Plavix + Aspirin No Better than Aspirin Alone in Preventing 2nd Strokes, May Up Bleeding and Death Risks, Study Finds

New research is raising doubts about the usefulness of Plavix in preventing a recurrent stroke.  According to a study published in The New England Journal of Medicine, the combination of Plavix and aspirin is no better at preventing second strokes in people who’ve suffered a previous lacunar stroke compared to aspirin alone.  The addition of Plavix to an aspirin regimen also upped the likelihood of serious gastrointestinal bleeding and death, according to the study.

Lacunar strokes, which account for roughly one-fifth of all strokes, occur in the small blood vessels in the brain, according to a report from HealthDay News.  They are generally associated with chronic high blood pressure, and depending on where they occur, can cause disability. People who have had a lacunar stroke are usually prescribed antiplatelet therapy to reduce their risk of a second stroke.

The Plavix portion of this study, dubbed the Secondary Prevention of Small Subcortical Strokes (SPS3) trial, was designed to determine if adding Plavix to aspirin would offer better protection to these patients than aspirin alone.  According to HealthDay News, the Plavix arm of the SPS3 study was stopped last August, after the U.S. National Institutes of Health (NIH) determined that there was “little likelihood of benefit in favor of aspirin plus clopidogrel [Plavix] [for] recurrent stroke should the study continue to conclusion.”  However, an arm of the trial investigating whether aggressive blood pressure treatments can prevent strokes and cognitive decline was allowed to continue.

In the Plavix portion of the trial, more than 3,000 patients who had suffered a lacunar stroke were randomly selected to receive either a combination of aspirin and Plavix, or aspirin and a placebo. During the study’s 8-year follow-up, the rate of second stroke was almost even between the two groups: 2.5 percent for patients treated with the Plavix-aspirin combo, compared with 2.7 percent among those taking just aspirin.

However, those in the Plavix-aspirin combo group had a higher rate of serious side effects.  The rate of serious bleeding – mostly gastrointestinal bleeding – among those taking the drug combo was 2.1 percent versus 1.1 percent in the aspirin-only group.  At the same time, there were 113 deaths recorded among Plavix-aspirin patients, and only 77 in the aspirin group.

“For all stroke therapeutics, there is a need to balance the potential benefits against the risks. The SPS3 findings establish that for lacunar stroke, dual therapy with aspirin and clopidogrel carries significant risk and minimal benefit,”  Walter Koroshetz, M.D., deputy director of National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, said in a press release.

Current practice guidelines recommend aspirin alone, Plavix alone, or aspirin plus dipyridamole for secondary prevention after most types of stroke.  According to the NINDS press release, the SPS3 results are consistent with those guidelines.

This entry was posted in Pharmaceuticals, Plavix and tagged . Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.