Sato Masayo, Ye Wenyu, Sugihara Tomoko, Isaka Yoshitaka
Medical Development Unit Japan, Eli Lilly Japan K.K, 7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.
Eli Lilly and Company, Indianapolis, IN, USA.
BMC Musculoskelet Disord. 2016 Nov 25;17(1):489. doi: 10.1186/s12891-016-1344-9.
Osteoporosis, osteoporosis-related fractures, and diabetes are considerable health burdens in Japan. Diabetes in patients with osteoporosis has been reported to be associated with increased fracture risk. This retrospective analysis of a Japanese hospital claims database investigated the real-world effect of type 2 diabetes mellitus (T2DM) on the incidence of clinical fractures, costs, and healthcare resource utilization in patients with osteoporosis and a subgroup of patients prescribed raloxifene.
Women aged ≥50 years diagnosed with osteoporosis who had a first prescription claim for osteoporosis treatment with a pre-index period ≥12 months and a post-index period of 30 months were selected from a database extract (April 2008-July 2013). Patients prescribed raloxifene were classed as a subgroup. Patients diagnosed with T2DM constituted the T2DM group; all other patients (excluding patients with type 1 diabetes mellitus) constituted the non-diabetes mellitus (non-DM) group. Groups were matched by exact matching, using selected baseline characteristics. Patient demographic and clinical characteristics were compared using chi-squared tests, t-tests, or Wilcoxon rank sum tests. Time to first fracture was examined using Kaplan-Meier survival analysis.
Overall, the T2DM and non-DM groups had 7580 and 7979 patients, respectively; following matching, there were 3273 patients per group. In the raloxifene subgroup, the T2DM and non-DM groups had 668 and 699 patients, respectively; following matching, there were 239 patients per group. At baseline, the T2DM group (overall and raloxifene subgroup) had significantly higher healthcare resource utilization and comorbidities. During the post-index period, a similar pattern was observed in the overall group, even after matching; the T2DM group also had a higher incidence of fracture. In the raloxifene subgroup, after matching, there were no significant differences in fracture incidence or costs and fewer differences in healthcare resource utilization between the T2DM and non-DM groups.
These findings suggest that comorbid T2DM increases fracture incidence in patients with osteoporosis, compared with patients without DM. Increases in fracture incidence were accompanied by greater costs and healthcare resource utilization, which are important considerations for clinical practice in Japan. Further research investigating the use of raloxifene for treatment of osteoporosis with comorbid T2DM may also be warranted.
骨质疏松症、与骨质疏松症相关的骨折以及糖尿病是日本相当沉重的健康负担。据报道,骨质疏松症患者中的糖尿病与骨折风险增加有关。这项对日本医院理赔数据库的回顾性分析调查了2型糖尿病(T2DM)对骨质疏松症患者以及服用雷洛昔芬的患者亚组临床骨折发生率、成本和医疗资源利用的实际影响。
从数据库提取物(2008年4月至2013年7月)中选取年龄≥50岁、被诊断为骨质疏松症且首次开具骨质疏松症治疗处方、索引前期≥12个月且索引后期为30个月的女性。服用雷洛昔芬的患者被归类为一个亚组。被诊断为T2DM的患者构成T2DM组;所有其他患者(不包括1型糖尿病患者)构成非糖尿病(非DM)组。使用选定的基线特征通过精确匹配对各组进行匹配。使用卡方检验、t检验或Wilcoxon秩和检验比较患者的人口统计学和临床特征。使用Kaplan-Meier生存分析检查首次骨折的时间。
总体而言,T2DM组和非DM组分别有7580例和7979例患者;匹配后,每组有3273例患者。在雷洛昔芬亚组中,T2DM组和非DM组分别有668例和699例患者;匹配后,每组有239例患者。在基线时,T2DM组(总体和雷洛昔芬亚组)的医疗资源利用和合并症显著更高。在索引后期,即使在匹配后,总体组中也观察到类似模式;T2DM组的骨折发生率也更高。在雷洛昔芬亚组中,匹配后,T2DM组和非DM组在骨折发生率或成本方面没有显著差异,在医疗资源利用方面的差异也较少。
这些发现表明,与无糖尿病的患者相比,合并T2DM会增加骨质疏松症患者的骨折发生率。骨折发生率的增加伴随着更高的成本和医疗资源利用,这是日本临床实践中的重要考虑因素。对使用雷洛昔芬治疗合并T2DM的骨质疏松症进行进一步研究可能也是必要的。