Table 3.
Effects of canagliflozin vs placebo and each dose of canagliflozin vs placebo on fracture types and fracture locations in the CANVAS Program, CANVAS and CANVAS-R
| CANVAS Program HR (95% CI) (canagliflozin vs placebo) |
CANVAS HR (95% CI) (canagliflozin vs placebo) |
CANVAS-R HR (95% CI) (canagliflozin vs placebo) |
p interactiona | CANVAS | p 100 mg vs 300 mgb | ||
|---|---|---|---|---|---|---|---|
| HR (95% CI) (100 mg vs placebo) |
HR (95% CI) (300 mg vs placebo) |
||||||
| All fracture | 1.26 (1.04, 1.52)c,*, n = 496 | 1.55 (1.21, 1.97)c,*, n = 350 | 0.86 (0.62, 1.19)c, n = 146 | 0.005* | 1.45 (1.10, 1.92)*, n = 210 | 1.64 (1.25, 2.15)*,n = 225 | 0.34 |
| Type | |||||||
| Low-trauma | 1.23 (0.99, 1.52)c, n = 379 | 1.56 (1.18, 2.06)c,*, n = 271 | 0.76 (0.52, 1.12)c, n = 108 | 0.003* | 1.47 (1.07, 2.01)*, n = 162 | 1.66 (1.22, 2.25)*, n = 174 | 0.39 |
| High-trauma | 1.30 (0.83, 2.05), n = 89 | 1.21 (0.71, 2.06), n = 66 | 1.55 (0.67, 3.58), n = 23 | 0.63 | 1.08 (0.58, 2.00), n = 40 | 1.34 (0.74, 2.42), n = 45 | 0.46 |
| Pathological | 1.96 (0.39, 9.91), n = 8 | 1.93 (0.22, 17.30), n = 5 | 2.00 (0.18, 22.00), n = 3 | 0.99 | 1.93 (0.17, 21.28), n = 3 | 1.94 (0.18, 21.42), n = 3 | 1.00 |
| Stress | 0.59 (0.08, 4.27), n = 4 | 0.99 (0.09, 10.90), n = 3 | –, n = 1 | – | 1.98 (0.18, 21.79), n = 3 | –, n = 1 | – |
| Otherd | 0.82 (0.40, 1.66), n = 32 | 0.72 (0.30, 1.77), n = 20 | 0.99 (0.32, 3.08), n = 12 | 0.67 | 0.48 (0.15, 1.60), n = 12 | 0.97 (0.36, 2.58), n = 16 | 0.26 |
| Location | |||||||
| Upper limbe | 1.25 (0.91, 1.71), n = 184 | 1.40 (0.96, 2.05), n = 139 | 0.95 (0.53, 1.70), n = 45 | 0.28 | 1.39 (0.90, 2.12), n = 87 | 1.41 (0.92, 2.16), n = 88 | 0.92 |
| Lower limbf | 1.19 (0.90, 1.58), n = 221 | 1.47 (1.02, 2.11)*, n = 156 | 0.80 (0.49, 1.30), n = 65 | 0.05* | 1.35 (0.90, 2.04), n = 93 | 1.58 (1.06, 2.36)*, n = 102 | 0.40 |
| Spineg | 1.40 (0.72, 2.70), n = 43 | 1.40 (0.62, 3.12), n = 31 | 1.39 (0.44, 4.39), n = 12 | 1.00 | 1.09 (0.42, 2.83), n = 17 | 1.70 (0.71, 4.06), n = 22 | 0.30 |
| Pelvis | 1.36 (0.47, 3.96), n = 16 | 0.85 (0.25, 2.89), n = 11 | 3.96 (0.44, 35.46), n = 5 | 0.23 | 0.73 (0.16, 3.26), n = 7 | 0.96 (0.24, 3.85), n = 8 | 0.71 |
| Skull or facial bone | 1.45 (0.59, 3.57), n = 23 | 1.93 (0.55, 6.86), n = 15 | 1.00 (0.25, 3.98), n = 8 | 0.49 | 1.93 (0.48, 7.70), n = 9 | 1.94 (0.49, 7.77), n = 9 | 1.00 |
| Thoracic cage | 1.34 (0.81, 2.22), n = 72 | 1.85 (0.92, 3.71), n = 48 | 0.84 (0.38, 1.88), n = 24 | 0.15 | 1.55 (0.70, 3.42), n = 26 | 2.14 (1.02, 4.53)*, n = 32 | 0.33 |
ap interaction between CANVAS and CANVAS-R
bp 100 mg vs 300 mg tests the difference between the canagliflozin 100 mg and 300 mg groups in CANVAS
cPreviously reported in Neal et al (2017) [8]
dIncluding avascular necrosis, infectious, no trauma or unknown type
eIncluding clavicle, scapula, humerus, radius, ulna, wrist and hand fracture
fIncluding hip, femur, patella, tibia, fibula, ankle, foot and calcaneus fracture
gIncluding cervical, thoracic and lumbar spine fracture
*p <0.05
n, number of participants with an event