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FDA开展对ARB 致癌风险和应用状况的审查工作

FDA reviewing cancer risk and use of ARBs

2010-07-20 【发表评论】
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ST LOUIS (MD Consult) - On July 15, 2010, the US Food and Drug Administration (FDA) announced that it is conducting a review of the class of medications known as angiotensin receptor blockers (ARBs) after results from a recently published study suggested that use of these drugs may be associated with a small increased risk of cancer. At this time, the FDA believes that the benefits of these medicines continue to outweigh their potential risks.

Results of the meta-analysis showed a small increased risk of reported new cancers in patients who were receiving an ARB compared with patients who were not receiving an ARB. No statistically significant difference in the number of cancer deaths was observed. The majority of patients included in the studies reviewed were receiving the ARB telmisartan; therefore, the applicability of the cancer-related findings to all ARBs is uncertain.

These clinical trials were not designed to study the effects of ARBs on cancer risk. The analysis included data from trials in which there was no adjudication of cancer-related adverse events. In the trials, it was not possible to determine whether the events represented new diagnoses of cancer or events related to a preexisting cancer. Thus, the actual number of new cancer occurrences is unknown.

Angiotensin receptor blockers are prescribed for patients with hypertension and other conditions (eg, heart failure). Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten. Angiotensin receptor blockers are also sold in combination with other medications.

The FDA plans to review the available data on ARBs, and to evaluate additional ways to better assess a possible link between the use of ARBs and cancer. The agency will update the public when this review is complete.

圣路易斯(MD Consult)——2010715日,美国食品药品管理局(FDA)宣布,FDA正在对血管紧张素受体拮抗剂(ARB)类药物进行审查,审查原因为近期发表的一项研究显示使用这类药可能与癌症风险小幅增加有关。目前,FDA认为这类药的收益超出其潜在风险。

 

荟萃分析结果表明,与未在服用ARB的患者相比,正在服用ARB者的新发癌症风险小幅增加。在癌症死亡例数上未观察到显著的统计学差异。研究中所纳入的大多数患者均在接受ARB替米沙坦治疗;因此,尚不确定这一癌症相关的研究结果是否适用于所有的ARB类药物。

 

这些临床试验的目的并非探讨ARB对癌症风险的影响。荟萃分析中所包括的数据源自未对癌症相关不良事件进行裁定的临床试验。在这些试验中,无法判定这类事件是代表新诊断的癌症抑或与早先存在的癌症相关的事件,所以并不清楚新发癌症的实际例数。

 

血管紧张素受体拮抗剂适用于治疗高血压及其他疾病 (心力衰竭)。商品名包括AtacandAvaproBenicarCozaarDiovanMicardis以及Teveten。市售的血管紧张素受体拮抗剂还包括与其他药物构成的复方制剂。

 

FDA计划对有关ARB的现有数据进行审查,并采用其他评价方法更好地评估服用ARB与癌症之间可能存在的关联。FDA在审查完成时会将最新情况公之于众。


Subjects:
general_primary, cardiology
学科代码:
内科学, 心血管病学

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疾病资源中心  疾病资源中心
 病例分析

 王燕燕 王曙

上海交通大学附属瑞金医院内分泌科

患者,女,69岁。2009年1月无明显诱因下出现乏力,当时程度较轻,未予以重视。2009年3月患者乏力症状加重,尿色逐渐加深,大便习惯改变,颜色变淡。4月18日入我院感染科治疗,诉轻度头晕、心慌,体重减轻10kg。无肝区疼痛,无发热,无腹痛、腹泻、腹胀、里急后重,无恶性、呕吐等。入院半月前于外院就诊,查肝功能:ALT 601IU/L,AST 785IU/L,TBIL 97.7umol/L,白蛋白 41g/L,甲状腺功能:游离T3 30.6pmol/L,游离T4 51.9pmol/L,心电图示快速房颤。
 

医学数据库  医学数据库



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