by Gary Pepper, M.D.
Chances are, if you have diabetes you have heard about a new class of drugs to treat high blood sugar (glucose). The first of these new medications to gain FDA approval in the U.S., in 2013, is Invokana manufactured and promoted by Janssen Pharmaceuticals and Johnson & Johnson. In the last year and a half the number of these drugs known as SGLT2 inhibitors, has multiplied faster than tribbles to include Farxiga, Xigduo, Jardiance and Invokamet. Prescriptions for these medications are also showing explosive growth, increasing 300% since January 2014. A recent forecast by Express Scripts calls for this one class of drugs to be responsible for about a 20% increase in the yearly cost of prescriptions per all members per year for the next 3 years . The explanation behind the eager adoption and dissemination of this brand new class of medications may eventually serve as a tragic lesson for diabetic patients and for the medical community in general. (more…)
The FDA just announced its approval of linagliptin (Tradjenta), a new diabetes medication developed by Eli Lilly and Company and Boehringer Inglheim. Linagliptin is the third drug to be approved in the class of medications commonly known as gliptins (scientifically known as dipeptidyl peptidase-4 (DPP-4) inhibitors) which block the destruction of a glucose controlling hormone, GLP-1. Januvia, developed by Merck and Company, was the first of the gliptins to be approved in 2006. Three years later in 2009, Onglyza, developed by AstraZeneca was approved while two other similar drugs were withdrawn from the approval process in the meantime.
Diabetes drugs are evaluated by the FDA for safety and for their ability to combat diabetes by lowering blood sugar. Assuming the drug being evaluated is safe then we will want to know how effectively the new medicine lowers the blood sugar. The glycohemoglobin A1c blood test represents the average blood sugar for the prior 3 months, and is the most concise way of assessing an individuals over all blood sugar control. By determining the ability of a medicine to lower the “glycoA1c†we can get a very accurate idea of the strength of the medicine for diabetes treatment. In general, physicians set a glycoA1c goal of 7% or less for their diabetic patients which equates to an average blood sugar level of 154 mg/dl or 8.6 mmol/L.
Linagliptin passed the FDA’s strigent safety review. Several large studies sponsored by the drug developers show the linagliptin lowers glycohemoglobin A1c by about 0.5. For example, if a person has a glycoA1c of 7.5 % before starting linagliptin, they can anticipate it will be 7.0% when on the medication. This translates to an average blood sugar of 169 mg/dl dropping to 154. This is virtually the same effect found with Januvia and Onglyza, the other medicines in this group.This amount of blood sugar lowering seems feeble but the benefit is even worse then that. Here’s why.
Blood tests are accurate enough for the clinical purposes of physician’s diagnosing and treating their patients. “Clinical purposes†allow for some fuzziness in measurements. Does it matter to a patient’s health if the blood sugar is 200 or 210? Not really. In general, a variation of 10% is acceptable for clinical blood tests, meaning that if a result is given as 100, a repeat measurement of the same blood sample could read between 95 and 105. For the glycohemoglobin A1c test a variation of 0.5 is common with standard laboratory techniques. For an individual on linagliptin there is virtually no way to determine if the change in glycoA1c is due to the medication or is simply within the variation of the blood test. Not very impressive is it?
How much is the average person going to pay for this unimpressive effect? I researched the retail cost of Januvia, the sister drug to linagliptin. Drugstore.com lists a price of $216 for 30 pills after a 18% saving. $7 per pill….wow!! I assume linagliptin will be priced competitively. Compare this to the price of $13 for a month’s supply of metformin, currently the most prescribed oral agent for treating diabetes. In contrast, metformin shows a 1.5% to 2% drop in glycohemoglobin A1c, more than three times that of the gliptins such as linagliptin.
I have used both Januvia and Onglyza in my medical practice. As advertised, I haven’t encountered significant side effects. Also, as advertised the effect of these medicines to lower blood sugar has been disappointing and complaints by patients about the cost has been a constant theme. At the same time my email inbox is stuffed with invitations to join online symposiums with paid experts inevitably focusing on how to ramp up my use of these drugs. The sales pitch is given in inflated marketing lingo as a “change in the treatment paradigm†for treating diabetes. Buyer beware, is my advice for the health care consumer starting a new medication for treating type 2 diabetes.
The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of “something missing†in the way suffers of hypothyroidism are treated for their disease.
Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.
Without effective intervention the early stage of type 2 diabetes known as prediabetes carries a high risk of progressing to outright diabetes. Metabolism.com provides an up-to-date summary of recommendations from national authorities, for preventing and possibly reversing this life long affliction
Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.
By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”
Off- Label Use
The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.
GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.
by Gary Pepper, M.D.
