While data from the ROADMAP trial and the Medicare study have suggested that high-dose olmesartan may increase cardiovascular risk in diabetic patients, when considering the data from all trials and studies, they are not conclusive. To evaluate these findings, we reviewed additional studies, including a large study in Medicare patients. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. This safety review was prompted by the results of the ROADMAP trial. Do not stop taking olmesartan or any blood pressure medication without first discussing it with your health care professional. It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems such as heart disease and stroke, as well as kidney failure and other health problems. Patients should discuss any questions they have with their health care professionals. As a result, our recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but we will require information about some of the studies to be included in the drug labels. ![]() Food and Drug Administration (FDA) has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients.
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