If pharmaceutical drugs were able to compete in a high school popularity contest, then Merck & Co.’s new experimental cholesterol medication anacetrapib would be voted “most likely to reduce the risk of stroke, cardiovascular (CV) events and death.” The novel drug is able to increase high-density lipoprotein (HDL), the “good” cholesterol, while simultaneously lowering low-density lipoprotein (LDL), or “bad” cholesterol. In a randomized, double-blinded, placebo-controlled trial, 1,623 patients already taking statins because they either had a higher-than-average risk of heart attack or suffered from diabetes were assigned to receive 100 mg of either anacetrapib or placebo daily for 18 months. After six months, patients taking anacetrapib reduced their LDL measures by 39.8 percent compared to placebo and increased their HDL cholesterol levels by an average of 138.1 percent.
Some doctors were overjoyed by the preliminary results. “The data look spectacular, beyond what anybody would have expected,” said Dr. Robert Eckel, a University of Colorado cardiologist and previous president of the American Heart Association. “It’s like a rocket to Jupiter versus one to the moon. I can think of many of my patients who could use the drug right now.”
Despite the excitement, it will still take several years before the drug becomes available, and more testing is needed to determine if anacetrapib is actually able to reduce the amount of heart attacks, strokes and deaths for patients on the drug. “While this study deals with biomarkers (HDL and LDL cholesterol levels) rather than clinical outcomes, it must be noted that drugs which lower LDL and raise HDL without untoward adverse effects are a sort of Holy Grail for cardiovascular research,” adds ACSH’s Dr. Gilbert Ross.
This is not the first time, however, that physicians and researchers got excited about a new therapy that later turned out to be a flop. Four years ago, Pfizer Inc. took an $800 million hit after walking away from torcetrapib, a similar drug that was associated with blood pressure problems. “The proof is in the pudding,” says Dr. Ross. “This is exactly why clinical outcomes must be further studied to determine if the biomarker improvements actually correlate with fewer CV events, strokes and deaths.”