The Current Treatment Paradigm

By the time Sensipar® is typically initiated in the course of secondary hyperparathyroidism (HPT) treatment, laboratory parameters have substantially increased1

A recent chart audit revealed that on average, Sensipar® was initiated at month 24 of dialysis, after laboratory parameters had worsened significantly. The mean levels of PTH, serum calcium, and serum phosphorus, at initiation of Sensipar®, were
652 pg/mL, 9.66 mg/dL, and 6.11 mg/dL respectively.1 The failure of the current treatment paradigm indicates that it may be time to re-evaluate the approach.

The current treatment approach uses Sensipar® later in the course of therapy1

Sensipar® ESRD Dialysis Patient Chart Audit, Harris Interactive. Survey conducted Q4 2008.1
*1.7 months between dialysis start date and secondary HPT diagnosis.
†Converted to paricalcitol equivalents (2.0 mcg of paricalcitol = 1.0 mcg of doxercalciferol = 0.5 mcg of calcitriol).
‡Individual laboratory n varied based on available patient data.
Ca = calcium; P = phosphorus.

This Q4 2008 chart audit of 557 dialysis patients (Sensipar® ESRD Dialysis Patient Chart Audit) conducted by Harris Interactive demonstrated that the current secondary HPT treatment paradigm primarily consists of vitamin D and phosphate binders as first-line therapy, with Sensipar® often used later in the course of therapy.1 This pattern follows the traditional treatment methodology that focuses on the management of hyperphosphatemia and phosphate retention through control of dietary phosphorus intake, use of phosphate binders, and the optimization of traditional therapy. With this approach, PTH control often follows with large quantities of vitamin D therapy.2,3 Typically Sensipar® is added months to years after dialysis, vitamin D, and phosphate binder therapy have been instituted.1

In this chart audit, the mean time from dialysis start to secondary HPT diagnosis was 1.7 months with phosphate binders being initiated only 0.3 months later (2.0 months from therapy start) and vitamin D being initiated on average 1.7 months after secondary HPT diagnosis (3.4 months from dialysis start). The mean vitamin D dose was 5.35 mcg paricalcitol equivalents per administration. Sensipar® was initiated on average 24.0 months after start of therapy. Typically, Sensipar® is initiated late in the course of secondary HPT treatment, when secondary HPT laboratory parameters are substantially elevated. At Sensipar® initiation, mean and median laboratory values were the following:1

  • Mean iPTH: 652 pg/mL; median = 540 pg/mL; (n=526)
  • Mean serum calcium = 9.66 mg/dL; median = 9.60 mg/dL; (n=535)
  • Mean serum phosphorus = 6.11 mg/dL; median = 6.00 mg/dL; (n=535)

The chart audit consisted of 557 patients on dialysis from 150 nephrologists. Each nephrologist provided patient information from between 2 and 6 patients on dialysis who were either on Sensipar® or had taken it in the past. Patients were selected randomly within the following general constraints: at least 1 patient must have been initiated on Sensipar® between August 1, 2007, and July 31, 2008; and at least 1 must be currently taking Sensipar® and have been initiated on Sensipar® after July 31, 2008.1

The current treatment paradigm has proven unsuccessful in bringing patients to key secondary HPT treatment goals2,4

The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI™) defined 4 treatment goals for secondary HPT: parathyroid hormone (PTH), serum calcium and phosphorus, and calcium-phosphorous product (Ca x P).2 The current treatment approach utilizes vitamin D and phosphate binders as first-line therapy while using Sensipar® later in the course of therapy.1 Management of secondary HPT goals has proven challenging with this treatment approach because it has been difficult to lower PTH while simultaneously reducing Ca x P, calcium, and phosphorus.2,4 In fact, data from the OutcomesPlus database demonstrate that 85% of all patients fail to achieve all 4 of the KDOQI™ treatment goals with this approach.4 Goals were defined as mean iPTH 150 to 300 pg/mL, mean serum calcium 8.4 to 9.5 mg/dL, mean serum phosphorus 3.5 to 5.5 mg/dL, and mean Ca x P < 55 mg2/dL2.2

Patients achieving key treatment goals for secondary HPT with the current treatment paradigm4

Data on file, Amgen; [OutcomesPlus Database; January, 2009].4

This analysis included de-identified patient data from large and small dialysis organizations shared with Amgen each month per contractual agreement. These data are reported cross-sectionally and form a report known as OutcomesPlus. The OutcomesPlus database began in 2004, and data are pulled quarterly. Total N varies, with the N for January 2009 being 328,259 and the total database including 863,307 patient data sets. Because of patient switching between dialysis organizations, some duplication in patient count may occur.4

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KDOQI™ is a trademark of the National Kidney Foundation, Inc.