Tredaptive Cholesterol Drug Axed Over Serious Side Effect Fears

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Tredaptive Cholesterol Drug Axed Over Serious Side Effect Fears

Main Category: Cholesterol
Also Included In: Cardiovascular / Cardiology | Clinical Trials / Drug Trials
Article Date: 12 Jan 2013

Doctors are being told that cholesterol drug Tredaptive does not work and can trigger serious and sometimes life-threatening side effects. They have been told to stop prescribing the medication.

Merck has announced plans to stop producing the extended-release niacin/laropiprant drug Tredaptive . The drug, used to manage dyslipidemia (high levels of cholesterol and fat in the blood), is not approved in the U.S. and the company is about to suspend the worldwide availability of it completely.

These measures come following the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, the results of which indicate that the drug is not nearly as effective as previously thought. The drug was found to be associated with a number of serious adverse events. This comes as conclusive evidence to dismiss previous research that claimed the drug could be used as a possible approach of treating patients with dyslipidaemia.

The company has already started notifying regulatory bodies in countries where the drug is still available to ensure that health care providers cease the availability of the drug.

Merck is strongly advising all physicians to discontinue prescribing the drug to patients and consider finding other treatment options for those who are currently taking it. They encourage patients to talk with their physician before completely stopping the medication.

According to Michael Rosenblatt, M.D., Chief Medical Officer, Merck:

"Patients currently taking TREDAPTIVE are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of TREDAPTIVE,"

The HPS2-THRIVE study was carried out by a team of researchers from Oxford University and involved 25,673 patients who were considered to be at high risk for cardiovascular events. They monitored the effectiveness of extended release niacin and laropiprant plus statin therapy versus only statin therapy.

The patients were followed up for an average of 3.9 years. At the end of follow-up the researchers found that combining statin therapy with extended release niacin and laropiprant didn't reduce the risk of coronary deaths, nonfatal heart attacks, strokes or revascularizations compared to those who were solely on the statin therapy.

In fact patients who underwent a combination of statin therapy with extended release niacin and laropiprant were more likely to experience serious non-fatal adverse events.

According to Merck:

"Preliminary analyses suggest that the adverse events fall within the following broad categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin. Additional analyses are ongoing to understand the adverse events within these categories."

The drug is sold in over 40 countries worldwide and is sold under a variety of different brand names (REVACLYN in Italy and Portugal and CORDAPTIVE in other countries).

Written by Joseph Nordqvist
Copyright: MediLexicon International Ltd

Original article posted on Medical News Today.
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