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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|
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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