Skriver Charlotte, Cronin-Fenton Deirdre, Borgquist Signe, Hansen Viuff Jakob, Alkner Sara, Rydén Lisa, Lænkholm Anne-Vibeke, Manjer Jonas, Bengtsson Ylva, Frederiksen Kirsten, Friis Søren, Mellemkjær Lene
Danish Cancer Institute, Copenhagen, Denmark.
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Br J Cancer. 2025 May;132(9):828-836. doi: 10.1038/s41416-025-02974-x. Epub 2025 Mar 8.
Statins have been suggested to protect against breast cancer risk, but the observational evidence is inconclusive. We examined the association between statin use and breast cancer incidence among women at higher risk of breast cancer due to a history of benign breast disease (BBD).
Using Danish registries, we identified cancer-free women aged ≥50 years during 1996-2018 with a history of BBD and no prior statin prescriptions. Using Cox regression, we estimated multivariable-adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) for invasive breast cancer through 2020 with time-varying statin use defined according to continuity, duration, and intensity (estimated average daily dose), derived from prescription data.
Among 111,550 women, 7629 were diagnosed with breast cancer during median follow-up of 12.2 years. Overall statin use was not associated with breast cancer incidence (adjusted HR = 0.99; 95% CI, 0.93-1.06), with similar associations observed according to continuity and duration of use. However, long-term (≥10 years), high-intensity statin use was associated with a reduced HR of 0.75 (95% CI, 0.60-0.96).
Our findings did not indicate an association for overall statin use with breast cancer incidence among women with BBD. The inverse association with long-term, high-dose statin use requires further evaluation.
他汀类药物已被认为可预防乳腺癌风险，但观察性证据尚无定论。我们研究了有良性乳腺疾病（BBD）病史、患乳腺癌风险较高的女性中他汀类药物使用与乳腺癌发病率之间的关联。
利用丹麦登记处的数据，我们确定了1996年至2018年期间年龄≥50岁、有BBD病史且此前无他汀类药物处方的无癌女性。通过Cox回归，我们根据连续性、持续时间和强度（估计平均日剂量）定义的随时间变化的他汀类药物使用情况，从处方数据中估计了2020年前侵袭性乳腺癌的多变量调整风险比（HR）及95%置信区间（CI）。
在111,550名女性中，中位随访12.2年期间有7629人被诊断患有乳腺癌。总体他汀类药物使用与乳腺癌发病率无关（调整后HR = 0.99；95%CI，0.93 - 1.06），根据使用的连续性和持续时间观察到类似的关联。然而，长期（≥10年）高强度他汀类药物使用与HR降低至0.75相关（95%CI，0.60 - 0.96）。
我们的研究结果并未表明在有BBD的女性中总体他汀类药物使用与乳腺癌发病率之间存在关联。长期高剂量他汀类药物使用的反向关联需要进一步评估。
