Vytorin Labeling Updated to Include New Study Data in CKD Patients
Merck announced that the FDA has approved updated labeling for Vytorin (ezetimibe/simvastatin) that includes results from the Study of Heart and Renal Protection (SHARP), published last June in The Lancet. A total of 9,438 patients with chronic kidney disease (CKD) were enrolled. Approximately one-third of the patients were undergoing dialysis therapy for end-stage renal disease at the time of entry, and the remaining patients were pre-dialysis patients with advanced CKD with a median estimated glomerular filtration rate of 25.6mL/min/1.73m2.
SHARP demonstrated that treatment with Vytorin 10mg/20mg versus placebo reduced the risk for major vascular events in this CKD population. In the primary intent-to-treat analysis, 639 (15.2%) of 4,193 patients initially allocated to Vytorin and 749 (17.9%) of 4,191 patients initially allocated to placebo experienced a major vascular event, which corresponded to a significant (P=0.001) relative risk reduction of 16%. The effect of Vytorin on major vascular events was less among patients on dialysis compared with those not on dialysis. Among 3,023 patients on dialysis at baseline, Vytorin reduced the risk of major vascular events by 6% (relative risk of 0.94, with 95% CI 0.80–1.09), compared with 22% (relative risk of 0.78, with 95% CI 0.69–0.89) among 6,247 patients not on dialysis at baseline.
Vytorin is indicated as adjunctive therapy to diet for the reduction of total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and non–HDL-cholesterol, and to increase HDL-cholesterol in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia when diet alone is not enough.
For more information call (800) 672-6372 or visit http://www.vytorin.com/.