Table 2. Primary efficacy parameter results (ITT population).
|
Primary efficacy parameters |
Placebo responder (N=395), n (%) |
Linaclotide responder (N=405), n (%) |
Difference |
Odds ratio (95% CI) |
P valuea |
NNT (95% CI) |
| FDA end point (each week, ≥30% decrease in worst abdominal pain+an increase ≥1 CSBM from baseline for at least 6/12 weeks) | 83 (21.0) | 136 (33.6) | 12.6 | 1.9 (1.4, 2.7) | <0.0001 | 8.0 (5.4, 15.5) |
| ≥30% Decrease in worst abdominal pain (each week, ≥30% decrease in abdominal pain from baseline for at least 9/12 weeks) | 107 (27.1) | 139 (34.3) | 7.2 | 1.4 (1.0, 1.9) | 0.0262 | 13.8 (7.4, 116.1) |
| ≥3 CSBMs and an increase of ≥1 CSBM (each week, ≥3 CSBM+an increase ≥1 CSBM from baseline for at least 9/12 weeks) | 25 (6.3) | 79 (19.5) | 13.2 | 3.7 (2.3, 5.9) | <0.0001 | 7.6 (5.6, 11.6) |
| Combined responder (each week ≥30% decrease in worst abdominal pain+≥3 CSBM+an increase ≥1 CSBM from baseline for at least 9/12 weeks) | 20 (5.1) | 49 (12.1) | 7.0 | 2.6 (1.5, 4.5) | 0.0004 | 14.2 (9.2, 31.3) |
CI, confidence interval; CSBM, complete spontaneous bowel movement; FDA, Food and Drug Administration; ITT, intent-to-treat; NNT, number needed to treat.
a
P values were based on a comparison of linaclotide vs. the placebo group using the Cochran–Mantel–Haenszel test.