Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China; The Bau Institute of Medical and Health Sciences Education, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China; Department of Family Medicine and Primary Care, The University of Hong Kong - Shenzhen Hospital, Shenzhen, Guangdong, China.
J Clin Epidemiol. 2024 Aug;172:111425. doi: 10.1016/j.jclinepi.2024.111425. Epub 2024 Jun 14.
Controversy exists regarding potential cancer risks associated with long-term statin use. This study aimed to use real-world data to investigate the association between cancer incidence and sustained statin use over a 10-year period.
Using territory-wide public electronic medical records in Hong Kong, we emulated a sequence of nested target trials on patients who met indications for statin initiation in each calendar month from January 2009 to December 2011. Statin initiators and noninitiators were matched in a 1:1 ratio to mimic the randomization of eligible person-trials at baseline. Pooled logistic regression was applied to obtain the hazard ratios for the cancer incidence of statin initiation in intention-to-treat analysis, with the adjustment of baseline confounders and the inverse probability weighting accounting for the postbaseline confounders in per-protocol analysis.
Among 8,560,051 eligible person-trials, 119,715 noninitiators were matched to 119,715 initiators for analysis. Over the 10-year study period, the estimated hazard ratio of overall cancer incidence was 0.96 (0.87, 1.05), and the standardized 10-year risk difference was -0.4% (-1.3%, 0.4%) in the per-protocol analysis. For the cancer subtypes of interest (ie, breast cancer, colorectal cancer, hematological cancer, pancreatic cancer, prostate cancer, urothelial carcinoma, and lung cancer), the 10-year risk differences ranged from -0.3% to 0.2% in the per-protocol analysis. No observable risk change for cancer was found in all patient subgroups with regards to their sex, age (<70/≥70 years), Charlson Comorbidity Index (≤4/>4), and statin indication.
Statin use has no impact on cancer incidence over a 10-year follow-up period, including all cancer subtypes of interest and patient subgroups with regards to sex, age, comorbidities, and statin indications.
长期使用他汀类药物与癌症风险之间存在争议。本研究旨在利用真实世界的数据，调查在 10 年期间癌症发病率与持续他汀类药物使用之间的关联。
利用香港全港范围的公共电子病历，我们在 2009 年 1 月至 2011 年 12 月的每个日历月对符合他汀类药物起始指征的患者进行嵌套目标试验序列模拟。他汀类药物起始者和非起始者以 1:1 的比例匹配，以模拟基线时合格个体试验的随机化。意向治疗分析中采用汇总逻辑回归获得他汀类药物起始的癌症发病率的风险比，调整基线混杂因素，并在方案分析中使用逆概率加权法考虑基线后混杂因素。
在 8560015 个合格的个体试验中，119715 名非起始者与 119715 名起始者进行了匹配分析。在 10 年的研究期间，总体癌症发病率的估计风险比为 0.96（0.87，1.05），在方案分析中标准化的 10 年风险差异为-0.4%（-1.3%，0.4%）。对于感兴趣的癌症亚型（即乳腺癌、结直肠癌、血液恶性肿瘤、胰腺癌、前列腺癌、尿路上皮癌和肺癌），在方案分析中，10 年风险差异范围为-0.3%至 0.2%。在所有患者亚组中，无论性别、年龄（<70/≥70 岁）、Charlson 合并症指数（≤4/>4）和他汀类药物指征，均未观察到癌症风险的变化。
在 10 年的随访期间，他汀类药物的使用对癌症发病率没有影响，包括所有感兴趣的癌症亚型以及性别、年龄、合并症和他汀类药物指征方面的所有患者亚组。
