Buysman Erin K, Chow Wing, Henk Henry J, Rupnow Marcia F T
Optum , Eden Prairie, MN , USA.
Curr Med Res Opin. 2015 Jan;31(1):137-43. doi: 10.1185/03007995.2014.982750. Epub 2014 Nov 12.
Canagliflozin is a sodium glucose co-transporter 2 inhibitor that has been shown to improve glycemic control in type 2 diabetes mellitus (T2DM). This study aimed to describe the characteristics, treatment utilization, and outcomes of patients treated with canagliflozin in the real world within the first 6 months of it being commercially available.
This retrospective cohort study used a large US health plan database for commercial and Medicare Advantage enrollees. Patients aged 18 and over with T2DM who filled a canagliflozin prescription during 1 April 2013 to 30 September 2013 were eligible for inclusion. Patients were required to be enrolled for 6 months before (baseline period) and 3 months after (follow-up period) the first canagliflozin claim.
Overall, 3234 patients met study criteria (mean age was 55.7 years; 43.4% were female). Among patients with available lab data at baseline and follow-up, mean HbA1c decreased from 8.54% at baseline to 7.76% at follow-up (p < 0.001); the proportion of patients with HbA1c ≥9.0% decreased by more than half (from 32.0% at baseline to 15.5% at follow-up, p < 0.001). Almost all (94.8%) patients received at least one baseline antihyperglycemic agent; among them, 33.6% received two and 41.5% received three or more agents. Compared to baseline, usage of antihyperglycemic agents during follow-up was lower for metformin, sulfonylureas, insulin, DPP-4 inhibitors, GLP-1 receptor agonists and thiazolidinediones.
Patients treated with canagliflozin when first available in the US typically had poorly controlled HbA1c levels at baseline and had received multiple prior antihyperglycemic agents. Following the first canagliflozin claim, they had an improvement in HbA1c levels and used fewer antihyperglycemic agents. These study results should help clinicians and payers better understand the initial profile of patients receiving canagliflozin and short-term outcomes in the real world. Given the short follow-up time frame and the fact that HbA1c data was not available in all patients, future research on longer term outcomes is warranted.
卡格列净是一种钠-葡萄糖协同转运蛋白2抑制剂,已被证明可改善2型糖尿病(T2DM)患者的血糖控制。本研究旨在描述卡格列净在上市后的前6个月内在现实世界中治疗的患者的特征、治疗利用情况和结局。
这项回顾性队列研究使用了美国一个大型健康计划数据库,纳入商业保险和医疗保险优势计划的参保者。2013年4月1日至2013年9月30日期间开具卡格列净处方的18岁及以上T2DM患者符合纳入标准。患者在首次开具卡格列净处方前需参保6个月(基线期),之后需参保3个月(随访期)。
总体而言,3234名患者符合研究标准(平均年龄55.7岁;43.4%为女性)。在基线和随访时有可用实验室数据的患者中,平均糖化血红蛋白(HbA1c)从基线时的8.54%降至随访时的7.76%(p<0.001);HbA1c≥9.0%的患者比例下降了一半以上(从基线时的32.0%降至随访时的15.5%,p<0.001)。几乎所有(94.8%)患者在基线时至少接受过一种降糖药物治疗;其中,33.6%接受过两种药物治疗,41.5%接受过三种或更多药物治疗。与基线相比,随访期间二甲双胍、磺脲类药物、胰岛素、二肽基肽酶-4抑制剂、胰高血糖素样肽-1受体激动剂和噻唑烷二酮类药物的使用减少。
在美国首次使用卡格列净治疗的患者,基线时糖化血红蛋白水平通常控制不佳,且之前接受过多种降糖药物治疗。首次开具卡格列净处方后,他们的糖化血红蛋白水平有所改善,且使用的降糖药物减少。这些研究结果应有助于临床医生和支付方更好地了解接受卡格列净治疗的患者的初始情况以及现实世界中的短期结局。鉴于随访时间较短且并非所有患者都有糖化血红蛋白数据,有必要对长期结局进行进一步研究。