Ezetimibe/Simvastatin在降低膽固醇上可能優於Atorvastatin


  March 14, 2005 (奧蘭多) - 美國心臟醫學學會(ACC)的2005年科學年會上,一項對向式研究結果顯示,在比較過ezetimibe/simvastatin (複方藥,商品名Vytorin)與atorvastatin (40mg)後發現,該複方藥物在降低低密度脂蛋白(LDL)膽固醇的效果上,顯然有著較好的效果。
  
  休士頓衛理公會德倍基心臟醫學中心,心血管疾病預防中心主任Christie Ballantyne醫師表示,ezetimibe/simvastatin的複方藥物可以將LDL濃度降低56%,而atorvastatin卻只能降低36%。
  
  除了可以降低高血脂症患者的總膽固醇外,使用複方藥物,有82%的患者LDL膽固醇的濃度可以低至100 mg/dL以下,Atorvastatin的使用者中,只有47%可以達到這樣的效果;在P<0.001水準下,這樣的差值已經達到統計上的明顯差異。
  
  Ballantyne醫師表示,有關降低LDL膽固醇的議題,目前已經有了很多討論,特別是對於高危險群的患者;根據本研究顯示,以國家膽固醇教育計畫成人治療流程第三版(NCEP-ATP-III)為標準,相較於使用atorvastatin 40mg的患者,使用Vytorin 10/40複方藥的高危險群患者,可以達到NCEP-ATP-III所制定的目標濃度以下,亦即100 mg/dL;Vytorin 10/40試驗組中有57%的患者,LDL膽固醇濃度低於70 mg/dL,Atorvastatin 10mg組中只有23%獲致NCEP-ATP-III所制定的目標。
  
  本項研究為期6週,在多個臨床中心進行,為雙盲性及隨機分配的設計,一共有8個試驗組,以平行比較組的方式進行試驗;Ballantyne的研究小組進行了LDL膽固醇的降低效果評比,評比的藥物為等同於statin毫克劑量的ezetimibe/simvastatin及atorvastatin,有1902位高膽固醇症的患者參與試驗;平均的初始LDL膽固醇濃度為166到169 mg/dL。
  
  Ezetimibe/simvastatin的研究結果發表時,另一高劑量atorvastatin的新目標治療研究(TNT)也在同一天稍晚的臨床試驗議程中作出發表,TNT的研究亦刊載於新英格蘭醫學期刊(NEJM)上;TNT試驗的結果發現,以atorvastatin 80mg作治療,致命及非致命性的心肌梗塞、中風、冠狀動脈心臟病致死率等的相關風險,下降了22%,中風的機率下降了25%,同時LDL膽固醇濃度可以下降至80 mg/dL以下,另一atorvastatin 10mg的試驗組,其LDL膽固醇的治療目標則為100 mg/dL以下。
  
  密西根大學醫學院的Bertram Pitt醫師在NEJM的評論中,針對TNT的研究結果提出他的看法,將ezetimibe加入statin療程的做法會有某些啟發,一些醫師會在低劑量的statin中加入另外的藥物,如ezetimibe;因為他們相信,這類的合併用藥不但更安全,而且可以獲致等同於每日atorvastatin 80 mg在降低LDL膽固醇上的效果。
  
  北卡羅萊納大學心血管科學及醫學中心的主任Sidney Smith醫師對Ballantyne的研究作出評論,他向Medscape表示,我們相信,主要的目的是在於LDL的降低,而不是單一藥物的治療效果。
  
  Smith醫師並未參與Ballantyne醫師的試驗,也未涉入TNT試驗,但他指出,最強而有力的數據是來自statin的試驗結果;我們並沒有數據是關於非statin藥物,這類藥物的使用是否可以在降低LDL膽固醇上獲致類似的結果,目前還不清楚;但是我希望能夠看到這樣的試驗,亦即證明類似ezetimibe/simvastatin的合併用藥,不只可以在降低膽固醇方面獲致與statin一樣的程度,或許更好,對於屬於危險群患者,這類的合併用藥是否可以改善治療效果,也應一併評估。
  
  同時,Smith醫師表示,看起來,Ezetimibe/simvastatin合併藥物的治療會是一項有效的療法。

Ezetimibe/Simvastatin May Be M

By Peggy Peck
Medscape Medical News

March 14, 2005 (Orlando) — A head-to-head comparison of ezetimibe and simvastatin — the polypill marketed as Vytorin — to atorvastatin (40 mg) found that the combination pill was more effective at lowering low-density lipoprotein (LDL) cholesterol, according to results reported here at the American College of Cardiology 2005 Annual Scientific Session.

Christie Ballantyne, MD, director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center in Houston, Texas, said the ezetimibesimvastatin combination reduced LDL cholesterol levels by 56% compared with a 36% reduction for atorvastatin.

In addition to overall cholesterol-lowering in the high-risk hyperlipidemic patients, about 82% of patients receiving the combination therapy achieved an LDL cholesterol level less than 100 mg/dL compared with 47% of patients receiving atorvastatin 10 mg. That reduction reached statistical significance at the P < .001 level.

"There has been a good deal of discussion about achieving even lower LDL cholesterol goals, especially in higher-risk patients," Dr. Ballantyne said. "This study demonstrated that not only did more high-risk patients taking Vytorin 10/40 achieve the National Cholesterol Education Program Adult Treatment Panel III goal of less than 100 mg/dL compared with atorvastatin 40 mg, but also that 57% of patients taking Vytorin 10/40 reduced LDL cholesterol to less than 70 mg/dL, while only 23% of the patients taking atorvastatin 10 mg achieved that goal."

In the six-week, multicenter, double-blind, randomized, eight-group, parallel-group study, Dr. Ballantyne and colleagues compared the LDL cholesterol–reducing efficacy of milligram-equivalent statin doses of ezetimibe/simvastatin and atorvastatin in 1,902 patients with hypercholesterolemia. Average baseline LDL cholesterol measurements ranged from 166 to 169 mg/dL.

The ezetimibe/simvastatin study was reported the same day that results of the high-dose atorvastatin Treat to New Targets (TNT) study was presented during a late-breaking clinical trials session and released online by the New England Journal of Medicine (NEJM). The TNT study found a 22% reduction in relative risk of fatal and nonfatal myocardial infarction and stroke and coronary heart disease mortality and a 25% reduction in stroke for patients treated with 80 mg atorvastatin to an LDL cholesterol target of less than 80 mg/dL compared with those receiving 10 mg of atorvastatin and treated to an LDL cholesterol goal of 100 mg/dL.

Bertram Pitt, MD, from the University of Michigan School of Medicine, Ann Arbor, who authored an editorial accompanying the TNT results in the NEJM, alluded to the use of adding ezetimibe to a statin regimen. He suggested that “some clinicians may choose to add an agent, such as ezetimibe...to a lower dose of a statin in the belief that this combination is as effective as 80 mg of atorvastatin per day in lowering LDL cholesterol but safer.”

Commenting on the results of Dr. Ballantyne's study, Sidney Smith, MD, director of the Center for Cardiovascular Science and Medicine at the University of North Carolina in Chapel Hill and a spokesperson for the American Heart Association, told Medscape that “we believe the benefits are related to the lower LDL target” rather than treatment with a specific drug.

But Dr. Smith, who was not involved in either Dr. Ballantyne's study or the TNT study, pointed out that the "strongest data — and only outcomes results [to date] — have come with statin therapy. We don't have the data on outcomes that treating to lower targets with nonstatin drugs would produce similar results. That is a study I would like to see performed. It would be designed to show if a combination product such as ezetimibe/simvastatin can not only lower cholesterol as well as or better than a statin alone, but whether that combination results in improved outcomes for at-risk individuals.”

Meanwhile, Dr. Smith said it does appear that the ezetimibe/simvastatin combination is an effective treatment.

The study was funded by Merck & Co, the maker of Vytorin.

ACC 2005 Annual Scientific Session: Abstract 1129-111. Presented March 8, 2005.

Reviewed by Gary D. Vogin, MD

    
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