Article date: January 2013
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. Recent use of Tredaptive in the UK has been less than 3000 patients.
A European review of Tredaptive (and similar medicines available outside the UK) 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.
New data show risks outweigh benefits
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 heart attack 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.
UK healthcare professionals were sent a letter highlighting the new information on Tredaptive in December 2012, and advised not to start any new patients on the drug.
In the light of the latest evidence, the benefit-risk balance for Tredaptive is considered negative, and the medicine has been recalled . A letter informing healthcare professionals of this decision was circulated in .
Advice for healthcare professionals:
- tredaptive has been recalled since 18 January 2013
- patients currently taking Tredaptive should make a non-urgent appointment to discuss their treatment options with their doctor
Press release from the European Medicines Agency
BNF section 2.12: Lipid-regulating drugs
Article citation: Drug Safety Update January 2013, vol 6, issue 6: S1
Published 11 December 2014