Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study

Toshiko Kamo, Masaharu Maeda, Misari Oe, Hiroshi Kato, Jun Shigemura, Kazuhiko Kuribayashi, Yuko Hoshino, Toshiko Kamo, Masaharu Maeda, Misari Oe, Hiroshi Kato, Jun Shigemura, Kazuhiko Kuribayashi, Yuko Hoshino

Abstract

Background: Many of the posttraumatic stress disorder (PTSD) treatment guidelines recognize the use of selective serotonin reuptake inhibitors as first-line pharmacological treatment. In Japan, there were no published studies investigating the effectiveness and safety of sertraline for PTSD in a clinical setting.

Methods: We conducted a retrospective medical chart review of the dosage, effectiveness, and safety of sertraline for the PTSD treatment in Japan. Data were collected from medical charts of patients of PTSD, caused by various types of trauma, who were treated with sertraline between July 2006 and October 2012 during their regular clinical practice. To evaluate the effectiveness, the investigators retrospectively assessed the severity and improvement of the symptoms using the Clinical Global Impressions - Severity and the Clinical Global Impressions - Improvement.

Results: The study population was 122 Japanese patients aged ≥18 years with a diagnosis of PTSD who were treated with sertraline (median duration, 10.6 months). Doses ranged from 12.5 to 150 mg/day, mostly 25 and 50 mg/day. The median duration of observation was 10.8 months. Out of those, 50% of patients were regarded as responders by using the Clinical Global Impressions - Improvement at the end of sertraline treatment or the last observation. Two-thirds (65.6%) of patients improved in the severity of PTSD, as assessed by Clinical Global Impressions - Severity, whereas 32.8% showed no change, and 1.6% worsened. Subgroups analyses and logistic regression analyses suggested that the type of traumatic events was the factor with the highest influence on the response rate. The adverse events in this chart review were consistent with the known safety profile of sertraline. There were no reports of serious or severe adverse events considered to be related to sertraline.

Conclusions: Our study suggested the effectiveness of sertraline for the treatment of PTSD in a Japanese clinical setting, and the obtained safety profile was consistent with the generally known safety profile of sertraline.

Trial registration: ClinicalTrials.gov (Identification No. NCT01607593 ). Registered May 21, 2012.

Keywords: Antidepressant; Chart review; Japan; Pharmacotherapy; Posttraumatic stress disorder (PTSD); Selective serotonin reuptake inhibitors (SSRI); Sertraline.

Figures

Fig. 1
Fig. 1
Propotion of responder in Clinical Grobal Impression-Improvement Ratings by patient characteristics. Responders: patients who were rated as “very much improved” or “much improved” in the CGI-I rating. Values in the bar chart represent the proportion (%) of patients. Age-subgroups were divided by the quartiles. No sexual assault: patients experienced traumatic events including physical assault, but no sexual assault. No physical assault: patients experienced traumatic events including sexual assault, but no physical assault
Fig. 2
Fig. 2
Dosage (mg/day) by baseline CGI-S score. Values in the bar chart represent the number of patients
Fig. 3
Fig. 3
Dosage (mg/day) by traumatic event. Values in the bar chart represent the number of patients. Both: patients experienced traumatic events both physical assault and sexual assault. No sexual: patients experienced traumatic events including physical assault, but no sexual assault. No physical: patients experienced traumatic events including sexual assault, but no physical assault. Neither: patients experienced traumatic events neither physical assault or sexual assault

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