Background and Purpose- It has been suggested that statins increase the risk of intracerebral hemorrhage in individuals with a history of stroke, which has led to a precautionary principle of avoiding statins in patients with prior intracerebral hemorrhage. However, such prescribing reticence may be unfounded and potentially harmful when considering the well-established benefits of statins. This study is so far the largest to explore the statin-associated risk of intracerebral hemorrhage in individuals with prior stroke. Methods- We conducted a population-based, propensity score-matched cohort study using information from Danish national registers. We included all individuals initiating statin treatment after a first-time stroke diagnosis (intracerebral hemorrhage, N=2728 or ischemic stroke, N=52 964) during 2002 to 2016. For up to 10 years of follow-up, they were compared with a 1:5 propensity score-matched group of statin nonusers with the same type of first-time stroke. The difference between groups was measured by adjusted hazard ratios for intracerebral hemorrhage calculated by type of first-time stroke as a function of time since statin initiation. Results- Within the study period, 118 new intracerebral hemorrhages occurred among statin users with prior intracerebral hemorrhage and 319 new intracerebral hemorrhages in users with prior ischemic stroke. The risk of intracerebral hemorrhage was similar for statin users and nonusers when evaluated among those with prior intracerebral hemorrhage, and it was reduced by half in those with prior ischemic stroke. These findings were consistent over time since statin initiation and could not be explained by concomitant initiation of other medications, by dilution of treatment effect (due to changes in exposure status over time), or by healthy initiator bias. Conclusions- This large study found no evidence that statins increase the risk of intracerebral hemorrhage in individuals with prior stroke; perhaps the risk is even lower in the subgroup of individuals with prior ischemic stroke.

中文翻译：

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他汀类药物和中风病史患者的脑出血风险。

背景和目的-已经提出，他汀类药物可增加中风病史患者脑出血的风险，这导致了预防性原则，避免了先前有脑出血的患者使用他汀类药物。但是，当考虑到他汀类药物的既定益处时，这种开处方的沉默可能是没有根据的，并且可能有害。迄今为止，这项研究是探索与他汀类药物相关的先前卒中患者脑出血风险的最大研究。方法-我们使用来自丹麦国家名册的信息进行了基于人群的倾向得分匹配的队列研究。我们纳入了2002年至2016年首次中风诊断后开始他汀类药物治疗的所有患者（脑出血，N = 2728或缺血性中风，N = 52964）。在长达10年的随访中，将他们与具有相同初次卒中类型的他汀类非使用者的1：5倾向评分匹配组进行了比较。两组之间的差异是通过调整脑卒中出血的危险比来衡量的，该危险比由他汀类药物开始以来的首次卒中类型随时间的变化而计算。结果-在研究期内，先前有脑出血的他汀类药物使用者中发生了118例新的脑内出血，而先前有缺血性卒中的使用者中有319例新的脑内出血。他汀类药物使用者和非使用者中脑出血的风险在既往有脑出血的人中进行评估时相似，在先前有缺血性中风的人中减少了一半。自他汀类药物启动以来，这些发现在时间上是一致的，不能用其他药物的同时启动，治疗效果的稀释（由于暴露状态随时间的变化）或健康引发剂的偏倚来解释。结论：这项大型研究发现没有证据表明他汀类药物会增加先前卒中患者脑出血的风险。在先前有缺血性中风的个体亚组中，风险可能更低。