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Mixed Results for Low-Dose Statin in Second Stroke

— Pravastatin didn't reduce incidence of recurrent stroke, but did offer other benefits.

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NASHVILLE, Tenn. -- Treating stroke patients with low-dose pravastatin (Pravachol) did not appear to prevent the occurrence of a second stroke, Japanese researchers reported here.

In patients with noncardioembolic ischemic stroke, the risk of stroke was 2.55% a year among patients taking 10-mg daily pravastatin compared with 2.65% a year for patients taking other medications at the discretion of their physician after a median follow-up of nearly 5 years, said , of the University of Hiroshima, and colleagues.

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

However, there appeared to be a decline in atherosclerotic-type strokes among the patients treated with low-dose, Matsumoto noted in a press conference at the International Stroke Conference.

There were no statistically significant differences at baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, cause of the index stroke, or in the use of antiplatelet agents, Matsumoto stated.

But after 4.9 years of follow-up, patients taking pravastatin achieved about a 10% reduction in total cholesterol (P<0.001) and significant reductions in LDL cholesterol (P<0.001) and triglycerides, (P=0.006) along with an increase in HDL cholesterol (P=0.004).

Nevertheless, treatment with pravastatin was not potent enough to significantly impact overall stroke occurrence, which was the primary endpoint of the so-called , Matsumoto said.

"In Japan, it is still unclear if hyperlipidemia is a risk factor of recurrent stroke in the ischemic stroke patients without coronary heart disease," Matsumoto explained. He noted that in other trials, the use of statins decreased the incidence of cardiovascular diseases, including coronary heart disease and ischemic stroke, in this patient population.

He also pointed out that high dose of atorvastatin (Lipitor) decreased the overall incidence of strokes in patients with stroke or transient ischemia attacks (TIA) in the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) Trial.

Matsumoto's group hypothesized that the cholesterol-lowering effects could be expected to attenuate cerebrovascular inflammation and atherosclerosis.

They planned to recruit 3,000 patients for J-STARTS trial, but after 7 years enrollment was truncated at 1,578 patients. They assigned 793 patients to pravastatin and 785 patients to control. Matsumoto pointed out that follow-up was achieved despite earthquakes and a tsunami in the area where many of the patients and researchers lived.

Looking at secondary endpoints, the research team noted that, almost from the start of the follow-up period, the incidence curves separated when atherothrombotic strokes were observed. For patients on pravastatin, the risk of this type of stroke was 0.21% per year compared with a rate of 0.65% a year for controls (hazard ratio 0.33, 95% CI 0.15-0.74). This was a statistically significant finding even after adjustment for the index subtype of stroke, elevated blood pressure, and diabetes status, they reported.

In commenting on the trial, press conference moderator cautioned that the trial results may not apply to many U.S. patients.

"The dose of pravastatin is lower than we would normally give our patients, but in many cases we have to reduce medication levels in treating people from Asia," he told MedPage Today, adding that the dose used in this study was not inappropriate. "In cholesterol-lowering therapy, we [in the U.S] would use a dose of at least 40 mg a day of pravastatin," he said.

Obviagele, who is professor and chair of neurology at the Medical University of the South Carolina in Charleston, said he was intrigued by the difference in the atherothrombotic-caused strokes. "It makes sense that treatment with a cholesterol-lowering agent might make a difference in these strokes caused by atheromas which are more similar to heart disease," he said. "I think there is something there; something to investigate."

Disclosures

Matsumoto disclosed no relevant relationships with industry. Some co-authors disclosed relevant relationships with sanofi-aventis, Daiichi Sankyo, Lundbeck, Mitsubishi Tanabe Pharma Cooperation, Kyowa Hakko Kirin Pharma, Otsuka, Bayer, Asteras Pharma, AstraZeneca, EPS, Boehringer Ingelheim, Pfizer, Stryker, Medicos Hirata, and Sawai Pharma.

Obviagele disclosed no relevant relationships with industry.

Primary Source

International Stroke Conference

Source Reference: Matsumoto M, et al "The Japan Statin Treatment Against Recurrent Stroke (J-STARS): a multicenter, randomized, open-label, parallel-group study" ISC 2015; Abstract LB16.