Guidelines for Type 2 Diabetes: EBM in Practice

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The American College of Physicians (ACP) has established guideline statements for the management of HbA1c in non-pregnant adults using medication. They considered the research behind guidelines set by four other major physician organizations for treating type 2 diabetes. After reviewing that data, they have proposed four guidelines for use when treating patients. These are non binding guidelines; the choice is always left to the physician and the patient. But I think they get back to what evidence-based medicine should have always been about: use the best science and research and work with the patient to see what they want to do. Let’s take a look.

ACP Guideline Statements

These are the statements:

Guidance Statement 1
Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients’ preferences, patients’ general health and life expectancy, treatment burden, and costs of care.

Guidance Statement 2
Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes.

Guidance Statement 3
Clinicians should consider de-intensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%.

Guidance Statement 4
Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population.

EBM and Guideline Statements

I think the Guideline Statements reflect what EBM was always supposed to be about: consider the patient and what they want. I have spoken to many adults with type 2 diabetes who become frustrated with their inability to reach the HbA1c goals their physician has set. If they can’t reach it, more medication seems to be the only solution, and that’s not what they want.

I think these guidelines bring the patient or their caregiver into the equation. What price does the patient have to pay with their body? How much will it affect their life positively or negatively? Are there real improvements in quality of life if the HbA1c is 6.5% versus 7.0%? What is the cost of emotional stress?

The new guideline statements are a great addition to a physician’s repertoire: treat the patient as an individual. The patient comes before statistics and hazard ratios.

The Bottom Line

While not all organizations are going to adopt these guidelines, they’re important. There has been significant pushback from other organizations, all suggesting that there are new medications that may prevent some of the negative effects of prior treatment. “New medications”—they’ve learned nothing.

The one opportunity I see is that there’s hope for all of us who want to work at getting control of our lifestyle and reduce the dependence on medications as recommended by statement three. You say you don’t want to take medication? Excellent! Here is your chance to prove it.

Eat less. Eat better. Move more.

What are you prepared to do today?

Dr. Chet

 

Reference: Ann Intern Med. doi:10.7326/M17-0939.

 

What Is Evidence-Based Medicine?

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The term evidence-based medicine (EBM) dominates the scientific literature related to the treatment of disease. In short, the use of EBM is intended to treat patients based on the best available science and research; only the largest, best designed, and strongest studies are used when setting up the standards for treatment. That seems to make sense. That applies to the use of medications for the treatment of type 2 diabetes in adults as well as other diseases.

In the past, physicians primarily depended on their training. It doesn’t mean they didn’t use science to guide their decisions, but where and how physicians were trained influenced their treatment decisions more than research and science. That’s why EBM was developed; the use of solid evidence when considering treatment of patients keeps treatment up to date.

The problem is that the way EBM evolved appears to have excluded one of the primary purposes of how it began: consideration of the values and preferences of the patient. Treating patients should never be a one-way street. Your doctor should be a trusted advisor, not a dictator, and should give you the most up-to-date options for treatment of your condition; then you decide together which treatment option fits your life. The clinical and research evidence guides the physician in what to do along with knowledge of your personal health history, but only in the context of what you want.

For example, if after discussing all the options, a patient decides an earlier death is preferable to extending life by taking medication and suffering horrible side effects, that’s a valid preference that the doctor must respect. Another example: if the patient’s life expectancy is less than 10 years or so, pain management may be a better option than joint replacement when all the ramifications of major surgery are considered. That kind of joint decision-making is what EBM is supposed to be all about.

Saturday I’ll look at the guidelines for HbA1c proposed by the American College of Physicians in light of EBM. It’s a Memo you don’t want to miss.

What are you prepared to do today?

Dr. Chet

 

Reference: Ann Intern Med. doi:10.7326/M17-0939.

 

A New Approach to HbA1c

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Type 2 diabetes is a significant problem in North America and it’s spreading throughout the entire world. The treatment standard has always focused on controlling blood sugar, especially HbA1c. Normal is less than 5.7%. For most individuals, reducing the HbA1c to under 6.5% has been the goal for pharmacologic treatment.

HbA1c is a protein found on red blood cells that indicates blood glucose levels over the past 90 days. It develops when hemoglobin, a protein within red blood cells that carries oxygen throughout your body, bonds with glucose in the blood. Think of it as the sugar you ate over the last three months getting stuck to your red blood cells; the higher your HbA1c, the worse your control of your blood sugar has been. For a prediabetic, that means your days of diabetes meds and finger pricks is getting closer. For a diabetic, that opens the door to many of the worst consequences of diabetes, such as heart and kidney disease, blindness, and nerve damage.

Recently, the American College of Physicians published new guidance statements for the use of medications for controlling HbA1c. A committee of physicians examined the data behind the current standards of treatment for four of the major physician organizations including the American Diabetes Association. In the simplest terms, they wanted to know what benefits or hazards occur when treating adults with type 2 diabetes with medications. Should the goal be to get the HbA1c as low as possible with drugs? Or should the individual be part of the treatment equation?

This is an important issue and the topic for this week. I’m going to review evidence-based medicine on Thursday. You can get the entire story by listening to the Straight Talk on Health on evidence-based medicine, normally available only to Members and Insiders; I cover the entire concept of how EBM began and what it was intended to be. For those of you who haven’t chosen a membership yet, get more info here.

What are you prepared to do today?

Dr. Chet

 

Reference: Ann Intern Med. doi:10.7326/M17-0939.

 

Spring Break!

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Paula and I are taking this week off for Spring Break, but as you can see we’re spending it in Michigan where it isn’t exactly beach weather. We’ll be back with more health news next week.

What are you prepared to do today?

Dr. Chet

The Truth Behind the Obesity Paradox

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In my opinion, the short answer to the obesity paradox is that it doesn’t really exist. But what fun would that be? That doesn’t teach you anything. Let’s take a look at the problems with the research that contributed to this paradox.
 

Study One: Dialysis, BMI, and Mortality

A study of dialysis patients led to the first observation that people with higher BMIs lived longer (1). After tracking over 1,300 subjects on dialysis for a year, researchers found that those who were overweight had a decreased risk of dying and had fewer hospital stays when compared to those who were underweight. This may have been the study that yielded the name The Obesity Paradox. The problem? The study lasted only one year. Trying to generalize what will happen to all overweight and obese people on dialysis from a study that lasted only one year and at only a single location isn’t realistic. It raises an intriguing question, but we’ll need a much more extensive study to really make a solid prediction.
 

Study Two: The Rotterdam Study

I described this study on Thursday (2). While the study appeared to show a protective benefit from being overweight or obese, the subjects were elderly with an average age of 77 at the study’s beginning. One risk factor that you cannot change is age: the older you are, the more likely you are to die. But that’s not the whole story. We can probably say that older people may live longer with a little extra weight, but to extend that prediction to all age groups isn’t valid.
 

Study Three: BMI and Mortality

While this study claimed to analyze the data on over two million people, it was still a meta-analysis (3), which doesn’t yield cause and effect, just a statistical association. Further, they used studies of varying lengths without necessarily knowing exact causes of deaths. They also did not have precise BMIs on everyone; some studies included metrics such as BMI under 27.5 and over 27.5. They tried to include the highest number of subjects, but the quality of data varied and that made it a mess. Researchers chose too many different types of studies in the meta-analysis, and it just doesn’t work. I wouldn’t bet my life on it.
 

Study Four: A Broader Look

The real problem with every approach is the lack of acknowledgement that people with advanced disease may have lost weight before they were included in the study; diseases such as heart failure, diabetes, or renal disease will often lead to weight loss. Those who were heavier when disease hit had the benefit of extra energy stored as fat to deal with the disease, and that could explain the outcomes of those studies. It had nothing to do with being obese; it was a matter of timing.

A study published last month appears to confirm that (4). Researchers in the Cardiovascular Disease Lifetime Risk Pooling Project obtained data from 10 different longitudinal studies, including individual-level data and accurate mortality data. They found that as BMI increased, the death rate from all forms of CVD increased. For those who carried extra weight while younger, CVD occurred earlier, making it more likely they would die before their time.
 

The Bottom Line

As I said, there really is no obesity paradox. Being overweight or obese carries with it risks of degenerative disease. Some people may have better genes and may gain protection for a few years. But in the end, being overweight or obese carries a higher risk of various diseases than the limited protection from an advanced disease you may gain by carrying extra weight. So my advice is the same as it always was: if you’re overweight, your best bet for a long, healthy life is to lose it.

What are you prepared to do today?

Dr. Chet

 

References:
1. Kidney International, Vol. 55 (1999), pp. 1560–1567.
2. European Heart Journal (2001) 22, 1318–1327.
3. JAMA. 2013; 309(1): 71–82.
4. JAMA Cardiol. doi:10.1001/jamacardio.2018.0022.

 

Does a Little Extra Weight Keep You Alive?

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The Rotterdam Study was begun in 1991 to investigate the risk factors of cardiovascular, neurological, ophthalmological, and endocrine diseases in people 55 and older (1). The study is still ongoing, but periodically subsets of subjects are examined to find out which characteristics are associated with these diseases. In a study published in 2001, researchers reported on a group of subjects who were diagnosed with heart failure at the beginning of the study and followed for an average of six years—181 out of over 5,000 subjects. By the end of five years, 85 subjects had died. One of the observations that researchers noted was that a higher BMI was associated with reduced mortality; in plain terms, the heavier people were more likely to stay alive.

It didn’t stop there. In 2013, a study was published that directly examined the relationship between BMI and mortality (2). This meta-analysis included 97 studies and examined more than 2.88 million participants and more than 270,000 deaths. They reported that while grades 2 and 3 obesity (grade 2: BMI of 35-39.9; grade 3: BMI more than 40) were associated with increased mortality, grade 1 (BMI of 30-34.9) was not, and the overweight category (BMI of 25-29.9) actually showed a reduced risk of dying. (How do you rate? Check your BMI here.)

Is this true? Is body weight not associated with an increased risk of death? Have we been trying to lose weight for no reason? I’ll finish this on Saturday.

What are you prepared to do today?

Dr. Chet

 

References:
1. European Heart Journal (2001) 22, 1318–1327.
2. JAMA. 2013 January 2; 309(1): 71–82.

 

What Is the Obesity Paradox?

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Did you ever hear something that didn’t seem to make sense? That seemed to go against everything you thought to be true? One example of this is something called “The Obesity Paradox.” I’ve seen a few headlines this week that have talked about it, so it’s time to address it in the Memo.

One of the variables that we would think is related to the development of cardiovascular disease would be body weight. It seems logical: as weight increases, so does the strain on pumping the blood through the additional blood vessels required to feed the extra fat and muscle. People who are overweight may eat the wrong foods, consume too much food, and move too little.

But since the early 2000s, several studies have been published seeming to show that body weight wasn’t necessarily a risk factor for CVD or an early death. They showed that those who were overweight, a BMI between 25.0 and 29.9, had lower mortality rates than those who were normal weight. Some showed that stage-one obesity, a BMI between 30.0 and 34.9, was also not related to mortality. Thus the term “The Obesity Paradox” was coined. But is it true? We’ll take a look at the research the rest of the week.

What are you prepared to do today?

Dr. Chet

 

Special Memo: 28 Years!

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Paula and I are celebrating our 28th wedding anniversary today. Yep, the photo is our wedding picture from 1990—a couple of crazy kids (in their late 30s) vowing to tackle life together. It’s been a great experience, through more good times than not. In the movie As Good as It Gets, Jack Nicholson says one of the great lines in cinema: “You make me want to be a better man.” I can’t say that I would ever come up with something as profound as that, but I can say that you want a partner who can help you be better than you are. I am, and it’s due to sharing the past 28 years with Paula.

Paula adds: “We’ve always accepted each other as we are. That makes marriage a lot less ‘work’ than if you go into it wanting to remake each other—although I did get him to change his hairstyle.”

 

Thanks for being a regular reader and for sharing our celebration of 28 years together.

What are you prepared to do today?

Dr. Chet

 

Research Update on Vaping

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Tin, aluminum, lead, and zinc: those are the metals that were found in the aerosol generated by various e-cigarette devices in a recently published study. Sounds like exactly what you want to inhale deep into your lungs, right?

Researchers in Maryland recruited volunteer vapers to test the liquid in the tank, the aerosol, and the remaining fluid in their e-cigarette tanks; 56 subjects provided their e-cigarette for analysis. Testing these metals is no easy task. All samples were collected in sterile conditions, and all tests were compared to samples known to be pure and also with calibrating liquids. The objective was to see what contributions the heating coil might have made to the metals in the aerosol.

Levels of tin, aluminum, lead, and zinc increased after exposure to the coil and the heat it generates, and that’s being distributed into the lungs. Did the metals all come from the coil? No, the e-liquid already had the metals, but the amounts increased after conversion to aerosol.

This adds to the growing body of research that suggests vaping is not benign and is potentially harmful. We won’t know how harmful for years, possibly decades, when those who began vaping years ago are tested and found to have higher rates of lung disorders. If you continue to vape, you may look forward to being one of those subjects. It’s your body. It’s your choice.

What are you prepared to do today?

Dr. Chet

 

Reference: Environ Res 159:313–320, PMID: 28837903, 10.1016/j.envres.2017.08.014.

 

Do Calcium Supplements Harm Your Heart?

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Over the past few years, concern has grown about the relationship between heart disease and calcium intake. A couple of studies have shown a possible association between calcium intake and cardiovascular disease. In an article also published this month in the Journal of Women’s Health (1), two clinicians reported on a number of studies including one that examined calcium intake and heart disease. Their purpose was to update clinical guidelines for physicians and internists who regularly treat women and heart disease.

They selected a study that included a meta-analysis of studies on calcium intake from food and supplements (2). You know my position on meta-analysis and its overuse and limitations, but in this case, the researchers wanted to establish positions for both the National Osteoporosis Foundation and the American Society for Preventive Cardiology on calcium intake and heart disease. I think the use of this statistical method was warranted.

After an exhaustive review of the studies and re-analysis of the data, researchers found that calcium intake, from either food or supplements, at levels up to 2,000–2,500 mg per day are not associated with CVD risks in generally healthy adults. Although they found a few trials that reported increased risks with higher calcium intake, the risks were small and not considered to be clinically important even though they were statistically significant. The results applied to women and men.

At this point, with data from tens of thousands of subject, taking calcium from food or supplements will not harm your heart if you’re healthy. Does that mean you should limit calcium if you’re not healthy? No. There just isn’t sufficient data to know. In my opinion, if you take 800–1,000 mg of calcium per day, I think you’ll be fine but you should always check with your physician. You need calcium for many reasons, including bone and blood health and conducting signals between nerves. Especially if you don’t consume a lot of dairy, take your calcium supplement.

What are you prepared to do today?

Dr. Chet

 

References:
1. J Women’s Health DOI: 10.1089/jwh.2018.6932
2. Ann Intern Med 2016;165:856–866.