These volunteers started the study with a four-week lead-in on a diet developed by the U.S. National Institutes of Health to reduce cholesterol. Continuing this diet, for the next 12 weeks, the patients took a placebo or 25, 50, or 100 mg of eprotirome in addition to whatever statin they had already been taking. The researchers then analyzed the patients' levels of LDL cholesterol, HDL (or "good") cholesterol, triglycerides, apo B, and Lp(a).
The researchers found that among the patients taking the 25, 50 or 100 mg doses of eprotirome reduced their LDL cholesterol levels by 22 percent, 28 percent, and 32 percent respectively, compared to only 6.5 percent in those taking placebo. Remarkably, they also found similar dose-related reductions in triglycerides, apo B, and Lp(a).
They also found modest reductions in HDL cholesterol of approximately 3 percent. Low HDL has been associated with increased cardiovascular disease risk, since HDL levels reflect how much artery-blocking cholesterol is being ferried away from blood vessels and back to the liver. However, Ladenson says he and his colleagues believe this small decrease could reflect the livers' increased processing of cholesterol in general, which could actually lower cardiovascular disease risk.
When the researchers evaluated study subjects for the harmful side effects that can accompany increased thyroid hormone, they found no indications of increased heartbeat abnormalities, increased bone turnover, or other symptoms of thyroid hormone excess.
Ladenson adds that though previous studies have shown that high levels of Lp(a) are associated with an increased risk of cardiovascular disease, no drug existed to lower this lipid.
"Although we've long known a high Lp(a) is strongly associated with increased risk of future cardiovascular disease, we've had no idea if lowering Lp(a) actually diminishes cardiovascular disease risk," he says. "We can finally address this question with this drug."
Source: Johns Hopkins Medical Institutions