Out-Of-Favor Drug Shows Promise In Restenosis

Probucol, an old lipid-lowering agent taken off the market by HoechstMarion Roussel in 1995, has been found to cut the rate of restenosis after angioplasty, according to a study reported in the New England Journal of Medicine (August 7). However, the new study also found that taking antioxidant multivitamins, either alone or in combination with the drug, provided no benefit in this indication.

Probucol is no longer on the market in Europe and the USA, having been withdrawn in 1995 in advance of a US Food and Drug Administration advisory committee meeting to discuss the product's supposed lack of efficacy. The drug was originally marketed under the trade name Lorelco, but was approved when there was less understanding of the pathology of hypercholesterolemia. In addition to its lowering effects on low-density lipoprotein cholesterol, probucol also lowers high-density lipoprotein cholesterol, and HDL particles are now known to be protective against coronary artery disease.

The product was never a major earner for HMR; in 1994 probucol's sales were just under $14 million. However, the drug is still on the market in Japan, where antioxidant treatment as a concept is more widely regarded. Japanese physicians use probucol as a treatment for stomach cancer, but four small (uncontrolled) clinical studies have been published in Japan which support probucol's role post-angioplasty.