High doses of a cholesterol-lowering drug may help some stroke survivors avoid a second stroke and future heart problems, the first test of this approach found.
Experts said medical guidelines will probably be changed to recommend high doses of statin drugs as a routine part of stroke care for certain patients.
For every 100 people given high doses of the statin Lipitor, there were about two fewer strokes and three to four fewer major heart problems than among those given dummy pills, but also one more hemorrhagic stroke, or bleeding into the brain.
“Even with that risk, you can clearly see a benefit,” said Dr. Adnan Qureshi, director of the cerebral vascular program at University of Medicine and Dentistry of New Jersey in Newark.
Previous studies in heart patients found that statins cut the risk of a stroke, but this was the first test of one of the drugs specifically in stroke survivors.
The findings were published in Thursday’s New England Journal of Medicine. Lipitor’s maker, Pfizer Inc., paid for the study.
Led by researchers at Rosalind Franklin University of Medicine and Science in North Chicago, the study involved 4,731 people who had had a stroke or mini-stroke but no history of heart disease.
Half took the highest dose of Lipitor; the rest, a placebo. Over an average of five years, 11 percent of those on Lipitor had a second stroke, compared with 13 percent of the others. Bleeding strokes occurred in just over 2 percent of those on Lipitor versus nearly 1.5 percent in the placebo group.
“It really is an advance,” the lead researcher, Dr. K.M.A. Welch, said of adding statins to stroke patients’ routine care.
The Lipitor patients also had one-third fewer heart attacks and other cardiac problems than the group on dummy pills. Deaths were the same in both groups.
Patients in the study had average levels of LDL, or bad cholesterol, and the statins pushed the Lipitor group down to very low levels.
“You can’t say from this study that people placed on this regimen live longer, but you can argue that they live better, from fewer strokes and other cardiovascular” complications, said Dr. Robert Adams, a Medical College of Georgia neurologist.
Adams, vice chairman of an American Stroke Association panel that earlier this year updated guidelines on preventing second strokes, said they now state that some stroke survivors without heart disease “are reasonable candidates” for use of a cholesterol drug to prevent another stroke. He called the 80-milligram dose used in the study high; standard doses for heart patients run from 10 to 40 milligrams.
Lipitor’s benefit in this study “was relatively modest,” Dr. David Kent of Tufts-New England Medical Center wrote in an editorial in the journal.