Nov. 15, 2011 (Orlando, Fla.) -- Once again, an experimental pill that boosts levels of HDL "good" cholesterol has shown promising results in a mid-stage study.
In a three-month study of nearly 400 people, the drug evacetrapib raised HDL and lowered LDL, the so-called "bad cholesterol" -- both when given alone and with standard cholesterol-lowering statin drugs.
Importantly, evacetrapib did not routinely increase blood pressure or produce any of the other toxic effects that halted development of its predecessor, torcetrapib.
The big question, however, is whether raising levels of good cholesterol will prevent heart attacks, strokes, and deaths, says Robert Harrington, MD, of Duke University Medical Center in Durham, N.C. He was not involved with the study, but has consulted for the maker of another HDL-boosting drug.
More people have to be followed for longer periods of time to ensure the drug both prevents heart problems and is safe over the long term, he tells WebMD.
"With torcetrapib, we didn’t see the problem until thousands of patients were taking it for longer periods," Harrington says.
The study appears in the Nov. 16 issue of The Journal of the American Medical Association. It was released early online today to coincide with its presentation at the American Heart Association (AHA) Scientific Sessions.
Search for an HDL Booster
While credited with making a substantial dent in heart disease, the use of statin drugs that lower bad cholesterol doesn't prevent all heart attacks.
That’s why the search is on for drugs that boost levels of HDL "good" cholesterol, which is thought to ferry cholesterol from the bloodstream to the liver, where it can be disposed of.
The research suffered an early setback when development of torcetrapib was halted after the drug was linked to an increased risk of heart attacks and death from heart disease.
Like torcetrapib, evacetrapib works by blocking a process that transforms good cholesterol into bad cholesterol.
Impact of Evacetrapib
The new study involved 398 people with elevated LDL "bad" cholesterol or low HDL "good" cholesterol. They were given either a placebo, evacetrapib alone, a statin alone, or a statin plus evacetrapib for 12 weeks.
Among the findings:
- HDL "good" cholesterol levels more than doubled in those given the highest dose of evacetrapib, often shooting up to a level that is considered protective against heart disease, according to the American Heart Association.
- Among patients on the highest dose, average LDL "bad" cholesterol levels dropped to healthy levels.
- When administered in combination with statin therapy, evacetrapib about doubled HDL levels and resulted in greater reductions in LDL levels than statins alone.
Safety analyses were very reassuring, says study head Stephen J. Nicholls, MBBS, PhD, of the Cleveland Clinic. He is an unpaid consultant to Eli Lilly, the maker of the drug.
"This gives us a lot of confidence to move in to a [late-stage] trial," he tells WebMD. "But until we see a big clinical trial in which one of these new agents actually lowers the risk of heart attack, stroke, or death, the jury is still out on whether HDL raising actually works."
AHA spokesperson Robert Eckel, MD, of the University of Colorado in Denver, agrees. ”We have to await the results of the [upcoming] trials," he tells WebMD.