LONDON--The European Medicines Agency, or EMA, Friday said it has started a review of the safety and efficacy of Tredaptive, Pelzont and Trevaclyn, identical medicines that are used to treat adults with dyslipidaemia, particularly combined mixed dyslipidaemia and primary hypercholesterolaemia.
-Review was triggered because the Agency was informed by the pharmaceutical company Merck, Sharp & Dohme of the preliminary results of a large, long-term study comparing the clinical effects of adding these medicines to statins (standard medicines used to reduce cholesterol) with statin treatment alone.
-Study raises questions about the efficacy of the medicine when added to statins, as this did not reduce the risk of major vascular events compared with statin therapy alone.
-Preliminary results saw a higher frequency of non-fatal but serious side effects in patients taking the medicines than in patients only taking statins.
-Pharmacovigilance Risk Assessment Committee (>> PRODUCTIVITY TECHS CORP) will assess the data and make a recommendation to the Committee on Medicinal Products for Human Use (>> Champion Industries, Inc.), which will issue an opinion on the regulatory action required.
-Opinion is expected in January 2013.
-Write to Tapan Panchal at [email protected]
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