Watson Louise, Das Romita, Farquhar Ruth, Langerman Haya, Barnett Anthony H
a Explore-Epi Ltd , Norfolk , UK ;
b MSD UK , Hoddesdon , UK ;
Curr Med Res Opin. 2016 Sep;32(9):1465-75. doi: 10.1185/03007995.2016.1157462. Epub 2016 Mar 23.
Type 2 diabetes mellitus (TD2M) treatment focuses on achieving glycemic control, with HbA1c targeted at 6.5-7.5%. Clinicians commonly delay treatment intensification despite patients failing glycemic targets. This study evaluated longitudinal clinical and cost outcomes in patients failing metformin monotherapy using electronic medical records.
Adults with incident T2DM were identified in the UK Clinical Practice Research Datalink (CPRD) from 1 January 2000 to 31 March 2014. Patients were initiated on metformin monotherapy but had not reached target (HbA1c <7%). Patients were grouped by time to intensification of second-line therapy from first recorded HbA1c ≥7%: Group A, rapid intensification within 365 days; Group B, delayed intensification days 366-1824; Group C, never intensified. Patients were followed from day 366 for 5 years until end of study, switch to insulin, migration or death.
The study evaluated baseline clinical and medication characteristics which were re-evaluated each year, including HbA1c, weight, cholesterol and concomitant prescribing.
A total of 6710 patients were included (Group A 2647, Group B 2452, Group C 1611). Group A achieved a significant decline in HbA1c at 1 year post-index date compared to Groups B and C (-1.13% Group A; +0.26% Group B, +0.16% Group C). A significantly higher proportion of patients achieved HbA1c target < 7% in Group A (Group A [45.8%]; Group B [19.1%], p < 0.0001). Using an adjusted hazard model, Group A was found to achieve the HbA1c target from the index date significantly faster than Group B (hazard ratio 3.25 [95% CI 2.87-3.69]). The most commonly prescribed second-line medications were sulfonylureas in Groups A and B throughout observation and were associated with significant weight gain (+1.3 kg per patient) in the adjusted models.
Patients who were rapidly intensified achieved a maintained reduction in HbA1c faster than those with delayed intensification or no second-line therapy, despite a higher baseline HbA1c.
2型糖尿病(TD2M)的治疗重点是实现血糖控制,糖化血红蛋白(HbA1c)目标为6.5 - 7.5%。尽管患者未达到血糖目标,但临床医生通常会延迟强化治疗。本研究使用电子病历评估了二甲双胍单药治疗失败患者的纵向临床和成本结局。
在英国临床实践研究数据链(CPRD)中识别出2000年1月1日至2014年3月31日期间新诊断为T2DM的成年人。患者开始接受二甲双胍单药治疗,但未达到目标(HbA1c < 7%)。根据从首次记录的HbA1c≥7%到二线治疗强化的时间对患者进行分组:A组,在365天内快速强化;B组,延迟强化366 - 1824天;C组,从未强化。从第366天开始对患者进行5年随访,直至研究结束、改用胰岛素、转出或死亡。
该研究评估了每年重新评估的基线临床和用药特征,包括HbA1c、体重、胆固醇和联合用药情况。
共纳入6710例患者(A组2647例,B组2452例,C组1611例)。与B组和C组相比,A组在索引日期后1年时HbA1c显著下降(A组为-1.13%;B组为+0.26%,C组为+0.16%)。A组中达到HbA1c目标<7%的患者比例显著更高(A组[45.8%];B组[19.1%],p < 0.0001)。使用校正后的风险模型发现,A组从索引日期起达到HbA1c目标的速度明显快于B组(风险比3.25[95%CI 2.87 - 3.69])。在整个观察期间,A组和B组最常用的二线药物是磺脲类药物,在校正模型中与显著体重增加(每位患者+1.3 kg)相关。
尽管基线HbA1c较高,但快速强化治疗的患者比延迟强化或未接受二线治疗的患者更快实现并维持HbA1c降低。