Table 2.
Vital Signs and Weight During Acute Treatment
| Acute period vital signs and weight | Duloxetine (60 mg QD) n=105 | Duloxetine (30 mg QD) n=114 | Fluoxetine (20 mg QD) n=112 | Placebo n=117 |
|---|---|---|---|---|
| Vital signs and weight mean change (MMRM)a | ||||
| Weight, kg (mean[SE]) | −0.5 (0.2)*§β | 0.2 (0.2) | 0.5 (0.2) | 0.7 (0.2) |
| Sitting pulse, bpm (mean[SE]) | −0.3 (1.0) | −1.3 (1.0) | −1.7 (1.0) | −0.5 (1.0) |
| Sitting systolic blood pressure, mm Hg (mean[SE]) | 1.2 (0.9) | 0.1 (0.9) | 0.3 (0.9) | −0.5 (0.9) |
| Sitting diastolic blood pressure, mm Hg (mean[SE]) | 2.8 (0.8)β | 0.6 (0.8) | 1.7 (0.8) | 0.7 (0.8) |
| PCS vital signs and weight at any time | ||||
| PCS decrease in weight (n/N, %)b | 14/105 (13.3)* | 10/114 (8.8) | 13/112 (11.6) | 6/117 (5.1) |
| PCS increase in pulse (n/N, %)c | 0/105 (0.0) | 0/114 (0.0) | 0/112 (0.0) | 0/117 (0.0) |
| PCS decrease in pulse (n/N, %)b | 0/100 (0.0) | 0/108 (0.0) | 0/108 (0.0) | 0/112 (0.0) |
| PCS systolic blood pressure (n/N, %)c | 8/88 (9.1) | 12/95 (12.6) | 12/93 (12.9) | 10/98 (10.2) |
| PCS diastolic blood pressure (n/N, %)c | 11/93 (11.8) | 7/100 (7.0) | 10/99 (10.1) | 5/110 (4.5) |
| PCS vital signs and weight at end-point | ||||
| PCS decrease in weight (n/N, %)b | 8/105 (7.6) | 4/114 (3.5) | 8/112 (7.1) | 3/117 (2.6) |
| PCS increase in pulse (n/N, %)c | 0/105 (0.0) | 0/114 (0.0) | 0/112 (0.0) | 0/117 (0.0) |
| PCS decrease in pulse (n/N, %)b | 0/100 (0.0) | 0/108 (0.0) | 0/108 (0.0) | 0/112 (0.0) |
| PCS systolic blood pressure (n/N, %)c | 4/88 (4.5) | 4/95 (4.2) | 2/93 (2.2) | 1/98 (1.0) |
| PCS diastolic blood pressure (n/N, %)c | 4/93 (4.3) | 2/100 (2.0) | 2/99 (2.0) | 2/110 (1.8) |
| Sustained elevation in blood pressure | ||||
| Sustained elevation in systolic blood pressure (n/N, %)c | 0/88 (0.0) | 0/95 (0.0) | 1/93 (1.1) | 1/98 (1.0) |
| Sustained elevation in diastolic blood pressure (n/N, %)c | 0/93 (0.0) | 1/100 (1.0) | 1/99 (1.0) | 0/110 (0.0) |
Baseline was defined as last observation during the screening period, and end-point was the 10 week end-point of the acute treatment period.
N=number of patients with high or normal values at baseline and with at least one nonmissing postbaseline measure; n=number of patients with a potentially clinically significant (PCS) postbaseline measurement.
N=number of patients with low or normal values at baseline and with at least one nonmissing postbaseline measure; n=number of patients with a PCS postbaseline measurement.
p<0.05 vs. placebo; βp<0.05 vs. duloxetine 30 mg; §p<0.05 vs. fluoxetine
PCS increase in blood pressure=increase ≥5 mm Hg from baseline high to a value above the 95th percentile based on age, height, and sex (National High Blood Pressure Education Program Working Group 2004).
PCS decrease in pulse=decrease ≥25 bpm from baseline low to a value of <60 bpm for children or decrease ≥15 bpm from baseline low to a value <50 bpm for adolescents.
PCS increase in pulse=increase ≥15 bpm from baseline high to a value >140 bpm for children or increase ≥15 bpm from baseline high to a value >120 bpm for adolescents.
PCS decrease in weight=decrease ≥3.5% from baseline low.
Sustained elevation in blood pressure=PCS blood pressure at three consecutive post-baseline visits.
MMRM, mixed effects model repeated measures.