Table 1: Select Primary and Secondary Efficacy Measures for Duloxetine in the Treatment of MDD

Efficacy Measures
Goldstein5
Detke12
Detke6
. . . .
. Mean Change from Baseline . .
HAM-D-17 D: -9.73
P: -6.61(p=0.009)
D: -10.91
P: -6.05 (p<0.001)
D: -10.46
P: -8.29 (p=0.024)
CGI-S D: -1.67
P: -1.07 (p=0.007)
D: -1.87
P: -0.97 (p<0.001)
D: -1.74
P: -1.51 (p=0.15)
PGI-I D: +2.92
P: +2.27 (p=0.006)
D: +3.27
P: +2.48 (p<0.001)
D: +2.59
P: +3.00 (p=0.014)

P = Placebo
D = Duloxetine
Definition of scales14-17
HAM-D-17 (Hamilton Rating Scale for Depression-17): Most widely used rating scale for depression. Ratings to assess symptoms of depression done by clinician through clinical interview on a 0 to 4 spectrum (0 = none, 4 = most severe).14

CGI-I, CGI-S (Clinical Global Impressions): Three-item scale which measures overall illness factors. Severity of Illness (CGI-S) rated by clinician on a 1 to 7 scale (1 = normal, 7 = among the most severely ill patients). Global Improvement (CGI-I) rated by clinician on a 1 to 7 scale (1 = very much improved, 7 = very much worse). Designed to be used to assess change over time.14

PGI (Patient Global Impressions - Improvement): A scale used by the patient to rate their own improvement based on a 0 to 7 scale (0 = not assessed, 7 = very much worse).

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Table 2. Incidence of Adverse Events in Duloxetine-Treated MDD Patients9

  Percentage of Patients Reporting Event
  Duloxetine N=1139 Placebo N=777
Nausea*
20
7
Dry Mouth
15
6
Constipation
11
4
Insomnia
11
6
Dizziness
9
5
Diarrhea
8
6
Fatigue
8
4
Decreased Appetite
8
2
Somnolence
7
3
Increased Sweating
6
2

Duloxetine vs. Placebo
*Nausea was the only common adverse event that led to discontinuation and is considered to be drug-related.


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Table 3. Incidence of Adverse Events in Duloxetine-Treated DN Patients9

  Percentage of Patients Reporting Event
  Duloxetine 60 mg once daily Placebo
Nausea*
22
9
Constipation
11
3
Dry Mouth
7
4
Decreased appetite
4
<1
Somnolence*
15
5
Dizziness*
14
6
Fatigue*
12
5
Increased Sweating
6
2

Duloxetine vs Placebo
*Nausea, somnolence, dizziness, and fatigue were the most common adverse events that led to discontinuation and are considered to be drug-related.

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Table 4. Cost Comparison24

Drug
Formulary Status
Strength
Cost (AWP)/Tablet
Duloxetine (Cymbalta®)
F
20 mg
$3.05
.
.
30 mg
$3.42
.
.
60 mg
$3.42
Venlafaxine (Effexor®)
F
25 mg
$1.83
.
.
37.5 mg
$1.88
.
.
50 mg
$1.94
.
.
75 mg
$2.06
.
.
100 mg
$2.18
Venlafaxine (Effexor® XR)
F
37.5 mg
$3.04
.
.
75 mg
$3.41
.
.
150 mg
$3.71
Fluoxetine (generic)
F
10 mg
$2.60
.
.
20 mg
$2.67
.
.
40 mg
$5.34

F = FormularyAWP = Average Wholesale Price

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