Article Figures & Data
Figures
- Figure 1.
Patient disposition. Enrollment, randomization, and follow-up of study participants. PTH, parathyroid hormone.
- Figure 2.
Percentage change in mean PTH suppression over time. The target PTH suppression was 40%–60% below each patient’s baseline PTH measurement. Solid symbols are the paricalcitol group, and open symbols are the calcitriol group. All on-treatment results were significantly below baseline PTH in both groups (P<0.05). *P<0.01 (PTH suppression was significantly greater at these times in the paricalcitol group compared with the calcitriol group).
- Figure 3.
Proportion of patients achieving ≥40% suppression in PTH at any time during the trial by study week. The median time to at least a 40% reduction in PTH was earlier in the paricalcitol group (8 weeks; IQR, 4, 12) compared with the calcitriol group (12 weeks; IQR, 8, 18; P=0.02). IQR, interquartile range.
- Figure 4.
Mean change in calcium and phosphorus during and after withdrawal of treatment. Data are shown as the mean values±SD from baseline in serum calcium (A) and phosphorus (B) during treatment and 1 week after treatment withdrawal at week 24. Solid symbols are the paricalcitol group, and open symbols are the calcitriol group. *P<0.05 versus baseline for paricalcitol; **P<0.05 versus baseline for calcitriol. Week 25 calcium and phosphorus values are also significantly lower than week 24 values (P<0.05), but are not different from baseline.
Tables
Characteristic Paricalcitol Group (n=54) Calcitriol Group (n=56) Age (yr) 66.6±13.2 64.7±12.6 Weight (kg) 92.4±21.7 97.6±28.4 BP (mmHg) Systolic 132.5±16.5 136.5±18.2 Diastolic 71.1±11.9 71.7±11.7 Race African American 33 (61) 41 (73) Caucasian 18 (33) 14 (25) Other 3 (6) 1 (2) Creatinine (mg/dl) 2.49±0.72 2.63±0.83 eGFR (ml/min per 1.73 m2) 27.8±9.3 27.0±9.2 cCa (mg/dl) 9.32±0.35 9.36±0.40 Phosphorus (mg/dl) 3.66±0.56 3.74±0.52 PTH (pg/ml) 176 (142, 221) 209 (158, 287) Albumin (g/dl) 3.9±0.36 3.75±0.38 Alkaline phosphatase (U/L) 80 (65, 104) 77.5 (70.75, 94.5) Urine phosphorus/creatinine ratio (mg/g) 418 (341, 562) 435 (322, 504) Data are expressed as the mean±SD, n (%), or median (interquartile range). cCa, albumin-corrected calcium; PTH, parathyroid hormone.
Outcome Paricalcitol Group (n=53) Calcitriol Group (n=54) P Value Primary outcome Confirmed cCa>10.5 mg/dl 3 (5.7) 1 (1.9) 0.36 Secondary outcomes Any cCa>10.5 mg/dl 7 (13.2) 4 (7.4) 0.36 >40% PTH reduction 52 (98) 47 (87) 0.03 >60% PTH reduction 45 (83) 28 (52) <0.001 Change in PTH, 24 wk (%)a −52±23 −46±21 0.17 Total capsules 240 (180, 298) 292 (231, 405) 0.01 Change in cCa (mg/dl)a +0.38 (0.10, 0.60) +0.28 (0.14, 0.52) 0.27 Change in phosphorus (mg/dl)a +0.2 (−0.1, 0.7) +0.3 (0.0, 0.6) 0.88 Change in alkaline phosphatase (U/L)a −9.0 (−22.2, 1.0) −13.0 (−23.5, −8.0) 0.32 Any phosphorus>4.5 mg/dl 21 (40) 28 (52) 0.21 eGFR (ml/min per 1.73 m2), 24 wka 24.0±8.6 22.6±9.6 0.45 Urine phosphorus/creatinine ratio (mg/g), 24 wk 377 (292, 528) 414 (326, 514) 0.62 Data are expressed as the mean±SD, n (%), or median (interquartile range).
↵a These results are significantly different from baseline. See Results and Discussion sections for further details.
Adverse Event Paricalcitol Group (n=53) Calcitriol Group (n=54) Any adverse event 37 (70) 35 (65) Serious adverse event 11 (21) 14 (26) Event type Dermatologic 7 (13) 7 (13) Neurologic 11 (21) 6 (11) Gastrointestinal 10 (19) 4 (7) Genitourinary 7 (13) 5 (9) Endocrine 4 (8) 10 (19) Respiratory 7 (13) 7 (13) Musculoskeletal 15 (28) 12 (22) Cardiac 9 (17) 7 (13) Psychiatric 2 (4) 2 (4) Other 6 (12) 6 (11) Data are expressed as n (%).
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