Details

Autor(en) / Beteiligte

• Pezzullo, A M
• Ferraro, C
• Sellitto, C
• Iannaccone, T
• Giudice, V
• Centola, R
• Manzo, V
• Salvo, F
• Filippelli, A

Titel

Pharmacovigilance of Selective Serotonin Reuptake Inhibitors and Gender Differences in Stroke Incidence

Ist Teil von

• Drug safety, 2022-10, Vol.45 (10), p.1262-1263

Ort / Verlag

Auckland: Springer Nature B.V

Erscheinungsjahr

2022

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Introduction: Selective Serotonin Reuptake Inhibitors (SSRI), commonly used for treating depression, have better tolerability and fewer adverse drug-related reactions (ADRs) compared to other antidepressants [1]; however, some severe ADRs can occur, such as QT interval prolongation [2]. It has been also suggested that people treated with SSRI are at an increased risk of ischemic stroke and having a stroke with unfavorable outcomes [3]. Objective: To investigate sex differences in the incidence of stroke and SSRI use. Methods: A retrospective case-non-case observational study of ADRs reported to the World Health Organization Vigibase database from March 1988 to March 2022. Cases were defined as all "Central nervous system hemorrhages and cerebrovascular conditions" using the Standardized MedDRA Query (SMQ), while all other severe ADRs were included as non-cases. Cases were then divided into ischemic or hemorrhagic cerebrovascular conditions. Studied drugs were: citalopram, escitalopram, sertraline, paroxetine, fluoxetine, fluvoxamine. Age-adjusted reporting odds ratios and 95% confidence intervals (aROR, 95% CI) were calculated for each condition and sex, and ratios of aROR (RROR) were used for investigating gender differences in stroke incidence related to SSRI use. I2 and Cochran Q were used to investigate the heterogeneity between drugs aROR and RROR. Results: Overall, escitalopram and citalopram were associated with higher stroke aROR (1.87, 1.70-2.04 and 1.48, 1.35-1.63; respectively) compared to sertraline, paroxetine, fluoxetine, and fluvoxamine (1.10, 1.01-1.19; 1.11, 1.02-1.21; 0.96, 0.88-1.05; and 0.36, 0.25-0.52; respectively) (I2 = 99%; P < 0.0001). Overall, escitalopram and citalopram were associated with greater aROR for hemorrhagic strokes (1.99, 1.79-2.21 and 1.42, 1.27-1.60; respectively) compared to other antidepressants (sertraline, 1.16, 1.05-1.27; paroxetine, 1.14, 1.03-1.26; fluoxetine, 0.98, 0.88-1.08; and fluvoxamine, 0.31, 0.20-0.50; respectively) (I2 = 98.7%; P < 0.0001). Females using escitalopram and citalopram had increased RROR for ischemic stroke (1.48, 1.08-2.03 and 1.42, 1.05-1.90; respectively) compared to males; the other drugs did not present a different reporting risk between sex (sertraline, RROR = 0.83, 0.67-1.04; paroxetine, 0.77, 0.60-0.99; fluoxetine, 1.04, 0.81-1.32; and fluvoxamine, 1.50, 0.53-4.27; respectively) (I2 = 90.1%; P = 0.002). Conclusion: This study has identified gender differences in reporting central nervous system hemorrhages and cerebrovascular conditions during SSRI treatment, as females treated with escitalopram and citalopram had an increased risk of ischemic stroke compared to males.