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Medical experts are warning that use of Benicar together with many heart drugs may not help patients suffering from high blood pressure and heart problems, and the combination may in fact cause kidney damage and other health risks.
Researchers from the Erasmus University Medical Center in the Netherlands conducted an analysis of recent medical data on the use of Benicar’s active ingredient, olmesartan, in combination with heart drugs known as beta blockers and angiotensin-converting-enzyme (ACE) inhibitors.
The analysis was published in the online edition of the medical journal Nature Reviews Nephrology on March 24, warning that the drug combo decreases kidney function and increases the risk of heart problems and death.
A.H. Jan Danser and Anton H. van den Meiracker, noted that a clinical trial, known as SUPPORT, looked at combining Benicar, ACE inhibitors, and beta blockers in an effort to help patients with hypertension who also had chronic, but stable heart failure. Benicar is an angiotensin-receptor blocker (ARB).
ACE inhibitors, like Cozaar and generic losartan, are used to treat hypertension and congestive heart failure. Beta blockers are used to manage heart rhythm problems and to prevent a second heart attack. They include drugs such as Lopressor, Levatol, and Toprol XL.
“Unfortunately, this triple renin-angiotensin-aldosterone system (RAAS) blockade was associated with worsening of renal function and increases in cardiac events and mortality,” Danser and van den Meiracker wrote. “Several of these drugs are often combined — for example in heart failure — but shc approaches may ultimately lead to RAAS annihilation with adverse consequences such as hypotension, renal dysfunction and hyperkalemia.”
Their report was based on findings published in January in the European Heart Journal by researchers from Japan. They conducted a randomized, blinded endpoint study involving 1,147 patients with hypertension and chronic heart failure.
That study found that patients given Benicar had a 64% increased risk of developing kidney problems. When Benicar was combined with the heart drugs, the risk of kidney problems was 85% higher, and the mortality rate increased by 50%.
Researchers also looked at a primary endpoint that was a combination of all-cause death, non-fatal acute heart attack, strokes, and hospitalization for worsening heart failure, and found that the side effects of Benicar in combination with the heart drugs led to an increased overall 47% increased risk of these health problems.
Danser and van den Meiracker looked at the data and said they found very few beneficial effects.
“In conclusion, the findings of the SUPPORT trial, performed in patients with stable chronic heart failure and hypertension, confirm and extend those of previous studies of dual or triple RAAS blockade in other settings,” they concluded. “They demonstrate that too intensive blockade of the RAAS can be deleterious for the kidney, especially if renal function is already compromised when an additional RAAS blocker is added.”
Benicar Intestinal Side Effects
The findings come as the makers of Benicar face criticism over failure to adequately warn about the risk of intestinal side effects associated with the drug, including chronic diarrhea and other symptoms of a condition known as sprue-like enteropathy.
Benicar (olmesartan medoxomil) is part of a family of Daiichi Sankyo hypertension drugs, which also includes Benicar HCT, Azor and Tribenzor. All of the blood pressure drugs include the active ingredient olmesartan, which has been linked to the development sprue-like enteropathy.
As a result of the lack of warnings provided by the drug makers, many users have repeatedly been hospitalized with severe diarrhea, as doctors were unaware that the symptoms may be caused by their blood pressure medication. The Benicar problems have often been misdiagnosed as Celiac disease or unclassified sprue, resulting in continued use of the medication, which could leave users with long-term intestinal damage.
Although the diarrhea symptoms associated with sprue-like enteropathy typically resolve when the medication is no longer used, the problems can cause permanent damage to the intestines, known as villous atrophy from Benicar.
Daiich Sankyo and Forest Laboratories face a growing number of Benicar lawsuits by patients who say the companies failed to provide adequate warning of the risk of sprue-like enteropathy.