Evaluating the Potential of Prevalent New User Design as an Alternative When New User Design is Impractical.

IF 2.7 Q2 MEDICINE, GENERAL & INTERNAL

Pragmatic and Observational Research Pub Date : 2025-07-31 eCollection Date: 2025-01-01 DOI:10.2147/POR.S517514

Takuma Koinuma, Manabu Akazawa

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Abstract

Purpose: The New User Design can be applied if the target drug has not been administered for a specified period. Therefore, comparisons between drugs administered alone are easier to undertake than comparisons of drugs used in combination. Thus, assessing concomitant medications may be associated with several challenges, including limitations to the New User Design. One such limitation is performing analyses that consider the history of administration of drugs of the same class. In the present study, we considered the limitations of the New User Design and proposed solutions based on the potential of the Prevalent New User Design.

Patients and methods: Using the Japan Medical Data Center database (JMDC), patients diagnosed with diabetes mellitus who received sulfonylureas (SUs) between December 2009 and December 2010 with subsequent addition or switch to dipeptidyl peptidase-4 inhibitors (DPP4Is) were categorized into the SU+DPP4I group. The odds ratio (OR) was estimated using conditional logistic regression analysis. Using the "elapsed time" and "number of prescriptions" axes of the Prevalent New User Design, records from 1,426 and 1,342 individuals, respectively, were analyzed.

Results: The hypoglycemia risk ORs were 1.50 (95% confidence interval [CI] 0.25-9.00) for the "elapsed time" axis and 1.67 (95% CI 0.40-7.00) for the "number of prescriptions" axis. These findings are consistent with the results of a meta-analysis of previous randomized controlled trials.

Conclusion: Our findings suggest that the Prevalent New User Design can be effectively applied for real-world risk assessment scenarios; this design constitutes a potential alternative design to the New User Design. We adopted a Prevalent New User Design considering the patients' treatment history. However, there was a limitation in that we could not obtain information regarding the patients' perceptions of treatment prior to initiating therapy.

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当新用户设计不切实际时，评估流行新用户设计作为替代方案的潜力。

目的：如果目标药物在规定的时间内未给药，则可以申请新用户设计。因此，单独用药的比较比联合用药的比较更容易进行。因此，评估伴随用药可能会带来一些挑战，包括新用户设计的局限性。其中一个限制是进行分析时要考虑同类药物的用药史。在本研究中，我们考虑了新用户设计的局限性，并根据流行新用户设计的潜力提出了解决方案。患者和方法：使用日本医疗数据中心数据库（JMDC），将2009年12月至2010年12月期间接受磺脲类药物（SUs）治疗并随后添加或切换到二肽基肽酶-4抑制剂（DPP4Is）的糖尿病患者分为SU+DPP4I组。比值比（OR）采用条件logistic回归分析估计。使用流行新用户设计的“经过时间”和“处方数量”轴，分别分析了来自1,426和1,342个人的记录。结果：“经过时间”轴的低血糖风险or值为1.50(95%可信区间[CI] 0.25-9.00)，“处方数”轴的低血糖风险or值为1.67（95%可信区间[CI] 0.40-7.00）。这些发现与先前随机对照试验的荟萃分析结果一致。结论：研究结果表明，流行新用户设计可以有效地应用于现实世界的风险评估场景；此设计构成了新用户设计的潜在替代设计。考虑到患者的治疗历史，我们采用了流行的新用户设计。然而，在开始治疗之前，我们无法获得有关患者对治疗的看法的信息，这是有局限性的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-

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期刊介绍： Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.