Table 5.

Peak exercise oxygen uptake, ventilatory threshold, and erythropoietin with voxelotor treatment

Voxelotor/placeboPlacebo700 mg/d900 mg/dVoxelotor-treated pooledP* for pooled voxelotor vs placebo
N46612
Peak exercise oxygen uptake VO2 max, mL/min/kg
 Median baseline (range)23.3 (15.7-23.8)16.7 (8.2-19.6)21.2 (17.1-23.4)18.9 (8.2-23.4)
 Median change at day 91 (range)−2.4 (−7.5 to 0.3)1.0 (−6.6 to 2.1)−1.9 (−5.0 to −0.4)−0.4 (−6.6 to 2.1)NS
Ventilatory threshold oxygen uptake, mL/min/kg
 Median baseline (range)11.9 (11.7-12.7)9.4 (6.4-12.4)12.8 (11.5-16.3)12.0 (6.4-16.3)
 Median change at day 91 (range)−1.4 (−5.5 to 2.3)1.6 (−0.1 to 4.7)−1.4 (−1.8 to 1.4)0.6 (−1.8 to 4.7)NS
Erythropoietin
 Median baseline mU/mL (IQR 25%:75%)112.2 (46.5, 183.0)91.2 (77.6, 125.0)113.5 (42.4, 150.0)104.4 (68.6, 137.5)
 % Median change to day 90 (IQR 25%:75%)−43.5 (−79.3, 19.7)0.4 (−32.9, 27.6)−7.2 (−11.5, −4.7)−5.2 (−22.2, 14.8)NS
Vital signs: heart rate at rest
 Median baseline, beats per minute (range)83 (75-93)81 (65-101)87 (71-99)81 (65-101)
 Median change to day 91 (range)17 (17)11 (6-38)3 (0-5)6 (0-38)NC
Vital signs: heart rate at peak exercise
 Median baseline, beats per minute (range)162 (160-162)150 (116-173)171 (146-184)164 (116-184)
 Median change to day 91 (range)−12 (−28 to 4)−2 (−20 to 16)1 (−7 to 8)−2 (−20 to 16)NC
  • CPET (peak exercise and ventilatory threshold) not available in all patients. CPET data available for n = 3 (placebo), n = 5 (900 mg), n = 11 (voxelotor-treated pooled).

  • IQR, interquartile range; NC, not calculated; NS, not significant.

  • * Two-sample Student t test.