Henry Jessica M, Fuller Matthew A
Louis Stokes Cleveland Veteran Affairs Medical Center, Cleveland, OH 44106, USA.
J Pharm Pract. 2011 Oct;24(5):447-51. doi: 10.1177/0897190011422875.
Asenapine is a new psychopharmacologic agent approved for the acute and maintenance treatment of schizophrenia and the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder. The efficacy of asenapine in treating schizophrenia was evaluated in four 6-week studies in which placebo and active controls (risperidone, olanzapine, and haloperidol) were used. Two 3-week placebo-controlled trials examined the efficacy of asenapine and active control (olanzapine) in the treatment of bipolar I disorder. Asenapine demonstrated efficacy in relation to placebo for 2 of the acute schizophrenia trials and both trials examining the acute treatment of bipolar I disorder. Several factors should be examined when considering asenapine therapy in relation to other antipsychotics including efficacy, atypicality of receptor binding, obstacles to administration and compliance, and finally cost. No efficacy advantage is evident with asenapine over other antipsychotic agents. Barriers to achieving compliance with asenapine include the recommendations of twice daily dosing, the need to avoid food and liquids for at least 10 minutes postadministration, the need for patient cooperation with sublingual administration, and the low bioavailability of the tablet if swallowed. Finally, no cost advantage is evident for using asenapine in comparison to the already available generic risperidone or other soon-to-be generic atypical antipsychotics.
阿塞那平是一种新型精神药理学药物,被批准用于精神分裂症的急性和维持治疗以及与双相I型障碍相关的躁狂和混合发作的急性和维持治疗。在四项为期6周的研究中评估了阿塞那平治疗精神分裂症的疗效,这些研究使用了安慰剂和活性对照药(利培酮、奥氮平和氟哌啶醇)。两项为期3周的安慰剂对照试验考察了阿塞那平及活性对照药(奥氮平)治疗双相I型障碍的疗效。在两项急性精神分裂症试验以及两项考察双相I型障碍急性治疗的试验中,阿塞那平相对于安慰剂均显示出疗效。在考虑阿塞那平治疗相对于其他抗精神病药物时,应考察几个因素,包括疗效、受体结合的非典型性、给药和依从性方面的障碍,以及最终的成本。阿塞那平与其他抗精神病药物相比并无明显的疗效优势。阿塞那平在实现依从性方面的障碍包括每日两次给药的建议、给药后至少10分钟内需避免进食和饮水、患者需配合舌下给药,以及片剂若被吞服生物利用度较低。最后,与已有的通用型利培酮或其他即将成为通用型的非典型抗精神病药物相比,使用阿塞那平并无明显的成本优势。