2011, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[5]  A. Levin,et al.  Prevalence of abnormal serum vitamin D, PTH, calcium, and phosphorus in patients with chronic kidney disease: results of the study to evaluate early kidney disease. , 2007, Kidney international.

[6]  K. Kalantar-Zadeh,et al.  Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial. , 2012, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[7]  J. Craig,et al.  Meta-analysis: Vitamin D Compounds in Chronic Kidney Disease , 2007, Annals of Internal Medicine.

[8]  M. Budoff,et al.  Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. , 2006, Kidney international.

[9]  N. Powe,et al.  Impact of activated vitamin D and race on survival among hemodialysis patients. , 2008, Journal of the American Society of Nephrology : JASN.

[10]  A. Covic,et al.  Vitamin D receptor activation: clinical outcomes. , 2011, Contributions to nephrology.

[11]  M. Molnar,et al.  Calcium, phosphate and parathyroid metabolism in kidney transplanted patients , 2009, International Urology and Nephrology.

[12]  K. Kalantar-Zadeh,et al.  Vitamin D receptor activation and survival in chronic kidney disease. , 2008, Kidney international.

[13]  A. B. Hill The Environment and Disease: Association or Causation? , 1965, Proceedings of the Royal Society of Medicine.

[14]  R. Thadhani Targeted ablation of the vitamin D 1alpha-hydroxylase gene: getting to the heart of the matter. , 2008, Kidney international.

[15]  N. Powe,et al.  Changes in serum calcium, phosphate, and PTH and the risk of death in incident dialysis patients: a longitudinal study. , 2006, Kidney international.

[16]  S. Solomon,et al.  The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease , 2011, Clinical trials.

[17]  James M. Robins,et al.  Marginal Structural Models versus Structural nested Models as Tools for Causal inference , 2000 .

[18]  S. Solomon,et al.  Vitamin D Receptor Activation and Left Ventricular Hypertrophy in Advanced Kidney Disease , 2011, American Journal of Nephrology.

[19]  Keith C. Norris,et al.  Racial and Ethnic Differences in Mortality of Hemodialysis Patients: Role of Dietary and Nutritional Status and Inflammation , 2011, American Journal of Nephrology.

[20]  S. Greenland,et al.  Ratio of paricalcitol dosage to serum parathyroid hormone level and survival in maintenance hemodialysis patients. , 2008, Clinical journal of the American Society of Nephrology : CJASN.

[21]  K. Kalantar-Zadeh,et al.  Observational studies versus randomized controlled trials: avenues to causal inference in nephrology. , 2012, Advances in chronic kidney disease.

[22]  R. Zafra,et al.  The effect of vitamin D derivatives on vascular calcification associated with inflammation. , 2012, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[23]  Keith C. Norris,et al.  K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. , 2003, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[24]  M. Hernán,et al.  Activated injectable vitamin D and hemodialysis survival: a historical cohort study. , 2005, Journal of the American Society of Nephrology : JASN.

[25]  M. Wolf,et al.  VITAMIN D IN HEALTH AND DISEASE: Beyond Minerals and Parathyroid Hormone: Role of Active Vitamin D in End‐Stage Renal Disease , 2005, Seminars in dialysis.

[26]  R. Wolfe,et al.  The survival advantage for haemodialysis patients taking vitamin D is questioned: findings from the Dialysis Outcomes and Practice Patterns Study. , 2008, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[27]  S. Greenland,et al.  Association of hemodialysis treatment time and dose with mortality and the role of race and sex. , 2010, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[28]  S. Fishbane,et al.  Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial. , 2009, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[29]  Alex J. Brown,et al.  Drug Insight: vitamin D analogs in the treatment of secondary hyperparathyroidism in patients with chronic kidney disease , 2007, Nature Clinical Practice Endocrinology &Metabolism.

[30]  Grace H. Lee,et al.  Impact of kidney bone disease and its management on survival of patients on dialysis. , 2007, Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation.

[31]  Keith C. Norris,et al.  Impact of Race on Hyperparathyroidism, Mineral Disarrays, Administered Vitamin D Mimetic, and Survival in Hemodialysis Patients , 2010, Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research.

[32]  E. Bedrick,et al.  Mortality risk among hemodialysis patients receiving different vitamin D analogs. , 2006, Kidney international.

[33]  D. Rubin,et al.  The central role of the propensity score in observational studies for causal effects , 1983 .

[34]  D. Batlle,et al.  Antiproteinuric effect of oral paricalcitol in chronic kidney disease. , 2005, Kidney international.

[35]  J. Muñoz-Castañeda,et al.  Vitamin D and Vascular Calcification in Chronic Kidney Disease , 2011, Kidney and Blood Pressure Research.

[36]  H. Parving,et al.  Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial , 2010, The Lancet.

[37]  Norbert Lameire,et al.  Chronic kidney disease-mineral-bone disorder: a new paradigm. , 2007, Advances in chronic kidney disease.

[38]  M. Wolf,et al.  Vitamin D in patients with kidney disease: cautiously optimistic. , 2007, Advances in chronic kidney disease.

[39]  S. Kennedy,et al.  Association of the malnutrition-inflammation score with clinical outcomes in kidney transplant recipients. , 2011, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[40]  National Kidney Foundation K-DOQI: Clinical practice guidelines for bone metabolism and disease in chronic kidney disease , 2007 .

[41]  I. Salusky,et al.  VITAMIN D IN HEALTH AND DISEASE: Role of Parathyroid Hormone and Therapy with Active Vitamin D Sterols in Renal Osteodystrophy , 2005, Seminars in dialysis.

[42]  D. Cusi,et al.  The Effect of Paricalcitol on Vascular Calcification and Cardiovascular Disease in Uremia: Beyond PTH Control , 2011, International journal of nephrology.

[43]  K. Berta,et al.  Bone mineral density and parathyroid function in patients on maintenance hemodialysis , 2011, International Urology and Nephrology.

[44]  T. Cantor Editorials: Parathyroid Hormone Assay Drift: An Unappreciated Problem in Dialysis Patient Management , 2005, Seminars in dialysis.

[45]  S. Anker,et al.  The obesity paradox and mortality associated with surrogates of body size and muscle mass in patients receiving hemodialysis. , 2010, Mayo Clinic proceedings.

[46]  K. Hruska,et al.  PHOSPHORUS METABOLISM AND MANAGEMENT IN CHRONIC KIDNEY DISEASE: Renal Osteodystrophy, Phosphate Homeostasis, and Vascular Calcification , 2007, Seminars in dialysis.

[47]  G. Chertow,et al.  Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. , 2004, Journal of the American Society of Nephrology : JASN.

[48]  Lilia R. Lukowsky,et al.  Blood pressure and survival in long-term hemodialysis patients with and without polycystic kidney disease , 2010, Journal of hypertension.

[49]  C. Ronco,et al.  The impact of paricalcitol on left ventricular hypertrophy. , 2011, Contributions to nephrology.

[50]  G. Eknoyan,et al.  Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). , 2006, Kidney international.

[51]  Keith C. Norris,et al.  Association of Cumulatively Low or High Serum Calcium Levels with Mortality in Long-Term Hemodialysis Patients , 2010, American Journal of Nephrology.

[52]  Keith C. Norris,et al.  Role of nutritional status and inflammation in higher survival of African American and Hispanic hemodialysis patients. , 2011, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[53]  L. Quarles,et al.  Development and progression of secondary hyperparathyroidism in chronic kidney disease: lessons from molecular genetics. , 2008, Kidney international.

[54]  K. Kalantar-Zadeh,et al.  Association of Malnutrition-Inflammation Score with quality of life and mortality in hemodialysis patients: a 5-year prospective cohort study. , 2009, American journal of kidney diseases : the official journal of the National Kidney Foundation.