Worth Keeping An Eye On, Re Merck's Cozaar®

First, the caveats: it is quite possible this is an artifact, and it is also quite possible that, even if it is not an artifact, it is something specific to the unique configuration of compounds in Daiichi's Benicar^®.

It is also important to note that no similar effect has been seen in any of the prior Cozaar^® or Diovan^® (Novartis) studies. Even so, FDA will follow-up and monitor this entire class of anti-hypertension drugs, and properly so. Reuters reporting tonight, here:

. . . .In the long-term trials, patients with type 2 diabetes were given either Benicar or placebo to determine whether Benicar would slow the progression of kidney disease or progression of the diabetes.

In the larger of the two trials, Benicar did appear to slow the onset of kidney disease, Daiichi said.

But an unexpected finding in both trials was a greater number of deaths from heart attack, stroke or sudden death in the Benicar-treated patients compared with those who took a placebo, the FDA said. . . .

There are several classes of drugs that work through different mechanisms to treat high blood pressure. Benicar belongs to a class known as angiotensin receptor blockers, or ARBs, that are also used to prevent kidney failure.

Other ARBs include Merck & Co's Cozaar and Novartis AG's Diovan.

"There was a numerical imbalance in some of the cardiovascular side effects," Gormley said. "We've never seen that before in other studies and I don't think we've seen that with other ARBs". . . .

Even so, worth monitoring -- I'll report any material developments, here. [Earlier items -- on Cozaar's loss of patent protection, and some subsequent Merck attempts at shenanigans -- in April 2010 linked here.]