November 25th, 2010.
The results of a new clinical trial have established the safety of a new drug that boosts the blood level of the good HDL cholesterol while lowering that of the bad LDL cholesterol. These results open the way for a larger trial to see whether the drug will also reduce the risk of having a heart attack.
The results of the trial, co –chaired by the Heart Research Institute’s (HRI) Director, Professor Philip Barter, were presented at the American Heart Association’s Annual Scientific Sessions in Chicago last week and published simultaneously in the prestigious New England Journal of Medicine.
The Merck sponsored DEFINE trial found the investigational drug anacetrapib dramatically raises the good HDL cholesterol while lowering the bad LDL cholesterol. Results also showed the drug had none of the safety concerns that brought down a similar previous drug, torcetrapib.
“When given atop background statin therapy, anacetrapib reduced the level of LDL cholesterol by about 40% and more than doubled the level of HDL cholesterol,” Professor Barter said.
“Clearly, the drug needs further testing, but these initial findings of safety are most encouraging and will enable us to determine whether the dramatic effects it has on the levels of good and bad cholesterol can translate into significant benefits to those at risk of heart attack or stroke.”
Professor Barter said it was important to get reassurance that the drug did not share the safety problems of its predecessor, torcetrapib before launching into a full hard outcomes trial.
To provide such reassurance, the DEFINE trial included 1,623 patients with or at high risk for coronary heart disease and who already had their level of LDL cholesterol reduced by statin therapy. These patients were randomized to receive anacetrapib or placebo daily for 18 months.
None of the safety problems found with torcetrapib were observed.
“We can now be confident a cholesterol drug so powerful that some researchers believe it could become the best weapon yet against heart disease has passed a critical test of its safety,” Professor Barter said.
But he urged caution saying that we will not have the true answer until the drug is tested in a very large trial designed to discover whether the drug actually reduces heart attacks.
The drug manufacturer, Merck, will now sponsor a four year study in 30,000 patients to determine its ability to reduce the risk of heart attack. This trial will be designed, run and analyzed by an academic steering committee of experienced researchers based mainly in Oxford University in the UK and the Brigham and Women's Hospital in Boston, USA. This steering committee, of which Professor Barter is a member, is independent of the sponsoring company.
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