斯利康心血管药物Brilinta临床试验效果显著

近日一项临床试验表明，长期服用阿斯利康的Brilinta（替卡格雷）可以使具有心脏病或中风病史的患者的死亡率降低16%，这项研究可能会大幅增加这款药物的销量，对阿斯利康而言无疑是一利好消息，但对医生而言，开处方前要充分考虑该药物带来的风险和收益，尤其是该药物可能造成出血的风险。

波士顿布里翰妇女医院的研究人员Marc Sabatine表示，尽管Brilinta造成出血的风险增加，但是相较于患者心肌梗死或中风而死的风险，这一点还是可以忽视。重要的是，并没有证据表明该药物会造成脑出血概率增加，因此相对而言还是非常安全的。

而马萨诸塞大学医学院的John Keaney表示，Brilinta（替卡格雷）作为一个强效抗凝血剂，它的药理作用与副作用之间实际上是一对“脆弱的平衡”。每10000名服用Brilinta（替卡格雷）的患者中，每年约有42名患者能成功地预防心血管死亡，但与此同时也有31患者发生了大出血。

目前针对一年以上心脏病史患者的标准治疗方案是服用阿司匹林来预防凝血，而增加Brilinta（替卡格雷）作为新的标准疗法无疑会增加阿斯利康的销量。去年阿斯利康拒绝将这款药物出售给辉瑞，据阿斯利康估计，2023年之前，Brilinta（替卡格雷）每年能为阿斯利康创造35亿美元的收益。也有分析师降低了这一数字，认为在2020年之前每年的销售额约为15亿美元。无论如何，这都比2014年的4.76亿美元高出许多。

阿斯利康此前表示，这一阳性结果的临床试验是阿斯利康史上最大的临床试验，共有21000名患者参与。而其中的很多细节仅在每年召开的美国心脏病学会年会上披露过，而更多的细节将会继续发表在《新英格兰医学杂志》上。

实验组每日服用60mg Brilinta（替卡格雷）加阿司匹林，其恶性心血管疾病的发病率为7.77%，而对照组仅服用阿司匹林，发病率为9.04%。与对照组相比，实验组的患病率下降了16个百分点。而服用90mg的患病率下降了15个百分点。然而，实验组的大出血比率为2.30%，对照组是1.06%，这说明Brilinta（替卡格雷）也会增加出血概率。

与Brilinta（替卡格雷）展开激烈竞争的同类药物还有赛诺菲以及百时美施贵宝的老药Plavix，还有礼来的Effient。

该临床试验结果表明持续服用Brilinta（替卡格雷）至少能为患者带来3年左右的预防作用，目前阿斯利康已经在欧洲和美国提出了长期使用Brilinta（替卡格雷）的申请。

原文 Long-term use of AstraZeneca heart drug brings benefits， some risks

Long-term use of AstraZeneca's drug Brilinta can cut the risk of death， another heart attack or stroke in patients with a history of past attacks by 16 percent， a keenly awaited clinical trial showed on Saturday.

The finding may boost sales of the blood-thinner， which AstraZeneca is relying on to drive growth， although doctors must balance its benefits against bleeding risks.

"There will be more bleeding， but I think the benefit for patients in terms of reducing their risk of dying or having another heart attack or stroke outweighs that，" trial researcher Marc Sabatine of Boston's Brigham and Women's Hospital told Reuters.

Importantly， there was no excess of fatal or irreversible bleeding into the brain.

John Keaney of the University of Massachusetts Medical School， who was not involved in the study， said there was a "fragile balance" to be struck in using potent blood-thinners that can trigger bleeding.

He noted that for each 10，000 patients treated， Brilinta would prevent 42 cardiovascular events annually but cause 31 major bleeds.

The current standard care for patients more than one year on from a heart attack is aspirin alone to prevent clotting， so adding Brilinta would open a major new sales opportunity.

Until now Brilinta has struggled to gain traction， though AstraZeneca flagged its potential to sell $3.5 billion annually by 2023 when it fought off a takeover bid by Pfizer last year.

Analyst forecasts currently suggest sales of $1.5 billion by 2020， against $476 million in 2014， according to Thomson Reuters Cortellis.

AstraZeneca had said previously the 21，000-patient trial， its biggest ever， was positive but details were only unveiled at the American College of Cardiology annual meeting， with simultaneous publication in the New England Journal of Medicine.

Among patients on twice-a-day 60-mg Brilinta plus aspirin， 7.77 percent suffered adverse cardiovascular events against 9.04 percent for the aspirin-only group， a relative risk reduction of 16 percent. For 90-mg Brilinta， the risk reduction was 15 percent.

There was major bleeding in 2.30 percent of 60-mg Brilinta patients against 1.06 percent for those taking aspirin only.

AstraZeneca's Brilinta head， Tom Keith-Roach， sees the study boosting sales and doubling the number of eligible patients. "I think it is going to strengthen our trajectory，" he said.

Brilinta competes with Sanofi and Bristol-Myers Squibb's older drug Plavix， now available as a cheap generic， and Eli Lilly's Effient.

AstraZeneca recently filed for long-term use of Brilinta in Europe and the United States， based on the latest trial results， which showed that the benefit from taking Brilinta continued to accrue for nearly three years.