Romera Irene, Díaz Silvia, Sicras-Mainar Antoni, López-Simarro Flora, Dilla Tatiana, Artime Esther, Reviriego Jesús
Medical Department, Eli Lilly and Company, Alcobendas, Madrid, Spain.
Real Life Data, Badalona, Barcelona, Spain.
Diabetes Ther. 2020 Feb;11(2):437-451. doi: 10.1007/s13300-019-00745-5. Epub 2019 Dec 28.
To evaluate clinical inertia in patients with type 2 diabetes mellitus (T2DM), obesity and poor glycaemic control in routine clinical practice.
This was a retrospective, observational study based on the analysis of medical records from the BIG-PAC® database. Subjects who required medical care in 2013 with the following characteristics were enrolled in the study: age ≥ 30 years, diagnosis of T2DM, glycosylated haemoglobin (HbA1c) ≥ 8%, obesity (body mass index [BMI] ≥ 30 kg/m) and treatment with ≥ 2 oral antidiabetic drugs (OADs). Inertia was evaluated by time (days) to the first intensification during the period while HbA1c levels were ≥ 8% and percentage of patients whose treatment was not intensified at 6 months, 1, 2 and 3 years and the end of follow-up. The minimum length of follow-up was 4 years. Descriptive analyses and Kaplan-Meier survival curves were performed.
A total of 13,824 patients with T2DM receiving ≥ 2 OADs were identified; of these 2709 (19.6%) had HbA1c ≥ 8% and BMI ≥ 30 kg/m, thus fulfilling the inclusion criteria. Of these 2709 patients, the mean age was 65.5 (standard deviation [SD] 12.0) years; 54.9% were male, mean HbA1c level was 9.2% (SD 1.3%); mean BMI was 32.1 (SD 0.9) kg/m; and mean time from diagnosis was 8.2 (SD 3.0) years. HbA1c remained ≥ 8% for a median of 440 (95% confidence interval [CI] 421-459) days. The median time to first intensification was 456 (95% CI 429-483) days. No intensification had occurred in 77.8, 59.5, 41.5, 28.1 and 22.4% of patients at 6 months, 1, 2, 3 years and the end of follow-up, respectively.
The patients with T2DM analysed in this study had a mean HbA1c of 9.2% at baseline, and this remained at ≥ 8% for > 1 year. The time to the first treatment intensification was longer than that recommended by guidelines. Treatment was not intensified in a large percentage of patients, with almost 60% of patients not receiving intensification at 1 year of follow-up.
评估2型糖尿病(T2DM)患者、肥胖患者以及血糖控制不佳患者在常规临床实践中的临床惰性。
这是一项基于对BIG-PAC®数据库中的病历进行分析的回顾性观察研究。2013年需要医疗护理且具有以下特征的受试者被纳入研究:年龄≥30岁、T2DM诊断、糖化血红蛋白(HbA1c)≥8%、肥胖(体重指数[BMI]≥30kg/m)以及接受≥2种口服降糖药(OADs)治疗。通过在HbA1c水平≥8%期间至首次强化治疗的时间(天数)以及在6个月、1年、2年、3年和随访结束时治疗未强化的患者百分比来评估惰性。随访的最短时长为4年。进行了描述性分析和Kaplan-Meier生存曲线分析。
共识别出13824例接受≥2种OADs治疗的T2DM患者;其中2709例(19.6%)HbA1c≥8%且BMI≥30kg/m,因此符合纳入标准。在这2709例患者中,平均年龄为65.5(标准差[SD]12.0)岁;54.9%为男性,平均HbA1c水平为9.2%(SD 1.3%);平均BMI为32.1(SD 0.9)kg/m;自诊断以来的平均时间为8.2(SD 3.0)年。HbA1c≥8%的中位时间为440天(95%置信区间[CI]421 - 459)。首次强化治疗的中位时间为456天(95%CI 429 - 483)。在6个月、1年、2年、3年和随访结束时,分别有77.8%、59.5%、41.5%、28.1%和22.4%的患者未进行强化治疗。
本研究中分析的T2DM患者基线时平均HbA1c为9.2%,且该水平≥8%持续超过1年。首次治疗强化的时间长于指南推荐时间。很大一部分患者的治疗未得到强化,近60%的患者在随访1年时未接受强化治疗。