PDF(Pubmed)
Abstract：
BACKGROUND: Bexarotene, which has been approved for use in Japan since 2016, is an effective drug for cutaneous T-cell lymphoma; however, careful management is imperative because of its adverse events. We previously demonstrated the severity of bexarotene-associated hypertriglyceridemia and the need for bexarotene dose reduction for patients with cutaneous T-cell lymphoma and high body mass index (BMI); however, high BMI does not affect the efficacy of combined bexarotene and phototherapy treatment.
OBJECTIVE: This study aimed to verify the effects of BMI on hypertriglyceridemia associated with oral bexarotene therapy.
METHODS: We conducted a post hoc analysis of data from a previous randomized, open-label clinical study that compared combined bexarotene-phototherapy treatment with bexarotene monotherapy for cutaneous T-cell lymphoma by dividing patients into two groups based on BMI (<23 kg/m2 and ≥23 kg/m2).
RESULTS: No statistically significant association was observed between patients with BMI ≥23 kg/m2 and severe hypertriglyceridemia; however, there was a significant association between BMI ≥23 kg/m2 and severe hypertriglyceridemia for patients who received bexarotene monotherapy, but not for those who received combined bexarotene-phototherapy treatment. The exact reasons for the discrepancies between the results of this thorough analysis and those of our past research are unclear. However, high BMI may be a risk factor for hypertriglyceridemia. Additional unidentified risk factors could also affect treatment outcomes.
CONCLUSIONS: High BMI is the primary reason for hypertriglyceridemia-associated bexarotene dose reduction; however, unexplored risk factors other than high BMI could exist.
OBJECTIVE: This study aimed to verify the effects of BMI on hypertriglyceridemia associated with oral bexarotene therapy.
METHODS: We conducted a post hoc analysis of data from a previous randomized, open-label clinical study that compared combined bexarotene-phototherapy treatment with bexarotene monotherapy for cutaneous T-cell lymphoma by dividing patients into two groups based on BMI (<23 kg/m2 and ≥23 kg/m2).
RESULTS: No statistically significant association was observed between patients with BMI ≥23 kg/m2 and severe hypertriglyceridemia; however, there was a significant association between BMI ≥23 kg/m2 and severe hypertriglyceridemia for patients who received bexarotene monotherapy, but not for those who received combined bexarotene-phototherapy treatment. The exact reasons for the discrepancies between the results of this thorough analysis and those of our past research are unclear. However, high BMI may be a risk factor for hypertriglyceridemia. Additional unidentified risk factors could also affect treatment outcomes.
CONCLUSIONS: High BMI is the primary reason for hypertriglyceridemia-associated bexarotene dose reduction; however, unexplored risk factors other than high BMI could exist.
摘要：
背景：贝沙罗汀，自2016年以来已在日本批准使用，是治疗皮肤T细胞淋巴瘤的有效药物;然而，谨慎的管理是必要的，因为它的不良事件。我们以前证明了皮肤T细胞淋巴瘤和高体重指数（BMI）患者与贝沙罗汀相关的高甘油三酯血症的严重程度和需要减少贝沙罗汀剂量；然而，高BMI不影响贝沙罗汀和光疗联合治疗的疗效。
目的：本研究旨在验证BMI对口服贝沙罗汀治疗相关高甘油三酯血症的影响。
方法：我们对之前的随机数据进行了事后分析，一项开放性临床研究,通过根据BMI(<23kg/m2和≥23kg/m2)将患者分为两组,比较贝沙罗汀光疗联合贝沙罗汀治疗皮肤T细胞淋巴瘤。
结果：BMI≥23kg/m2的患者与严重的高甘油三酯血症之间没有统计学上的显著关联；然而，在接受贝沙罗汀单药治疗的患者中,BMI≥23kg/m2与重度高甘油三酯血症之间存在显著关联,但不适用于接受贝沙罗汀联合光疗治疗的人。这项彻底分析的结果与我们过去的研究结果之间存在差异的确切原因尚不清楚。然而,高BMI可能是高甘油三酯血症的危险因素.其他未知的风险因素也可能影响治疗结果。
结论：高BMI是高甘油三酯血症相关贝沙罗汀剂量减少的主要原因；然而，可能存在高BMI以外的未探索危险因素.
目的：本研究旨在验证BMI对口服贝沙罗汀治疗相关高甘油三酯血症的影响。
方法：我们对之前的随机数据进行了事后分析，一项开放性临床研究,通过根据BMI(<23kg/m2和≥23kg/m2)将患者分为两组,比较贝沙罗汀光疗联合贝沙罗汀治疗皮肤T细胞淋巴瘤。
结果：BMI≥23kg/m2的患者与严重的高甘油三酯血症之间没有统计学上的显著关联；然而，在接受贝沙罗汀单药治疗的患者中,BMI≥23kg/m2与重度高甘油三酯血症之间存在显著关联,但不适用于接受贝沙罗汀联合光疗治疗的人。这项彻底分析的结果与我们过去的研究结果之间存在差异的确切原因尚不清楚。然而,高BMI可能是高甘油三酯血症的危险因素.其他未知的风险因素也可能影响治疗结果。
结论：高BMI是高甘油三酯血症相关贝沙罗汀剂量减少的主要原因；然而，可能存在高BMI以外的未探索危险因素.
