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A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM).
Clin J Am Soc Nephrol. 2015 Jun 05; 10(6):1031-40.CJ

Abstract

BACKGROUND AND OBJECTIVES

Direct comparison of cinacalcet and vitamin D analogs as monotherapies to lower parathyroid hormone (PTH) levels has not been undertaken.

DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS

This was a prospective, multicenter, phase 4, randomized, open-label study that enrolled participants from 2010 to 2012. Adult participants (n=312) on hemodialysis with PTH >450 pg/ml were randomized 1:1 to 12 months of treatment with either cinacalcet (n=155) or vitamin D analogs (n=157) to evaluate the mean percentage change in plasma PTH level (primary end point) and the proportion of participants achieving plasma PTH <300 pg/ml or a ≥30% decrease in PTH (secondary end points). A preplanned analysis to determine whether there were important region-by-treatment interactions was also undertaken.

RESULTS

Baseline mean PTH was 846 pg/ml (n=155) for cinacalcet and 816 pg/ml (n=157) for vitamin D analog therapy. The mean (95% confidence interval) percentage change from baseline in PTH was -12.1% (-20.0% to -4.1%) in the cinacalcet arm and -7.0% (-14.9% to 0.8%) in the vitamin D analog arm, a difference of -5.0% (-15.4% to 5.4%) (P=0.35). Similarly, there was no difference in achievement of secondary efficacy end points between arms (19.4% and 15.3% of participants with PTH≤300 pg/ml and 42.6% and 33.8% of participants had a PTH reduction >30% in the cinacalcet and vitamin D analog arms, respectively). A prespecified analysis revealed a large treatment-by-region interaction, with nominally greater response to cinacalcet compared with vitamin D analogs in non-United States participants (US versus non-US participants, P<0.001). Hypocalcemia was more common in the cinacalcet arm, whereas hypercalcemia and hyperphosphatemia occurred more often in the vitamin D analog arm.

CONCLUSIONS

Participants had similar modest reductions in PTH with either cinacalcet or vitamin D analog monotherapy over 52 weeks of treatment, but effects varied by region. Treatments differed with regard to effect on calcium and phosphorus levels.

Authors+Show Affiliations

Division of Nephrology, Hennepin County Medical Center, Minneapolis, Minnesota; james.wetmore@hcmed.org.Fresenius Medical Care, St. Petersburg, Russia;Division of Nephrology and Hypertension, NorthShore University HealthSystem, Evanston, Illinois;Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada;Columbia Nephrology Associates, Columbia, South Carolina; and.Amgen Inc., Thousand Oaks, California.Amgen Inc., Thousand Oaks, California.Amgen Inc., Thousand Oaks, California.

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

25904755

Citation

Wetmore, James B., et al. "A Randomized Trial of Cinacalcet Versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM)." Clinical Journal of the American Society of Nephrology : CJASN, vol. 10, no. 6, 2015, pp. 1031-40.
Wetmore JB, Gurevich K, Sprague S, et al. A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clin J Am Soc Nephrol. 2015;10(6):1031-40.
Wetmore, J. B., Gurevich, K., Sprague, S., Da Roza, G., Buerkert, J., Reiner, M., Goodman, W., & Cooper, K. (2015). A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clinical Journal of the American Society of Nephrology : CJASN, 10(6), 1031-40. https://doi.org/10.2215/CJN.07050714
Wetmore JB, et al. A Randomized Trial of Cinacalcet Versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1031-40. PubMed PMID: 25904755.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). AU - Wetmore,James B, AU - Gurevich,Konstantin, AU - Sprague,Stuart, AU - Da Roza,Gerald, AU - Buerkert,John, AU - Reiner,Maureen, AU - Goodman,William, AU - Cooper,Kerry, Y1 - 2015/04/22/ PY - 2014/07/15/received PY - 2015/03/31/accepted PY - 2015/4/24/entrez PY - 2015/4/24/pubmed PY - 2016/3/10/medline KW - CKD KW - ESRD KW - dialysis SP - 1031 EP - 40 JF - Clinical journal of the American Society of Nephrology : CJASN JO - Clin J Am Soc Nephrol VL - 10 IS - 6 N2 - BACKGROUND AND OBJECTIVES: Direct comparison of cinacalcet and vitamin D analogs as monotherapies to lower parathyroid hormone (PTH) levels has not been undertaken. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a prospective, multicenter, phase 4, randomized, open-label study that enrolled participants from 2010 to 2012. Adult participants (n=312) on hemodialysis with PTH >450 pg/ml were randomized 1:1 to 12 months of treatment with either cinacalcet (n=155) or vitamin D analogs (n=157) to evaluate the mean percentage change in plasma PTH level (primary end point) and the proportion of participants achieving plasma PTH <300 pg/ml or a ≥30% decrease in PTH (secondary end points). A preplanned analysis to determine whether there were important region-by-treatment interactions was also undertaken. RESULTS: Baseline mean PTH was 846 pg/ml (n=155) for cinacalcet and 816 pg/ml (n=157) for vitamin D analog therapy. The mean (95% confidence interval) percentage change from baseline in PTH was -12.1% (-20.0% to -4.1%) in the cinacalcet arm and -7.0% (-14.9% to 0.8%) in the vitamin D analog arm, a difference of -5.0% (-15.4% to 5.4%) (P=0.35). Similarly, there was no difference in achievement of secondary efficacy end points between arms (19.4% and 15.3% of participants with PTH≤300 pg/ml and 42.6% and 33.8% of participants had a PTH reduction >30% in the cinacalcet and vitamin D analog arms, respectively). A prespecified analysis revealed a large treatment-by-region interaction, with nominally greater response to cinacalcet compared with vitamin D analogs in non-United States participants (US versus non-US participants, P<0.001). Hypocalcemia was more common in the cinacalcet arm, whereas hypercalcemia and hyperphosphatemia occurred more often in the vitamin D analog arm. CONCLUSIONS: Participants had similar modest reductions in PTH with either cinacalcet or vitamin D analog monotherapy over 52 weeks of treatment, but effects varied by region. Treatments differed with regard to effect on calcium and phosphorus levels. SN - 1555-905X UR - https://wwww.unboundmedicine.com/medline/citation/25904755/A_Randomized_Trial_of_Cinacalcet_versus_Vitamin_D_Analogs_as_Monotherapy_in_Secondary_Hyperparathyroidism__PARADIGM__ DB - PRIME DP - Unbound Medicine ER -