Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Acumen LLC, Burlingame, CA.
Diabetes Care. 2020 Apr;43(4):785-792. doi: 10.2337/dc19-0614. Epub 2020 Feb 19.
To assess whether initiation of insulin glargine (glargine), compared with initiation of NPH or insulin detemir (detemir), was associated with an increased risk of breast cancer in women with diabetes.
This was a retrospective new-user cohort study of female Medicare beneficiaries aged ≥65 years initiating glargine (203,159), detemir (67,012), or NPH (47,388) from September 2006 to September 2015, with follow-up through May 2017. Weighted Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs for incidence of breast cancer according to ever use, cumulative duration of use, cumulative dose of insulin, length of follow-up time, and a combination of dose and length of follow-up time.
Ever use of glargine was not associated with an increased risk of breast cancer compared with NPH (HR 0.97; 95% CI 0.88-1.06) or detemir (HR 0.98; 95% CI 0.92-1.05). No increased risk was seen with glargine use compared with either NPH or detemir by duration of insulin use, length of follow-up, or cumulative dose of insulin. No increased risk of breast cancer was observed in medium- or high-dose glargine users compared with low-dose users.
Overall, glargine use was not associated with an increased risk of breast cancer compared with NPH or detemir in female Medicare beneficiaries.
评估与起始使用 NPH 或胰岛素地特胰岛素相比，起始使用甘精胰岛素是否会增加女性糖尿病患者罹患乳腺癌的风险。
这是一项回顾性新使用者队列研究，纳入了 2006 年 9 月至 2015 年 9 月期间≥65 岁的女性 Medicare 受益人群，起始使用甘精胰岛素（203159 例）、地特胰岛素（67012 例）或 NPH（47388 例），随访至 2017 年 5 月。使用加权 Cox 比例风险回归来估计根据是否使用、累计使用时间、胰岛素累积剂量、随访时间长度以及剂量和随访时间长度的组合，乳腺癌发病率的风险比（HR）和 95%置信区间（CI）。
与 NPH（HR 0.97；95%CI 0.88-1.06）或地特胰岛素（HR 0.98；95%CI 0.92-1.05）相比，使用甘精胰岛素与乳腺癌风险增加无关。与 NPH 或地特胰岛素相比，使用甘精胰岛素的时间、随访时间长度或胰岛素累积剂量均未见乳腺癌风险增加。与低剂量甘精胰岛素使用者相比，中剂量或高剂量甘精胰岛素使用者未观察到乳腺癌风险增加。
总体而言，与 NPH 或地特胰岛素相比，女性 Medicare 受益人群使用甘精胰岛素与乳腺癌风险增加无关。
