Table 2:
Characteristics | PRIMO (Multinational) | OPERA (Chinese) | Comments |
---|---|---|---|
n | 227 (115/112) | N = 60 (30/30) | |
eGFR (ml/min/1.73 m2) | 31 (24–43) | 19.7 (16–30.6) | Opera mean (IQR) |
LVH | Mild moderate or no LVH | Moderate to severe LVH | |
Diagnosis | MRI/echo | Echo | MRI (primary endpoint) |
Initial dosing | Mostly 2 µg paricalcitol/day | Mostly 1µg paricalcitol/day (2 µg if >500 pg/ml) | 48 weeks PRIMO; 52 weeks OPERA |
iPTH absolute basal values (pg/ml) | Paricalcitol group: 100 (66–174); placebo group: 106 (71–153) | Paricalcitol group: 156 (108–235) Placebo group: 129 (121–176) Post-paricalcitol: 51 (37–78) | |
ΔLVMI (g/m2) | Paricalcitol group 0.34 g/m2 (−0.14–0.83) versus placebo group −0.07 g/m2 (−0.55–0.42 g/m2); adjusted least squares mean (95% CI) | Paricalcitol group −2.59 g/m2 (−6.13–0.32) versus placebo group −4.85 g/m2 (−9.89–1.10); median (IQR) | NS |
Hypercalcaemia | 23% | 43.3 versus 3.3% | OPERA 70% on calcium-based phosphate binders |
Other | Lower hospitalization rate | Lower hospitalization rate (no CV events in paricalcitol group) | Underpowered for events (OPERA 0 versus 6) |
IQR: interquartile range; LVMI: left ventricular mass index; MRI: magnetic resonance image; NSL not significant.