U.S. Food and Drug Administration Releases Olmesartan-related Safety Information

Business News, September 15 Recently, the US Food and Drug Administration (FDA) released information that it is evaluating two clinical trials of olmesartan (Benicar). Both trials found that patients with type 2 diabetes had a higher incidence of cardiovascular events after using the antihypertensive drug olmesartan than those who received placebo. The FDA's assessment is continuing, and it has not yet been concluded that olmesartan can increase the risk of death. The benefits of using olmesartan for hypertensive patients are still greater than the potential risks.

The two clinical trials evaluated by the FDA are ROADMAP and ORIENT studies. Both are long-term clinical trials. Subjects have type 2 diabetes and are given olmesartan or placebo to see if olmesartan treatment can reduce kidney disease. occur. Both studies had unexpected findings that the olmesartan group had a higher number of deaths due to cardiovascular events (heart attack, sudden death, or stroke) than the placebo group.

Olmesartan is an angiotensin II antagonist (ARBs) and another class of drugs known as angiotensin-converting enzyme inhibitors (ACEIs) have been evaluated in many studies. Involving thousands of patients at risk of cardiovascular disease, such as those with a history of heart disease or history of heart failure. There were no reports of increased risk of cardiovascular-related deaths in these trials. In fact, some studies have shown that ARBs and ACEIs are very effective in treating patients at high risk for certain cardiovascular disorders.

The FDA recommends that patients should not arbitrarily stop the treatment of olmesartan unless requested by a doctor. It is recommended that medical professionals prescribe the drug according to the instructions in the instructions, and report any adverse events.

Data Summary:

ROADMAP (Omersametan and the Randomized Trial to Prevent Diabetic Microalbuminuria) is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in Europe. The trial included 4447 patients with type 2 diabetes and at least one other risk factor for cardiovascular disease, but these patients did not have a clear diagnosis of kidney disease. Patients were randomized to olmesartan (40 mg daily) or placebo and were allowed to use anti-hypertensive drugs other than ACEIs or ARBs.

The ROADMAP study aims to assess whether olmesartan can delay the production of microalbuminuria. The vast majority of patients have 3 to 5 risk factors for cardiovascular disease, and 80% of patients use other antihypertensive drugs. The median exposure time for olmesartan is 39 months.

ORIENT (Omersartan reduces the incidence of end-stage renal disease in patients with diabetic nephropathy) is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in Japan and Hong Kong. Patients with type 2 diabetes (n=566) and those with a definite diagnosis of kidney disease were randomized to olmesartan (10-4040 mg daily) or placebo and were allowed to use other antihypertensive drugs including ACEIs, but ARBs cannot be used. The primary composite endpoint is the patient's serum creatinine level for the first time, renal end-stage, all-cause mortality.

Both studies had unexpected findings that patients receiving olmesartan had a higher number of deaths from cardiovascular events than placebo.

When considering the results of these trials, it should be noted that other trials of olmesartan and other ARBs have not found an increased risk of cardiovascular-related deaths, which is important.

To assess the risk of cardiovascular death associated with olmesartan, the FDA plans to review the main data from both studies and all Olmesartan clinical data, and to better understand the findings in the ROADMAP and ORIENT studies by other means.