| Autor: |
Oliveira-Maia, Albino J., Morrens, Joachim, Rive, Benoit, Godinov, Yordan, Cabrieto, Jedelyn, Perualila, Nolen, Barbreau, Sebastien, Mulhern-Haughey, Siobhán |
| Předmět: |
|
| Zdroj: |
Frontiers in Psychiatry; 2023, p1-12, 12p |
| Abstrakt: |
Background: Treatment resistant depression (TRD) affects 10--30% of patients with major depressive disorder. In 4-week trials, esketamine nasal spray (NS) was efficacious vs. placebo when both were initiated in addition to a new selective serotonin or serotonin norepinephrine reuptake inhibitor. However, comparison with an extended range of real-world treatments (RWT) is lacking. Methods: ICEBERG was an adjusted indirect treatment comparison using propensity score-based inverse probability weighting, performed on 6-month response and remission data from patients receiving esketamine NS plus oral antidepressant from the SUSTAIN-2 (NCT02497287; clinicaltrials.gov) study, compared with patients receiving other RWT from the European Observational TRD Cohort (EOTC; NCT03373253; clinicaltrials.gov) study. SUSTAIN-2 was a long-term open-label study of esketamine NS, while the EOTC was conducted at a time when esketamine NS was not available as RWT. Threshold and sensitivity analyses were conducted to assess how robust the primary analyses were. Results: Patients receiving esketamine NS had a higher probability of 6-month response (49.7% [95% confidence interval (CI) 45.6--53.9]) and remission (33.6% [95% CI 29.7--37.6]) vs. patients receiving RWT (26.4% [95% CI 21.5--31.4] and 18.2% [95% CI 13.9--22.5], respectively), according to rescaled average treatment effect among treated estimates. Resulting adjusted odds ratios (OR) and relative risk (RR) favoured esketamine NS over RWT for 6-month response (OR 2.756 [95% CI 2.034--3.733], p <0.0001; RR 1.882 [95% CI 1.534--2.310], p <0.0001) and remission (OR 2.276 [95% CI 1.621--3.196], p <0.0001; RR 1.847 [95% CI 1.418--2.406], p <0.0001). Threshold analyses suggested that differences between the two studies were robust, and results were consistent across extensive sensitivity analyses. Conclusion: ICEBERG supports that, at 6 months, esketamine NS has a substantial and significant benefit over RWT for patients with TRD. While results may be affected by unobserved confounding factors, threshold analyses suggested these were unlikely to impact the study conclusions. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
|
