Division of Nephrology and Endocrinology, University of Tokyo School of Medicine, Tokyo, Japan.
Division of Nephrology, Department of Medicine, Mitsui Memorial Hospital, Tokyo, Japan.
Kidney360. 2020 Jun 16;1(8):740-745. doi: 10.34067/KID.0002262020. eCollection 2020 Aug 27.
The development and prompt dissemination of the first drug against a particular disease can contribute to improvements in national health status and medical economy end points and are assumedly affected by socioeconomic factors that have yet to be analyzed. Tolvaptan, a vasopressin receptor 2 antagonist, was developed to treat hyponatremia, congestive heart failure, and cirrhosis ascites, although the approved indications may differ among countries. In Japan, high-dose tolvaptan tablets were approved as the first drug for autosomal dominant polycystic kidney disease (ADPKD) in 2014. This study aimed to better understand the factors that influence the total number of regional prescriptions of tolvaptan for ADPKD since its launch.
The National Database of Health Insurance Claims and Specific Health Checkups of Japan Open Data was used as a national claim-based database. In each of the 47 prefectures in Japan, the total prescribed number of 30 mg tolvaptan tablets between 2015 and 2017 was examined. The parameters explaining the prescription variation among regions were then examined by correlation analysis.
Prescriptions for high-dose tolvaptan increased substantially 2 years after the drug's approval; however, the increase differed by approximately 21-fold between regions. Population density was positively associated with prescribed 30 mg tolvaptan tablets per 1000 population in 2015 (=0.47, <0.001). In addition, the increase in prescribed number of tablets per 1000 population was correlated with population density in 2016-2017 (=0.30, =0.04).
This macro perspective analysis revealed an urban-rural inequity in prescriptions for the newly approved drug for ADPKD. Further studies are needed to elucidate the factors affecting the geographic variation.
针对特定疾病的首款药物的研发和迅速推广有助于改善国民健康状况和医疗经济终点,且预计会受到尚未分析的社会经济因素的影响。托伐普坦是一种血管加压素受体 2 拮抗剂,最初被开发用于治疗低钠血症、充血性心力衰竭和肝硬化腹水,但各国的批准适应症可能有所不同。在日本,高剂量托伐普坦片于 2014 年被批准为常染色体显性多囊肾病(ADPKD)的首款药物。本研究旨在更好地了解自上市以来影响 ADPKD 托伐普坦区域总处方数量的因素。
本研究使用国家健康保险索赔和特定健康检查的日本公开数据库作为国家索赔数据库。在日本的 47 个都道府县中,检查了 2015 年至 2017 年期间 30 毫克托伐普坦片的总处方数量。然后通过相关分析检查解释区域处方差异的参数。
高剂量托伐普坦的处方量在药物批准后 2 年内大幅增加;然而,各地区之间的增加幅度差异约为 21 倍。人口密度与 2015 年每 1000 人服用的 30 毫克托伐普坦片数量呈正相关(=0.47,<0.001)。此外,2016-2017 年每 1000 人服用的片剂数量增加与人口密度相关(=0.30,=0.04)。
这项宏观角度的分析揭示了新批准的 ADPKD 药物处方在城乡之间的不平等。需要进一步研究阐明影响地域差异的因素。