Bibliographic Details
| Title: |
Adjunctive cariprazine for the treatment of major depressive disorder: Number needed to treat, number needed to harm, and likelihood to be helped or harmed. |
| Authors: |
Citrome, L.1 (AUTHOR) nntman@gmail.com, Reda, I.1,2 (AUTHOR), Kerolous, M.1,2 (AUTHOR) |
| Source: |
Journal of Affective Disorders. Jan2025, Vol. 369, p1238-1247. 10p. |
| Subject Terms: |
*MENTAL depression, *TARDIVE dyskinesia, *PLACEBOS, *ANTIPSYCHOTIC agents |
| Abstract: |
The number needed to treat (NNT) for efficacy and number needed to harm (NNH) for tolerability/safety were evaluated for adjunctive cariprazine in major depressive disorder (MDD). Data were extracted from five randomized, double-blind, placebo-controlled trials of adjunctive cariprazine in MDD. NNTs (response, remission, severity shift) and NNHs (discontinuations due to adverse events [AEs], AEs, laboratory shifts) were determined in dose groupings; likelihood to be helped/harmed (LHH) was calculated. NNTs (95 % CI) for adjunctive cariprazine versus placebo were statistically significant at week 6/early termination for response on the Montgomery–Åsberg Depression Rating Scale (MADRS), as defined by a decrease in total score ≥ 50 % (doses ≥ 1 mg/d = 12 [9–21]; 1–2 mg/d = 12 [8–25]; 2–4.5 mg/d = 14 [9–43]) and other response/remission outcomes. NNHs for cariprazine versus placebo were generally ≥ 10 for AEs that were statistically significant; an apparent dose-response was seen for akathisia (lower dose = 24 [17–43]; higher dose = 9 [7–11]). LHHs were ≥ 1 (acceptable benefit/harm ratio) for MADRS total score response versus most important cariprazine AEs in most dose groupings. For response versus discontinuation because of an AE, adjunctive cariprazine 1–2 mg/d had a more favorable response/tolerability profile in indirect comparison with other approved atypical antipsychotics. Post hoc analysis; indirect comparisons. Patients receiving adjunctive cariprazine encountered benefits more often than harms; NNT values at week 6/early termination were statistically significant versus placebo on response/remission outcomes across dose groupings from the five pooled studies. Adjunctive cariprazine was well tolerated; NNH values versus placebo were generally > 10, with better akathisia tolerability in the lower-dose range. • Effect sizes were evaluated for adjunctive cariprazine in patients with MDD. • NNTs for response were significant for cariprazine vs placebo across dose groups. • Adjunctive cariprazine was well tolerated, with NNHs versus placebo mostly >10. • Response NNTs were comparable for cariprazine and other MDD-approved antipsychotics. • Except for akathisia, cariprazine LHHs were ≥ 1 (more likely to benefit than harm). [ABSTRACT FROM AUTHOR] |
|
Copyright of Journal of Affective Disorders is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Academic Search Complete |
