Weiden Peter J, Schooler Nina R, Weedon Jeremy C, Elmouchtari Abdel, Sunakawa Ayako, Goldfinger Stephen M
Center for Cognitive Medicine, Department of Psychiatry, University of Illinois, Chicago, IL 60612, USA.
J Clin Psychiatry. 2009 Oct;70(10):1397-406. doi: 10.4088/JCP.09m05284yel.
Nonadherence for first-episode schizophrenia is a major unsolved challenge. The long-acting injectable route is an appealing strategy, but there are concerns about acceptability. We report on acceptance and initial adherence outcomes with risperidone long-acting injection (RLAI) in first-episode schizophrenia patients.
We conducted a prospective randomized controlled trial in which we enrolled patients defined by appropriate Structured Clinical Interview for DSM-IV diagnosis and < or = 16 weeks of lifetime antipsychotic exposure. Participants were randomly assigned (2:1 ratio) to a recommendation of changing to RLAI versus continuing on oral therapy (ORAL). Nonadherence behavior was defined as a medication gap > or = 14 days. Adherence attitudes were determined by the Rating of Medication Influences (ROMI) scale. A priori analysis defined treatment groups as intent-to-treat (ITT) and as-actually-treated (AAT) for the first 12 weeks after initial randomization. Participants were enrolled from December 2004 to March 2007.
Of 46 eligible patients, 37 were randomly assigned, 11 to ORAL and 26 to RLAI. Nineteen of 26 patients (73%) accepted the RLAI recommendation. There were no differences in adherence behavior at 12 weeks based on initial randomization (Kaplan-Meier survival for ITT: 76% [95% CI, 35%-90%] adherent for RLAI vs 72% [95% CI, 55%-89%] for ORAL; log-rank P = .78), but patients accepting RLAI were significantly more likely to be adherent than patients staying on ORAL (AAT: 89% [95% CI, 64%-97%] adherent for RLAI vs 59% [95% CI, 32%-78%] for ORAL; log-rank P = .035). There were no ROMI attitude differences between either treatment group comparison at 12 weeks.
Most first-episode patients taking oral antipsychotics will accept a recommendation of RLAI therapy. On the basis of initial randomization status, an RLAI recommendation did not affect adherence behavior at 12 weeks. However, acceptance of RLAI was associated with significantly better adherence. Regardless of whether RLAI is recommended or accepted, there is no adverse impact on subsequent medication attitudes at 12 weeks. These results support the feasibility and acceptability of introducing RLAI as a treatment option for first-episode schizophrenia patients.
clinicaltrials.gov Identifier: NCT00220714.
首发精神分裂症患者的治疗依从性不佳是一个尚未解决的主要挑战。长效注射途径是一种有吸引力的策略，但人们对其可接受性存在担忧。我们报告了首发精神分裂症患者接受利培酮长效注射剂（RLAI）治疗的接受度和初始依从性结果。
我们进行了一项前瞻性随机对照试验，纳入了通过适当的DSM-IV结构化临床访谈确诊且终生抗精神病药物暴露时间≤16周的患者。参与者被随机分配（2:1比例）接受改用RLAI的建议或继续口服治疗（ORAL）。不依从行为定义为用药间隔≥14天。依从态度由药物影响评分（ROMI）量表确定。预先分析将治疗组定义为初始随机分组后前12周的意向性治疗（ITT）组和实际治疗（AAT）组。参与者于2004年12月至2007年3月入组。
46名符合条件的患者中，37名被随机分配，11名接受ORAL治疗，26名接受RLAI治疗。26名患者中有19名（73%）接受了RLAI治疗建议。基于初始随机分组，12周时的依从行为无差异（ITT的Kaplan-Meier生存率：RLAI组为76%[95%CI，35%-90%]，ORAL组为72%[95%CI，55%-89%]；对数秩检验P = 0.78），但接受RLAI治疗的患者比继续接受ORAL治疗的患者更有可能坚持治疗（AAT：RLAI组为89%[95%CI，64%-97%]，ORAL组为59%[95%CI，32%-78%]；对数秩检验P = 0.035）。12周时，两个治疗组之间的ROMI态度无差异。
大多数服用口服抗精神病药物的首发患者会接受RLAI治疗建议。基于初始随机分组状态，RLAI治疗建议在12周时不影响依从行为。然而，接受RLAI治疗与显著更好的依从性相关。无论RLAI是被推荐还是被接受，在12周时对后续用药态度均无不利影响。这些结果支持将RLAI作为首发精神分裂症患者的一种治疗选择的可行性和可接受性。
clinicaltrials.gov标识符：NCT00220714。
