According to data from the National Stroke Association, up to 40 percent of patients who have had a stroke will experience a second stroke within five years of the first. An international team of researchers recently completed a study to determine if the cholesterol-lowering drug Lipitor® (atorvastatin calcium) would reduce the occurrence of a second stroke. The Stroke Prevention by Aggressive Reduction of Cholesterol Levels (SPARCL) team of investigators, led by Dr. K. Michael Welch, neurologist and President and CEO of Rosalind Franklin University of Medicine and Science, published their research in today’s issue of the New England Journal of Medicine.
The SPARCL study included 4,731 patients with no history of heart disease who had experienced a stroke or TIA (mini stroke) within six months of study enrollment. The patients had mildly elevated cholesterol levels, and received either 80 mg of Lipitor® or a placebo; they were then monitored for an average of five years.
Study findings indicate that patients taking Lipitor® experienced a 16-percent reduction in the risk of secondary stroke compared with patients taking a placebo. Lipitor patients also saw a 35-percent reduction in the risk of major coronary events (cardiac death, non-fatal heart attacks, or resuscitated cardiac arrest) compared to the patients taking placebo. “These cardiovascular results are remarkable in a population not known to have had heart disease,” said principal investigator, Dr. K. Michael Welch.
The SPARCL study researchers conclude that their results support the initiation of statin (i.e., Lipitor®) treatment shortly after a stroke or TIA. “We believe that the findings indicate that Lipitor 80 should become an established part of secondary stroke prevention,” said Dr. Welch.
An analysis of the SPARCL data was designed and conducted after the study ended to explore the types of strokes - ischemic or hemorrhagic - that occurred among patients in the study. Eighty-five percent of the strokes in this trial were ischemic. Patients taking Lipitor® experienced a 22-percent reduction in the risk of ischemic stroke.
Also, the number of patients in the analysis who experienced Hemorrhagic stroke was very small. There were more patients in the Lipitor® group who experienced this type of stroke (2.3 percent), compared to patients taking placebo (1.4 percent). However, the overall benefit in terms of reducing the risk of stroke was still significant despite this increase, and there was no difference in the number of deaths from Hemorrhagic stroke between the two treatment groups.
Every year, an estimated 15 million people worldwide suffer strokes, and 10 million will either remain disabled or die. Strokes also exact a heavy economic toll, with the lifetime cost of treating one patient with a stroke averaging more than $3 million. Reducing the risk of stroke through the application of new data, such as those revealed by the SPARCL investigation, is a key priority in cardiovascular medicine.
The 16-percent reduction in secondary stroke risk that was achieved through aggressively reducing cholesterol levels of study patients is indeed significant. “These data are important information for physicians because patients who have had a stroke are at much greater risk for suffering another one, yet treatment options to reduce their risk are limited,” commented Dr. Welch.
SPARCL is an investigator-led trial coordinated by an independent steering committee and funded by Pfizer, Inc.
Rosalind Franklin University of Medicine and Science
Revision date: July 8, 2011
Last revised: by Jorge P. Ribeiro, MD