Prevalence, associated causes, and explanatory variables of non-adherence of generic imatinib in chronic myeloid leukemia

J. Estrada-Acevedo, Juliana Madrigal-Cadavid, Alejandra Rendon-Montoya, C. A. Gómez-Mercado, Erika Alejandra Giraldo-Gallo, Dorys Cardona-Arango, Á. Segura-Cardona
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Abstract

Introduction: Imatinib has become the standard first-line therapy CML in chronic accelerated and blastic phases and has demonstrated hematologic, cytogenetic, and molecular response rates of over 90%. The non-adherence represents one of the main reasons for not achieving therapeutic success, increased disease progression, risk of resistance, and higher mortality rates. Although drug adherence to imatinib has been analyzed in several studies, its prevalence and associated causes are widely variable. Objective: To determine the prevalence of non-adherence of generic imatinib in chronic myeloid leukemia, associated causes, the proportion of patients who improve this non-compliance, and its explanatory variables. Methods: A retrospective observational cross-sectional analytical study was performed on patients with Chronic Myeloid Leukemia regarding treatment with imatinib generic brand, dispensed by a health institution between August 2018 and December 2022. Drug adherence status was defined as the dependent variable and sociodemographic, clinical, and pharmacological variables as independent variables. The information was extracted from a database of pharmacotherapeutic follow-ups performed on patients automatically identified through algorithms as non-adherent. Pharmacists contacted the patient to intervene and improve this compliance. Univariate, bivariate, and multivariate analysis was performed. Results: A total of 315 patients were analyzed, with a mean age of 52±17 years, median treatment time of 250 days [RIC 97-362], 11% were polymedicated and 16.8% were multimorbid; 30.5% were non-adherent. The associated causes were lack of specialist appointment (39.6%), delay in authorization by the insurer (31.9%) and not having a current medical prescription (5.5%). Of the non-adherent patients, 86% had a history of pharmacological non-adherence and 61% of non-timely claims. After the pharmacist’s intervention, 80% improved this inadequate compliance. During the bivariate analysis, the variables age, time on treatment, and having a history of non-adherence were found to be significant, which, in the multivariate model, behaved as risks with statistical significance. When adjusting the model for the other variables, although they continued to behave as risks, only the variable of a history of non-adherence remained statistically significant. Conclusion: The prevalence of non-adherence is higher than that reported in the literature, the associated causes are mainly administrative, and the persons at greater risk of presenting this health outcome are those with greater age, less time in treatment, and those with a history of non-adherence to other medications.
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慢性髓性白血病患者不坚持使用普通伊马替尼的普遍性、相关原因和解释变量
简介伊马替尼已成为慢性骨髓增生性白血病(CML)慢性加速期和白血病期的标准一线疗法,其血液学、细胞遗传学和分子反应率超过90%。不依从性是导致治疗失败、疾病进展加剧、耐药风险和死亡率升高的主要原因之一。虽然已有多项研究对伊马替尼的服药依从性进行了分析,但其发生率和相关原因却千差万别。研究目的确定慢性髓性白血病患者非专利伊马替尼不依从性的发生率、相关原因、改善这种不依从性的患者比例及其解释变量。研究方法对某医疗机构在2018年8月至2022年12月期间配发的慢性粒细胞白血病患者进行了一项关于伊马替尼仿制药治疗的回顾性观察横断面分析研究。药物依从性状况被定义为因变量,社会人口学、临床和药理学变量被定义为自变量。这些信息是从一个数据库中提取的,该数据库对通过算法自动识别为不依从的患者进行了药物治疗随访。药剂师与患者取得联系,对其进行干预,以提高其依从性。研究进行了单变量、双变量和多变量分析。结果:共分析了 315 名患者,平均年龄为(52±17)岁,中位治疗时间为 250 天[RIC 97-362],11% 的患者服用多种药物,16.8% 的患者患有多种疾病;30.5% 的患者未依从治疗。相关原因是没有预约专科医生(39.6%)、保险公司延迟授权(31.9%)和没有当前的医疗处方(5.5%)。在不按时服药的患者中,86% 有不按时服药的历史,61% 有不按时报销的历史。在药剂师的干预下,80% 的患者改善了不依从性。在双变量分析中,年龄、接受治疗时间和有不依从史等变量被认为具有显著性,在多变量模型中,这些变量表现为具有统计学意义的风险。在根据其他变量对模型进行调整后,虽然这些变量仍然具有风险性,但只有有不坚持治疗史这一变量仍具有统计学意义。结论不按时服药的发生率高于文献报道的发生率,相关原因主要是行政管理,出现这种健康结果的风险较大的人群是那些年龄较大、接受治疗时间较短以及有不按时服用其他药物史的人群。
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