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).
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.
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.
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