Celecoxib與心血管疾病風險上升有關


  Dec. 17, 2004 - Celebrex的製造商輝瑞藥廠今天表示,收納到the Adenoma Prevention with Celecoxib(APC)試驗中的受試者,服用cyclooxygenase(COX)-2抑制劑celecoxib(Celebrex)發生心血管事件的風險高出2倍。
  
  這項大型隨機分派、雙盲、安慰劑控制的多中心臨床試驗,目的是要研究celecoxib是否可以預防之前患有大腸瘜肉病患發生大腸直腸癌;服用celecoxib的,相較於沒有服用這個藥物的受試者,其發生致命以及非致命心臟病發的風險高出2.5倍。
  
  收納到這項試驗的受試者已經停止繼續服用試驗藥物。
  
  根據輝瑞藥廠的聲明,另一個目前正在進行的臨床試驗,研究celecoxib是否可以預防大腸直腸癌,稱為the Prevention of Colorectal Sporadic Adenomatous Polyps(PreSAP)試驗,顯示相較於服用安慰劑病患,服用celecoxib並不會使心血管疾病風險的增加;這項臨床試驗使用與APC試驗相同評估心臟功能的方式,以及同樣的安全性監測委員會。
  
  Celecoxib與rofecoxib(Vioxx)是同一類藥物;Vioxx在一項大腸直腸癌預防試驗中,發現會增加心臟病發的風險,所以被迫下架;輝瑞藥廠也製造販賣valdecoxib(Bextra),另一個COX-2抑制劑。
  
  輝瑞藥廠的執行長Hank McKinnell在新聞中表示,輝瑞藥廠以最快的速度去詳細暸解APC試驗的結果,而且快速地將這項資訊告知有關當局、醫師以及世界各地的病患們。
  
  APC試驗的研究人員要求病患每日服用celecoxib 400或800毫克;接受celecoxib治療關節炎的病患每日通常服用100到400毫克。
  
  APC與PreSAP試驗已經收納超過3,600位患者,有些病患已經服用celecoxib長達4年。
  
  輝瑞藥廠附帶表示,有2,000多位病患被收納到另外一個研究celecoxib是否可以預防阿茲海默氏症的試驗;在這些病患中,有超過750位每日服用400毫克的celecoxib;截至12月10日,這項試驗的安全性委員會決定繼續進行這項試驗。
  
  輝瑞藥廠表示,昨晚才獲知APC試驗中有關心臟方面的發現;國家癌症機構(NCI)正在執行這項臨床試驗;一位NCI的發言人向WebMD表示,這項試驗的安全性委員會昨天晚上開會到深夜11點半。
  
  不過,這項新發現的影響目前還不清楚;根據富比士公司的統計,celecoxib在美國是第9位暢銷的藥物,2003年銷售金額高達26億美金。

Celecoxib Linked to Increased<

By Daniel J. DeNoon
Medscape Medical News

Dec. 17, 2004 — The cyclo-oxygenase (COX)-2 inhibitor celecoxib (Celebrex) more than doubled the risk of cardiovascular events in subjects enrolled in the Adenoma Prevention with Celecoxib (APC) study, celecoxib maker Pfizer Inc said today.

The large randomized, double-blind, placebo-controlled, multicenter study was designed to investigate whether celecoxib could prevent colon cancer in people who had previously had colon polyps. Subjects who took celecoxib had 2.5 times as many fatal and nonfatal heart attacks as those who did not take the drug.

Patients enrolled in the trial are being told to stop taking study medication.

According to a statement from Pfizer, the Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trial, another ongoing study looking at whether celecoxib can prevent colon cancer, "revealed no greater cardiovascular risk than placebo." This trial used the same heart measures and the same safety monitoring board as the APC trial.

Celecoxib is in the same class of drugs as rofecoxib (Vioxx). Vioxx was withdrawn from the market after a colon cancer prevention trial found it increased the risk of heart attacks. Pfizer also manufactures valdecoxib (Bextra), another COX-2 inhibitor.

"Pfizer is taking immediate steps to fully understand the [APC study] results and rapidly communicate new information to regulators, physicians, and patients around the world," Pfizer CEO Hank McKinnell says in a news release.

Investigators in the APC trial gave patients 400 mg and 800 mg doses of celecoxib per day. People who take celecoxib for arthritis are prescribed doses of 100 mg to 400 mg per day.

The APC and PreSAP trials have enrolled some 3,600 people. Some of them have been taking celecoxib for more than four years.

Pfizer notes that some 2,000 people are enrolled in another study looking at whether celecoxib can prevent Alzheimer's disease in high-risk people. Some 750 of these patients are taking 400 mg of delecoxib daily. As of Dec. 10, this study's safety review board decided to proceed with the study.

Pfizer says it learned of the heart findings from the APC study last night. The National Cancer Institute (NCI) is conducting the study. An NCI spokesman tells WebMD that the trial's safety monitoring board met until 11:30 p.m. last night.

The impact of the new findings is not yet clear. Celecoxib is the ninth best-selling drug in the U.S., with 2003 sales of 2.6 billion, according to Forbes.com.

Reviewed By Michael Smith, MD.

    
相關報導
移除卵巢不能降低糖尿病女性的CVD風險
2015/11/11 上午 09:31:25
甲狀腺功能過高與失智症有關
2015/11/4 上午 10:18:09
心電圖測量可預測慢性腎病患者的心血管原因死亡
2015/7/22 上午 09:57:51

上一頁
   1   2   3   4   5   6   7   8   9   10  




回上一頁