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| |  Extended-Release Dipyridamole Plus Aspirin Fails to Prove Non-Equivalence With Clopidogrel: Presented at ESC By Ed Susman NICE, France -- May 14, 2008 -- Researchers who conducted the long-anticipated Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) failed to show that treatment with extended-release dipyridamole plus aspirin was noninferior to clopidogrel in stroke patients. Ralph L. Sacco, MD, Professor of Neurology, University of Miami, Miami, Florida, presented the findings here at the 17th Annual Meeting of the European Stroke Conference (ESC). The trial results, which covered several areas of stroke treatment, were described in 3 presentations, each dealing with a different aspect of the trial. The 20,332 patients were selected for the trial from 695 centres in 35 countries on 6 continents after being diagnosed with a nonembolic ischaemic stroke. In the study 10,181 patients were randomised to receive the dipyridamole regimen and 10,151 to clopidogrel, one of the recognised standards of care for poststroke treatment. The patients had an average age of 66 years and two-thirds were men; about three-quarters had high blood pressure and 28% were diabetic; 46% had high cholesterol. The primary outcome of the trial was designed to show that the dipyridamole arm of the study was noninferior to clopidogrel and then, if noninferiority to clopidogrel was established, the trialists would test the results for superiority. The researchers had hypothesised that the dipyridamole-containing regimen would show a 13% improvement over clopidogrel in preventing a second stroke. Noninferiority was to be established if the difference between the treatments was less than 1.075. However, the study results failed to achieve either of the objectives, Dr. Sacco said in the plenary sessions on May 14. In the primary outcome -- prevention of a second stroke -- 916 (9%) dipyridamole patients had strokes compared with 898 (8.8%) of clopidogrel patients (P = .783). "Although the event rate for the primary outcomes was nearly identical for both regimens, the trial failed to meet the noninferior criteria," Dr. Sacco said. When the researchers analysed the types of strokes that occurred in the study patients, they found that 25 fewer ischaemic strokes occurred with the dipyridamole regimen than with clopidogrel; but 38 more haemorrhagic strokes occurred with the dipyridamole regimen than with clopidogrel. There were more haemorrhages and intracranial bleeding with the dipyridamole regimen than with clopidogrel (P = .06). Mortality rates after 4.0 years were 7.8% in the dipyridamole arm and 8.1% in the clopidogrel arm, Dr. Sacco said.
[Presentation title: Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) Trial: Comparison of a Fixed-Dose Combination of Extended-Release Dipyridamole Plus ASA With Clopidogrel.]
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