More on preventing type II diabetes

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Category : Medical Rants

The diabetes epidemic has become the number one health problem in the US, and many industrialized countries. Unfortunately, as countries improve their economic base, diabetes increases (in parallel with waist lines).

Thus, our opulence has a serious medical downside. Many experts would like to develop strategies for preventing diabetes.

We know that lifestyle modification can prevent diabetes. Exercise, eat right and lose weight remains the mantra. Some patients can accept the mantra, but some cannot.

So, we have an increasing number of studies looking a pharmaceuticals to prevent diabetes. Here is another one:

Drug Can Prevent Diabetes in Many at High Risk, Study Suggests

Drug therapy can prevent the development of diabetes in millions of people who are at high risk for the disease, a major study suggests, potentially opening a new path for curbing a worldwide epidemic.

In the study, presented Friday at a meeting in Copenhagen of the European Association for the Study of Diabetes, people in high-risk categories who took the drug rosiglitazone for three years reduced their chance of developing diabetes by two-thirds. The study involved about 5,000 people in 21 countries. “This is a very large effect, the kind of thing that you don’t expect to see in a clinical trial,” said Hertzel Gerstein, the study’s main author, a professor at McMaster University in Hamilton, Ontario. “Ten, even five years ago, we really didn’t know what people could do to reduce their risk of diabetes. Now we are developing an arsenal.”

But some independent scientists and advocacy groups expressed skepticism about the study, which was published Friday on the Internet by The Lancet, the British medical journal, and promoted extensively by GlaxoSmithKline, which makes rosiglitazone and sells it under the brand name Avandia.

“We’ve looked carefully at the data and it’s just hard to know how many people would benefit and at what cost,” said Cathy Moulton, a care adviser for Diabetes UK, an advocacy group in London. “We’re worried that people may think there’s a quick fix, when what is proved to work is lifestyle changes. For the moment, we don’t think we can solve this epidemic with a pill.”

So what should we think. We have solid evidence (do you believe in Evidence Based Medicine) that a drug works. We have a strong religious belief that lifestyle changes are better than drugs.

In many ways this controversy mirrors all medical controversies. How do we interpret data? Some would argue that we have a new arbiter – EBM. However, one cannot evaluate evidence in a vacuum. We always add values and context. This discussion makes the problem very clear.

I favor attempting lifestyle changes. I also believe that I would recommend treatments that have a high probability of preventing diabetes. Type II Diabetes is a devastating disease. Prevention trumps treatments.

But then I have injected my own value structure. I would rather have my patients take a drug to prevent diabetes than have them develop diabetes. I would love for them to accept lifestyle changes, but remain skeptical about the probability of success.

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Comments (8)

I saw a patient today. His A1C in June was 9.6. I told him he should start on Byetta injections, that he really needed to lose weight, and that the host of diabetic complications, which I listed for him, awaited him.

I also stressed the value of lifestyle modification, diet and exercise. I gave him the tools to improve. I saw him today. His A1C was 5.9. He has lost 42 pounds. Says he looks and feels the best he has in years.

I asked him what he thought of the Byetta now.

He never filled it.

He has changed his way of thinking about the diabetes, instead of being something he couldn’t do anything about, he felt that he could see it as a challenge to overcome. Previously he was on 3 oral meds, now he is only taking his metformin as he was getting hypoglycemic reactions.

Obviously this is not a typical story. But is that because we have so many therapies we can throw at our patients that they cease to believe they have control over these issues?

Avandia can cause CHF serious enough to require hospitalization. Metformin causes serious GI side effects in about 5% of cases. Obviously I use these drugs, but the diabetics who do the best are the ones who work with their diet, change their exercise pattern, and take their disease seriously. Proper education remains, in my opinion the best preventive, and I worry that we are starting to do with blood sugar what we have already done with blood lipids.

YMMV 🙂

Evan makes two important points. First: “But is that because we have so many therapies we can throw at our patients that they cease to believe they have control over these issues?” As a patient we are often confronted with a large number of choices, and without time or resources, we are forced to turn our care over to our doctors. Thus, we become passive participants in the health care decision making process.

Second “Proper education remains, in my opinion the best preventive, and I worry that we are starting to do with blood sugar what we have already done with blood lipids.” Having watched the medical field for a number of years I have seen problem after problem, medication after medication, come and go.

Starvation diets and a BMI of less the 20 was the goal a number of years ago. To achieve this end fen-phen was the drug of choice. We have all seen the rage of “pre” conditions and the accompanying medications. For the last several years statins have been the rage with some doctors making them standard for all of their patients.

So the question left unanswered is: Will this become the new statin with full page ads and high profile doctors singing it’s praises? Will patients say: It’s OK, I am on the pill? I am afraid the answer to both of these questions is yes. Life style changes will be swept aside and we will only see this as a growing problem, both here and abroad.

The reasoning in the Lancet study is almost circular. The definition of diabetes used in the study was, predictably, determined by elevated blood sugar or abnormal glucose tolerance testing. Patients were randomized to placebo or rosiglitazone, a drug that we know lowers blood sugar. Patients on rosiglitazone were less likely to have blood glucose levels high enough to meet the definition of diabetes. So the study proved that a drug that lowers blood sugar seems to do so even in patients whose initial blood sugar didn’t meet the definition of diabetes.
Duh.
The real question is whether treating patients with so-called “pre-diabetes” with drugs does more good than delaying drug therapy until the get “real” diabetes.
This study didn’t measure a lot of clinically important outcomes, and only followed patients for 3 years, so it was incapable of determining whether there were clinical benefits of drug treatment.
In addition, patients who got rosiglitazone had a trend toward more cardiovascular events, and had statistically significantly more CHF (although the numbers were small.) This suggests that treating patients with this drug has the potential for harm.
So it remains completely unclear whether treatment of “pre-diabetes” with rosiglitazone does more good than harm.

Let me take an opposing view of those who feel we stand in the way of lifestyle changes by giving medicines. There are plenty of things that sound simple, but are very difficult. Quitting smoking is simple: you just stop. It is, however, not an easy thing for most smokers to do. Most doctors assume patients smoke because they don’t realize the consequences, but this is a patronizing perspective. What, do you expect the patient to say: “Gosh, doc, I didn’t realize smoking was bad for me! I’ll quit now!” The same applies for lifestyle changes in a diabetic or pre-diabetic. You need to educate them, but you also must be realistic. If education does not help (which is the case 90-95% of the time), you medicate them. I think the same question will come up when a good and safe long-term weight loss medication comes up. Should we give it? I say YES! Our goal is to promote health. Would it be better if they did it without medication? Of course. It would also be good if the Israelis and Palestinians stopped fighting. Simple, but not likely.

DB?!?!

What’s this comment about a “religious belief”?
DB – “We have a strong religious belief that lifestyle changes are better than drugs.”

What about the Diabetes Prevention Program trial comparing placebo, metformin, & lifestyle changes? It was well done & showed that lifestyle had 58% reduction in prevention of progression from Prediabetes to Diabetes vs. a 31% reduction for metformin.

The Finnish studies also showed a 58% reduction with lifestyle.

If you don’t believe me, read the ADA guideline review below:

http://care.diabetesjournals.org/cgi/content/full/29/suppl_1/s4#SEC5

Some follow up studies of the Finnish studies showed a dose response curve with exercise, the more exercise, the greater reduction.

I’m very skeptical about the rosiglitazone study for several reasons:

1. They didn’t use a lifestyle arm. Why? Maybe because other studies showed that lifestyle works better & they didn’t want something else beating out their profitable drug.
2. A good study should try to beat the best alternative, not just placebo or an inferior treatment.
3. It was heavily funded by the makers of rosiglitazone & they may have influenced the data. Who knows, maybe there was a lifestyle arm & they suppressed it when it was just as good or better than rosiglitazone?

Dr. Bob

Rob,

If our goal is to promote health, than that to me is the key issue with these primary prevention studies. You’re taking a patient who is largely healthy. The diabetes cut-offs have already been hugely expanded over the last decade, so people who are truly at risk are already heavily treated.

With this, we are asked to take a person who does NOT meet the criteria for a disease and treat him for that disease, so that he may avoid getting it, when we already have a perfectly healthy way for him to avoid getting it. Screening patients with impaired glucose tolerance for the development of diabetes, then treating their diabetes would (I am nearly certain) have less cost, similar, if not identical efficacy, and would identify far fewer patients as seriously ill in their own minds.

If the goal is health … primum non nocere.

My point is not that everyone with pre-diabetes should be put on meds. My point is that people too easily put forth lifestyle as an easy option. Most primary care physicians do not have the time to go into depth with patients what this lifestyle change entails. We do our best, and I even send pre-diabetics to diabetes education (if I can, because most of the time it is not paid for). Furthermore, even if you do give lifestyle advice, you are often telling them what they already know. Sometimes the threat of a medication can get the on the wagon of lifestyle change, but we need to consider all the options. Doctors too often treat patients who don’t do the lifestyle changes as being stupid – as if they are not intelligent enough to understand the importance of these changes. I think this is a bad way to approch this problem because most people do realize the facts. Is the obesity “epidemic” due to people getting dumber? I think people have more information than they have had in the past, but it does not do a lot of good.

Again, this is not a call to just give up on emphasis of lifestyle changes, I just think it needs to be put in the proper perspective.

Hi Medrants,

I love your aggressive practical approach to pre-diabetes/metabolic syndrome/glucose intolerance.

You’ll probably save more patients than you will kill, BUT, not if you use rosiglitazone. The DREAM trial was a falsely designed study because they picked the wrong medication – they should have picked the overwhelming best choice of medications for diabetes — METFORMIN.

All this talk about rosiglitazone being great at reducing insulin resistance has minimized the fact that Metformin is pretty darn good at it too. Not to mention metformin is associated with weight loss. Metformin has many other advantages: ie. no heart failure problems like the TZDs and no weight gain/hypoglycemia like glyburide.

Oh yeah, why not throw in the fact it reduces your chance of cancer death ! http://bmj.bmjjournals.com/cgi/content/full/330/7503/1304 . NONE of the other medications did that.

Did I mention that metformin was affordable and has an established track record for safety ?

The DREAM died when they chose the wrong drug. Of course, it “*MIGHT*” have to do with the fact that metformin is generic and rosiglitazone isn’t.

😉

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