This article is more than 5 years old. Information may no longer be current.
FDA committee recommends new drug applications for ezetimibe, simvastatin
Click Here to Manage Email Alerts
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee today recommended approval of the new drug application for ezetimibe/simvastatin for the prevention of major vascular events in patients with pre-dialysis chronic kidney disease, but not for patients with end-stage renal disease already receiving dialysis.
Looking at data from the Study of Heart and Renal Protection (SHARP) trial, 16 out of 16 committee members voted that the efficacy and safety data provide substantial evidence to support approval of ezetimibe/simvastatin 10/20 mg for the prevention of major vascular events in patients with pre-dialysis chronic kidney disease. However, for patients with end-stage renal disease already receiving dialysis, 10 out of 16 committee members voted that the efficacy and safety does not provide substantial evidence for approval.
Abraham Thomas, MD, MPH, FACP, the division head of Endocrinology, Diabetes, Bone and Mineral Disorders and Hypertension at the Henry Ford Hospital, suggested that there was not enough information provided for patients with end-stage renal disease.
“As the average patient goes toward end-stage, renal dialysis takes more and more medications. If they have diabetes they may be on two or three medications for that,” he said. “They may be on three, four, five or six blood pressure medications. Medications for calcium for their elevated PTH, for their phosphate, vitamins, it goes on and on. You have to have a pretty clear indication that there’s going to be some efficacy to add another one to the regimen. It affects adherence for other medications which may also be very important for their care and so when we add the 10th or 11th medication I think we have to have pretty good data, and it probably does need an additional trial with larger amounts of subjects enrolled.”
The SHARP trial compared the reduction of major vascular events between ezetimibe/simvastatin and placebo. In the study, patients were randomly assigned to placebo, ezetimibe/simvastatin or simvastatin for 1 year. Patients in the simvastatin group were then randomly assigned to placebo or ezetimibe/simvastatin after 1 year. The primary outcome of first major vascular event showed that the combination reduced major vascular events by 16% (risk ratio=0.84; 95% CI, 0.75-0.93) vs. placebo.
The indications proposed for ezetimibe/simvastatin include risk reduction of major CV events in patients with chronic kidney disease.
Although the FDA is not required to follow the recommendations of the advisory committees, it usually does.
 |
Follow CardiologyToday.com on Twitter. |