Asenapine Versus Olanzapine in People With Persistent Negative Symptoms of Schizophrenia

被引:47
作者
Buchanan, Robert W. [1 ]
Panagides, John [2 ]
Zhao, Jun [3 ]
Phiri, Phillip [3 ]
den Hollander, Wil [3 ]
Ha, Xianwei [3 ]
Kouassi, Alex [3 ]
Alphs, Larry [4 ,6 ]
Schooler, Nina [5 ]
Szegedi, Armin [3 ]
Cazorla, Pilar [3 ]
机构
[1] Univ Maryland, Sch Med, Dept Psychiat, Baltimore, MD 21201 USA
[2] Merck, Schering Plough, Summit, NJ USA
[3] Merck, Rahway, NJ USA
[4] Pfizer Global R&D, Ann Arbor, MI USA
[5] Suny Downstate Med Ctr, Brooklyn, NY 11203 USA
[6] Pfizer Inc, New York, NY USA
关键词
asenapine; NSA-16; olanzapine; persistent negative symptoms; schizophrenia; DOUBLE-BLIND; CONSENSUS STATEMENT; CLINICAL-TRIAL; PLACEBO; RISPERIDONE; EFFICACY; DEFICIT; AMISULPRIDE; SCALE; HALOPERIDOL;
D O I
10.1097/JCP.0b013e31823f880a
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Two randomized, double-blind, 26-week core studies (Eastern [EH] and Western Hemisphere [WH]) tested the hypothesis that asenapine is superior to olanzapine for persistent negative symptoms of schizophrenia; 26-week extension studies assessed the comparative long-term efficacy and safety of these agents. In the core studies, 949 people were randomized to asenapine (n = 241 and 244) or olanzapine (n = 240 and 224); 26-week completion rates with asenapine were 64.7% and 49.6% (olanzapine, 80.4% and 63.8%) in the EH and WH, respectively. In the EH and WH extensions, respectively (asenapine, n = 134 and 86; olanzapine, n = 172 and 110), 52-week completion rates were 84.3% and 66.3% with asenapine (olanzapine, 89.0% and 80.9%). Asenapine was not superior to olanzapine in change in the 16-item Negative Symptom Assessment Scale total score in either core study, but asenapine was superior to olanzapine at week 52 in the WH extension study. Olanzapine was associated with modest, but significantly greater, changes in PANSS positive subscale score at various assessment times in both core studies and the WH extension study. Incidence of treatment-emergent adverse events was comparable between treatments across studies. Weight gain was consistently lower with asenapine. Extrapyramidal symptom-related adverse event incidence was higher with asenapine (EH: 8.3%; 95% confidence interval [CI], 5.1%-12.5%; WH: 16.4%; 95% CI, 11.9%-21.6%) than olanzapine (EH: 3.3%; 95% CI, 1.4%-6.4%; WH: 12.1%; 95% CI, 8.1%-17.0%), but Extrapyramidal Symptom Rating Scale-Abbreviated total score changes did not significantly differ between treatments. In conclusion, asenapine superiority over olanzapine was not observed in the core studies. Both treatments improved persistent negative symptoms, but discontinuation rates were higher with asenapine.
引用
收藏
页码:36 / 45
页数:10
相关论文
共 33 条
  • [11] Modification of sample size in group sequential clinical trials
    Cui, L
    Hung, HMJ
    Wang, SJ
    [J]. BIOMETRICS, 1999, 55 (03) : 853 - 857
  • [12] Danion JM, 1999, AM J PSYCHIAT, V156, P610
  • [13] Guy W., 1976, ECDEU Assessment Manual for Psychopharmacology, V76, P217
  • [14] THE QUALITY OF LIFE SCALE - AN INSTRUMENT FOR RATING THE SCHIZOPHRENIC DEFICIT SYNDROME
    HEINRICHS, DW
    HANLON, TE
    CARPENTER, WT
    [J]. SCHIZOPHRENIA BULLETIN, 1984, 10 (03) : 388 - 398
  • [15] Schizophrenia and increased risks of cardiovascular disease
    Hennekens, CH
    Hennekens, AR
    Hollar, D
    Casey, DE
    [J]. AMERICAN HEART JOURNAL, 2005, 150 (06) : 1115 - 1121
  • [16] Commentary: Consensus statement on negative symptoms
    Kane, J
    [J]. SCHIZOPHRENIA BULLETIN, 2006, 32 (02) : 223 - 224
  • [17] THE POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) FOR SCHIZOPHRENIA
    KAY, SR
    FISZBEIN, A
    OPLER, LA
    [J]. SCHIZOPHRENIA BULLETIN, 1987, 13 (02) : 261 - 276
  • [18] A separate disease within the syndrome of schizophrenia
    Kirkpatrick, B
    Buchanan, RW
    Ross, DE
    Carpenter, WT
    [J]. ARCHIVES OF GENERAL PSYCHIATRY, 2001, 58 (02) : 165 - 171
  • [19] The NIMH-MATRICS consensus statement on negative symptoms
    Kirkpatrick, B
    Fenton, WS
    Carpenter, WT
    Marder, SR
    [J]. SCHIZOPHRENIA BULLETIN, 2006, 32 (02) : 214 - 219
  • [20] Differential efficacy of olanzapine for deficit and nondeficit negative symptoms in schizophrenia
    Kopelowicz, A
    Zarate, R
    Tripodis, K
    Gonzalez, V
    Mintz, J
    [J]. AMERICAN JOURNAL OF PSYCHIATRY, 2000, 157 (06) : 987 - 993