I noticed a lot of comment action recently on a previous post about Januvia. I guess more and more people have now tried Merck’s new type 2 “Wonder Drug” and want to share their experiences, good and bad. Some are delighted with the glucose control sans injections, while others complain of headaches, nausea, and swollen feet and joints.

“That doesn’t surprise me at all,” says David Kliff of Diabetic Investor, who’s done extensive comparisons of Januvia and Byetta. I queried him yesterday on whether he thought it was true that Januvia is going to “eat Byetta’s lunch.”

Apparently some Merck drug reps are pitching physicians on Januvia as the new “oral Byetta” — same glucose control effects, but easier to prescribe and teach (no injections), and easier for patients to “remain compliant.”

“Calling it ‘oral Byetta’ is a vast overstatement,” Kliff tells me. “Byetta blows it away for effectiveness in A1c results, and if you add in the weight loss effects and possible slowing of beta cell dustruction, Byetta’s a much better drug. And the fact that it’s injectable? I don’t view as that as a negative.”

Maybe not, but many people surely do.

The bigger issue is probably side effects. The nausea side effect of Byetta is well known, while Januvia claims to be side-effect-free. At least for now…

“What bothers me is what we don’t know,” Kliff says. “Look at Avandia and Actos, for example. They’ve been out for over 5 years and we’re just now learning about the bone fracture data… If side effects start to emerge, we have to ask: is it an isolated instance or is it a trend? Is it really a problem with all the DPP-4 drugs?”

(There’s also the new combo drug Janumet — Januvia with Metformin, which is relies on the Metformin for improved A1c results, but also has well-known unpleasant gastro-intestinal side effects.)

It’s looking like Merck got an incredibly lucky break here: Januvia sailed through FDA approvals and has come charging out of the gate with an “enormously successful start” (10% of new diabetic prescriptions). Meanwhile, its competitor from Novartis, Galvus, has been held up with the FDA for safety concerns. Hmmm…

Merck has every advantage here, and they’re running with it. Apparently at the recent AACE meeting in Seattle, there was a flurry of physician excitement about Januvia. “Merck has an army of salespeople, and they’re handing out samples like it’s candy,” Kliff says.

“Every drug has some drawback… If side effects do develop from Januvia, then it’s no longer this Wonder Drug, but just another drug with side effects. That’s why I think anointing it a Wonder Drug now is premature… because we don’t know so much yet,” Kliff concludes.

All I know is that there are a lot of people delighted with the effects of Byetta (after the initial nausea phase subsides).

Want to know more about Januvia and Galvus? Check out the discussion forum at Diabetes.Blog.com.

Wednesday, May 9th, 2007 | Permalink | Comments (8)