目的:评估包括子宫内膜癌在内的选定安全结局的风险,子宫内膜增生,与雌激素/孕激素联合激素治疗(EP)相比,使用结合雌激素/巴泽昔芬(CE/BZA)的女性患乳腺癌。
方法:我们在五个美国医疗保健索赔数据库中进行了一项新用户队列研究,这些数据库代表了超过9200万女性。从2014年5月1日至2019年8月30日,我们包括CE/BZA或EP新用户。EP用户倾向评分(PS)与CE/BZA用户匹配。子宫内膜癌的发病率,子宫内膜增生,乳腺癌,使用基于索赔的算法确定另外8个癌症和心血管结局.使用随机效应模型估计比率(RR)和跨数据库汇集的差异。
结果:研究人群包括10,596CE/BZA和33,818PS匹配EP新用户。CE/BZA使用者的子宫内膜癌和子宫内膜增生发生率略高(每10,000人年增加1.6和0.4例),尽管由于病例数量少,精度受到限制(子宫内膜癌:RR,1.50[95%置信区间{CI},0.79-2.88];子宫内膜增生:RR,1.69[95%CI,0.51-5.61])。CE/BZA使用者的乳腺癌发病率较低(每10,000人年减少9.1例;RR,0.79;95%CI,0.58-1.05)。CE/BZA用户的其他结果比率略高,但置信区间与更广泛的可能关联兼容。
结论:CE/BZA使用者的子宫内膜癌和子宫内膜增生的发生率可能略高,和较低的乳腺癌发病率,比EP用户在使用的头几年。
To assess the risk of select safety outcomes including endometrial cancer, endometrial hyperplasia, and breast cancer among women using conjugated estrogens/bazedoxifene (CE/BZA) as compared with estrogen/progestin combination hormone therapy (EP).
We conducted a new-user cohort
study in five US healthcare claims databases representing more than 92 million women. We included CE/BZA or EP new users from May 1, 2014, to August 30, 2019. EP users were propensity score (PS) matched to users of CE/BZA. Incidence of endometrial cancer, endometrial hyperplasia, breast cancer, and eight additional cancer and cardiovascular outcomes were ascertained using claims-based algorithms. Rate ratios (RR) and differences pooled across databases were estimated using random-effects models.
The
study population included 10,596 CE/BZA and 33,818 PS-matched EP new users. Rates of endometrial cancer and endometrial hyperplasia were slightly higher among CE/BZA users (1.6 and 0.4 additional cases per 10,000 person-years), although precision was limited because of small numbers of cases (endometrial cancer: RR, 1.50 [95% confidence interval {CI}, 0.79-2.88]; endometrial hyperplasia: RR, 1.69 [95% CI, 0.51-5.61]). Breast cancer incidence was lower in CE/BZA users (9.1 fewer cases per 10,000 person-years; RR, 0.79; 95% CI, 0.58-1.05). Rates of other outcomes were slightly higher among CE/BZA users, but with confidence intervals compatible with a wider range of possible associations.
CE/BZA users might experience slightly higher rates of endometrial cancer and endometrial hyperplasia, and a lower rate of breast cancer, than EP users in the first years of use.