Research adds to mixed view of statin–ICH link
MedWire News: Findings from a large retrospective cohort study argue against statins raising the risk for intracerebral hemorrhage (ICH) in patients with ischemic stroke.
The results support some recent studies but contradict others, including a decision analysis and the original post-hoc analyses of statin clinical trials that first raised concerns over the effect of statins on ICH risk.
For the current study, Daniel Hackam (University of Western Ontario, London, Canada) and team assembled a cohort of 8936 statin users and an equal number of controls matched according to a propensity score for the likelihood of receiving a statin. During a median of 4.2 years of follow up, 213 patients had an ICH, with rates of 2.94 and 3.71 per 1000 patient-years in statin users and nonusers, respectively. The difference between the two groups was not statistically significant.
The researchers then conducted sensitivity analyses, which showed that the risk for ICH associated with statin therapy did not differ according to patient age, gender, and socioeconomic status; whether they had hypertension, diabetes, or chronic kidney disease; and whether they were taking oral anticoagulants or antiplatelets.
Hackam et al also conducted specificity analyses, to determine if statin use was a marker of differences in healthcare provision. These showed that statin users and nonusers were equally likely to undergo tests of vitamin B12 and D levels and bone mineral density, and to undergo endoscopy and elective knee replacement.
"These findings argue against major healthy user bias or screening bias in our cohort," the researchers write in the Archives of Neurology.
In an editorial, Philip Gorelick (University of Illinois College of Medicine, Chicago, USA) contrasts the findings with those from post-hoc analyses of the statin clinical trials, saying that both types of study have clear limitations, so the picture remains unclear.
"Until we have additional, high-level evidence to clarify the statin-ICH risk relationship, I recommend careful control of modifiable risks for brain hemorrhage such as blood pressure in those who are treated with a statin," he says.
Gorelick adds: "The clinical decision to administer a statin following ICH remains a challenging one with available evidence tilting in the direction of withholding such therapy, especially when there is a history of lobar brain hemorrhage. I have found that input from patients and their family members after they have been informed about the possible bleeding risks of statin therapy as they relate to the individual patient may be useful in making the final decision for that patient."
MedWire (http://www.medwire-news.md/) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Eleanor McDermid