Surgery Section, Durham VA Medical Center, Durham, NC, USA.
Prostate Cancer Prostatic Dis. 2013 Sep;16(3):254-9. doi: 10.1038/pcan.2013.10. Epub 2013 Apr 9.
Statins are associated with lower PSA levels. As PSA is the primary method for prostate cancer (PC) screening, this confounds any associations between statins and risk of being diagnosed with PC. Thus, we examined the association between statins and cancer and high-grade cancer in REDUCE, where biopsies were largely PSA-independent.
Post-hoc secondary analysis of REDUCE, which was a prospective multinational randomized controlled trial of dutasteride vs placebo for 4 years among men aged 50-75 years with PSA of 2.5-10.0 ng ml(-1) and a negative biopsy at baseline, and included PSA-independent biopsies mandated at 2- and 4-years. Analyses were limited to men who underwent at least one biopsy while under study (n=6729). The association between baseline statin use and risk of overall, high-grade (Gleason ≥ 7) or low-grade (Gleason ≤ 6) PC vs no cancer was examined using multinomial logistic regression adjusting for age, race, baseline PSA, prostate volume, rectal examination findings, body mass index (BMI), comorbidities, smoking, alcohol intake and treatment arm.
Of 6729 men who had at least one biopsy while on study, 1174 (17.5%) were taking a statin at baseline. Men taking statins were older, had lower PSA levels, higher BMI values and lower serum testosterone and dihydrotestosterone levels, though differences, were slight. Statin use was not associated with overall PC diagnosis (multivariable OR 1.05, 95% CI 0.89-1.24, P=0.54). When stratified by grade, statin use was not associated with low-grade (multivariable OR 1.03, 95% CI 0.85-1.25, P=0.75) or high-grade cancer (multivariable OR 1.11, 95% CI 0.85-1.45, P=0.46). The major limitation is the inclusion of only men with a negative baseline biopsy.
Among men with a negative baseline biopsy and follow-up biopsies largely independent of PSA, statins were not associated with cancer or high-grade cancer.
他汀类药物与较低的 PSA 水平有关。由于 PSA 是前列腺癌（PC）筛查的主要方法，这会混淆他汀类药物与被诊断为 PC 的风险之间的任何关联。因此，我们在 REDUCE 中检查了他汀类药物与癌症和高级别癌症之间的关联，在 REDUCE 中，活检在很大程度上与 PSA 无关。
对 REDUCE 的事后二次分析，这是一项为期 4 年的多中心、随机、安慰剂对照试验，比较了 dutasteride 与安慰剂在年龄为 50-75 岁、PSA 为 2.5-10.0ng/ml 和基线时阴性活检的男性中的疗效，并且包括在 2 年和 4 年时进行的与 PSA 无关的活检。分析仅限于在研究期间至少进行过一次活检的男性（n=6729）。使用多变量逻辑回归调整年龄、种族、基线 PSA、前列腺体积、直肠检查结果、体重指数（BMI）、合并症、吸烟、饮酒和治疗组，检查基线他汀类药物使用与总体、高级别（Gleason≥7）或低级别（Gleason≤6）PC 与无癌症之间的关联。
在研究期间至少进行过一次活检的 6729 名男性中，有 1174 名（17.5%）男性在基线时服用他汀类药物。服用他汀类药物的男性年龄较大，PSA 水平较低，BMI 值较高，血清睾酮和二氢睾酮水平较低，但差异很小。他汀类药物的使用与总体 PC 诊断无关（多变量 OR 1.05，95%CI 0.89-1.24，P=0.54）。按等级分层时，他汀类药物的使用与低级别（多变量 OR 1.03，95%CI 0.85-1.25，P=0.75）或高级别癌症（多变量 OR 1.11，95%CI 0.85-1.45，P=0.46）无关。主要限制是仅纳入基线时阴性活检的男性。
在基线时阴性活检且后续活检在很大程度上独立于 PSA 的男性中，他汀类药物与癌症或高级别癌症无关。
