Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.
Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial.
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DOI：
10.1001/jama.2014.4310
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发表时间：
2014-05-21
影响因子：
120.7
通讯作者：
Stroup, T. Scott
中科院分区：
文献类型：
--
作者：
McEvoy, Joseph P.;Byerly, Matthew;Hamer, Robert M.;Dominik, Rosalie;Swartz, Marvin S.;Rosenheck, Robert A.;Ray, Neepa;Lamberti, J. Steven;Buckley, Peter F.;Wilkins, Tania M.;Stroup, T. Scott
长效注射（LAI）抗精神病药用于减少精神分裂症谱系障碍的药物不依从性和随后的复发。尚未评估LAI版本的第二代（非典型）和较老抗精神病药的相对有效性。比较第二代LAI抗精神病药棕榈酸帕利哌酮（PP）与较老的LAI抗精神病药氟哌啶醇癸酸酯（HD）的有效性。在美国22个临床研究中心进行的多中心、双盲、随机临床试验。311例随机患者（PP=157，HD=154）是诊断为精神分裂症或情感性精神障碍的成人，临床评估为有复发风险，可能从LAI抗精神病药物中获益。每月肌肉注射HD 25-200 mg或PP 39-234 mg，持续24个月。疗效失败，反映了研究药物对精神病理学控制不充分，由设盲裁定委员会确定。关键次要结局是抗精神病药物的常见不良反应。PP组与HD组的疗效失败率无统计学显著差异（校正风险比0.98，95%置信区间[CI] 0.65-1.47）。平均而言，PP组患者体重增加，HD组患者体重减轻; 6个月后，PP组的最小二乘平均体重变化为+2.17 kg（1.25至3.09），HD组为-0.96 kg（-1.88至-0.04）。服用PP的患者血清催乳素显著增加（男性34.56 µg/L（29.75至39.37）vs. 15.41（10.73至20.08），p<0.001;女性75.19（63.03至87.36）vs. 26.84（13.29至40.40），p<0.001）。接受HD治疗的患者静坐不能的总体评分增幅显著更大（0.73 [0.59至0.87] vs. 0.45 [0.31至0.59]，p=0.006）。在精神分裂症或情感性精神障碍成人患者中，棕榈酸帕利哌酮与癸酸氟哌啶醇治疗相比，在疗效失败方面没有统计学显著差异，但与体重增加更多和血清催乳素增加更多相关，而氟哌啶醇与静坐不能更多相关。然而，基于95%置信限，不能排除治疗之间疗效失败的临床有意义的差异。clinicaltrials.gov标识符NCT 01136772
Long-acting injectable (LAI) antipsychotics are used to reduce medication non-adherence and subsequent relapse in schizophrenia-spectrum disorders. The relative effectiveness of LAI versions of second-generation (atypical) and older antipsychotics has not been assessed. To compare the effectiveness of the second-generation LAI antipsychotic paliperidone palmitate (PP) to the older LAI antipsychotic haloperidol decanoate (HD). Multisite, double-blind, randomized clinical trial conducted at 22 clinical research sites in the U.S. The 311 randomized patients (PP=157, HD=154) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a LAI antipsychotic. Intramuscular injections of HD 25–200 mg or PP 39–234 mg every month for up to 24 months. Efficacy failure, which reflected inadequate control of psychopathology by the study medication, as determined by a blinded adjudication committee. Key secondary outcomes were common adverse effects of antipsychotic medications. There was no statistically significant difference in the rate of efficacy failure for PP compared to HD (adjusted hazard ratio 0.98, 95% confidence interval [CI] 0.65–1.47). On average, patients on PP gained and those on HD lost weight; after six months the least squares mean weight change on PP was +2.17 kg (1.25 to 3.09) and on HD was −0.96 kg (−1.88 to −0.04). Patients taking PP had significantly greater increases in serum prolactin (men 34.56 µg/L (29.75 to 39.37) vs. 15.41 (10.73 to 20.08), p<0.001; women 75.19 (63.03 to 87.36) vs. 26.84 (13.29 to 40.40), p<0.001). Patients taking HD had significantly larger increases in global ratings of akathisia (0.73 [0.59 to 0.87] vs. 0.45 [0.31 to 0.59], p=0.006). Among adults with schizophrenia or schizoaffective disorder, treatment with paliperidone palmitate compared with haloperidol decanoate did not result in a statistically significant difference in efficacy failure, but was associated with more weight gain and greater increases in serum prolactin, whereas haloperidol was associated with more akathisia. However, based on the 95% confidence limits, a clinically meaningful difference in efficacy failure between treatments cannot be ruled out. clinicaltrials.gov identifier NCT01136772
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DOI：
10.1097/nmd.0000000000000065
发表时间：
2014-01
期刊：
The Journal of nervous and mental disease
影响因子：
--
作者：
Rosenheck R;Lin H
通讯作者：
Lin H
影响因子：
158.5
作者：
Csernansky, JG;Mahmoud, R;Brenner, R
通讯作者：
Brenner, R
影响因子：
168.9
作者：
Leucht, Stefan;Corves, Caroline;Davis, John M.
通讯作者：
Davis, John M.
影响因子：
158.5
作者：
Rosenheck, Robert A.;Krystal, John H.;Liang, Matthew H.
通讯作者：
Liang, Matthew H.
影响因子：
4.5
作者：
Goff, DC;Sullivan, LM;Lieberman, JA
通讯作者：
Lieberman, JA