Drug lowers cholesterol in men receiving androgen deprivation therapy

An oral drug under development for the treatment of multiple side effects of androgen deprivation therapy appears to lower total cholesterol levels, according to an interim analysis of phase III clinical trial results.

The analysis was performed in the first 197 subjects who completed 1 year of the trial. Prostate cancer patients on androgen deprivation therapy who received toremifene citrate (Acapodene), 80 mg, had lower total cholesterol (-7.1%; p=.001), LDL cholesterol (-9.0%; p=.003), and triglycerides (-20.1%; p=.009), a reduction in the total cholesterol/HDL choleseterol ratio (-11.7%; p<.001), and higher HDL levels (+5.4%; p=.018) compared with men receiving a placebo.

“As patients are living longer with prostate cancer because of ADT, serious side effects have become major causes of morbidity and even death,” said lead author Matthew R. Smith, MD, PhD, of Harvard Medical School, Boston. “A medicine that is able to address multiple side effects of ADT would mark important progress in the care of prostate cancer patients.”

GTx, which is developing toremifene, is conducting a pivotal phase III trial of the drug for the treatment of multiple serious side effects of ADT in approximately 1,400 men at more than 150 sites in the United States and Mexico. The primary endpoint of the trial is a reduction in vertebral fractures. Secondary endpoints include improvements in bone mineral density, hot flashes, gynecomastia, and lipid profiles.