Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, UK.
Department of Histopathology and Morbid Anatomy, Trinity Translational Medicine Institute, Trinity College Dublin, Dublin, Ireland.
BJU Int. 2020 Feb;125(2):226-233. doi: 10.1111/bju.14905. Epub 2019 Sep 27.
To test the association between statin use and prostate volume (PV) change over time using data from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial, a 4-year randomised controlled trial testing dutasteride for prostate cancer chemoprevention.
SUBJECTS/PATIENTS AND METHODS: We identified men with a baseline negative prostate biopsy from REDUCE who did not undergo prostate surgery or develop prostate cancer over the trial period. Men reported statin use at baseline. PV was determined from transrectal ultrasonography performed to guide prostate biopsy at baseline, and 2- and 4-years after randomisation. Multivariable generalised estimating equations tested differences in PV change over time by statin use, overall and stratified by treatment arm. We tested for interactions between statins and time in association with PV using the Wald test.
Of 4106 men, 17% used statins at baseline. Baseline PV did not differ by statin use. Relative to non-users, statin users had decreasing PVs over the trial period (P = 0.027). Similar patterns were seen in the dutasteride and placebo arms, although neither reached statistical significance. The mean estimated PV was modestly but significantly lower in statin users relative to non-users in the dutasteride arm at 2-years (4.5%, P = 0.032) and 4-years (4.0%, P = 0.033), with similar (3-3.3%) but non-significant effects in the placebo arm.
If confirmed, our present findings support a role for statins in modestly attenuating PV growth, with a magnitude of effect in line with previously reported prostate-specific antigen-lowering effects of statins (~4%). Future studies are needed to assess whether this putative role for statins in PV growth could impact lower urinary tract symptom development or progression.
利用来自 REDUCE 试验的数据来检验他汀类药物使用与前列腺体积(PV)随时间变化的关系,该试验是一项为期 4 年的随机对照试验,旨在测试度他雄胺预防前列腺癌的效果。
受试者/患者和方法:我们从 REDUCE 试验中确定了基线时前列腺活检阴性且在试验期间未接受前列腺手术或未发生前列腺癌的男性。男性在基线时报告了他汀类药物的使用情况。PV 是通过基线时进行的经直肠超声检查确定的,并且在随机分组后 2 年和 4 年进行。多变量广义估计方程测试了他汀类药物使用与时间对 PV 变化的影响,总体上和按治疗组分层。我们使用 Wald 检验测试了他汀类药物与时间之间与 PV 相关的相互作用。
在 4106 名男性中,17%的人在基线时使用了他汀类药物。基线时的 PV 与他汀类药物的使用无关。与非使用者相比,他汀类药物使用者在试验期间的 PV 逐渐减少(P=0.027)。在度他雄胺和安慰剂组中也观察到了类似的模式,但均无统计学意义。在度他雄胺组中,与非使用者相比,他汀类药物使用者在 2 年(4.5%,P=0.032)和 4 年(4.0%,P=0.033)时的平均估计 PV 略低,但具有统计学意义,在安慰剂组中也有类似的(3-3.3%)但无统计学意义的效果。
如果得到证实,我们目前的发现支持他汀类药物在适度减轻 PV 生长方面的作用,其作用幅度与先前报道的他汀类药物降低前列腺特异性抗原的效果一致(约 4%)。需要进一步的研究来评估他汀类药物在 PV 生长中的这种潜在作用是否会影响下尿路症状的发展或进展。