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首页> 外文期刊>Schizophrenia research >Effect of ziprasidone dose on all-cause discontinuation rates in acute schizophrenia and schizoaffective disorder: a post-hoc analysis of 4 fixed-dose randomized clinical trials.
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Effect of ziprasidone dose on all-cause discontinuation rates in acute schizophrenia and schizoaffective disorder: a post-hoc analysis of 4 fixed-dose randomized clinical trials.

机译：齐拉西酮剂量对急性精神分裂症和精神分裂症患者全因停药率的影响：对4项固定剂量随机临床试验的事后分析。

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BACKGROUND: Higher dose ziprasidone has been associated with improved treatment outcomes in patients with schizophrenia or schizoaffective disorder. This study examines the relationship of ziprasidone dose and all-cause discontinuation in randomized clinical trials in patients with an acute exacerbation of schizophrenia or schizoaffective disorder. METHOD: Data were analyzed for the first 28 days from 4 pivotal, randomized, double-blind, fixed-dose ziprasidone trials. Patients in these trials had a DSM-IV diagnosis of schizophrenia or schizoaffective disorder where ziprasidone was administered twice daily with food. Data were analyzed to examine the association between ziprasidone dose and all-cause discontinuation due to lack of efficacy, adverse events, or because of other reasons, relative to placebo. Differences in discontinuation were evaluated using Cox proportional hazard models and number needed to treat (NNT). RESULTS: All-cause discontinuation for ziprasidone ranged from a low of 26.9% for the 160 mg/d dose group, to 40.9% for the 40 mg/d and 45.5% for the 80 mg/d groups, compared with 49.5% for placebo. The NNTs for avoiding 1 additional all-cause discontinuation compared with placebo were 12 (40 mg/d; n=186), 25 (80 mg/d; n=154), 9 (120 mg/d; n=125), and 4 (160 mg/d; n=104). The 120 mg/d and 160 mg/d groups were the only ziprasidone regimens associated with significantly lower all-cause discontinuation rates versus placebo in both the survival analysis (p=0.031 and <0.0001, respectively) and in examination of the NNT. The 160 mg/d group was associated with lower all-cause discontinuation rates versus lower-dose ziprasidone regimens (p=0.0158 for versus 40 mg/d, p=0.002 for versus 80 mg/d). Efficacy accounted for 51% of all medication discontinuations across ziprasidone groups, compared with 62% for placebo. Findings for overall discontinuation due to lack of efficacy are consistent with results for all-cause discontinuation. CONCLUSIONS: Consistent with previous reports, higher doses of ziprasidone (120-160 mg/d, dosed twice daily with meals) are associated with significantly lower all-cause discontinuation rates and more favorable NNTs versus placebo. This was primarily driven by lower rates of discontinuation due to lack of efficacy.
机译：背景：精神分裂症或精神分裂症患者的高剂量齐拉西酮治疗效果改善。这项研究在患有精神分裂症或精神分裂症的急性加重患者的随机临床试验中研究了齐拉西酮剂量与全因停药的关系。方法：分析了4项关键，随机，双盲，固定剂量的ziprasidone试验的前28天的数据。这些试验的患者通过DSM-IV诊断为精神分裂症或精神分裂症，其中每天两次与食物一起服用齐拉西酮。分析数据以检查相对于安慰剂而言，由于缺乏功效，不良事件或由于其他原因，齐拉西酮剂量与全因停药之间的关联。使用Cox比例风险模型和需要治疗的人数（NNT）评估停药的差异。结果：齐拉西酮的全因停药范围从160 mg / d剂量组的26.9％的低点到40 mg / d和80 mg / d组的40.9％的低点，而安慰剂的49.5％ 。与安慰剂相比，避免1种额外的全因停药的NNT为12（40 mg / d; n = 186），25（80 mg / d; n = 154），9（120 mg / d; n = 125），和4（160mg / d; n ＝ 104）。在生存率分析（分别为p = 0.031和<0.0001）和NNT检查中，120 mg / d和160 mg / d的组是唯一的齐拉西酮方案，与安慰剂相比，所有原因的联用率均显着降低。与较低剂量的齐拉西酮方案相比，160 mg / d组的全因停药率较低（p = 0.0158 vs 40 mg / d，p = 0.002 vs 80 mg / d）。齐拉西酮治疗组中，所有药物停用的有效性占51％，而安慰剂组的这一比例为62％。因缺乏疗效而导致整体停药的结果与全因停药的结果一致。结论：与以前的报道一致，与安慰剂相比，更高剂量的齐拉西酮（120-160 mg / d，每天两次，随餐服用）与更低的全因停药率和更有利的NNTs相关。这主要是由于缺乏功效而降低了停药率。

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