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FDA announces ongoing safety review of olmesartan | Resource Center: Type 2 Diabetes The FDA is evaluating data from two clinical trials in which patients with type 2 diabetes assigned olmesartan, an angiotensin II receptor blocker, had a higher rate for death from a cardiovascular cause when compared with patients assigned placebo. As of press time, the FDA�s review is ongoing, and officials have not determined whether the drug increases the risk for death. 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. Olmesartan Reviews Ratings at Drugs.com A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Advanced Phonetic My 65-yr-old-Darling-Husband takes Benicar for HTN; and even though I'm an RN, didn't know what would happen to a person taking Benicar who becomes run down Twice after burning the candle at both ends my DH had episodes of profuse sweating, a non-palpable pulse, and passed out v-low BP. Cardiologist finally said Benicar can cause zero BP.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. The renal results from this study are interesting and add to the debate about the renal benefits of RAS drugs in people with type 2 diabetes.
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