Tuesday, September 27, 2011

Never Be The First To Prescribe And Never Be The Last

Never be the first to prescribe a new drug and never be the last.  Why?  Aren't new(er) drugs better?  Not always!  Sure, they're at least just as good (they have to be in order to get passed) as their older competitors and sometimes even better.  But by dint of being new, we don't have the same safety data that we do w/our older drugs.  Remember, better the devil you know than the devil you don't know.  I use this bit of introduction to bring to light a study published earlier this summer (I can't read everything, you know!) in a journal I don't usually peruse, in which exenatide (sold as Byetta) and sitagliptin (sold as Januvia & Janumet) were linked to pancreatic cancer.

Exenatide was approved over 6 years ago as a revolutionary new way to control sugars in patients with diabetes.  As a side note, it's derived from the saliva of the gila monster. Both exenatide & sitagliptin are incretins,  members of a new class of drugs (both oral and injectable) that help maintain glucose homeostasis.  Besides being a daily injectable medication, exenatide's major downfall has been an increase risk for pancreatitis, which was first noted approximately 4 years ago by the Food & Drug Administration.  I suppose this was tempered by an association with weight loss (which encouraged off-label use), most likely due to pronounced nausea, vomiting & anorexia.

These points were highlighted & debated during the recent European Association for the Study of Diabetes meeting last week.  More importantly, as pointed out in the accompanying editorial, while exenatide was approved based upon its ability to lower Hemoglobin A1c, there have been no studies demonstrating any clinically relevant outcomes.  Similarly, while we have studies demonstrating how well niacin raises HDL, we have none demonstrating a decrease in cardiovascular events, much less mortality, unlike their older competitors.

Which brings me back to the beginning.  Never be the first, but never be the last, either.


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