Simultaneous Control of Parathyroid Hormone and Phosphorus

High parathyroid hormone (PTH) is often associated with elevated phosphorus1

As the data in the chart below demonstrate, high PTH levels and elevated phosphorus levels often accompany each other. In addition, patients with an iPTH > 300 pg/mL are most likely to also have phosphorus levels > 5.5 mg/dL.1 This association between high PTH and high phosphorus reinforces the KDOQI™ recommendations for controlling both laboratory parameters.2

Association between high PTH and elevated phosphorus levels1

Data on file, Amgen.1

These data are derived from de-identified patient data from large and small dialysis organizations shared with Amgen each month per contractual agreement. 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.1

Starting Sensipar® earlier helped more dialysis patients achieve simultaneous control of parathyroid hormone (PTH) and phosphorus1

In the phase 3 trials, more dialysis patients achieved PTH and phosphorus goals when Sensipar® was added to traditional therapy earlier (iPTH 300 - 500 pg/mL) compared with initiating therapy later in the course of disease (iPTH > 800 pg/mL).1 In the Sensipar® treatment group, the percentage of patients who simultaneously achieved the treatment goals for iPTH and phosphorus decreased from 40% to 13% as the disease severity shifted from less severe (baseline values iPTH of
300 - 500 pg/mL) to the most severe patients (baseline iPTH values > 800 pg/mL). For all 3 baseline iPTH ranges, more patients in the Sensipar® treatment groups concurrently achieved the treatment goals for iPTH and phosphorus than in the groups treated with vitamin D and phosphate binders alone. Approximately 27% of subjects overall had severe secondary hyperparathyroidism (HPT) (iPTH > 800 pg/mL).1 After treatment with Sensipar®:

  1. 56% of subjects achieved an iPTH level of ≤300 pg/mL compared to 10% of the patients in the control group
    (P < 0.001)3
  2. 33% of Sensipar®-treated patients compared to 9% of patients in the control group had a mean iPTH value of 150 to 300 pg/mL, corresponding to the full KDOQI™ target range2,3

Phase 3 results were based on three 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies conducted in chronic kidney disease (CKD) patients with secondary HPT on dialysis (N = 1,136). Traditional therapy included vitamin D and phosphate binders, if prescribed.3

More patients achieved PTH and phosphorus goals with earlier initiation of Sensipar®1

Data on file, Amgen.1
Pooled phase 3 studies published in: Moe et al, Kidney Int, 2005.3

Read more about:

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