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 have risen since October 20102

The percentage of patients on dialysis with a mean iPTH > 400 pg/mL and > 600 pg/mL has risen since October 2010 The percentage of patients on dialysis with a mean iPTH > 400 pg/mL and > 600 pg/mL has risen since October 2010

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 July 2012 = 274,117. Because of patient switching between dialysis organizations, some duplication in patient count may occur.2

  • In a separate analysis, the DOPPS Practice Monitor data showed the percentage of patients with iPTH > 600 pg/mL increased from 11% in August 2010 to 19% in April 20123

DOPPS = Dialysis Outcomes and Practice Patterns Study.


References

  • 2. Data on file, Amgen [OutcomesPlus Database; July 2012].
  • 3. Arbor Research Collaborative for Health. Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor Featured Measures October 2012 (data through April 2012). http://www.dopps.org/DPM/Default.aspx. Accessed November 8, 2012.

Important Safety Information

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 Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.



In Phase 3 studies, initiating Sensipar® at iPTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal4,5,†

In phase 3 studies, initiating Sensipar® at PTH 300-500 pg/mL enabled 60% of patients to achieve study PTH treatment goal. In phase 3 studies, initiating Sensipar® 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.5,6

  • 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)4,5

Treatment goal was defined as mean iPTH ≤ 250 pg/mL.5

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

  • 4. 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.
  • 5. Sensipar® (cinacalcet) prescribing information, Amgen.
  • 6. Data on file, Amgen [Cinacalcet Integrated Analyses of Efficacy; 2003].

Sensipar® lowered blood levels of PTH, calcium, and phosphorus in patients on dialysis with secondary HPT.7,8

Indications

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

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

Sensipar® treatment should not be initiated 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.

Indications

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

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

Sensipar® (cinacalcet) treatment should not be initiated 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.

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 Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL.

Patients with moderate to severe hepatic impairment should be monitored throughout treatment with Sensipar®, as cinacalcet exposure assessed by area under the curve (AUC) was higher than in patients with normal hepatic function.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

In clinical trials of patients with secondary HPT comparing Sensipar® to placebo, the most commonly reported side effects were nausea (31% vs. 19%), vomiting (27% vs. 15%), and diarrhea (21% vs. 20%).

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. Arbor Research Collaborative for Health. Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor Featured Measures October 2012 (data through April 2012). http://www.dopps.org/DPM/Default.aspx. Accessed November 8, 2012.
  4. 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.
  5. Sensipar® (cinacalcet) prescribing information, Amgen.
  6. Data on file, Amgen [Cinacalcet Integrated Analyses of Efficacy; 2003].
  7. 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.
  8. Ureña-Torres P, Bridges I, Christiano C, et al. Efficacy of cinacalcet with low-dose vitamin D in incident haemodialysis subjects with secondary hyperparathyroidism [published online ahead of print January 16, 2013]. Nephrol Dial Transplant. doi: 10.1093/ndt/gfs568.
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