FDA issues early communication about ongoing review of Vytorin.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued an Early Communication Jan. 25 r garding the agency's ongoing review of Vytorin based on preliminary results from a recently completed study on this cholesterol-lowering drug cholesterol-lowering drug Therapeutics Any of a family of agents that ↓ serum cholesterol; the most cost-effective agents for lowering LDL-C are nicotinic acid and lovastatin; the most efficient for ↑ HDL-C are nicotinic acid and gemfibrozil . Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin simvastatin /sim·va·stat·in/ (sim´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated ) in one tablet. The ENHANCE trial tested Vytorin among patients with a rare genetic predisposition genetic predisposition Molecular medicine The tendency to suffer from certain genetic diseases–eg, Huntington's disease, or inherit certain skills–eg, musical talent to dangerously high cholesterol Cholesterol, High Definition Cholesterol is a fatty substance found in animal tissue and is an important component to the human body. It is manufactured in the liver and carried throughout the body in the bloodstream. levels (See related story in "Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. " section, page 17). On Jan. 14, Merck and Schering Plough issued a press release reporting preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous het·er·o·zy·gous adj. 1. Having different alleles at one or more corresponding chromosomal loci. 2. Of or relating to a heterozygote. Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone. Merck and Schering Plough stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid arteries despite greater lowering of LDL-cholesterol with Vytorin compared to simvastatin. FDA has not received a final study report and announced that "at this time it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone." ENHANCE was a two-year, multi-national, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind study conducted in 720 patients with heterozygous familial hypercholesterolemia (HeFH), a condition that is associated with very high cholesterol levels and affects approximately 0.2% of the population. Half of the patients were treated with 10 mg of Zetia combined with 80 mg of Zocor and half with 80 mg of Zocor alone. Many studies have supported the conclusion that lowering cholesterol levels reduces the risk for heart attack and stroke. Zetia inhibits the absorption of cholesterol in the intestine and is approved to lower LDL-cholesterol levels. Zocor is a statin stat·in n. Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol. approved to reduce LDL LDL - ["LDL: A Logic-Based Data-Language", S. Tsur et al, Proc VLDB 1986, Kyoto Japan, Aug 1986, pp.33-41]. and increase high-density lipoprotein (HDL (Hardware Description Language) A language used to describe the functions of an electronic circuit for documentation, simulation or logic synthesis (or all three). Although many proprietary HDLs have been developed, Verilog and VHDL are the major standards. ) cholesterol levels and reduce the risk of cardiovascular events such as heart attack and stroke. Vytorin is approved for reducing LDL and increasing HDL cholesterol levels. There are no clinical studies available that demonstrate a reduction in risk of heart attack or stroke when Zetia is used alone or in combination with a statin, including the fixed-dosed combination drug Vytorin. While the overall incidence of cardiovascular events in ENHANCE was similar in both the Vytorin and Zocoralone groups, there were not enough patients in this study to reliably test whether treatment with the combination drug compared with the statin alone reduces the risk of cardiovascular events. An ongoing trial known as IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) is examining this question in 12,500 patients and will likely be completed in 2011. Once Merck and Schering Plough complete the analysis of the unblinded data from ENHANCE, they will submit a final study report to FDA. FDA estimates it will take approximately six months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL-lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA's current approach to drugs that lower LDL cholesterol are warranted. Full text of the Early Communication about an Ongoing Data Review for the ENHANCE Study can be found at: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm By Joseph Pickett, Associate Editor |
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