Male Patientsa
 
 Female Patientsa
 
 Duloxetine (n=175)
 Placebo 
(n=83)
 Duloxetine 
(n=241)
 Placebo 
(n=126)
 
ASEX Total (Items 1 to 5)  
 0.56b
 -1.07
 -1.15
 -1.07
 
Item 1 — Sex drive  
 -0.07
 -0.12
 -0.32
 -0.24
 
Item 2 — Arousal  
 0.01
 -0.26
 -0.21
 -0.18
 
Item 3 — Ability to achieve erection (men); Lubrication (women)  
 0.03

 -0.25

 -0.17

 -0.18
 
Item 4 — Ease of reaching orgasm  
 0.40c
 -0.24
 -0.09
 -0.13
 
Item 5 — Orgasm satisfaction
 0.09
 -0.13
 -0.11
 -0.17
6.7 Vital Sign Changes in Adults
 
In placebo-controlled clinical trials across approved indications for change from baseline to endpoint, duloxetine treatment was associated with mean increases of 0.23 mm Hg in systolic blood pressure and 0.73 mm Hg in diastolic blood pressure compared to mean decreases of 1.09 mm Hg systolic and 0.55 mm Hg diastolic in placebo-treated patients. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure [see Warnings and Precautions (5.3, 5.11)].

Duloxetine treatment, for up to 26 weeks in placebo-controlled trials across approved indications, typically caused a small increase in heart rate for change from baseline to endpoint compared to placebo of up to 1.37 beats per minute (increase of 1.20 beats per minute in duloxetine-treated patients, decrease of 0.17 beats per minute in placebo-treated patients).

6.8 Laboratory Changes in Adults
 
Duloxetine treatment in placebo-controlled clinical trials across approved indications, was associated with small mean increases from baseline to endpoint in ALT, AST, CPK, and alkaline phosphatase; infrequent, modest, transient, abnormal values were observed for these analytes in duloxetine-treated patients when compared with placebo-treated patients [see Warnings and Precautions (5.2)]. High bicarbonate, cholesterol, and abnormal (high or low) potassium, were observed more frequently in duloxetine treated patients compared to placebo. 

6.9 Electrocardiogram Changes in Adults
 
The effect of duloxetine 160 mg and 200 mg administered twice daily to steady state was eva luated in a randomized, double-blinded, two-way crossover study in 117 healthy female subjects. No QT interval prolongation was detected. Duloxetine appears to be associated with concentration-dependent but not clinically meaningful QT shortening.

6.10 Other Adverse Reactions Observed During the Premarketing and Postmarketing Clinical Trial eva luation of Duloxetine in Adults
 
Following is a list of treatment-emergent adverse reactions reported by patients treated with duloxetine in clinical trials. In clinical trials of all indications, 34,756 patients were treated with duloxetine. Of these, 26.9% (9337) took duloxetine for at least 6 months, and 12.4% (4317) for at least one year. The following listing is not intended to include reactions (1) already listed in previous tables or elsewhere in la