積極的降脂療法可以降低心血管疾病的發生


  March 8, 2005 - 美國心臟病醫學會(American College of Cardiology)在本週二舉行的2005年科學年會上有一項發表指出,一項研究數據顯示,由於積極的降脂療法可以將低密度脂蛋白(LDL)膽固醇濃度降至80mg/dL以下,所以致命及非致命性的心肌梗塞、中風、冠狀心臟病等所引發的死亡相關風險,降低了22%。
  
  一項由輝瑞藥廠贊助的研究,名為「新標的治療」(Treating to New Target, TNT),發表於新英格蘭醫學期刊線上版。
  
  這項合併性研究的試驗終點,皆對患者作出正面的效益;除此之外,接受atorvastatin 10mg治療的患者,平均的LDL膽固醇濃度為101mg/dL,積極治療組的患者(使用atorvastatin 80mg),在相較之下,其中風的風險降低了25%。
  
  紐約州立大學保健科學中心的John C. LaRosa表示,從LDL濃度為100開始,我們在冠狀動脈病變的治療上,已經進入了一個新紀元;LaRosa醫師在ACC的全體會議上發表他的研究結果。
  
  以10mg atorvastatin作治療,經過8週的開放標記試驗後,平均LDL膽固醇降至130mg/dL以下的患者,以隨機分配的方式繼續給予10mg或80mg日劑量的atorvastatin;試驗追蹤期為4.9年。
  
  主要試驗終點之判定,端視致命或非致命性的中風或心肌梗塞,心臟在停止後經過復甦,或因冠狀動脈心臟病而死亡。
  
  在80mg試驗組中,試驗終點的案例有434件,10mg組則有558件;換言之,絕對風險的降低率為2.2%,相對風險則降低了22%。
  
  另外,80mg組的主冠狀動脈病變發生率,較之10mg組低了20%;在因充血性心臟衰竭而住院的風險方面,高劑量組較之低劑量組低了25%。
  
  然而,以上所述的這些正面效益並未導致副作用的增加;一共有5個橫紋肌溶解的案例,高劑量組佔了兩例;兩組之間,死亡率並無顯著差異;但是,LaRosa醫師表示,本項研究並非注重在顯現死亡率的差異。
  
  北卡羅萊納大學心血管醫學科學中心的主任,同時也是美國心臟病醫學會的Sidney Smith醫師,對本研究的結果表示熱衷,至於死亡率是否有差異,Smith醫師並不表關心;他向Medscape表示,如果可以選擇,我想大部分的人都想要沒有中風的活著。
  
  Smith醫師表示,他和其他的心臟科醫師們,從去年三月開始,就期待著TNT的試驗結果,因為一項哈佛的研究在當時曾提到,LDL膽固醇以積極的方式降至70mg/dL以下,足以將各種因素導致的死亡率降低28%,心肌梗塞的死亡風險可以降低25%,緊急心臟復甦的需要也可獲致相同程度的降低;該項研究的試驗比較組,分別為atorvastatin 80mg及pravastatin 40mg。
  
  Smith醫師指出,現在改變醫療程序還言之過早,因為還有兩項試驗會在未來的12個月內完成,皆為statin的高低劑量比較試驗。
  
  去年statin試驗的主研究員,來自哈佛的心臟科醫師Christopher P. Cannon則不表贊同,他表示,為什麼要等?對於患者,這是一項安全又有效的方法,現在應該把積極的statin療法納入正規的臨床治療當中。
  
  Smith及Cannon皆未參與本次的研究。
  
  在記者會上,LaRosa醫師指出,我們不應該根據一單獨的研究結果就改變臨床治療標準;但是,LaRosa也表示,以80mg的atorvastatin作治療是絕對安全的。

Aggressive Lipid-Lowering Ther

By Peggy Peck
Medscape Medical News

March 8, 2005 (Orlando) — Aggressive lipid-lowering therapy to achieve low-density lipoprotein (LDL) cholesterol levels of less than 80 mg/dL is associated with a 22% reduction in relative risk of fatal and nonfatal myocardial infarction and stroke and coronary heart disease mortality, according to data reported here Tuesday at the American College of Cardiology 2005 Annual Scientific Session.

Results of the Pfizer-sponsored 10,001 patient study, Treating to New Targets (TNT), were also published online by the New England Journal of Medicine.

In addition to the benefit demonstrated in the combined primary end point, patients in the aggressive treatment group (atorvastatin, 80 mg) had a 25% reduction in risk of stroke compared with patients treated with 10 mg of atorvastatin to a mean LDL cholesterol level of 101 mg/dL (P = .007).

"We have entered a new era in the treatment of established coronary disease from starting at an LDL of 100," said principal investigator John C. LaRosa, MD, from the State University of New York Health Science Center in Brooklyn. Dr. LaRosa presented the findings at an ACC plenary session.

After an eight-week open-label run in treatment with 10 mg of atorvastatin, patients who achieved a mean LDL cholesterol level of less than 130 mg/dL were randomized to 10 mg (n = 5,006) or 80 mg (n = 4,995) of atorvastatin per day. The patients were followed for 4.9 years.

The primary end point was occurrence of fatal or nonfatal stroke or myocardial infarction, resuscitation after cardiac arrest, or death from coronary heart disease.

In the 80-mg group, there were 434 events compared with 558 events in the 10-mg treatment group. This was an absolute risk reduction of 2.2% and a relative risk reduction of 22% (P = .0002), Dr. LaRosa said.

In addition, the risk for a major coronary event was reduced by 20% in the 80-mg group compared with the 10-mg group (P = .002), and the risk of hospitalization for congestive heart failure was reduced by 25% in the high-dose group vs the low-dose group (P = .01).

Moreover, the benefits were achieved without any significant increases in adverse events. There were five cases of rhabdomyolysis (two in the high-dose group). There was, however, no difference in overall mortality between the two groups, but Dr. LaRosa said the study was not powered to show a difference.

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, was enthusiastic about the results and not overly concerned about the failure to demonstrate a benefit in overall mortality. As he explained in an interview with Medscape, "Given the choice, I think most people would like to be alive without a stroke than alive with a stroke."

Dr. Smith said that he and other cardiologists have been awaiting the TNT results since last March, when a study from Harvard researchers reported that aggressive LDL cholesterol lowering to less than 70 mg/dL was associated with a 28% reduction in all-cause mortality and a 25% reduction in risk of death from MI or need for urgent revascularization compared with less aggressive treatment. That study compared 80 mg of atorvastatin to 40 mg of pravastatin.

Dr. Smith said, however, that it is probably too soon to change treatment guidelines because two more large studies comparing high-dose statins to lower-dose statins are expected to be reported in the next 12 months.

Christopher P. Cannon, MD, the Harvard cardiologist who was the principal investigator of last year's statin study, is less cautious. "Why wait? This works, is safe, and benefits patients," Dr. Cannon told Medscape. At the very least, he said he thinks that is time to incorporate aggressive statin treatment into clinical practice.

Neither Dr. Smith nor Dr. Cannon was involved in the study.

Speaking at a press conference, Dr. LaRosa said, "I don't think we should change guidelines on the basis of a single study." But he added that he is convinced that treatment with 80 mg of atorvastatin is "absolutely safe."

ACC 2005 Annual Scientific Session: Late-breaking clinical trials. Presented March 8, 2005.

Reviewed by Gary D. Vogin, MD

    
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