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Title: Mirtazapine More Effective Than Sertraline On Veterans' Post-Traumatic Stress Disorder: Presented at ECNP

"Mirtazapine More Effective Than Sertraline On Veterans' Post-Traumatic Stress Disorder: Presented at ECNP"

By Paula Moyer PRAGUE, CZECH REPUBLIC -- October 14, 2003 -- Mirtazapine (Remeron) may be a more attractive treatment option than sertraline (Zoloft) for addressing post-traumatic stress disorder (PTSD) in military veterans traumatised by their war experiences, according to findings presented here September 23rd at the 16th Congress of the European College of Neuropsychopharmacology. "Among responders, we saw a faster onset of action with mirtazapine," said Moon Yong Chung, MD, staff physician, neuropsychiatry department, Seoul Veterans Hospital, Republic of Korea, and professor of psychiatry, Yonsei University. Dr. Chung added that one reason for the difference might be mirtazapine's dual noradrenergic and serotonergic action. Sertraline is a selective serotonin reuptake inhibitor (SSRI), and has been approved by the United States Food and Drug Administration (FDA) for the treatment of PTSD. Dr. Chung and colleagues recruited 113 male veterans of the Korean and Vietnam Wars who had been diagnosed with PTSD and co-morbid depression. The participants were randomly assigned to a 6-week treatment -- 58 received mirtazapine 15 to 60 mg daily and 55 received 200 mg daily of sertraline. The investigators evaluated the drugs' efficacy with the Clinician Administered PTSD Scale (CAPS) 1 and 2, which include B, C and D symptom clusters, consisting of re-experience, avoidance, and hyperarousal, respectively; the Hamilton Rating Scale for Depression (HAMD-17); and the Clinical Global Impression Scale (CGI). The investigators evaluated the participants at baseline and at Weeks 1, 2, and 6 of the trial. The trial protocol defined a responder as one who had at least a 30% decrease in the CAPS-2 total severity, a decrease of 50% or more in the total HAMD-17 score, and a CGI score of "much improved" or more. The statistical analyses consisted of a paired t-test and multiple regression analysis. Among the original participants, 100 patients completed the study -- 51 in the mirtazapine group and 49 in the sertraline group. The mean daily dosages were 34.1 mg for mirtazapine and 101.5 mg for sertraline. In both groups the CAPS-2 total score, as well as the B, C, and D symptom clusters, decreased significantly at weeks 1, 2, and 6. The CAPS-2 total score reduction was 43% for mirtazapine and 37% for sertraline, with no significant difference between the groups. On the CAPS-2 total score, however, 13% of patients in the mirtazapine group had responded by week 1, compared to 2% for the sertraline group. By week 2, 51% of mirtazapine-treated patients had responded, compared to 31% in the sertraline group. At week 6, significantly more mirtazapine patients than sertraline patients were responders, with response rates for the two groups of 88% and 69%, respectively (p=0.039). The mean HAMD-17 total score and CGI score decreased significantly in both groups, with similar scores and response rates between the groups on all time points. The most common adverse effects for patients treated with mirtazapine were dry mouth (19.6%), constipation (19.6%), somnolence (15.7%) and weight gain (1.96%). For patients treated with sertraline, the most common adverse effects were indigestion (14.3%), palpitation (6.1%), agitation (2.0%), epigastric soreness (2.0%), insomnia (2.0%), and sexual dysfunction (2.0%). Dr. Chung said that the mirtazapine-related adverse effects were more easily tolerated than those related to sertraline. This study was funded by Organon, manufacturers of Remeron. [Study title: Efficacy And Tolerability Of Mirtazapine And Sertraline In Korean Veterans With Posttraumatic Stress Disorder. Abstract P6-015]

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