Marie Gavioli Elizabeth, Burger Alfred, Gamaleldin Aia, Eladghm Nourhan, Vider Etty
Arnold & Marie Schwartz College of Pharmacy and Health Sciences, 1 University Plaza, Brooklyn, NY, 11201, USA.
Department of Pharmacy, Mount Sinai Beth Israel, New York, NY, USA.
Support Care Cancer. 2022 Jul;30(7):6299-6305. doi: 10.1007/s00520-022-07081-8. Epub 2022 Apr 26.
Anorexia and weight loss are common complications in the elderly, advanced cancer population. Appetite stimulants are commonly used therapies for oncology patients with weight loss, yet their safety comparison remains unknown.
This was a two-center, retrospective, study conducted in New York City at Mount Sinai Beth Israel and New York University Langone from January 2016 to July 2019 in adult patients with histologic evidence of malignancy who were taking either megestrol acetate or mirtazapine as an appetite-stimulating medication. Endpoints included safety concerns of mortality, QTc prolongation, venous thromboembolism, fall, somnolence, xerostomia, and hallucinations. Effectiveness of weight gain or maintenance of weight was not assessed. A propensity score-matching analysis was performed using a logistic regression analysis to assess the two comparable groups.
The study included 350 patients (69.56 ± 13.31 years) with the most common malignancies being gastrointestinal, breast, and hematologic with metastasis present in over half the patients. Adverse events were commonly seen in the oncology population. After a propensity score-matched analysis, all safety outcomes associated with mirtazapine compared to megestrol acetate were similar; all-cause mortality (7%, n = 7 vs. 12%, n = 12, p = 0.23), QTc prolongation (31%, n = 31 vs. 31%, n = 31, p = 1.00), thromboembolism (11%, n = 11 vs. 11%, n = 11, p = 1.00), somnolence (29%, n = 30 vs. 22%, n = 23, p = 0.34), xerostomia (27%, n = 28 vs. 18%, n = 19, p = 0.24), and hallucinations (17%, n = 18 vs. 8%, n = 8, p = 0.06), respectfully.
There were no safety differences seen when evaluating both agents.
厌食和体重减轻是老年晚期癌症患者常见的并发症。食欲刺激剂是治疗癌症体重减轻患者常用的疗法,但其安全性比较尚不清楚。
这是一项在纽约市西奈山贝斯以色列医院和纽约大学朗格尼医学中心进行的双中心回顾性研究,研究对象为2016年1月至2019年7月期间有组织学恶性证据且正在服用醋酸甲地孕酮或米氮平作为食欲刺激药物的成年患者。终点包括死亡率、QTc延长、静脉血栓栓塞、跌倒、嗜睡、口干和幻觉等安全性问题。未评估体重增加或维持体重的有效性。使用逻辑回归分析进行倾向评分匹配分析,以评估两个可比组。
该研究纳入了350名患者(69.56±13.31岁),最常见的恶性肿瘤为胃肠道、乳腺和血液系统肿瘤,超过半数患者有转移。不良事件在肿瘤患者中很常见。经过倾向评分匹配分析,与醋酸甲地孕酮相比,米氮平相关的所有安全性结果相似;全因死亡率(7%,n = 7 vs. 12%,n = 12,p = 0.23)、QTc延长(31%,n = 31 vs. 31%,n = 31,p = 1.00)、血栓栓塞(11%,n = 11 vs. 11%,n = 11,p = 1.00)、嗜睡(29%,n = 30 vs. 22%,n = 23,p = 0.34)、口干(27%,n = 28 vs. 18%,n = 19,p = 0.24)和幻觉(17%,n = 18 vs. 8%,n = 8,p = 0.06)。
评估这两种药物时未发现安全性差异。