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FDA Drug Safety Communication: Ongoing safety review of Benicar(olmesartan) and cardiovascular events Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links The U.S. Food and Drug Administration (FDA) is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan)* had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.Benicar (also known as olmesartan) is in the class of drugs called angiotensin II receptor blockers (ARBs). These drugs and a closely related group of drugs called angiotensin-converting enzyme inhibitors (ACEIs) have been evaluated in many studies involving thousands of patients at high-risk for cardiovascular events, such as patients who had a previous heart attack or had heart failure. No increased risk of cardiovascular-related death has been reported in these trials and, in fact, some of these studies indicate ARBs and ACEIs are useful as treatments for certain patients at high-risk for cardiovascular events. Benicar (olmesartan): Ongoing Safety Review Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links [UPDATED 04/14/2011] After reviewing the results of the ROADMAP and ORIENT trials, FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients.: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.NPC Rapid Review Olmesartan reduces disease oriented outcomes but may have potential cardiovascular safety concerns Rapid reviews | Podcasts | Shared practice examples | Events | Publications and resources | FAQs | Email alerts | Newsroom | Contact us | A to Z found olmesartan delayed the onset of microalbuminuria in patients with type 2 diabetes and normoalbuminuria. While this disease-oriented outcome (DOO) suggested a potential benefit for olmesartan, of greater concern is that more patients taking olmesartan compared with placebo had fatal cardiovascular events � 15 patients (0.7%) vs. 3 patients (0.1%) (P=0.01).The authors of the current study state that RAS drug treatment may be beneficial in the early stages of type 2 diabetes, as ACE inhibitors have been shown to delay the onset of microalbuminuria in type 2 diabetes patients with hypertension but normoalbuminuria. Hence the rationale for this study, to ascertain whether the A2RA, olmesartan, could also be beneficial in delaying the onset of microalbuminuria in patients with type 2 diabetes and normoalbuminuria.
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