Table 3.
Pooled outcomes.
| Endpoint | Drug free | Start of drug-free period | End of drug-free period | P value |
|---|---|---|---|---|
| PINP (μg/mL) | Beginning | 43 ± 16 | 45 ± 18 | 0.95a |
| End | 49 ± 11 | 52 ± 16 | 0.52 | |
| PIIINP (μg/mL) | Beginning | 4.0 ± 1.1 | 3.7 ± 1.1 | 0.21 |
| End | 5.3 ± 1.6 | 5.8 ± 1.5 | 0.83 | |
| G3 (ng/mL) | Beginning | 10.7 ± 2.8 | 11.1 ± 2.6 | 0.36 |
| End | 10.4 ± 1.5 | 10.0 ± 1.5 | 0.82 | |
| 6MWD (feet) | Beginning | 1641.0 ± 257.2 | 1680.4 ± 243.9 | 0.42 |
| End | 1577.1 ± 289.5 | 1591.3 ± 203.2 | 0.2 | |
| SF-36 total | Beginning | 83.8 ± 9.7 | 83.6 ± 10.5 | 0.83 |
| End | 72.4 ± 16.8 | 65.2 ± 18.8 | 0.06 | |
| SF-36 physical | Beginning | 90.8 ± 11.0 | 90.4 ± 9.5 | 1.00a |
| End | 76.1 ± 15.8 | 69.4 ± 19.0 | 0.13a |
PINP indicates procollagen 1 N-terminal peptide; PIIINP, procollagen 3 N-terminal peptide; G3, galectin-3; 6MWD, 6-minute walk distance; SF-36, Short Form 36.
a
Includes patient randomized to a drug-free period at the end of the study who failed to show up for the final study visit.