June 22nd, 2010
• Aggrenox Fails to Beat Aspirin in Japanese Study
• Livalo Now Available in the U.S.
• New York Times Spotlights ICDs with Benefits
Larry Husten, PHD
Aggrenox Fails to Beat Aspirin in Japanese Study: Aggrenox, the combination of extended-release dipyridamole and aspirin, is indicated for the reduction of subsequent stroke in patients who have had a TIA or ischemic stroke. But results from JASAP (Japanese Aggrenox Stroke Prevention vs. Aspirin Programme), which compared Aggrenox to aspirin in 1294 patients, found that Aggrenox failed to cause a significant reduction in recurrent stroke; in fact, there was a trend toward more strokes in the Aggrenox group than in the aspirin group (45 vs. 32, P=0.097).
The manufacturer of Aggrenox, Boehringer Ingelheim, has not publicized the results, which were first received on February 16, 2010 and posted on ClinicalTrials.gov in March. News of JASAP was first reported on Pharmalot. Boehringer Ingelheim provided Pharmalot with a statement: “Because neither non-inferiority nor superiority of either treatment could be demonstrated, we cannot draw conclusions from this study about the relative efficacy of either agent.” Aggrenox’s initial approval was based on the results of the second European Stroke Prevention Study.
Livalo Now Available in the U.S.: Livalo (pitavastatin) is now available in the United States, according to the drug’s manufacturer, Eli Lilly. However, as noted on Pharmalot, Wall Street analysts question whether the drug will find a large commercial market.
New York Times Spotlights ICDs with Benefits: A feature article in the New York Times by Gina Kolata provides a mostly sunny view of ICDs with remote monitoring features. Although the article quotes Lynne Warner Stevenson as saying that “information overload is a very serious problem,” most of the comments in the story, including others by Stevenson, Leslie Saxon, and Richard Page, take a positive view of the devices. Page calls the new technology “potentially transformative.”
I’ve often wondered how aggrenox would compare versus aspirin… important results and it makes us wonder what the results would have looked like had it been an even larger trial. Looks like pitavastatin is supposed to be a more potent statin, like rosuvastatin, but less reliant on P450 for metabolism, like pravastatin. Good idea, but unclear how much traction this will get given the numerous other statins available… and safety and cost still issues to be determined…