Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Japan.
StatGroup ApS, Copenhagen, Denmark.
PLoS One. 2018 Sep 18;13(9):e0198160. doi: 10.1371/journal.pone.0198160. eCollection 2018.
This retrospective cohort study investigated whether clinical inertia, the failure to intensify treatment when required, exists in Japanese clinical practice, using the CoDiC® database. How and when patients with type 2 diabetes treated with basal insulin received treatment intensification was also described.
Patients with type 2 diabetes who initiated basal insulin between 2004 and 2011 were eligible for inclusion. Patients with an HbA1c ≥7.0% (≥53.0 mmol/mol) after 180 days of basal insulin titration were eligible for intensification, and their treatment was followed for up to 1.5 years. Endpoints were time to intensification, changes in HbA1c, and insulin dose.
Overall, 2351 patients initiated basal insulin treatment (mean HbA1c 9.4% [79.2 mmol/mol]), and 1279 patients were eligible for treatment intensification (HbA1c ≥7.0% [≥53.0 mmol/mol]) after the 180-day titration period. During the 1.5-year follow-up period (beyond the 180-day titration period), 270 (21%) of these patients received treatment intensification. In patients receiving treatment intensification, mean HbA1c decreased from 8.6 to 8.2% (70.5 to 66.1 mmol/mol) at end of follow-up. Treatment was intensified using bolus insulin in 126 (47%) patients and with premixed insulin in 144 (53%) patients. The estimated probability of intensifying treatment during the 12 months after recording HbA1c ≥7.0% (≥53.0 mmol/mol) was 22.8%, and 27.5% after 17 months. Mean end-of-follow-up daily insulin dose was 35.11 units for basal-bolus compared with 20.70 units for premix therapy.
This study suggests clinical inertia exists in basal insulin-treated patients with type 2 diabetes in Japan. Strategies are needed to increase the number of patients undergoing therapy intensification and to reduce the delay in intensification in Japan.
本回顾性队列研究使用 CoDiC®数据库探讨了临床惰性（即需要时未能加强治疗）是否存在于日本的临床实践中。还描述了接受基础胰岛素治疗的 2 型糖尿病患者如何以及何时进行治疗强化。
符合纳入标准的患者为 2004 年至 2011 年间开始接受基础胰岛素治疗的 2 型糖尿病患者。基础胰岛素滴定 180 天后 HbA1c≥7.0%（≥53.0mmol/mol）的患者有资格进行强化治疗，并对其治疗进行长达 1.5 年的随访。终点为强化治疗时间、HbA1c 变化和胰岛素剂量。
总体而言，2351 例患者开始接受基础胰岛素治疗（平均 HbA1c 9.4%[79.2mmol/mol]），180 天滴定期后 1279 例患者 HbA1c≥7.0%（≥53.0mmol/mol）符合治疗强化标准。在 1.5 年随访期间（超过 180 天滴定期），这些患者中有 270 例（21%）接受了治疗强化。在接受治疗强化的患者中，平均 HbA1c 从治疗结束时的 8.6%降至 8.2%（70.5 至 66.1mmol/mol）。126 例（47%）患者使用短效胰岛素强化治疗，144 例（53%）患者使用预混胰岛素强化治疗。记录 HbA1c≥7.0%（≥53.0mmol/mol）后 12 个月内强化治疗的估计概率为 22.8%，17 个月后为 27.5%。基础-餐时胰岛素治疗的平均终末随访日胰岛素剂量为 35.11 单位，预混胰岛素治疗为 20.70 单位。
本研究表明，日本接受基础胰岛素治疗的 2 型糖尿病患者存在临床惰性。需要采取策略来增加接受治疗强化的患者数量，并减少日本治疗强化的延迟。
