部份中文依折麦布辛伐他汀处方资料（仅供参考）
英文药名: VYTORIN(ezetimibe/simvastatin Tablets)

中文药名: 依泽替米贝辛伐他汀复方片

生产厂家：默沙东制药
药品简介:
Vytorin是依泽替米贝和辛伐他汀合剂，属于降胆固醇药物，应用到高胆固醇的个人。 Vytorin是通过减少小肠对胆固醇的吸收从而达到降低胆固醇的作用。
Vytorin（依折麦布辛伐他汀）片是默沙东新加坡分公司上市的复方制剂。用于治疗高血脂及难治性高血、高胆固醇等症。其复方制剂的有效成分是：依折麦布、辛伐他汀。
本药采用三种规格即：每片含量为：10mg;10mg\10mg;20mg\10mg;40mg。根据患者的病情合理选用其实用的规格。
依折麦布：
原发性高胆固醇血症：本品作为饮食控制以外的辅助治疗，可单独或与HMG-CoA还原酶抑制剂(他汀类)联合应用于治疗原发性(杂合子家族性或非家族性)高胆固醇血症，可降低总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白B(ApoB)。纯合子家族性高胆固醇血症(HoFH)：本品与他汀类联合应用，可作为其他降脂治疗的辅助疗法(如LDL-C血浆分离置换法)，或在其他降脂治疗无效时用于降低HoFH患者的TC和LDL-C水平。
纯合子谷甾醇血症(或植物甾醇血症)：本品作为饮食控制以外的辅助治疗，用于降低纯合子家族性谷甾醇血症患者的谷甾醇和植物甾醇水平。一种口服、强效的降脂药物，其作用机制与其它降脂药物不同(如：他汀类，胆酸螯合剂(树脂类)，苯氧酸衍生物和植物性固醇酯化物)。本品附着于小肠绒毛刷状缘，抑制胆固醇的吸收，从而降低小肠中的胆固醇向肝脏中的转运，使得肝脏胆固醇贮量降低从而增加血液中胆固醇的清除。
辛伐他汀：
辛伐他汀为HMG-CoA还原酶抑制剂。辛伐他汀可降低正常的和升高的低密度脂蛋白胆固醇（LDL-C）水平。低密度脂蛋白（LDL）由极低密度脂蛋白（VLDL）生成，主要通过与LDL受体结合代谢。
辛伐他汀降低LDL作用的机制在于降低VLDL胆固醇浓度和LDL受体的诱导作用，从而导致LDL-C的产生减少和/或分解代谢增加。载脂蛋白B（ApoB）在辛伐他汀治疗期间也有下降。因为每个LDL微粒包含一分子ApoB，而且在主要以LDL-C升高的病人（不伴随VLDL升高）体内仅发现很少的ApoB，均提示辛伐他汀不仅通过降低LDL而降低胆固醇，而且减少外周的LDL微粒的浓度。另外，辛伐他汀可降低VLDL和甘油三酯（TG），并升高HDL-C.辛伐他汀对于脂蛋白、纤维蛋白原和冠心病的其他的生化指标的影响尚不明确。
VYTORIN®（依折麦布和辛伐他汀[ezetimibe and simvastatin]）复方片剂
最初美国批准：2004年
作用机理
VYTORIN
血浆胆固醇从小肠吸收和内源性合成的。VYTORIN包含依泽替米贝和辛伐他汀，用行动的互补机制的两种降脂化合物。VYTORIN降低升高的总-C，LDL-C，载脂蛋白B，TG和非HDL-C的，并增加HDL-C的通过胆固醇吸收和合成的双重抑制。
依泽替米贝
依泽替米贝通过小肠抑制胆固醇的吸收降低血液中的胆固醇。依泽替米贝的分子目标已被证明是固醇转运，尼曼-皮克C1样1（NPC1L1），这是参与小肠对胆固醇的吸收和植物甾醇在为期2周的临床研究中18高胆固醇血症患者，依泽替米贝通过54％抑制肠胆固醇吸收，与安慰剂相比。依泽替米贝对脂溶性维生素A的血浆浓度没有临床有意义的效果，D和E和它没有削弱肾上腺皮质类固醇激素的生产。
。依折麦布本地化在小肠刷状缘和抑制胆固醇的吸收，导致在传送肠道胆固醇至肝脏，这会导致降低肝胆固醇存储的，并增加了从血液中的胆固醇的清除率的降低;这一独特的机制是互补的他汀类药物[见临床研究]。
辛伐他汀
辛伐他汀是一种前药和水解成其活性β羟基酸形式，辛伐他汀酸，之后施用。辛伐他汀是3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶，酶的特异性抑制剂，其催化转化的HMG-CoA来甲羟戊酸，在生物合成途径为胆固醇的早期和速率限制步骤。此外，辛伐他汀减少非常低密度脂蛋白（VLDL）和TG，并增加HDL-C。
适应症和用法
VYTORIN，其中包含胆固醇吸收抑制剂和HMG-CoA还原酶抑制剂（他汀类），被表示为辅助治疗饮食给：
降低升高总-C，LDL-C，载脂蛋白B，TG和非HDL-C，并增加HDL-C的原发性（杂合子家族和非家族性）高脂血症或混合性高脂血症。
减少患者的总升高-C和LDL-C与纯合子家族性高胆固醇血症（HoFH），作为辅助其他降脂治疗。
使用限制
VYTORIN对心血管发病率和死亡率之上该展示了辛伐他汀没有增量效益已经建立。
VYTORIN尚未研究在弗德利克森I型，III，IV和V血脂异常。
用法用量
剂量范围是10/10毫克/天至10/40毫克/天。
推荐的通常起始剂量是10/10或10/20毫克/天。
由于肌病的风险增加，包括横纹肌溶解，使用VYTORIN的10/80毫克的剂量应限于谁一直没有肌肉的证据长期（如12个月或以上）服用VYTORIN 10/80 MG患者毒性。
谁正在容忍VYTORIN的10/80-毫克的剂量需要对被禁忌或与剂量盖帽为辛伐他汀关联应被切换到替代他汀或基于他汀类药物治疗方案具有较少潜在的相互作用的药物发起谁患者用于药物 - 药物相互作用。
由于肌病的危险增加，包括横纹肌溶解，与VYTORIN的10/80-毫克的剂量相关，患者无法实现利用VYTORIN的10/40毫克剂量的LDL-C的目标不应滴定至10/80毫克的剂量，但应放在替代LDL-C的降处理（s）表示，提供了更大的LDL-C的降低。
VYTORIN的给药应该发生任何≥2前几小时或胆汁酸螯合剂的给药后≥4小时
剂型和规格
片剂（依泽替米贝毫克/辛伐他汀毫克）：10/10，10/20，10/40，10/80。
禁忌症
强CYP3A4抑制剂同时服用。
吉非贝齐，环孢素，达那唑或同时服用。
过敏这种药物的任何组件
活动性肝病或肝转氨酶水平的原因不明的持续升高。
妇女谁是怀孕或可能怀孕。
哺乳期的母亲
警告和注意事项
应建议患者肌病的风险增加，包括横纹肌溶解症，10/80-毫克的剂量
应建议患者及时报告任何不明原因的和/或持续性肌肉痛，触痛或虚弱。如果肌病诊断或怀疑VYTORIN，应立即停药。
骨骼肌的影响（例如，肌病和横纹肌溶解）：风险与高剂量和合并使用某些药物诱发因素增加包括高龄（≥65），女性，甲减失控和肾功能不全急性肾功能横纹肌溶解罕见的情况下失败继发于肌红蛋白尿已经报道
肝酶异常：肝转氨酶持续升高，可能会发生开始治疗前检查肝酶试验，然后根据临床指征
不良反应
常见（发生率≥2％和大于安慰剂）在临床试验中的不良反应:头痛，ALT升高，肌肉痛，上呼吸道感染，和腹泻
药物相互作用
的药物相互作用，肌病/横纹肌溶解的风险增加。
对于患者HoFH谁一直在服用80毫克辛伐他汀长期（如12个月或以上），无肌毒性的证据，不采取lomitapide当超过10/40毫克VYTORIN。
强CYP3A4抑制剂（例如，伊曲康唑，酮康唑，泊沙康唑，伏立康唑，红霉素，
克拉霉素，泰利霉素，
HIV蛋白酶抑制剂，用boceprevir，特拉匹韦，奈法唑酮，含cobicistat产品），吉非贝齐，环孢菌素，达那唑禁忌与VYTORIN
维拉帕米，地尔硫卓，决奈达隆不要每天超过10/10毫克VYTORIN
胺碘酮，氨氯地平，雷诺嗪不要每天超过10/20毫克VYTORIN
Lomitapide对于患有HoFH，不是每天都超过10/20毫克VYTORIN *
西柚汁避免柚子汁
香豆素类抗凝：辛伐他汀延长VYTORIN开始监测INR频繁，直到VYTORIN后开始治疗或改变稳定之前INR实现稳定INR
消胆胺：组合降低EZ曝光
VYTORIN® (ezetimibe/simvastatin) Significantly Reduced Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes in the Investigational IMPROVE-IT Study
CHICAGO--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the investigational IMPROVE-IT study met its primary and all secondary composite efficacy endpoints.
In IMPROVE-IT, patients taking the LDL-cholesterol-lowering medicine VYTORIN® (ezetimibe/simvastatin)–which combines simvastatin with the non-statin ZETIA® (ezetimibe) -experienced significantly fewer major cardiovascular events (as measured by a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, re-hospitalization for unstable angina or coronary revascularization occurring at least 30 days after randomization) than patients treated with simvastatin alone. The results from this 18,144-patient study of high-risk patients presenting with acute coronary syndromes were presented today during the late-breaking clinical trials session at the American Heart Association 2014 Scientific Sessions.
Because high-risk patients treated with statins, including those on treatment with low levels of LDL-cholesterol (LDL-C), continue to be at increased cardiovascular risk, IMPROVE-IT was designed to address whether lowering LDL-C to well under 70 mg/dL by adding ezetimibe to a statin further reduced cardiovascular events. In IMPROVE-IT, at seven years, 32.7 percent of patients taking VYTORIN experienced a primary endpoint event compared to 34.7 percent of patients taking simvastatin alone (hazard ratio of 0.936, p=0.016). Based on the LDL-C range compared in the study’s treatment arms (at one year, a mean LDL-C of 53 mg/dL versus 70 mg/dL, respectively), the 6.4 percent relative risk reduction observed in the VYTORIN arm in IMPROVE-IT was consistent with the treatment effect that had been projected based on prior studies of statins.
Merck plans to submit the data from IMPROVE-IT to the U.S. Food and Drug Administration in mid-2015 to support a new indication for reduction of major cardiovascular events for VYTORIN and ZETIA. VYTORIN and ZETIA are currently indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia.
The current U.S. Prescribing Information for both products states that the effect of ezetimibe on cardiovascular morbidity and mortality, alone or incremental to statin therapy, has not been determined.
“In IMPROVE-IT, the addition of ezetimibe to a statin resulted in a further reduction in cardiovascular events compared to statin therapy alone, which is the first time this has been directly shown in a study of a non-statin cholesterol-lowering medicine,” said study co-chairs, Drs.
Eugene Braunwald of Harvard Medical School and Robert Califf of Duke University. “The IMPROVE-IT data also address an important scientific question about lowering LDL-C to very low levels.”
VYTORIN (ezetimibe/simvastatin) should not be taken with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products); or with gemfibrozil, cyclosporine, or danazol. VYTORIN also should not be taken by anyone with active liver disease, unexplained persistent elevations of hepatic transaminase levels, or hypersensitivity to the product; or by women who are pregnant, nursing or may become pregnant.
ZETIA (ezetimibe) should not be taken by people with hypersensitivity to any component of the medication. Statin contraindications also apply when ZETIA is used with these drugs: statins are contraindicated in patients with active liver disease, unexplained persistent elevations in hepatic transaminase levels and in pregnant and nursing women. Refer to individual statin labels for details about who should not take that statin.
IMPROVE-IT compared very low LDL-C levels -- a range at or below 70 mg/dL
In IMPROVE-IT (IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial), the LDL-C levels compared were very low. At one year, the mean LDL-C level was 53 mg/dL in the VYTORIN group and 70 mg/dL in the simvastatin group, with a between-group difference of 17 mg/dL. When the IMPROVE-IT study was initiated in 2005, the optional recommended target LDL-C level in the United States for acute coronary syndrome patients and other groups considered to be at very high risk for cardiovascular events was <70 mg/dL. Prior cardiovascular outcomes studies of statins have not compared treatments at such low LDL-C levels (see Table).
At the start of the study, the average baseline LDL-C was approximately 95 mg/dL. Among treatment-naïve patients (about two-thirds of those in the study), the mean baseline LDL-C was 101 mg/dL.
Among patients on prior lipid lowering therapy at enrollment, the mean baseline LDL-C was 80 mg/dL.
Additional efficacy and safety results from IMPROVE-IT
Patients in IMPROVE-IT were initially randomized to treatment with VYTORIN (ezetimibe/simvastatin) 10/40 mg or simvastatin 40 mg. Patients were followed for up to nine years, with a median clinical follow-up of approximately six years.
In this event-driven study, 5,314 primary endpoint events were reported.
In addition to the significant result on the primary composite efficacy endpoint, patients taking VYTORIN experienced significant reductions compared to patients taking simvastatin alone on the three secondary composite efficacy endpoints, as follows:
•VYTORIN reduced the incidence of the composite endpoint of death due to all causes, major coronary events, and non-fatal stroke; this endpoint occurred in 38.7 percent of patients taking VYTORIN and 40.3 percent of patients taking simvastatin only (hazard ratio of 0.948, p=0.034).
•VYTORIN reduced the incidence of the composite endpoint of death due to coronary heart disease (CHD), non-fatal myocardial infarction (MI), and urgent coronary revascularization with either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) occurring at least 30 days after randomization; this endpoint occurred in 17.5 percent of patients taking VYTORIN and 18.9 percent of patients taking simvastatin only (hazard ratio of 0.912, p=0.016).
•VYTORIN reduced the incidence of the composite endpoint of cardiovascular death, non-fatal MI, documented unstable angina that requires admission into a hospital, all revascularization (including both coronary and non-coronary) occurring at least 30 days after randomization, and non-fatal stroke; this endpoint occurred in 34.5 percent of patients taking VYTORIN and 36.2 percent of patients taking simvastatin only (hazard ratio of 0.945, p=0.035).
There were no significant differences between treatment groups in adverse events of special interest, which included myopathy and rhabdomyolysis, gallbladder adverse events, liver enzyme elevations greater than or equal to three times the upper limit of normal (ULN) and cancer. These safety findings from IMPROVE-IT were generally consistent with current labeling for ezetimibe. Among 9,067 patients in the ezetimibe/simvastatin group vs. 9,077 patients in the simvastatin group, myopathy was reported in 0.2 percent vs. 0.1 percent of patients, respectively; rhabdomyolysis was reported in 0.1 percent vs. 0.2 percent; gallbladder-related adverse events were reported in 3.1 percent vs. 3.5 percent; cholecystectomy was reported in 1.5 percent vs. 1.5 percent; and alanine aminotransferase (ALT) and/or aspartate transaminase (AST) elevations (greater than or equal to three times ULN, consecutive) were reported in 2.5 percent vs. 2.3 percent of patients. Over seven years, cancer was reported in 10.2 percent of patients in both treatment groups.
“We believe that the IMPROVE-IT study makes an important scientific contribution to the body of evidence relating LDL-cholesterol levels to cardiovascular risk,” said Dr.
Roger Perlmutter, president, Merck Research Laboratories. “We are grateful to our collaborators at Harvard and Duke who led the study, their fellow
investigators, and to the thousands of patients around the world who participated in this study for their efforts.”
About VYTORIN® (ezetimibe/simvastatin)
VYTORIN contains ezetimibe and simvastatin. 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.
The Prescribing Information for VYTORIN states that no incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
VYTORIN is not indicated to reduce cardiovascular events in patients who have presented with acute coronary syndromes.
Selected cautionary information about VYTORIN
All patients starting therapy with VYTORIN, or whose dose of VYTORIN is being increased, should be advised of the risk of myopathy, including rhabdomyolysis, and told to promptly report any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing VYTORIN. VYTORIN should be discontinued immediately if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. VYTORIN contains simvastatin, which occasionally causes myopathy manifested as muscle pain, tenderness, or weakness with CK levels above 10 times ULN. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. Predisposing factors for myopathy include advanced age (≥65 years), female gender, uncontrolled hypothyroidism, and renal impairment. The risk of myopathy, including rhabdomyolysis, is dose related.
The 10/80 mg dose of VYTORIN should not be started in new patients. The risk of myopathy, including rhabdomyolysis, is greater in patients taking simvastatin 80 mg compared with other statin therapies with similar or greater LDL cholesterol lowering efficacy, and with lower doses of simvastatin. The 10/80 mg dose of VYTORIN (ezetimibe/simvastatin) should be used only in patients who have been taking that dose chronically (e.g., for 12 months or more) without evidence of muscle toxicity. If a patient who is currently tolerating the 10/80 mg dose needs to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin, that patient should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction. Please read Warnings and Precautions in the Prescribing Information for additional information.
In addition to drugs that are contraindicated because of an increased risk of myopathy/rhabdomyolysis, grapefruit juice should be avoided. Use caution when prescribing VYTORIN with a fenofibrate, and immediately discontinue both drugs if myopathy is diagnosed or suspected. Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be used when prescribing VYTORIN with colchicine.
The dose of VYTORIN should not exceed 10/10 mg daily in patients receiving verapamil, diltiazem or dronedarone, and 10/20 mg daily in patients receiving amiodarone, amlodipine or ranolazine. For patients with homozygous familial hypercholesterolemia (HoFH) taking lomitapide, the dose should not exceed 10/20 mg/day (or 10/40 mg/day for patients who have previously taken simvastatin 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity); patients initiating lomitapide should have their dose of VYTORIN reduced by 50%. The benefits of combined use of VYTORIN with these drugs, other fenofibrates, or niacin (≥1 g/day) should be carefully weighed against the potential risk of myopathy/rhabdomyolysis. Caution should be used when Chinese patients taking niacin (≥1 g/day) are coadministered doses of VYTORIN exceeding 10/20 mg/day; Chinese patients should not receive VYTORIN 10/80 mg with niacin.
Persistent elevations in hepatic transaminase can occur. Liver function tests should be performed at treatment initiation and thereafter when clinically indicated. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted promptly and not restarted unless an alternate etiology is found.
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including simvastatin.
In clinical trials, the most commonly reported side effects, regardless of cause, included headache (5.8 percent), increased ALT (3.7 percent), myalgia (3.6 percent), upper respiratory tract infection (3.6 percent), and diarrhea (2.8 percent).
VYTORIN tablets contain ezetimibe and simvastatin: 10 mg of ezetimibe and 10, 20, 40, or 80 mg of simvastatin (VYTORIN 10/10, 10/20, 10/40, or 10/80 mg, respectively). The usual dosage range is 10/10 mg/day to 10/40 mg/day; patients should not be titrated to the restricted 10/80-mg dose.
About ZETIA (ezetimibe)
ZETIA, administered alone or in combination with a statin, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, and non-HDL cholesterol in patients with primary (heterozygous familial and non-familial) hyperlipidemia when diet alone is not enough.
The Prescribing Information for ZETIA states that the effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA is not indicated for use with a statin to further reduce cardiovascular events in patients who have presented with acute coronary syndromes.
Selected cautionary information about ZETIA
When using ZETIA with a statin, also follow the label recommendations for that specific statin.
When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (greater than or equal to 3 times ULN) were slightly higher (1.3 percent) than those of statins alone (0.4 percent). Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations. Should an increase in ALT or AST greater than or equal to 3 times ULN persist, consider withdrawal of ZETIA and/or the statin.
Patients should be advised to promptly report muscle pain, tenderness, or weakness. Risk for skeletal muscle toxicity increases with higher statin doses, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Discontinue drug if myopathy is diagnosed or suspected.
ZETIA is not recommended in patients with moderate to severe hepatic impairment.
The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied. Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin versus a statin alone included nasopharyngitis (3.7 percent vs 3.3 percent), myalgia (3.2 percent vs 2.7 percent), upper respiratory tract infection (2.9 percent vs 2.8 percent), arthralgia (2.6 percent vs 2.4 percent), and diarrhea (2.5 percent vs 2.2 percent); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3 percent vs 2.5 percent), diarrhea (4.1 percent vs 3.7 percent), arthralgia (3.0 percent vs 2.2 percent), sinusitis (2.8 percent vs 2.2 percent), pain in extremity (2.7 percent vs 2.5 percent), and fatigue (2.4 percent vs 1.5 percent).
Additional information about the IMPROVE-IT study
IMPROVE-IT was an international, multi-center, randomized, double-blind active comparator trial of 18,144 high-risk patients presenting with acute coronary syndromes (ACS), including unstable angina (UA), non-ST-segment elevation acute myocardial infarction (NSTEMI), and ST-segment elevation acute myocardial infarction (STEMI). The study assessed the incidence of major cardiovascular events, as measured by a composite of cardiovascular death, non-fatal MI, non-fatal stroke, re-hospitalization for ACS, or coronary revascularization (occurring 30 days or more after the initial event), in patients treated with ezetimibe/simvastatin (VYTORIN) compared with patients treated with simvastatin alone.
All patients in the trial were started at doses of ezetimibe/simvastatin 10/40 mg or simvastatin 40 mg. Prior to a 2011 protocol amendment, the dose could be titrated to ezetimibe/simvastatin 10/80 mg or simvastatin 80 mg if successive LDL-C values exceeded 79 mg/dL. The study enrolled patients within 10 days of ACS hospitalization who had sufficient risk as defined in the protocol and who had an initial LDL-C of ≤125 mg/dL if lipid-lowering drug naïve or <100 mg/dL if on a prior prescription lipid-lowering therapy identified as no more potent than simvastatin 40 mg/day. The LDL-C entry limitations were designed to enroll patients reasonably anticipated to achieve LDL-C levels of 70 mg/dL or less in the simvastatin only cohort, which was the optional recommended target set in the 2004 update to the Adult Treatment Panel (ATP) III guidelines.
For additional information about the study, please see the accompanying study timeline.
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Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site。
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f58df9c-59fb-4d13-65be-4aff52f223e2
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VYTORIN TAB 10/80MG UU 30  EZETIMIBE/SIMVASTATIN     66582-0315-31  
VYTORIN TAB 10/20MG 30  EZETIMIBE/SIMVASTATIN     66582-0312-31 
VYTORIN TAB 10/40MG UU 30  EZETIMIBE/SIMVASTATIN     66582-0313-31
VYTORIN TAB 10/10MG UU 30  EZETIMIBE/SIMVASTATIN     66582-0311-31
VYTORIN TAB 10/40MG BULK 500=  EZETIMIBE/SIMVASTATIN     66582-0313-74
VYTORIN TAB 10/80MG UU 90  EZETIMIBE/SIMVASTATIN     66582-0315-54
VYTORIN TAB 10/80MG BULK 500=  EZETIMIBE/SIMVASTATIN     66582-0315-74
VYTORIN TAB 10/10MG UU 90  EZETIMIBE/SIMVASTATIN     66582-0311-54
VYTORIN TAB 10/20MG UU 90  EZETIMIBE/SIMVASTATIN     66582-0312-54
VYTORIN TAB 10/20MG BULK 1000=  EZETIMIBE/SIMVASTATIN     66582-0312-82
VYTORIN TAB 10/40MG UU 90  EZETIMIBE/SIMVASTATIN     66582-0313-54
VYTORIN TAB 10/20MG 10000=  EZETIMIBE/SIMVASTATIN     66582-0312-87