Table 6.
Vital signs and weight: treatment-emergent potentially clinically significant values
| 3–6-Month studies | ≥6-Month exposure | 1-Year study | ||||
|---|---|---|---|---|---|---|
| Placebo (N = 535) | Duloxetine (N = 876) | Duloxetine (N = 721) | Duloxetine (N = 350) | |||
| Abnormality | n/N (%) | n/N (%) | pa (duloxetine vs. placebo) | n/N (%) | n/N (%) | |
| Pulse | High | 1/527 (0.2) | 4/855 (0.5) | 0.308 | 1/721 (0.1) | 2/347 (0.6) |
| Low | 2/519 (0.4) | 3/846 (0.4) | 0.900 | 0/716 (0) | 0/348 (0) | |
| Sitting diastolic BP | High | 1/522 (0.2) | 6/847 (0.7) | 0.159 | 1/712 (0.1) | 8/342 (2.3) |
| Low | 3/523 (0.6) | 3/852 (0.4) | 0.607 | 2/718 (0.3) | 3/346 (0.9) | |
| Sitting systolic BP | High | 1/525 (0.2) | 3/848 (0.4) | 0.415 | 3/715 (0.4) | 6/347 (1.7) |
| Low | 3/517 (0.6) | 2/845 (0.2) | 0.525 | 1/708 (0.1) | 11/340 (3.2) | |
| Weight (kg) | Gain | 2/499 (0.4) | 10/823 (1.2) | 0.126 | 55/719 (7.6) | 28/348 (8.0) |
| Loss | 6/499 (1.2) | 18/823 (2.2) | 0.173 | 29/719 (4.0) | 17/348 (4.9) | |
Criteria for PCS values: systolic low (≤90 and decrease from baseline ≥20), systolic high (≥180 and increase from baseline ≥20), diastolic low (≤50 and decrease from baseline ≥15), diastolic high (≥105 and increase from baseline ≥15), pulse low (≤50 and decrease from baseline ≥15), pulse high (≥120 and increase from baseline ≥15), weight low (decrease from baseline ≥10%), high (increase from baseline ≥10%)
N number of patients at risk of having potentially clinically significant (PCS) values at baseline, n number of patients with a PCS postbaseline measurement
aCochran–Mantel–Haenszel test for general association, controlling for study