Improving Patient Experience and Treatment Adherence in the Adult, Outpatient Hemodialysis Population.

BACKGROUND: The commonly employed medication reconciliation process leaves room for mismanagement of medications in the complex end-stage renal disease patient population. PURPOSE: The purpose of this quality improvement project was to implement and evaluate a multidisciplinary education and feedback intervention designed to improve self-management for adults with end-stage renal disease. METHODS: A pre-post, same subject repeated measures design was used to evaluate the intervention. Laboratory values, vital signs, interdialytic weight gains, dialysis attendance, and questionnaires were used to assess regimen adherence. RESULTS: We observed improvements in patient outcomes including laboratory values, vital signs, and interdialytic weight gains. Significant improvements in process outcomes were also seen, including accuracy of medication lists, dialysis attendance, and use of remote pharmacy services. CONCLUSIONS: A comprehensive medication review, with concurrent pharmacist access, represents a time-effective approach to improved self-management and end-stage renal disease outcomes.

Paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a randomized controlled trial.

BACKGROUND: The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear. STUDY DESIGN: Randomized controlled trial. SETTING & PARTICIPANTS: 80 patients with CKD stages 3 or 4, 25(OH)D level <30 ng/mL, and SHPT in a single medical center. INTERVENTION: Ergocalciferol, 50,000 units, titrated to achieve serum levels ≥30 ng/mL versus paricalcitol, 1 or 2 µg/d, for 16 weeks. OUTCOMES: The occurrence of 2 consecutive parathyroid hormone (PTH) levels decreased by at least 30% from baseline. All analyses were intention to treat. RESULTS: Baseline characteristics in the 2 groups were similar. 21 patients (53%) on paricalcitol and 7 patients (18%) on ergocalciferol treatment achieved the primary outcome measure (P = 0.002). After 16 weeks, PTH levels did not decrease significantly in patients receiving ergocalciferol, but were decreased significantly in those treated with paricalcitol (mean estimate of between-group difference over 16 weeks of therapy, 43.9 pg/mL; 95% CI, 11.2-76.6; P = 0.009). Serum 25(OH)D levels increased significantly after 16 weeks in only the ergocalciferol group, but not the paricalcitol group (mean estimate of between-group difference over 16 weeks of therapy, 7.08 ng/mL; 95% CI, 4.32-9.85; P < 0.001). Episodes of hyperphosphatemia and hypercalcemia were not significantly different between the 2 groups. LIMITATIONS: Lack of blinding and use of surrogate end points. CONCLUSIONS: Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT.

Association of activated vitamin D treatment and mortality in chronic kidney disease.

BACKGROUND: Treatment of secondary hyperparathyroidism (SHPT) with activated vitamin D analogues is associated with better survival in patients receiving dialysis. It is unclear whether such a benefit is present in patients with predialysis chronic kidney disease (CKD). METHODS: We examined the association of oral calcitriol treatment with mortality and the incidence of dialysis in 520 male US veterans (mean [SD] age, 69.8 [10.3] years; 23.5% black) with CKD stages 3 to 5 and not yet receiving dialysis (mean [SD] estimated glomerular filtration rate, 30.8 [11.3]). Associations were examined by the Kaplan-Meier method and in Poisson regression models with adjustment for age, race, comorbidities, smoking, blood pressure, body mass index, use of phosphate binders, estimated glomerular filtration rate, proteinuria, white blood cell count, percentage of lymphocytes, and levels of parathyroid hormone, calcium, phosphorus, albumin, bicarbonate, and hemoglobin. RESULTS: Two hundred fifty-eight of 520 subjects received treatment with calcitriol, 0.25 to 0.5 microg/d, for a median duration of 2.1 years (range, 0.06-6.0 years). The incidence rate ratios for mortality and combined death and dialysis initiation were significantly lower in treated vs untreated patients (P < .001 for both in the fully adjusted models). Treatment with calcitriol was associated with a trend toward a lower incidence of dialysis. These results were consistent across different subgroups. CONCLUSIONS: Treatment with the activated vitamin D analogue calcitriol appears to be associated with significantly greater survival in patients with CKD not yet receiving dialysis. Randomized clinical trials are required to verify the causality of these associations and to examine whether similar associations are seen with different activated vitamin D analogues.

Association of markers of iron stores with outcomes in patients with nondialysis-dependent chronic kidney disease.

BACKGROUND AND OBJECTIVES: Assessments of iron stores by serum iron saturation ratio (ISAT) and ferritin are used to direct anemia therapy in chronic kidney disease (CKD) and are associated with clinical outcomes in patients on dialysis. The association of ISAT and ferritin with outcomes in patients with nondialysis-dependent CKD (NDD-CKD) has not been studied. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: All-cause mortality and progression of CKD [slopes of estimated GFR (eGFR)] were examined in 453 men with NDD-CKD. Mortality and the composite of mortality and ESRD were studied in Cox models. Slopes of eGFR were examined in mixed-effects models. RESULTS: Lower ISAT was associated with higher mortality; adjusted hazard ratio [95% confidence interval (CI)] with ISAT of <12%, 13 to 17%, and >23% versus 18 to 23%; 1.40 (0.99 to 1.98), 1.20 (0.82 to 1.76), and 0.97 (0.67 to 1.41), P = 0.025 for trend. ISAT was also associated with steeper slopes of eGFR (one log-unit higher ISAT associated with a slope of -0.89 ml/min/1.73 m(2) /yr (95% CI: -1.75, -0.02, P = 0.044). Serum ferritin level showed no significant association with outcomes overall, but a trend for higher mortality was observed in patients with a serum ferritin level >250 ng/ml. CONCLUSIONS: Higher ISAT is associated with lower mortality and with more progressive CKD. Clinical trials are needed to examine if correction of low iron levels can improve mortality without affecting kidney function in NDD-CKD.

Obesity is associated with secondary hyperparathyroidism in men with moderate and severe chronic kidney disease.

BACKGROUND AND OBJECTIVES: Obesity is associated with secondary hyperparathyroidism in the general population. The objective of this study is to explore whether the same association is present in patients with chronic kidney disease. DESIGN, SETTING, PARTICIPANTS & MEASUREMENTS: Linear regression models were used to examine the association between intact parathyroid hormone level and body mass index in 496 male US veterans (age 69.4 +/- 10.2 yr, 22.8% black) who had chronic kidney disease stages 2 to 5 and were not yet on dialysis (estimated GFR 31.8 +/- 11.2 ml/min per 1.73 m2). RESULTS: Higher intact parathyroid hormone was associated with higher body mass index after adjustment for age, race, diabetes, and serum calcium and phosphorus levels. This association was independent of age, race, diabetes status, and serum calcium and phosphorus but was limited to patient groups with lower albumin (P = 0.005 for the interaction term) or higher white blood cell count (P = 0.026 for the interaction term). CONCLUSIONS: Higher body mass index is associated with secondary hyperparathyroidism in patients who have chronic kidney disease and are not yet on dialysis, especially in patients with evidence of malnutrition and inflammation. Confirmation of these findings in other patient groups with chronic kidney disease and better characterization of the underlying mechanisms of action will be necessary before advocating weight loss as a means to treat secondary hyperparathyroidism in chronic kidney disease.