Table 1.
Patient characteristics by region
| Patient characteristic | Europe | Japan | North America |
|---|---|---|---|
| N patients | 5910 | 2627 | 18,251 |
| Characteristics at study entry | |||
| Age (years) | 65.9 ± 14.7 | 64.3 ± 12.3 | 62.7 ± 14.9 |
| Sex (% male) | 62% | 66% | 55% |
| Race (% black) | 2% | 0% | 37% |
| Vintage (years) | 1.9 (0.4, 5.1) | 3.8 (0.7, 9.2) | 2.0 (0.5, 4.6) |
| Catheter use (%) | 26% | 1% | 32% |
| Dialysate calcium (mEq/L) | 2.9 ± 0.3 | 2.8 ± 0.2 | 2.5 ± 0.2 |
| Mean over 9-month run-in period | |||
| BMI (kg/m2) | 26.3 ± 5.5 | 21.5 ± 3.5 | 28.7 ± 7.1 |
| Normalized PCR (g/kg/day) | 1.00 ± 0.22 | 0.93 ± 0.18 | 0.95 ± 0.22 |
| Hgb (g/dL) | 11.5 ± 1.0 | 10.6 ± 0.9 | 11.0 ± 0.9 |
| Serum creatinine (mg/dL) | 7.9 ± 2.4 | 10.4 ± 2.8 | 7.9 ± 2.8 |
| Serum albumin (g/dL) | 3.73 ± 0.43 | 3.71 ± 0.36 | 3.76 ± 0.38 |
| Serum calcium (mg/dL) | 9.0 ± 0.6 | 8.9 ± 0.6 | 9.0 ± 0.6 |
| Serum phosphorus (mg/dL) | 4.9 ± 1.2 | 5.4 ± 1.0 | 5.2 ± 1.2 |
| PTH (pg/mL)* | 233 (140, 377) | 126 (77, 192) | 283 (194, 425) |
| Slope over 9-month run-in period | |||
| Calcium (mg/dL per year) | 0.1 (−0.5, 0.8) | 0.1 (− 0.4, 0.7) | 0.1 (− 0.5, 0.7) |
| Phosphorus (mg/dL per year) | −0.1 (− 1.5, 1.4) | −0.2 (− 1.5, 1.2) | 0.1 (− 1.3, 1.5) |
| PTH (% change per month) | 0.6 (− 6.1, 7.1) | −1.0 (− 7.0, 4.9) | 0.5 (− 6.0, 7.1) |
| MSE over 9-month run-in period** | |||
| Calcium | 0.1 (0.1, 0.2) | 0.1 (0.1, 0.2) | 0.1 (0.1, 0.2) |
| Phosphorus | 0.6 (0.3, 1.1) | 0.5 (0.3, 1.0) | 0.7 (0.4, 1.3) |
| Log(PTH) | 0.1 (0.0, 0.2) | 0.1 (0.0, 0.2) | 0.1 (0.0, 0.3) |
| Medications over 9-month run-in period (% any prescription over 9 months) | |||
| Phosphate binder | 85% | 88% | 80% |
| Cinacalcet | 23% | 22% | 22% |
| IV vitamin D | 24% | 45% | 71% |
| Oral vitamin D | 51% | 45% | 26% |
| Any active vitamin D | 69% | 81% | 86% |
| Comorbid conditions (%) | |||
| Coronary artery disease | 37% | 28% | 34% |
| Congestive heart failure | 20% | 19% | 30% |
| Cerebrovascular disease | 16% | 13% | 11% |
| Peripheral vascular disease | 31% | 15% | 15% |
| Other cardiovascular disease | 31% | 24% | 19% |
| Hypertension | 87% | 81% | 82% |
| Diabetes | 38% | 41% | 62% |
| Neurologic disease | 12% | 7% | 8% |
| Psychiatric disorder | 18% | 5% | 15% |
| Lung disease | 15% | 4% | 12% |
| Cancer (non-skin) | 16% | 10% | 7% |
| Gastrointestinal bleeding | 5% | 4% | 3% |
| Recurrent cellulitis, gangrene | 9% | 3% | 9% |
Mean ± SD or median (IQR) or % shown
*Geometric mean: Exp(mean(log(PTH)))
**MSE mean squared error from fitted regression model over 9-month run-in period