Category Archives: Drugs for Diabetes

June 23, 2016 · 2:00 AM

Are These Two Diabetes Drugs Better Than the Others?

Better living through chemistry

Empagliflozin is a pill. Liraglutide is a once-daily subQ injection.

The two drugs in question are empagliflozin (aka Jardiance) and liraglutide (aka Victoza). Both are used to treat type 2 diabetes, not type 1.

A major problem we have with most diabetes drugs is that while they do lower blood sugars, we don’t have much evidence on whether they actually prolong life and prevent bad outcomes like heart attacks, strokes, cancer, blindness, kidney failure, amputations, and serious infections. It gets even more complicated. For instance, a given drug may eventually be proven to prolong life by a year via prevention of death from heart disease, while at the same time increasing the risk of spending that last year bedridden from a stroke.

It’s extremely difficult and costly to suss out these issues. It requires large clinical trials wherein half of the PWDs (people with diabetes) are treated with a particular drug, and the other half are treated with “standard therapy.” Five or 10 years later you compare clinical endpoints between the two groups. A couple studies have done this recently.

A blogger I follow, Larry Husten, wrote the following:

But it was the secondary goal of these trials that led to the transformation of the field. Baked into the trial design was the provision that if they were able to establish noninferiority then the trial investigators were permitted to test for superiority. The second phase began when Empa-Reg became the first trial to convincingly show a clear benefit, including a reduction in cardiovascular death and a reduction in hospitalization for heart failure. with empagliflozin (Jardiance, Merck). Then, more recently, the LEADER trial showed a significant reduction in cardiovascular events with liraglutide (Victoza, Novo Nordisk). In both trials nearly all the patients had significant established cardiovascular disease—precisely the population that cardiologists are likely to see.

Click the embedded links above for more details. Even better, read the original research reports if you have the time and knowledge. I support my family with a full-time job taking care of patients, so it will be a while (if ever) before I can dig into this further. (When my book sales make me independently wealthy, I’ll have more time for this!)

diabetic diet, low-carb Mediterranean Diet, low-carb, Conquer Diabetes and Prediabetes

Analyzing clinical reports requires a good grasp of logic, statistics, and basic science

Are the LEADER and Empa-Reg trials valid? Yeah, maybe. In an ideal world, other investigators would try to replicate the results with additional clinical trials. Are the published results free of fraud and bias? I don’t know.

Because we don’t know the long-term effects of many of our diabetes drugs, I favor doing as much as possible to control blood sugars with diet, exercise, and weight management.

Stay tuned for future developments.

Steve Parker, M.D.

PS: Just because one drug in a class of drugs reduces bad clinical outcomes, it doesn’t mean all drugs in the class do.

PPS: If it’s hard for you to pronounce empagliflozin and liraglutide, some of my books don’t even have them.

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April 10, 2016 · 3:01 PM

FDA Revises Guidelines for Use of Metformin In Those With Kidney Impairment

Conquer Diabetes and Prediabetes

Metformin is the most-recommended drug for type 2 diabetes

Recently the U.S. Food and Drug Administration revised their guidelines for physicians regarding use of metformin in patients with kidney impairment. This may make more patients candidates for the drug.

Physicians have been advised for years that type 2 diabetics with more than minimal kidney impairment should not be given metformin. Why? Metformin in the setting of kidney failure raises the risk of lactic acidosis.

The traditional test for kidney impairment is a blood test called creatinine. When kidneys start to fail, serum creatinine rises. Another way to measure kidney function is eGFR, which takes into account creatinine plus other factors.

By the way, you can’t tell about your kidney function simply from the way you feel; by the time you have signs or symptoms of renal failure until the process is fairly advanced.

The FDA now recommends not using  metformin if your eGFR (estimated glomerular function rate) is under 30 ml/min/1.73 m squared), and use only with extreme caution if eGFR drops below 45 while using metformin. Don’t start metformin if eGFR is between 30 and 45. Your doctor can calculate your eGFR and should do so annually if you take metformin.

Steve Parker, M.D.

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February 3, 2016 · 6:12 PM

Which Diabetes Drugs Cause Hypoglycemia?

Hypoglycemia—aka low blood sugar—can kill you. The most common cause is medications taken by people with diabetes.

DRUGS THAT RARELY, IF EVER, CAUSE HYPOGLYCEMIA

Diabetics not being treated with pills or insulin rarely need to worry about hypoglycemia. That’s usually true also for prediabetics. Yes, some type 2 diabetics control their condition with diet and exercise alone, without drugs.

Similarly, diabetics treated only with diet, metformin, colesevalam, sodium-glucose co-transport 2 inhibitor (SGLT2 inhibitor), and/or an alpha-glucosidase inhibitor (acarbose, miglitol) should not have much, if any, trouble with hypoglycemia. The DPP4-inhibitors (sitagliptan and saxagliptin) do not seem to cause low glucose levels, whether used alone or combined with metformin or a thiazoladinedione. Thiazolidinediones by themselves cause hypoglycemia in only 1 to 3% of users, but might cause a higher percentage in people on a reduced calorie diet. Bromocriptine may slightly increase the risk of hypoglycemia. GLP-1 analogues rarely cause hypoglycemia, but they can.

DRUGS THAT CAUSE HYPOGLYCEMIA

Regardless of diet, diabetics are at risk for hypoglycemia if they use any of the following drug classes. Also listed are a few of the individual drugs in some classes:

  • insulins
  • sulfonylureas: glipizide, glyburide, glimiperide, chlorpropamide, acetohexamide, tolbutamide
  • meglitinides: repaglinide, nateglinide
  • pramlintide plus insulin
  • possibly GLP-1 analogues
  • GLP-1 analogues (exanatide, liragultide, albiglutide, dulaglutide) when used with insulin, sufonylureas, or meglitinides
  • possibly thiazolidinediones: pioglitazone, rosiglitazone
  • possibly bromocriptine

BECOME THE EXPERT ON YOUR OWN DRUGS

If you take drugs for diabetes, you need to be your own pharmaceutical expert. Don’t depend solely on your physician or pharmacist. Your doctor has to be familiar with 150–200 drugs, and the pharmacist, even more. You only need to master two or three, I hope. Here are important things to know about your drugs:

  • interactions with other drugs or supplements you take, whether prescription or over-the-counter
  • how to monitor for drug toxicity (e.g., periodic blood tests)
  • potential adverse effects
  • is the money-saving generic just as good as the brand-name drug
  • what’s the maximum dose and how often can the dose be adjusted
  • if you take a brand-name drug, what’s the generic name

Steve Parker, M.D.

low-carb mediterranean diet

Front cover of book

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January 24, 2016 · 8:00 PM

Be Your Own Drug Expert

Open wide!

Open wide!

I recommend you become the expert on the diabetic drugs you take.

Don’t depend solely on your physician or pharmacist. Do research at reliable sources and keep written notes. With a little effort, you could quickly surpass your doctor’s knowledge of your specific drugs.

What are the side effects? How common are they? How soon do they work? Any interactions with other drugs? What’s the right dose, and how often can it be changed? Do you need blood tests to monitor for toxicity? How often? Who absolutely should not take this drug?

Along with everything else your doctor has to keep up with, he prescribes about a hundred drugs on a regular basis. You only have to learn about two or three. It could save your life.

Steve Parker, M.D.

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December 6, 2015 · 5:41 AM

Does Big Pharma Have Too Much Influence on Diabetes Management?

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“For this, I needed six years of college?!”

MedPageToday has a series of articles looking at socioeconomic issues related to diabetes drugs that have come onto the market in the last decade. They call it their Diabetes Drugs Investigation. I recommend the entire series to you if you have type 2 diabetes. The authors’ have five major points:

1. “Diabetes drugs improve lab tests, but not much more, particularly in pre-diabetics.” FDA drug approvals were based mostly on whether hemoglobin A1c or blood sugar levels improved, not on improvements in hard clinical endpoints such as risk of death, heart attacks, stroke, blindness, amputations, etc.

2. “Physicians and drug makers have reported diabetes drugs as the “primary suspect” in thousands of deaths and hospitalizations.”

3. “Diabetes drug makers paid physicians on influential panels millions of dollars.” The implication is that the panelists were not totally unbiased in their assessments of drug effectiveness and safety.

4. “Risk of a risk now equals disease.” This is about the latest redefinition of prediabetes which created many more “patients.” Prediabetes can progress to type 2 diabetes over a number of years: one of every four adults with prediabetes develops diabetes over the next 3 to 5 years. Some doctors are even treating prediabetes with diabetic drugs. (I recommend a “diet and exercise” approach.) The authors think the prediabetic label—one third of U.S. adults, including half of all folks over 65—is over-used and over-treated.

5. “The clinical threshold for diagnosing diabetes has crept lower and lower over the past decade.” For instance, in 1997 expert panels lowered the threshold defining diabetes from a fasting blood glucose level of 140 mg/dl (7.8 mmol/l) to 125 mg/dl (6.9 mmol/l). Four million more American adults became diabetics overnight. In 2003, they lowered the threshold for prediabetes from a fasting blood glucose from 110 mg/dl (6.1 mmol/l) to 100 mg/dl (5.6 mmol/l). Boom! 46 million more American prediabetics.

I fully agree with the authors that we don’t know which drugs for type 2 diabetes are the best in terms of prolonging life, preventing diabetes complications, and postponing heart attacks and strokes. Furthermore, we don’t know all the adverse long-term effects of most of these drugs. For instance, metformin had been on the market for over a decade before we figured out it’s linked to vitamin B12 deficiency. That’s why I try to convince my patients to do as much as they can, when able, with diet and exercise before resorting to one or more drugs. (All type 1 diabetics and a minority of type 2 diabetics must take insulin.) Maybe it’s healthier to focus primarily on drug therapy…but I don’t think so.

RTWT.

Steve Parker, M.D.

low-carb mediterranean diet

Front cover of book

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November 20, 2015 · 2:00 AM

What’s Wrong With Drugs for Diabetes?

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How about this one?

MedPageToday has an article on the “Bittersweet Diabetes Economy” talking about the cost of treating diabetes, Big Pharma influence on diagnosis and treatment of diabetes and prediabetes, and the unknown long-term effectiveness of diabetes drugs. Most of the article pertains to type 2 diabetes. A quote:

Last year, sales of diabetes drugs reached $23 billion [worldwide or U.S.?], according to the data from IMS Health, a drug market research firm. That was more than the combined revenue of the National Football League, Major League Baseball, and the National Basketball Association.

But from 2004 to 2013, none of the 30 new diabetes drugs that came on the market were proven to improve key outcomes, such as reducing heart attacks or strokes, blindness, or other complications of the disease, an investigation by MedPage Today and the Milwaukee Journal Sentinel found.

The U.S. Food and Drug Administration approved all of those drugs based on a surrogate endpoint: the ability to lower blood sugar. Many of the new drugs have dubious benefit; some can be harmful.

Another key outcome we don’t know about is prevention or postponement of death via drug therapy for type 2 diabetes.

Now you have some inkling of why I exhort my patients to maximize diet and exercise interventions before resorting to drugs, increasing drug dosages, or adding more drugs. (I’m not talking about type 1 diabetes here.)

RTWT.

Steve Parker, M.D.

low-carb mediterranean diet

Front cover of book

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November 4, 2015 · 8:42 PM

Well Over Half of Adults in U.S. Are On Drugs

"These are flying off the shelves!"

“But selling drugs is good for the economy, silly!”

Over the last decade, the percentage of U.S. adults taking prescription drugs has risen from 50 to 60%. UPI has the pertinent details. A snippet:

Many of the most used drugs reflect the effects of metabolic syndrome, a group of conditions tied to obesity and diet.

“Eight of the 10 most commonly used drugs in 2011-2012 are used to treat components of the cardiometabolic syndrome, including hypertension, diabetes, and dyslipidemia,” researchers wrote in the study, published in the Journal of the American Medical Association. “Another is a proton-pump inhibitor used for gastroesophageal reflux, a condition more prevalent among individuals who are overweight or obese. Thus, the increase in use of some agents may reflect the growing need for treatment of complications associated with the increase in overweight and obesity.”

I’m not anti-drug, generally. Lord knows I prescribe my fair share. But in addition to the cost of drugs, we have side effects and drug interactions to worry about. If we in the U.S. would effectively attack overweight and obesity, we’d be much better off.

It’s a lot easier to just pop a pill, isn’t it? Especially if someone else is paying for the pill.

Steve Parker, M.D.

PS: My books cost far less than most prescriptions and cause only rare paper cuts.

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August 20, 2015 · 7:21 PM

Does a New Diabetes Drug Reduce Heart Disease Risk?

diabetic mediterranean diet, Steve Parker MD

Pharmacist using her advanced degree to count pills

Larry Husten writing at CardioBrief mentions a recent press release alleging that empagliflozin reduces cardiovascular disease risk.

Larry points out a problem with diabetes drugs that I’ve been harping on for years: we don’t know the long-term outcomes and side effects of most of our drugs. As long as a diabetes drug reduces blood sugar and seems to be relatively safe in the short term, it will be approved for use by the U.S. Food and Drug Administration. Larry writes:

Until now the best thing anyone could say for sure about all the new diabetes drugs was that at least they didn’t kill people. That’s because although these drugs have been shown to be highly effective in reducing glucose levels, a series of large cardiovascular outcomes trials failed to provide any evidence of significant clinical benefit.

Cardiovascular disease is a major stalker of diabetics. I’m talking about heart attacks, strokes, heart failure, sudden cardiac death.

The aforementioned press release touts reduced cardiovascular disease risk in patients taking empagliflozin. What’s missing is any mention of overall death reduction. Even if the drug really prevents heart attacks and strokes, which I doubt, don’t you want to know about overall death rates? I do. For all we know, the drug could promote illness and death from infections and cancer while reducing heart attacks and strokes. The drug’s net effect could be premature death. 

I’m 99% sure the researchers doing the work have the mortality data. Unless they don’t want to know.

By no means am I against drug use. But if I had type 2 diabetes, I’d do all I can with exercise, weight control, and low-carb eating before resorting to new or higher doses of drugs.

Steve Parker, M.D.

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January 11, 2015 · 11:25 PM

Updated “Standards of Medical Care in Diabetes” Now Available Free Online

The American Diabetes Association every January updates their Standards of Medical Care in Diabetes. The document is lengthy, highly technical, and written for healthcare providers. Some of you may appreciate it. If I were a non-physician with diabetes, I’d learn as much about it as possible. Remember, no one cares about your health as much as you do. The 2015 version of the standards is called, appropriately enough, Standards of Medical Care in Diabetes—2015.

Updates to the guidlelines include:

  • recommendation not to sit inactively for over 90 minutes
  • pre-meal blood sugar target is now 80 to 130 mg/dl (4.4 to 7.2 mmol/l) instead of the old 70 to 130 mg/dl
  • added SGLT2 inhibitors to the drug treatment algorithm
  • recommended a diastolic blood pressure goal of 90 mmHg or less instead of the old 80 mmHg or less
  • increased the potential pool of statin drug users
  • added a section on management of diabetes during pregnancy

Steve Parker, M.D.

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December 29, 2014 · 8:29 PM

Dulaglutide Joins War Against Diabetes

In September, 2014, the U.S. Food and Drug Administration approved the fourth drug in the GLP-1 analogue class: dulaglutide. The granddaddy in the class is exenatide (Byetta). The new GLP-1 receptor agonist will be sold in the U.S. under the name of Trulicity. It’s a once-weekly injection.

This is only a summary and is liable to change. Get full information from your prescribing healthcare provider and pharmacist.

Even walking helps with blood sugar control

Even walking helps with blood sugar control

Uses

For adults with type 2 diabetes, in conjunction with diet and exercise. It’s not a first-line drug. It can be used by itself or in combination with metformin, pioglitazone, glimiperide (and presumably other sulfonylureas), and insulin lispro (e.g., Humalog, a rapid-acting insulin). The drug has not been tried with basal (long-acting) insulins.

Dose

Start with 0.75 mg subcutaneously every week. Can go up to 1.5 mg weekly if needed.

Adverse Effects

Hypoglycemia is rare, but possible, when GLP-1 analogues are used as the sole diabetes drug. When it happens, it’s rarely severe. But the risk increases substantially when dulaglutide is used along with insulin or insulin secretagogues such as sulfonylureas or meglitinides.

Common side effects are nausea, vomiting, diarrhea, abdominal pain, decreased appetite, dyspepsia, and fatigue.

It might cause thyroid tumors and pancreatitis.

Do Not Use If…

…you have a family or personal history of medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2 or pre-existing severe gastrointestinal disease. Those who are pregnant or nursing babies should probably not take it since we have no data on safety. Don’t use for diabetic ketoacidosis.

Use only with caution if you have a history of pancreatitis or known liver impairment.

Steve Parker, M.D.

Click for full prescribing information.

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