Safety Reporting and Adverse-Event Profile of Mirtazapine Described in Randomized Controlled Trials in Comparison with Other Classes of Antidepressants in the Acute-Phase Treatment of Adults with Depression
Norio WatanabeIchiro M OmoriAtsuo NakagawaAndrea CiprianiCorrado BarbuiHugh McGuireRachel ChurchillToshi A. Furukawa
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Mirtazapine is a new antidepressant whose effects on presynaptic adrenergic receptors leads to increased serotonergic transmission, and thus its antidepressant and antianxiety effects. It is equal in practical effectiveness to any currently marked antidepressant but may exert its effects earlier than some others. It is safe, well-tolerated and a useful addition to the drugs currently available for the treatment of mood and anxiety disorders.
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Of 580 patients randomly assigned to short-term, double-blind treatment with either mirtazapine, amitriptyline or placebo, a total of 217 patients clinically judged to be responders subsequently continued on the same medication for up to 2 years in the long-term treatment study (mirtazapine, n = 74; amitriptyline, n = 86 and placebo, n = 57). The efficacy of mirtazapine in relapse prevention was seen in an analysis of the first 20 weeks data. Significantly fewer patients relapsed during treatment with mirtazapine compared with placebo (p < 0.05), and a significantly longer time to relapse was shown on the survival analysis. There was a significant advantage for amitriptyline compared with placebo in the first 20 weeks, with fewer patients relapsing. There was a significant advantage for mirtazapine compared with amitriptyline at 20 weeks seen on the survival analysis (p < 0.05). The significant advantage for mirtazapine compared with placebo was also seen in the prophylactic phase of treatment after 20 weeks. At the endpoint there were significantly more patients in the placebo group with a return of symptoms and significantly fewer showing sustained response. Amitriptyline was better than placebo with fewer patients suffering a recurrence of symptoms, but there was no difference from placebo in the proportion of patients with sustained response. Mirtazapine was well tolerated with a side-effect profile similar to that of placebo. The only adverse event reported significantly more frequently on mirtazapine than on placebo was weight gain. Objectively measured weight gain was more frequent with amitriptyline (22% of patients) compared with mirtazapine (13% of patients). Amitriptyline was associated with significantly more adverse events than either mirtazapine or placebo, in particular sedative and anticholinergic side effects. The efficacy of mirtazapine in reducing the risk of relapse and the recurrence of depression, which on some measures showed an advantage compared with amitriptyline, coupled with its improved side-effect profile, commends this antidepressant for the long-term treatment of depression.
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Antidepressant drugs that act on serotonin and noradrenergic systems may be analgesic. The newer antidepressant mirtazapine (Remeron) has activity on noradrenergic and serotonergic transmission and is approved for the treatment of a Major Depressive Disorder. This paper describes a case that suggests that mirtazapine may also be useful in the treatment of chronic pain.
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Mirtazapine Treatment of a Severe Depressive Episode and Resolution of Elevated Inflammatory Markers
Depression has been shown to be associated with systemic inflammatory activity and the mode of action of several antidepressants appears to involve immunomodulation. Effects on immune system activity have also recently been observed in correlation with therapeutic response to mirtazapine in cardiac patients with depression, but no study has yet examined these effects in otherwise physically healthy depressed patients treated with mirtazapine. This report describes an association between a clinical antidepressant response and a decrease in markers of systemic inflammation observed during pharmacotherapy with mirtazapine in a severely depressed but physically well patient. This observation adds to the evidence that changes in inflammatory responses may be implicated in the mode of action of antidepressants. Further studies of antidepressant responses to mirtazapine and levels of inflammatory markers in depressed patients without medical comorbidity can help elucidate the role of the immune system in the pathophysiology of depression, and hence contribute to the development of novel antidepressant therapies.
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