Merck launches long-term Januvia trial

Can it be that Merck is going out looking for unexpected cardiovascular side effects? The drugmaker is preparing to launch a massive trial of its diabetes med Januvia, specifically to check for potential heart problems. The 14,000-patient study, helmed by Duke University, aims to gauge the safety of long-term use of the drug--which makes sense, considering diabetes is a chronic, lifelong illness.

It makes sense, but it's not necessarily every drugmaker's practice to seek out data on the long-term safety of meds for chronic maladies. Think Zyprexa [1], the Eli Lilly antipsychotic that's been shown to boost the risk of weight gain and diabetes [2], or Avandia [3], the GlaxoSmithKline diabetes drug that's been linked with cardiac problems. Or, closer to home for Merck, there's Vioxx [4], the arthritis painkiller pulled from the market after a plethora of serious adverse events such as heart attack and stroke.

Barbara Ryan, the Deutsche Bank analyst who dug up info on the new trial, said in an investor note (and we're quoting CNBC's Mike Huckman here), "MRK appears to have taken a proactive approach for Januvia in this regard, which is a positive in our view, as it will have such data well ahead of its competitors (though not till the end of 2014), which should help it to maintain a dominant position in the...market...."

The news of the study comes on the heels of an FDA advisory committee vote in favor of heart side-effect studies on new diabetes meds. Just for the record, Januvia posted third-quarter sales double the same period last year.

- read Huckman's column [5] at Seeking Alpha

ALSO: We heard from Merck about our story last week on CVS's doctor letter in support of Januvia use [6]. The drugmaker wanted to point out that the letter advocated adding Januvia to drug regimens that weren't currently working, rather than a complete drug switcheroo. Plus, as we noted in our piece, CVS wrote and sent the letter, and Merck didn't get ahold of any private patient info.

Related Articles:
Union: CVS flogged costly med for Merck [6]
Study: Januvia plays well with metformin [7]
Amylin: Byetta outperforms Januvia [8]
Docs: Use cheap diabetes meds first [9]