Early Statin Start After Stroke No Better for Outcomes

— Pleiotropic effects didn't pan out acutely in small randomized trial

Last Updated February 27, 2017
MedpageToday

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HOUSTON -- Statin therapy from day 1 for acute stroke patients with high cholesterol or already on one did not improve outcomes, the ASSORT randomized trial showed.

That early start to lipid-lowering treatment did not shift modified Rankin Scale scores compared with statin therapy delayed to day 7 post-stroke (adjusted common OR 0.84, 95% CI 0.53-1.3), Shinichi Yoshimura, MD, PhD, of Hyogo College of Medicine in Nisinomiya City, Japan, reported here at the International Stroke Conference.

Likewise there were no differences in change in NIH Stroke Scale scores to day 7, in unstable angina, large vessel or peripheral artery disease requiring treatment, new ischemic stroke, or subarachnoid or cerebral hemorrhage.

Safety was similar for death, overall adverse events, musculoskeletal events, and liver enzymes.

Despite the lack of benefit in this admittedly-underpowered, multicenter, open-label trial of 270 patients, the researchers weren't ready to give up on the possibility of pleiotropic benefit in acute stroke, suggesting instead using higher doses in more severe stroke in the next trial. ASSORT included mainly mild stroke, because patients had to be able to swallow oral medication soon after stroke. Daily doses used were 20-mg atorvastatin (Lipitor), 4-mg pitavastatin (Livalo), or 5-mg rosuvastatin (Crestor).

Some prior studies including a much larger Korean stroke registry found benefit, "so I think there's something here," agreed Philip Gorelick, MD, MPH, of the Michigan State University College of Human Medicine in Grand Rapids and an American Stroke Association spokesperson on a press conference panel.

However, there are other reasons than pleiotropic benefits to give a statin early after a stroke, commented conference chair Bruce Ovbiagele, MD, of the Medical University of South Carolina in Charleston, who also moderated the press briefing.

"While this might not have shown that it was effective in terms of the index stroke, you did notice that there's a difference in terms of LDL reduction at 21 days in the early dosing. So to me this is an endorsement of the early administration as a way to initiate secondary prevention early," he said.

Most U.S. centers do already start statin therapy for patients who meet treatment criteria at least some time during the index hospitalization, Ovbiagele noted.

Even if the evidence on earlier timing isn't solid, "if there's no harm and you could potentially start the prevention regimen early and optimize adherence in the community as much as possible, why not?" he said.

Disclosures

Yoshimura disclosed relationships with Sionogi Pharmaceutical, Takeda, Bristol-Meyers, Mitsubishi Tanabe Pharma, Sanofi, Boehringer-Ingelheim, Otsuka Pharmaceutical, Bayer, and Pfizer.

Primary Source

International Stroke Conference

Source Reference: Yoshimura S, et al "Randomized controlled trial of early versus delayed statin therapy in patients with acute ischemic stroke" ISC 2017; Abstract LB17.