WHITEHOUSE STATION (dpa-AFX) - Merck (MRK) announced that researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE study of TREDAPTIVE. Merck previously announced that the study did not meet its primary endpoint, and was taking steps to suspend the availability of TREDAPTIVE in countries where the medicine has been approved. The company said there were statistically significant increases in non-fatal serious adverse events observed in patients taking TREDAPTIVE plus statin therapy compared to patients taking placebo plus statin therapy. The events included: diabetic complications, new onset diabetes, infection, gastrointestinal, musculoskeletal, bleeding and skin. There was also a small excess in heart failure.
The study was independently conducted by the Clinical Trial Service Unit at Oxford University, the regulatory sponsor of the trial, and funded by Merck.
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