New type 2 diabetes/cholesterol drug approved
October 7th, 2011
02:31 PM ET

New type 2 diabetes/cholesterol drug approved

A new combination drug to treat both type 2 diabetes and high cholesterol was approved by the Food and Drug Administration Friday.  Juvisync  combines the blood sugar lowering drug  sitagliptin or Januvia with the cholesterol lowering drug  simvastatin sold under the brand name Zocor.

"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," said Dr. Mary H. Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking."

The three dosage strengths approved for sitagliptin/simvastatin were 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg.  The manufacturer, Merck & Co., will also develop additional fixed-dose combinations with a 50 mg dose of sitagliptin, the diabetes medication.  There are currently no plans to increase or decrease the simvastatin dose.

The FDA has looked at the possibility that statins could raise blood sugar levels in type 2 diabetics, but it says the risk is small and doesn't outweight the benefits statins provide in reducing heart disease in patients with diabetes. 

Approximately 20 million Americans have type 2 diabetes and many of those also have high cholesterol, according to the FDA.  Both are conditions that increase the risk of heart disease, kidney disease and stroke.  Diabetics face a 2 to 4 times greater risk of stroke and death due to heart disease than people without diabetes, according to the American Diabetes Association.

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soundoff (121 Responses)
  1. Steve

    Oops...a patent must have been about to end. New combo drug for two existing medications...voila, patent extension.

    October 7, 2011 at 17:05 | Report abuse | Reply
    • Brendalove

      Steve, I would say you got that right!!

      October 7, 2011 at 18:06 | Report abuse |
    • Migo

      Like, like, like!

      October 7, 2011 at 18:24 | Report abuse |
    • MB

      Simvastatin has been generic for 4 years and Januvia's patent doesnt expire for 6 more years.

      October 8, 2011 at 10:27 | Report abuse |
  2. Migo

    The catch (spoken as a type 2 diabetic): How much will it co$t? If it is priced out of reach (health insurance notwithstanding) it cannot be used by those who should get it.

    Wonder drugs are fabulous but they NEVER are presented at an affordable cost. NEVER...............

    October 7, 2011 at 17:07 | Report abuse | Reply
  3. Richard

    Ridiculous. Just take the two individual pills.

    October 7, 2011 at 17:10 | Report abuse | Reply
    • Leo

      That's what I was thinking.

      October 11, 2011 at 09:59 | Report abuse |
  4. William Wortman MD

    Seriously? Marketing a 'combination' pill to patients with Type 2 Diabetes Mellitus (T2DM)?
    Patients with T2DM are probably on the following medications at least: Aspirin, a Beta Blocker, an Ace Inhibitor/ARB, Metformin, a Sulfonylurea, possibly a diuretic and a Statin and maybe an additional anti-hypertensive medication.
    So Merck a& Co is taking a possible total of seven medications and combining two of them to bring the new grand total down to six pills per day? Wow, how convenient...
    By 'combining' Sitagliptin (an oral anti-hyperglycemic medication) with Simvastatin they get to market it as a trade/brand name product and charge more for it and suggest that this makes medication adherence easier. I see no benefit to this 'combination' for my patients but rather a benefit for fattening the bottom line of Merck & Co.
    My Bottom Line: Stick with generics and put more effort into PREVENTING T2DM!

    October 7, 2011 at 17:16 | Report abuse | Reply
    • Fred

      I was just going through the same thoughts and counting up my current pills in my head when I saw your comment. If one is already used to taking multiple pills and is used to the routine, what difference is it to cut down by 1 pill? Certainly it isn't worth spending additional money, at least not to me. Yay for WalMart $4 generics! If my doctor prescribes something not on WalMart's cheapo list I search around until I find an equivalent pill that *is* on the list and then ask her if we can work with that drug instead.

      October 7, 2011 at 17:37 | Report abuse |
    • Gerry

      I think that what you say is probably true. However...it sounds to me like you may have a ton of stock in..say...Pfizer or a different pharmaceutical company, and not so much, or any at all, in Merck & Co. And no, I don't work for Merck & Co.

      October 7, 2011 at 18:12 | Report abuse |
    • Migo

      Thank you! I'll gladly take my 5 (affordable) generics and stay vertical rather than pay MUCH more for a pseudo improvement that is designed to improve the drug manufacturer's bottom line rather than mine.

      Generics rule, thank you very much. Multiples are fine, as well.

      October 7, 2011 at 18:22 | Report abuse |
    • Galina L.

      There is no profit from preventing. Another doctor thinks combining drags is not perfect.http://diabeticmediterraneandiet.com/

      October 11, 2011 at 09:35 | Report abuse |
  5. David Emery

    It's a HELUVA lot cheaper to do this combination as 2 generic pills, which I've been doing for quite a while now.

    October 7, 2011 at 17:33 | Report abuse | Reply
  6. Todd

    Hey how about working on a cure for type 1 Diabetes (T1DM) because with all the new Juvenile and adult onset type 1's out here, the time has come to put an end to this serious business but......Then I start thinking about the movie, "The Fugitive" and think of how much money big pharma might lose is they ever come up with a cure for type 1. Hey big Pharma you guys are about to lose billions in insulin sales! I'd love for there to be a cure but everyone knows that big phama is not gonna be supporting that because then they lose their huge type 1 gravy train!

    October 7, 2011 at 17:33 | Report abuse | Reply
    • carol mona

      I agree. Type 2 can be cured...stop over eating and get some excercise! Find a cure for type 1.

      October 7, 2011 at 17:57 | Report abuse |
    • Migo

      Generally I agree with you but as a Type 2 diabetic who is "benefiting" from the genetic gift that keeps on giving, not ALL type 2 can be cured by loosing weight. I was at proper weight at diagnosis (and still am) and can't just get skinny and get well.

      It seems like we have an urban legend floating around that all type 2's are fat slobs...wrong, wrong, wrong.

      October 7, 2011 at 18:15 | Report abuse |
    • Leo

      Migo, we know that some Type-2 folks are not fat. There is definitely a genetic component, and some people are going to get it no matter what. And yes, that sucks and it's awful. And I understand the frustration – I'm 31 years old, a distance runner, and a veteran, and I've got an auto-immune condition that causes arthritis AND a bunch of other problems, and I get people trying to tell me that if I changed my diet (I eat very healthy), exercise (I STILL run, swim, row, climb, and weight-lift), or something else, that it would go away because somehow I must have caused the problem myself. And I know the stigma is far worse for type-2 diabetics.

      However, for a lot of people, their type-2 diabetes is triggered AND made severely worse by poor diet and lack of exercise. That's why MANY people CAN control their condition with just "diet and exercise." And naturally, anyone with type-2 will benefit from better diet and more exercise. The thing is that type-2 used to be relatively rare. Now, many MANY people have it, and there's a strong link to obesity.

      For the people who are going to get it even if they're not fat... that sucks. But you do have to admit that MOST people would not have it so badly, or would never have gotten it at all, if they took better care of themselves.

      October 11, 2011 at 10:22 | Report abuse |
    • Migo

      You deliberately miss my point that I was positing that the urban legend says that ALL Type 2 are sloppy fat slobs.

      But I suppose your lecture has educational value for other readers who may believe the "legend." And it is all too obvious that too many people DO believe it.

      October 11, 2011 at 17:57 | Report abuse |
  7. presri

    I take both metaformin and simvastatin. While metform didn't do any harm or side-affect, but simvastatin caused tremendous pain on leg. The doctor told me suspend for 3 weeks, then I saw my leg pains have significantly reduced. So be careful of combo drug.

    October 7, 2011 at 17:36 | Report abuse | Reply
    • Galina L.

      Cholesterol doesn't cause heard attacks http://www.coconut-info.com/diet_and_disease.htm , but statins are dangerous for your health

      October 11, 2011 at 09:29 | Report abuse |
  8. Isidoro Ringelheim

    That´s the opposite to what we teach to the students in Argentina. If you have collateral efects caused by the magic pill, ¿how will you know if you are a phisician, which one of all of all the drugs must be retired and which one benefits and causes no harm.

    October 7, 2011 at 17:51 | Report abuse | Reply
  9. franklin


    October 7, 2011 at 17:56 | Report abuse | Reply
    • Gerry

      franklin, shut up you skinny rude meanie. And no...I am not a fatty.

      October 7, 2011 at 18:14 | Report abuse |
    • Migo

      How totally bigoted you are in your self righteousness. NO not all type 2's are self indulgent fat slobs. WRONG.

      October 7, 2011 at 18:17 | Report abuse |
    • Kurt

      You're pretty ignorant. Not all diabetics are "fatties". I developed Type II diabetes two years ago and am 5'-8" and 145 pounds. Definitely not a "fatty". As a matter of fact, I'm in way better shape than most 42 year-olds. At the time I was diagnosed, I was active duty military and was pulling a tour at Ali Base in Iraq. I exercised 5 days/week and could run circles around folks half may age. I had just completed the Boston-Iraq satellite marathon and aced my fitness test with a perfect score. There was no explanation for my diagnosis as I had zero risk factors. I didn't eat a high sugar diet, wasn't sedentary, had no family history and was not in any ethnic category that was prone to the disease. According to my endocrinologist, some people just get it despite living a healthy lifestyle.

      October 7, 2011 at 18:33 | Report abuse |
    • Galina L.

      Huge amount of fatties will never develop diabetes because their pancreatic gland is able to create new beta-cells. Diabetics 2 don't have such ability.due to genetic.Check it here http://www.phlaunt.com/diabetes/. Just in case – I am not diabetic and I follow the low-carb-high-fat diet in order to be not fat and healthy.

      October 11, 2011 at 09:44 | Report abuse |
  10. Forrest

    I would just like a generic for Januvia- boy is it expensive. Are there any in the works?

    October 7, 2011 at 21:41 | Report abuse | Reply
  11. Toxins

    Sure we can get another pill to treat some symptoms of diabetes and cholesterol but why not just treat the causation of this disease? Nutrition is the key to good health and can reverse diabetes and high cholesterol. This excellent science based, non profit website talks all about it, check it out to discover a more effective cure!

    October 8, 2011 at 00:47 | Report abuse | Reply
  12. Charlie

    Type II diabetes is real, it is often a result of nonactivity and a relationship of our heredity. When the reflection in the mirror is not the view that makes you happy, diabetes or not, it's time for a rejuvination in the physical view. A serious disease such as diabetes should be a wake up call for all to take stock in the body, face, hair and all the asset that will lead you down a more healthy walk and journey in life. Maybe just then the curse of this deadly Diseases will flee.. http://www.greathairtransplants.com

    October 10, 2011 at 15:23 | Report abuse | Reply
  13. Owe my life to Rx

    I have a genetic defect that causes my cholesterol to be in the 700 range without Rx. Has nothing to do with what I eat. Size 8–although that has nothing to do with it either. Lipitor is going generic this year. Will make it cheaper to save my life.

    October 11, 2011 at 01:42 | Report abuse | Reply
    • Galina L.

      There is more and more data that there is no correlation between cholesterol number and heard attacks.http://chriskresser.com/cholesterol-doesnt-cause-heart-disease, http://www.thincs.org/ You would endanger you life with statins faster.. Please, check all facts before you do it..

      October 11, 2011 at 10:04 | Report abuse |
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