ADI International Institute for Drug Development, Basel, Switzerland.
Int J Psychiatry Clin Pract. 2009;13(2):109-16. doi: 10.1080/13651500802485262.
Objective. To assess clinical advantages of fast dissolving tablet (FDT) formulation of mirtazapine by comparison to conventional (CT) mirtazapine tablets in the treatment of depressed patients. Methods. A posteriori analyses of pooled data of a total of 30 studies (of at least 6 weeks duration, total N=3510) with CT and FDT in depressed patients was performed. Weight changes were recorded at baseline and regular intervals until the end of the study. Patient preferences for the one or the other formulation, as well as the appraisal of the FDT qualities, were assessed by means of a global internet-based survey including 5,428 patients. Results. Compared with mirtazapine CT, the FDT was associated with an average 0.3 kg less weight increase (P=0.0015) during the 6 weeks of treatment. The qualities and preference for FDT (global survey) were positively evaluated by the majority of patients. Particular advantages of FDT over CT were: better compliance (47.3% of raters), taste, ease and overall convenience of use (>75% of raters). Conclusions. The FDT mirtazapine differed from conventional tablets (CT) not only regarding somewhat less weight increase and overall use preference, but more importantly, regarding better compliance with treatment.
目的。通过比较米氮平速释片(FDT)与传统米氮平片剂(CT)在治疗抑郁症患者方面的临床优势,评估 FDT 制剂的临床优势。方法。对共 30 项研究(至少 6 周疗程,总 N=3510)的汇总数据进行回顾性分析,这些研究比较了 FDT 和 CT 在抑郁症患者中的疗效。记录患者在基线和研究结束前的定期时间点的体重变化。通过一项包含 5428 名患者的基于互联网的全球调查评估患者对一种或另一种制剂的偏好,以及对 FDT 质量的评价。结果。与米氮平 CT 相比,在治疗的 6 周内,FDT 平均体重增加减少了 0.3 公斤(P=0.0015)。大多数患者对 FDT 的质量和偏好给予了积极评价。FDT 相对于 CT 的主要优势在于:更好的顺应性(47.3%的评价者)、口感、使用方便性(>75%的评价者)。结论。FDT 米氮平与传统片剂(CT)不仅在体重增加和总体使用偏好方面存在差异,而且更重要的是在治疗的顺应性方面具有优势。