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Arena Pharmaceuticals, Inc. Message Board

  • jeremiahthirtythreeone jeremiahthirtythreeone Jul 17, 2013 11:17 PM Flag

    Dangerous novel new hypoglycemics and Belviq in T2DM

    The position of a novel class of drugs, the sodium-glucose cotransporter-2 (SGLT2) inhibitors, in the stepwise treatment of type 2 diabetes is currently unclear, but ongoing clinical trials will help better establish the place of these agents, says a new editorial in the Lancet, published online July 12 on a a 52-week, double-blind, phase 3 trial comparing one of the new SGLT-2 inhibitors, canagliflozin (Invokana, Janssen), with the sulfonylurea glimepiride in type 2 diabetes patients who are inadequately controlled on metformin.

    The Lancet, Early Online Publication, 12 July 2013

    Briefly, Canagliflozin - CANA (Invokana) given to patients on metformin in a 52 week, double blined, phase 3 trial when compared to patients with T2DM on metformin demonstrated the following:

    CANA 100 mg decreased A1C by 0.65
    CANA 300 mg decreased A1C by 0.74
    Weight loss was modest but some potentially serious complications need to be addressed – see below.

    In contrast, BELVIQ was given to patients on metformin and/or SFU (90% were on metformin when compared to patients with T2DM on metformin and/or SFU

    Belviq 10 mg bid decreased A1C by 0.9
    Belviq 10 mg qd decreased A1C by 1.0

    Then you have the additional tremendously important benefit of weight loss which none of the hypoglycemics in the market can boast about.

    There will be a day when the T2DM benefits of Belviq will be widely known. In the meantime big pharma continues to put out potentially dangerous hypoglycemics that are far more expensive and dangerous than Belviq. With the cost cutting that has become a major component in the delivery of health care will propel Belviq to one the top hypoglycemics out there – not only for cost savings but for safety and efficacy.

    What follows is the spin that continues with these new novel and dangerous and expensive hypoglycemics

    CONTINUED
    Daniel
    UCLA MD

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • jeremiahthirtythreeone jeremiahthirtythreeone Jul 17, 2013 11:18 PM Flag

      What follows is the spin that continues with these new novel and dangerous and expensive hypoglycemics

      As a drug class, SGLT2 inhibitors have been associated with some favorable effects — as well as the improved glycemia expected for a diabetes drug, they cause weight loss and lower blood pressure with no increase in heart rate, in addition to reducing triglycerides and increasing HDL

      But an increase in LDL cholesterol has also been observed with SGLT2 inhibition, and the significance of this needs to be further investigated. Also, probably because of the glycosuria they induce, SGLT-2 inhibitors increase the risk of genital mycotic infections and urinary-tract infections.

      Canagliflozin is the first SGLT2 inhibitor available in the United States, having been approved there in March. A second, dapagliflozin (Forxiga, Bristol-Myers Squibb/AstraZeneca), was already approved in Europe, in November 2012. But the US Food and Drug Administration (FDA) denied approval of dapagliflozin in January 2012 because of concerns about a cancer signal.

      However, several issues must first be ironed out before their ideal place is determined, they say. There are the long-term safety concerns, including cardiovascular as well as potential cerebrovascular and cancer risks, and class-related adverse effects on bone health, which will require close surveillance.

      Results extending the findings with regard to the 2 doses of canagliflozin compared with glimepiride, out to 104 weeks, have also recently been reported at the American Diabetes Association 2013 Scientific Sessions

      Also presented there were data showing canagliflozin 300 mg is superior and 100 mg noninferior — in terms of glycemic control — to the DPP-4 inhibitor sitagliptin (Januvia, Merck) in patients with type 2 diabetes already taking metformin .

      "These data suggest that canagliflozin might be more useful than sitagliptin as add-on to metformin in patients with type 2 diabetes," concluded the authors

      Daniel
      UCLA MD

      Sentiment: Strong Buy

      • 2 Replies to jeremiahthirtythreeone
      • jeremiahthirtythreeone jeremiahthirtythreeone Jul 17, 2013 11:25 PM Flag

        From the FDA website:
        "More than half (51%) of the NMEs [new molecular entities] approved in CY 2012 (20 of 39)

        were identified by FDA as First-in-Class, meaning drugs which, for

        example, use a new and unique mechanism of action for treating a

        medical condition. First-in-Class is one indicator of the innovative

        nature of a drug and 51% First-in-Class approval rate suggests that

        the group of CY 2012 NMEs is a field of highly innovative new

        products.

        ==================================
        Belviq is in the 2012 list of First-in-Class drugs.

        We have the beginning of a shift in the way we will be treating chronic diseases such as T2DM, obesity, and metabolic syndrome and this tiny NME will have a gigantic impact.

        Daniel
        UCLA MD

        Sentiment: Strong Buy

    • Thanks Daniel,

      We will continue to hold and fight off these crookstreets!!!!!!

      Sentiment: Hold

    • Great article. Thanks for the info

    • seems like a no-brainer, Bel should be flying off the shelves, ARNA should be $15, but so far not and not. Since apparently MD's are having a difficult time telling patients they are obese, maybe they can tell them to try Bel for T2DM, or maybe before it's too late and they get T2DM. Try that for a marketing idea and have Eisai send me 10,000 free shares of ARNA for doing their strategy job.

    • Cannot let this get buried!!

    • topppp

    • I have seen it myself.

    • Dr.Dan, great article as always. I think Belviq is very cheap being an Obesity pill as well as a safe competing Diabetic pill both in one. one can imagine as to how, it can improve the quality of lives of millions of people. Once covered by Major insurers/ Medicaid etc, it can have a great impact handling Diabesity.

    • Since the MF keeps pumping Invokana ( Canagliflozin ) here is another view on it ..from Dr Dan who is far more qualified than any blogger to talk about it... Read the whole thread to get all the info

      Sentiment: Strong Buy

    • Shorts are in an ambush because of so-called analysts like Jim Crammer and AF.

      Sentiment: Strong Buy

 
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