ST LOUIS (MD Consult) - On June 11, 2010, the US Food and Drug Administration (FDA) announced that data from 2 clinical trials revealed that patients receiving the antihypertensive Benicar (olmesartan) had a higher rate of death from a cardiovascular cause than did patients receiving placebo. In both trials (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention [ROADMAP] and Olmesartan Reducing Incidence of Endstage Renal Disease in Diabetic Nephropathy Trial [ORIENT]), patients with type 2 diabetes were given either Benicar or placebo to determine whether treatment with Benicar would slow the progression of kidney disease. ROADMAP and ORIENT are both long-term clinical trials.

The FDA's review of data from both trials is ongoing, and the agency has not concluded that Benicar increases the risk of death. To evaluate the possible association with olmesartan and increased cardiovascular-related death, the FDA plans to review the primary data from both trials and the total clinical trial data on olmesartan. The FDA currently believes that the benefits of using Benicar in patients with hypertension continue to outweigh its potential risks.

Benicar is an angiotensin II receptor blocker (ARB). Drugs in this class and in the closely related group of drugs known as angiotensin-converting enzyme inhibitors (ACEIs) have been evaluated in many studies involving thousands of patients at high risk for cardiovascular events (eg, patients with a history of myocardial infarction or heart failure). No increased risk of cardiovascular-related death has been reported in these trials, and, in fact, data from some of these studies indicate that ARBs and ACEIs are useful as treatments for certain patients at high risk for cardiovascular events.

The FDA plans to update the public when its review is complete.

圣路易斯(MD Consult)——2010年6月11日，美国食品药品管理局(FDA)宣布，两项临床试验的数据表明接受抗高血压药Benicar(奥美沙坦)治疗的患者心血管原因所致的死亡率高于接受安慰剂处置的患者。在 “奥美沙坦与预防糖尿病微量白蛋白尿随机试验(ROADMAP)”和“奥美沙坦降低糖尿病性肾病患者终末期肾病发病率试验(ORIENT)” 这两项试验中，2型糖尿病患者接受Benicar治疗或安慰剂处置，旨在确定Benicar治疗是否会延缓肾病的进展。ROADMAP研究和ORIENT研究均为长期临床试验。

 

FDA仍在对这两项试验的数据进行审核，尚未断定Benicar可增加死亡风险。为了评价奥美沙坦与心血管相关死亡率增加之间的可能相关性，FDA计划对两项研究的主要数据及有关奥美沙坦的整体临床试验数据进行审核。FDA目前认为高血压患者服用Benicar的收益仍超过其潜在风险。