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10.2215/CJN.07050714

http://scihub22266oqcxt.onion/10.2215/CJN.07050714
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C4455208!4455208 !25904755
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suck abstract from ncbi


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pmid25904755
      Clin+J+Am+Soc+Nephrol 2015 ; 10 (6 ): 1031-40
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  • A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM) #MMPMID25904755
  • Wetmore JB ; Gurevich K ; Sprague S ; Da Roza G ; Buerkert J ; Reiner M ; Goodman W ; Cooper K
  • Clin J Am Soc Nephrol 2015[Jun]; 10 (6 ): 1031-40 PMID25904755 show ga
  • 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.
  • |*Renal Dialysis/adverse effects [MESH]
  • |Aged [MESH]
  • |Aged, 80 and over [MESH]
  • |Australia [MESH]
  • |Biomarkers/blood [MESH]
  • |Calcimimetic Agents/adverse effects/*therapeutic use [MESH]
  • |Canada [MESH]
  • |Cinacalcet/adverse effects/*therapeutic use [MESH]
  • |Female [MESH]
  • |Humans [MESH]
  • |Hyperparathyroidism, Secondary/blood/diagnosis/*drug therapy [MESH]
  • |Kidney Failure, Chronic/blood/complications/diagnosis/*therapy [MESH]
  • |Male [MESH]
  • |Parathyroid Hormone/blood [MESH]
  • |Prospective Studies [MESH]
  • |Russia [MESH]
  • |Time Factors [MESH]
  • |Treatment Outcome [MESH]
  • |United States [MESH]


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