Table 3.
Summary of pharmacodynamic measures: mean (SE) Emax scores in the completers population (N = 38)a
| Measure | Placebo | Pitolisant 35.6 mg | Pitolisant 213.6 mg | Phentermine HCl 60 mg |
|---|---|---|---|---|
| Primary endpointb | ||||
| Drug Liking (“at this moment”) | 56.1 (2.1) | 57.3 (2.1)**** ,††††,c,d | 59.0 (2.1)**** ,††,c,d | 78.7 (2.8)†††† |
| Key secondary endpointsb | ||||
| Overall Drug Liking | 54.4 (2.2) | 52.7 (2.1)**** ,††††,c,d | 49.2 (4.3)** ,†††,c,d | 77.4 (3.8)†††† |
| Take Drug Again | 51.0 (2.9) | 49.4 (3.4)**** ,††††,c,d | 44.5 (4.9)**** ,†††,c,d | 78.7 (4.3)†††† |
| Good Drug Effects | 15.3 (4.4) | 15.7 (4.0)**** ,†,c,d | 26.3 (4.8)****c | 62.9 (5.2)†††† |
| High | 12.3 (3.9) | 15.7 (4.1)**** ,c | 35.3 (5.6)*** ,c | 58.6 (5.0)†††† |
| Other secondary endpointse | ||||
| Bad Drug Effects | 7.4 (3.2) | 6.7 (2.9) | 28.2 (5.7)* ,†† | 14.7 (3.5) |
| Relaxation/Agitation | 52.4 (2.1) | 53.2 (2.8) | 60.8 (2.9)†† | 62.9 (3.2)†† |
| Any Drug Effects | 17.2 (4.9) | 19.3 (4.5)**** | 41.6 (6.1)** ,††† | 63.6 (5.0)†††† |
| ARCI/MBG score | 3.4 (0.7) | 3.3 (0.7)**** | 3.9 (0.7)**** | 9.6 (0.9)†††† |
| ARCI/Amphetamine score | 2.7 (0.4) | 2.3 (0.4)**** | 3.1 (0.5)**** | 6.4 (0.5)†††† |
| ARCI/BG score | 6.0 (0.3) | 5.9 (0.3)**** | 6.1 (0.3)**** | 8.2 (0.4)†††† |
| ARCI/LSD score | 4.4 (0.3) | 4.5 (0.3)**** | 5.8 (0.4)†† | 6.1 (0.4)†††† |
a p values are based on a mixed-effects model for a crossover study and included treatment, period, treatment sequence, baseline, and carryover effects.
bBecause of the structure of the statistical hypothesis testing for the primary and key secondary endpoints, significant results for pitolisant compared with placebo indicate that mean Emax values were similar for pitolisant and placebo.
cStatistically significant comparison with phentermine indicates difference.
dStatistically significant comparison with placebo indicates similarity.
eFor other secondary endpoint comparisons, statistical significance indicates difference.
*p < 0.05 versus phentermine; **p < 0.01 versus phentermine; ***p < 0.001 versus phentermine; ****p < 0.0001 versus phentermine; †p < 0.05 versus placebo; ††p < 0.01 versus placebo; †††p < 0.001 versus placebo; ††††p < 0.0001 versus placebo.
ARCI = Addiction Research Center Inventory; BG = Benzedrine Group; Emax = peak maximum effect; LSD = lysergic acid diethylamine; MBG = Morphine-Benzedrine Group; SE = standard error.