10 years patient experience | Sensipar® (cinacalcet) Tablets | For patients on dialysis with Secondary Hyperparathyroidism

Efficacy by Baseline Parathyroid Hormone (PTH)

The 2010 US Kidney Disease Outcomes Quality Initiative (KDOQI) Commentary suggests intervening before intact parathyroid hormone (iPTH) reaches 600 pg/mL1,*

How many of your dialysis patients have an iPTH level > 600 pg/mL?

  • The US KDOQI Commentary publication in May 2010 states that marked iPTH changes between 130 and 600 pg/mL should trigger a response to avoid a future level outside this range1
  • Despite this recommendation, the percentage of dialysis patients with iPTH > 600 pg/mL has increased1,2

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

*To eliminate variability between assays, the same assay should be used for monitoring changes over time.

The percentage of patients on dialysis with a mean iPTH > 400 pg/mL and > 600 pg/mL has risen since October 20102

phase 3 studies, initiating Sensipar® (cinacalcet) at PTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal. phase 3 studies, initiating Sensipar® (cinacalcet) at PTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal.

Study Design

De-identified patient data from large and small dialysis organizations are shared with Amgen each month per contractual agreement. These data are reported cross-sectionally and from a report known as OutcomesPlus. The OutcomesPlus database began in 2004. Data are pulled monthly. Total N varies; N for August 2013 = 233,082. Because of patient switching between dialysis organizations, some duplication in patient count may occur.2

  • Despite the US KDOQI™ Commentary publication in May 2010, the percentage of patients on dialysis with iPTH > 600 pg/mL has increased.1,2

References

  • 1. Uhlig K, Berns JS, Kestenbaum B, et al. KDOQI™ US commentary on the 2009 KDIGO® clinical practice guideline for the diagnosis, evaluation, and treatment of CKD-mineral and bone disorder (CKD-MBD). Am J Kidney Dis. 2010;55:773-799.
  • 2. Data on file, Amgen; [OutcomesPlus Database; August 2013].

Important Safety Information

Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular arrhythmia. Cases of QT prolongation and ventricular arrhythmia secondary to hypocalcemia have been reported in patients treated with Sensipar®.

Significant reductions in calcium may lower the threshold for seizures. Patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.



In Phase 3 studies, initiating Sensipar® at iPTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal3,4,

In phase 3 studies, initiating Sensipar® (cinacalcet) at PTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal. In phase 3 studies, initiating Sensipar® (cinacalcet) at PTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal.

Study Design

Results are pooled from three phase 3, 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies comparing Sensipar® with placebo in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (HPT) on dialysis with iPTH ≥ 300 pg/mL and serum calcium (Ca) ≥ 8.4 mg/dL (N = 1136). Patients in both treatment arms could be treated with vitamin D sterols and/or phosphate binders. Mean baseline iPTH values in the Sensipar® group and placebo group were 733 pg/mL and 683 pg/mL, respectively. The primary endpoint of the studies was the proportion of patients achieving PTH level ≤ 250 pg/mL during the efficacy assessment phase. Patients were followed for a total of 26 weeks and were eligible for a 6-month extension, totaling 12 months of therapy.4,5

  • In phase 3 trials, 40% of Sensipar® patients (mean baseline iPTH: 733 pg/mL) achieved iPTH ≤ 250 pg/mL vs. 5% with placebo (mean baseline iPTH: 683 pg/mL)
    (P < 0.001)3,4

Treatment goal was defined as mean iPTH ≤ 250 pg/mL.4

Conventional care = vitamin D and/or phosphate binders, if prescribed. Not all patients received vitamin D or phosphate binders.

§Intent-to-treat analysis population.


References


Sensipar® lowered blood levels of PTH, calcium, and phosphorus in patients on dialysis with secondary HPT.6,7

Indications

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Limitations of Use:

Sensipar® is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Sensipar® (cinacalcet) is indicated for the treatment of severe hypercalcemia in adult patients with primary hyperparathyroidism (HPT) who are unable to undergo parathyroidectomy.

Sensipar® (cinacalcet) is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma (PC).

Important Safety Information

Sensipar® (cinacalcet) treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Sensipar® lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia. Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar®, including pediatric patients.

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Indications

Sensipar® (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Limitations of Use:

Sensipar® is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Sensipar® (cinacalcet) is indicated for the treatment of severe hypercalcemia in patients with primary hyperparathyroidism (HPT) who are unable to undergo parathyroidectomy.

Sensipar® (cinacalcet) is indicated for the treatment of hypercalcemia in patients with Parathyroid Carcinoma.

Important Safety Information

Please see Full Prescribing Information

References

  1. Uhlig K, Berns JS, Kestenbaum B, et al. KDOQI US commentary on the 2009 KDIGO clinical practice guideline for the diagnosis, evaluation, and treatment of CKD-mineral and bone disorder (CKD-MBD). Am J Kidney Dis. 2010;55(5):773-799.
  2. Data on file, Amgen; [OutcomesPlus Database; July 2012].
  3. Food and Drug Administration Center for Drug Evaluation and Research. Clinical review for NDA 21-688. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm. Accessed April 22, 2013.
  4. Sensipar® (cinacalcet) prescribing information, Amgen.
  5. Data on file, Amgen; [Cinacalcet Integrated Analysis of Efficacy; 2003].
  6. Messa P, Macário F, Yaqoob M, et al. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008;3:36-45.
  7. Ureña-Torres P, Bridges I, Christiano C, et al. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism. Nephrol Dial Transplant. 2013;28:1241-1254.
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