Bipolar Disorders Unit, Clinical Institute of Neurosciences, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, 08036 Barcelona, Catalonia, Spain.
Mental Health Division of Althaia, Xarxa Assistencial Universitária de Manresa, Catalonia, Spain.
Eur Psychiatry. 2015 Jun;30(4):528-34. doi: 10.1016/j.eurpsy.2015.01.003. Epub 2015 Feb 11.
Asenapine is the most recent compound that has been FDA- and EMA-approved for treatment of mania. Its efficacy and safety have been assessed in placebo-controlled trials, but little is known about its performance in routine clinical conditions. In this study, we compared features of patients treated with adjunctive asenapine or other adjunctive antipsychotics and the costs of the treatment.
A combined prospective and retrospective data collection and analysis was conducted from January 2011 to December 2013 following a clinical interview and assessment of manic and depressive symptoms (YMRS, HDRS-17), clinical state (CGI-BP-M), psychosocial functioning (FAST), sexual dysfunction (PRSexDQ) and health resource costs associated with treatment with adjunctive asenapine versus other adjunctive antipsychotics.
Hundred and fifty-two patients from different university hospitals were included. Fifty-three patients received adjunctive asenapine and 99 received other adjunctive antipsychotics concomitantly to mood stabilizers. Considering inpatients, those treated with adjunctive asenapine presented a significantly less severe manic episode (P=0.001), less psychotic symptoms (P=0.030) and more comorbid personality disorder (P=0.002). Regarding outpatients, those treated with adjunctive asenapine showed significantly less severe manic episode (P=0.046), more previous mixed episodes (P=0.013) and more sexual dysfunction at baseline (P=0.036). No significant differences were found in mean total costs per day.
Clinicians tended to use adjunctive asenapine in patients with less severe manic symptoms but more complex clinical profile, including more mixed episodes in the past, concomitant personality disorder, and sexual problems. Treatment with adjunctive asenapine was not associated with higher costs when compared to other options.
阿塞那平是最近获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准用于治疗躁狂症的化合物。其疗效和安全性已在安慰剂对照试验中得到评估，但在常规临床情况下的表现知之甚少。在这项研究中，我们比较了辅助使用阿塞那平或其他辅助抗精神病药物治疗的患者特征以及治疗的成本。
从 2011 年 1 月至 2013 年 12 月，我们通过临床访谈和评估躁狂和抑郁症状（YMRS、HDRS-17）、临床状态（CGI-BP-M）、心理社会功能（FAST）、性功能障碍（PRSexDQ）以及与辅助使用阿塞那平或其他辅助抗精神病药物相关的治疗费用，进行了前瞻性和回顾性的数据收集和分析。
共纳入了来自不同大学医院的 152 名患者。53 名患者接受了辅助阿塞那平治疗，99 名患者在接受心境稳定剂治疗的同时接受了其他辅助抗精神病药物治疗。对于住院患者，辅助使用阿塞那平治疗的患者躁狂发作明显较轻（P=0.001），精神病症状较轻（P=0.030），共病人格障碍较多（P=0.002）。对于门诊患者，辅助使用阿塞那平治疗的患者躁狂发作明显较轻（P=0.046），过去混合发作较多（P=0.013），基线时性功能障碍较多（P=0.036）。每天的总费用无显著差异。
临床医生倾向于在症状较轻但临床情况较复杂的患者中使用辅助阿塞那平，包括过去有更多混合发作、共病人格障碍和性功能问题的患者。与其他选择相比，辅助使用阿塞那平治疗并不与更高的成本相关。
