RVX-208 drug fails to increase good cholesterol levels in ASSURE trial

Published on September 4, 2013 at 4:49 AM · 1 Comment

The primary endpoint - the change in percent atheroma volume (PAV), or the amount of artery volume taken up by disease - was not met. The PAV decreased by 0.4 percent in the RVX-208 group and 0.3 percent in the placebo group. Secondary IVUS endpoints - the change in total atheroma volume (TAV), or size of the disease, and the change in atheroma volume in the most severely diseased portion of the artery - also did not differ substantially between the RVX-208 group and the placebo group. Further, the biochemical endpoints of increased aopA1 and HDL levels, and decreased LDL, or bad cholesterol levels, also failed compared to placebo.

"Our results show that RVX-208 treatment did not result in any measurable incremental benefit on plaque regression for patients with coronary artery disease and low HDL cholesterol," said Nicholls. "The findings could reflect either a lack of efficacy of RVX-208, or the general inability to improve on the benefits produced by statins and other cardiovascular therapies."

All of the patients in ASSURE were being treated with atorvastatin or rosuvastatin, drugs shown in clinical trials to lower LDL levels.

"Ever since statins were approved more than 25 years ago, there has been an intensive, concerted effort in the scientific community to find an HDL-raising drug that will work in tandem with statins and improve cardiovascular outcomes," said Steven Nissen, M.D., Chairman of the ASSURE trial and Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic. "Unfortunately, that search must go on."

Source: Cleveland Clinic

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  1. Tess Timina Tess Timina United States says:

    Would be really interested to hear input from the good docs at Cleveland on news since this Phase II failure.   Post hoc analysis indicated good results across the board when paired with rosuvastatin but not with atorvastatin.  also shown were lowered crp, mace events, selectivity to BD2, etc.  pending further trials properly powered to show proof, - at least to those of us watching from outside - this still looks more promising, despite missing primary endpoints. would love to hear some insights from the investigators.

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