Department of Population Health Science, School of Public and Population Health, University of Texas Medical Branch, Galveston.
Sealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston.
JAMA Netw Open. 2023 Dec 1;6(12):e2348213. doi: 10.1001/jamanetworkopen.2023.48213.
Although hormone therapy (HT) in perimenopausal women is associated with increased risk for venous thromboembolism (VTE), it is unclear to what extent statins may mitigate this HT-associated risk.
To estimate VTE risk in women aged 50 to 64 years taking HT with or without statins.
DESIGN, SETTING, AND PARTICIPANTS: This nested case-control study analyzed data from a commercially insured claims database in the US. Eligible participants included women aged 50 to 64 years with at least 1 year of continuous enrollment between 2008 and 2019. Data analysis occurred from January 2022 to August 2023.
Filled prescriptions for estrogens, progestogens, and statins were recorded in the 12 months prior to index. Recent HT was defined as any estrogen or progestogen exposure within 60 days before the index date. Current statin exposure was defined as 90 or more days of continuous exposure prior to and including the index date. Statin intensity was defined by the statin exposure 30 days prior to index.
Cases were identified with VTE diagnoses (diagnostic codes) preceded by at least 12 months without VTE and followed within 30 days by anticoagulation, an inferior vena cava filter placement, or death. Controls were matched to cases (10:1) on date and age. Conditional logistic regression models estimated risk for HT and statin exposures with odds ratios (OR), adjusted for comorbidities. Conditional logistic regression models were used to estimate VTE risk for HT and statin exposures with odds ratios (ORs), adjusted for comorbidities. Intensity of statin therapy was measured as a subgroup analysis.
The total sample of 223 949 individuals (mean [SD] age, 57.5 [4.4] years) included 20 359 cases and 203 590 matched controls. Of the entire sample, 19 558 individuals (8.73%) had recent HT exposure and 36 238 individuals (16.18%) had current statin exposure. In adjusted models, individuals with any recent HT exposure had greater odds of VTE compared with those with no recent HT exposure (OR, 1.51; 95% CI, 1.43-1.60). Individuals receiving current statin therapy had lower odds of VTE compared with those with no current statin exposure (OR, 0.88; 95% CI, 0.84-0.93). When compared with those not recently taking HT or statins, the odds of VTE were greater for those taking HT without statins (OR, 1.53; 95% CI, 1.44-1.63) and for those taking HT with statins (OR, 1.25; 95% CI, 1.10-1.43), but were lower for those taking statins without HT (OR, 0.89; 95% CI, 0.85-0.94). Individuals taking HT with statin therapy had 18% lower odds of VTE than those taking HT without statins (OR, 0.82; 95% CI, 0.71-0.94) and there was greater risk reduction with higher intensity statins.
In this case-control study, statin therapy was associated with reduced risk of VTE in women taking HT, with greater risk reduction with high-intensity statins. These findings suggest that statins may reduce risk of VTE in women exposed to HT and that HT may not be contraindicated in women taking statins.
尽管激素治疗（HT）在围绝经期妇女中与静脉血栓栓塞（VTE）风险增加有关，但尚不清楚他汀类药物在多大程度上可以减轻这种与 HT 相关的风险。
评估 50 至 64 岁服用 HT 加或不加他汀类药物的女性的 VTE 风险。
设计、设置和参与者：这项嵌套病例对照研究分析了来自美国商业保险索赔数据库的数据。合格的参与者包括至少在 2008 年至 2019 年期间连续登记了 1 年的 50 至 64 岁女性。数据分析于 2022 年 1 月至 2023 年 8 月进行。
在索引前的 12 个月内记录了雌激素、孕激素和他汀类药物的处方。最近的 HT 定义为索引日期前 60 天内任何雌激素或孕激素暴露。当前的他汀类药物暴露定义为索引日期前和包括索引日期在内的 90 天或以上的连续暴露。他汀类药物强度根据索引前 30 天的他汀类药物暴露情况定义。
通过至少 12 个月没有 VTE 且在 30 天内接受抗凝、下腔静脉滤器放置或死亡的方法确定 VTE 诊断（诊断代码）的病例。对照组与病例（10:1）按日期和年龄匹配。条件逻辑回归模型估计了 HT 和他汀类药物暴露的风险比（OR），调整了合并症。条件逻辑回归模型用于估计 HT 和他汀类药物暴露的 VTE 风险比（OR），调整了合并症。他汀类药物治疗强度作为亚组分析进行了测量。
共有 223949 名个体（平均[SD]年龄，57.5[4.4]岁）的总样本包括 20359 例病例和 203590 名匹配的对照。在整个样本中，19558 名个体（8.73%）有最近的 HT 暴露，36238 名个体（16.18%）有当前的他汀类药物暴露。在调整后的模型中，与没有最近 HT 暴露的个体相比，有任何最近 HT 暴露的个体发生 VTE 的可能性更高（OR，1.51；95%CI，1.43-1.60）。与没有当前他汀类药物暴露的个体相比，接受当前他汀类药物治疗的个体发生 VTE 的可能性较低（OR，0.88；95%CI，0.84-0.93）。与没有最近服用 HT 或他汀类药物的个体相比，服用 HT 但没有服用他汀类药物的个体发生 VTE 的可能性更高（OR，1.53；95%CI，1.44-1.63），服用 HT 但服用他汀类药物的个体发生 VTE 的可能性更高（OR，1.25；95%CI，1.10-1.43），但服用他汀类药物但没有服用 HT 的个体发生 VTE 的可能性较低（OR，0.89；95%CI，0.85-0.94）。与服用没有他汀类药物的 HT 的个体相比，服用 HT 加他汀类药物的个体发生 VTE 的可能性降低 18%（OR，0.82；95%CI，0.71-0.94），且高强度他汀类药物治疗的风险降低更大。
在这项病例对照研究中，他汀类药物治疗与服用 HT 的女性 VTE 风险降低相关，高强度他汀类药物治疗的风险降低更大。这些发现表明，他汀类药物可能降低暴露于 HT 的女性发生 VTE 的风险，并且 HT 可能不是服用他汀类药物的女性的禁忌症。
