背景:阿塞奈平具有独特的口服相关副作用,如舌下给药引起的苦味,这通常会导致停药。虽然FDA已经批准了黑樱桃味的阿塞那平,几个国家只规定了无味版本。具体来说,亚洲人通常报告经历阿塞那平的苦味,因为他们比其他种族对苦味更敏感。在这项研究中,目的是通过减少阿塞那平的苦味来提高依从性,我们研究了D-山梨醇的作用,在我们先前对精神分裂症患者中阿塞那平的苦味和连续性的基础研究中,降低了味觉传感器的苦味参数。
方法:本研究纳入20例成年精神分裂症患者,安慰剂对照,交叉试验。参与者在每次服用阿塞那平之前,用D-山梨糖醇或安慰剂单次给药冲洗口腔。然后,我们进行了问卷调查,并评估了阿塞那平苦味的变化(主要终点)和继续使用阿塞那平的意愿(次要终点)。
结果:D-山梨醇显著改善了阿塞那平的苦味(p=0.038)。尽管它没有显着增加继续阿塞那平的意愿(p=0.180),它确实显示出在增强继续的意愿方面比安慰剂有所改善,尤其是那些不习惯它味道的病人。
结论:我们的研究结果表明,D-山梨糖醇的单次给药可显著降低阿塞那平的苦味。在没有加味阿塞那平的国家,这一发现可以使不习惯其苦味的患者受益。
背景:本研究于2021年5月14日在日本临床试验注册中心(jRCTs041210019)注册。
BACKGROUND: Asenapine has unique orally-related side effects, such as a bitter taste induced by sublingual administration, which often results in discontinuation of the medication. While the FDA has approved black-cherry-flavored
asenapine, several countries have prescribed only unflavored versions. Specifically, Asians commonly report experiencing the bitterness of asenapine because they are more sensitive to bitter tastes than other ethnic groups. In this study, with the aim of improving adherence by reducing the bitterness of asenapine, we investigated the effects of D-sorbitol, which reduced the bitterness parameters of taste sensors in our previous basic study on the bitterness and continuity of asenapine among patients with schizophrenia.
METHODS: Twenty adult patients with schizophrenia were included in this single-blind, placebo-controlled, crossover trial. Participants rinsed their mouths with single-administration of D-sorbitol or a placebo prior to each administration of asenapine. We then conducted the questionnaires and assessed changes in the bitterness of
asenapine (primary end point) and willingness to continue its use (secondary end point).
RESULTS: D-sorbitol significantly improved the bitterness of
asenapine (p = 0.038). Although it did not significantly increase the willingness to continue
asenapine (p = 0.180), it did show improvement over the placebo in enhancing willingness to continue, especially in patients who were not accustomed to its taste.
CONCLUSIONS: Our findings indicate that single-administration of D-sorbitol significantly reduces the bitterness of asenapine. In countries where flavored asenapine is not available, this finding could benefit patients who were not accustomed to its bitter taste.
BACKGROUND: This study was registered in the Japan Registry of Clinical Trials (jRCTs041210019) on May 14, 2021.