Drugs Xagena
Tredaptive is a fixed-dose combination product containing extended-release Nicotinic acid ( 1000 mg ) and Laropiprant ( 20 mg ), which has been indicated for the treatment of dyslipidemia, particularly in patients with combined mixed dyslipidemia and in patients with primary hypercholesterolemia. It has been used in combination with a statin when the cholesterol-lowering effect of statin treatment alone is not sufficient, or alone in patients unable to take statins.
A European review of Tredaptive was started in December 2012 after new data from a large, long-term study ( HPS2-THRIVE ) involving over 25 000 patients suggested that the benefits of these medicines did not outweigh the risks.
The preliminary results of the study indicated that adding Tredaptive to Simvastatin did not provide significant additional benefit in reducing the risk of major vascular events such as myocardial infarction and stroke, compared with statin therapy alone. In addition, a higher frequency of non-fatal but serious adverse events was seen in patients taking Tredaptive with Simvastatin, compared with patients taking Simvastatin alone. These events included bleeding ( intracranial and gastro-intestinal ), myopathy, infections and new-onset diabetes.
In the light of the latest evidence, the benefit-risk balance for Tredaptive is considered negative, and the medicine has been recalled. ( Xagena )
Source: Drug Safety Update 2013 vol 6, issue 6: S1
XagenaMedicine_2013
