Trilipix is used to treat high cholesterol and high triglyceride levels. It is sometimes given together with other cholesterol-lowering medications as it lowers blood fats called triglycerides while boosting quote, unquote, good cholesterol (high-density lipoprotein). This week a FDA advisory panel has recommended that the drug continue to me marketed in such a fashion and in addition, Abbott be required to conduct a study in those patients prescribed to determine if the Trilipix statin combination reduces heart attacks. This study is estimated to cost Abbott upwards of $100 million USD.
The recommendation from that panel, which the FDA normally abides by in their final decisions, goes against the grain considering the existence of a government study that questioned the benefit of using Trilipix in combonation therapies with the popular Lipitor and Zocor for example. A 5,000-patient government study released in March showed that diabetic patients taking Trilipix plus a statin had just as many heart attacks as patients taking a statin alone putting the benefit of this added element in question.
Trilipix is not the first blockbuster drug that has come under scrutiny after disappointing study results. In 2008, Merck’s blockbuster cholesterol pill Vytorin was criticized after a study showed it was no better than a low-cost generic at reducing plaque buildup in certain arteries.
Nine out of 13 panelists voted that the drug’s label should keep the combination as an approved use. Six voted that the label should be updated with results from the government study. Three said the labeling does not need to be changed.
Abbott reported combined sales of $1.6 billion last year for Trilipix and TriCor, an older drug that contains the same active ingredient. Sales of both drugs are expected to decline after 2012 when TriCor loses patent protection, exposing it to low-cost generic competition. There are currently no generic Trilipix (fenofibric acid) products licensed for sale in the United States. The earliest predictable date that any generic versions of this medication could become available is January 2025, when the patent for Trilipix expires.
Trilipix is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
There is some research on fibrates that has shown a benefit in warding off heart attacks, although not overall mortality. Research shows the major growth in prescriptions in the United States has come from fenofibrate, particularly its more expensive brand-name forms.
In the United States, prescriptions for fibrate medication generally more than doubled from 336 prescriptions per 100,000 people in 2002 to 730 prescriptions per 100,000 people in December 2009. The increase in Canada wasn’t as steep, from 402 to 474 per 100,000 people.
And in the United States, prescriptions specifically for fenofibrate nearly tripled from 150 prescriptions for every 100,000 people in 2002 to 440 for every 100,000 people in 2009. In Canada, fenofibrate’s use rose much less steeply, from 321 to 429 per 100,000.
Sources:
Written by Sy Kraft