高血壓患者採Amlodipine基礎食療法優於Atenolol


  Sept. 7, 2005(斯德哥薾摩) - 根據盎格魯-斯堪的納維亞人心臟疾病研究結果試驗(ASCOT),藉由隨機試驗超過1萬9千名病患的一個複合研究中心之研究指出,對高血壓病患來說,一種鈣離子阻斷劑的食療法,較包括乙型阻斷劑及利尿劑的傳統食療法,更可以防止更多主要心血管疾病的發生。
  
  主導這項研究的瑞典蓋特堡大學醫學系副教授Bjorn Dahlof 醫學博士表示,在追蹤5.5年後,藥物安全間控委員會決定提前停止這項試驗,因為結果顯示鈣離子阻斷劑amlodipine(Norvasc)使用後,接續使用血管張力素轉化酶抑制劑,其效果優於傳統的治療法;傳統治療法為一種結合乙型阻斷劑及利尿劑的合併治療方法。
  
  Dahlof 博士在歐盟心臟病學代表大會年會中表示,在每次試驗終點時,結果皆顯示,現代的療法較舊式療法有更佳的效果。
  
  隨機選取採用鈣離子阻斷劑/及血管張力素轉化酶抑制劑的病患群組,相較於使用乙型阻斷劑及利尿劑者,發生主要心血管病變的風險降低了16%(P<.001)、發生糖尿病的風險降低30%(P<.0001)、中風的風險降低23%(P=.003)、死亡機率降低11%(P=.025)。
  
  Dahlof博士向Medscape表示,24%心血管病變死亡率的降低量,是死亡率降低的最大原因。
  
  ASCOT研究計畫是至今有關歐洲人高血壓症最大研究專案,研究母體包括19,257名病患,年齡40-79歲,不但罹患高血壓,而且至少帶有其他三種引發心血管病變的風險因素;在研究母體中,隨機選取9,639名,每天給予5-10 mg的amlodipine與perindopril(Aceon)一起服用,而另外9,618則給予50-100 mg bendroflumethiazide及鉀元素,依需求一起服用。
  
  在5.5年的追蹤研究中,相較於服用atenolol的病患組,服用amlodipine病患組有著較低的非致命的心肌梗塞(MI; 包括silent MIs )機率,致命的冠狀動脈心臟病(474 vs 429)發生率亦較低;這些狀況顯見於主要試驗終點的時間點上。
  
  不過,Dahlof博士表示,當我們排除silent MIs後,在每個試驗終點到達時,即可看出明顯的差別;致命性及非致命性的中風、總心血管疾病發生次數及治療情形、糖尿病的發生,以及所有致死原因等,在amlodipine病患組都明顯較低。
  
  在這兩種組別中,有15%的病患有副作用狀況,amlodipine的病患組有2%的比率產生嚴重副作用,atenolol組則為3%;Dahlof博士表示,對於少部分患者而言,這類藥物的可疑副作用,含胸痛、腹瀉等。
  
  此外,32%罹患糖尿病病患,及60%未患有糖尿病者皆獲致預期的血壓目標,無糖尿病者的收縮壓/舒張壓為140/90mm Hg,患有糖尿病者則為130/80 mm Hg。
  
  但是,隨機接受鈣離子阻斷劑病患的舒張壓,較服用乙型阻斷劑之患者,僅低約2.7 mm Hg。
  
  這項發現關於是否血壓因為療法不同而降低,或其他因素影響,也引發爭論。
  
  ASCOT調查研究人員,同時也是英格蘭倫敦帝大預防性心血管病變醫療研究教授Neil Poulter醫學博士表示,血壓本身的變化僅能解釋15-35%服用amlodipine的病患所獲致的結果;他向Medscape表示,可能的解釋是,鈣離子阻斷劑的好處會超過血壓的降低;而atenolol基礎治療卻與降低血壓無關,這是該項療法的負面效果。
  
  不過,前美國心臟協會(AHA)會長,現任伊利諾州芝加哥西北大學的醫學教授Robert Bonow醫學博士向Medscape表示,這主要是血壓降低效果,每項高血壓研究都曾顯示,血壓即使有著些微的降低,也會對結果造成影響。
  
  AHA發言人,同時也是賓州大學外科手術臨床醫學教授Tim Gardener醫學博士補充表示,我們需對混合藥物的使用要更小心些。
  
  Gardener向Medscape表示,更重要的是,你必須對療法作個別處理,不論是混合藥物治療,或最佳單藥治療,目標皆在獲致最佳的療高血壓治療效果。治療高血壓。
  
  這項研究係由輝瑞藥廠贊助。

Amlodipine-Based Regimen Bette

By
Medscape Medical News

Sept. 7, 2005 (Stockholm) — For patients with hypertension, a newer, calcium channel blocker–based regimen may prevent more major cardiovascular events than a more conventional regimen containing a thiazide diuretic and beta-blocker, according to the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), a multicenter, randomized controlled trial of more than 19,000 patients.

The trial's drug safety monitoring board stopped the trial prematurely after 5.5 years of follow-up when results showed the combination of the calcium-channel blocker amlodipine (Norvasc) followed by an angiotensin-converting enzyme (ACE) inhibitor was more beneficial than an older approach combining the beta-blocker atenolol and a diuretic, said lead investigator Bjorn Dahlof, MD, an associate professor of medicine at the University of Goteborg, Sweden.

For nearly every end point, “the more modern therapy fared better than the older treatment,” Dr. Dahlof reported here at the annual European Society of Cardiology Congress.

Patients who were randomized to the calcium-channel blocker/ACE inhibitor group had a 16% lower risk of major cardiovascular events (P < .001), a 30% lower risk of new-onset diabetes (P < .0001), a 23% lower risk of stroke (P = .003), and an 11% lower risk of death (P = .025) than patients in the beta-blocker/diuretic group.

The decrease in mortality “was almost totally driven by a 24% difference in cardiovascular mortality,” Dr. Dahlof told Medscape.

The ASCOT study, which is the largest European hypertension study to date, included 19,257 patients, aged 40 to 79 years, with hypertension and at least three other cardiovascular risk factors. Of those, 9,639 patients were randomized to a daily regimen of 5 to 10 mg of amlodipine, with perindopril (Aceon) as required, while 9,618 patients were given 50 to 100 mg of atenolol, with bendroflumethiazide and potassium as needed.

At 5.5 years of median follow-up, compared with patients in the atenolol group, those in the amlodipine group showed a slight trend toward a reduction in the incidence of the primary end point of a nonfatal myocardial infarction (MI; including silent MIs) or fatal coronary heart disease (474 vs 429, respectively; P = .1052).

“But when we excluded silent MIs, significance was reached for every endpoint,” Dr. Dahlof said. The rates of fatal and nonfatal stroke, total cardiovascular events and procedures, the development of diabetes, and all-cause mortality were all significantly lower in the amlodipine group.

Adverse events were experienced by 15% of patients in both groups, while serious adverse events affected 2% of those in the amlodipine group and 3% of those in the atenolol group. “It was the usual suspects for these classes of drugs — chest pain, diarrhea, and so on in a few patients,” Dr. Dahlof said.

In addition, 32% of the patients with diabetes and 60% of those without diabetes achieved both systolic and diastolic blood pressure goals: 140/90 mm Hg for patients without diabetes and 130/80 mm Hg for patients with diabetes.

But patients randomized to the calcium-channel blocker achieved systolic blood pressures that were only an average of 2.7 mm Hg lower than patients in the beta-blocker group.

The finding set off a debate about whether blood-pressure lowering or other factors are at play.

ASCOT investigator Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London in England, said blood pressure by itself can only explain 15% to 35% of the positive outcomes observed in the amlodipine group. Possible explanations include benefits of calcium-channel blockers that extend beyond blood-pressure lowering and disadvantages of an atenolol-based regimen that are unrelated to blood-pressure lowering, he told Medscape.

But Robert Bonow, MD, professor of medicine at Northwestern University in Chicago, Illinois, and past president of the American Heart Association (AHA), told Medscape, “This is primarily a blood pressure–lowering effect. Every study on hypertension has shown that even a small drop in blood pressure affects outcome.”

Added Tim Gardener, MD, a clinical professor of surgery at the University of Pennsylvania in Philadelphia and an AHA spokesperson, “We need to rein in a little enthusiasm about which combination of drugs is used.”

Most importantly, he told Medscape, “is that you individualize the treatment, arriving at the best drug or combination of drugs that treat the hypertension.”

The study was funded by Pfizer.

ESC 2005 Congress: Abstract 753. Presented Sept. 4, 2005

Lancet. 2005;366:895-906

Reviewed by Gary D. Vogin, MD

    
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