Posts Tagged ‘diabetes’
The Perfect Storm for Health Care
I knew things were bad, but recent data released from the National Health and Nutrition Examination Survey (NHANES) report that what I have been blogging about lately takes the cake (Excuse the pun.) The report is published @ Fryar CD, Hirsch R, et. al. Hypertension, high serum cholesterol, and diabetes: Racial and ethnic prevalence differences in U.S. adults, 1999-2006. Hyattsville, MD: National Center for Health Statistics, 2010.
In brief, the report outlines 45% of individuals who are 20 years or older have hypercholesterolemia, hypertension, or diabetes. 3% had all three, and 13% had two most commonly; hypertension and hypercholesterolemia.
In 15% of all US adults, these conditions are undiagnosed. The levels used in these studies are not as “stringent “as the levels with which we cardiologists work with, which would undoubtedly would lead to an increase in these issues.
This brings up many points. The first one is people are going to have to take more responsibility for their health. Weight loss is the primary goal, as it will lead to a decrease in all three of these events. If you are at your “ideal” weight (and who among us are), then medications are warranted to prevent the long term consequences of these illnesses. As I have blogged about before, these illnesses start early and progress silently over time until the myocardial infarction or stroke occurs. It doesn’t really do much good the hose the burning barn down. It is far better to protect the barn.
Data has shown and I have blogged that as your LDL cholesterol drops the event rate for stroke and myocardial infarction drops. There is no plateau. An LDL of 70 is better than 80 and an LDL of 50 is better than 70. If you are taking cholesterol medication, get the maximum benefit and take the maximum amount. There is no significant increase in side effects and that is well documented. One scary event that is occurring is the constant switching of medications by insurance companies for no other reason than price. The statin drugs are not the same and to reach “goal” the amounts that patients need vary widely. Don’t get lulled into the amount you are taking. If you don’t take the “right” amount, you are risking the side effects without the full benefit.
Hypertension is more controversial. As we have recently seen and I have blogged about the ACCORD trial shows that lower is not necessarily better. You should strive to keep your systolic numbers below 140 and your diastolic numbers below 90.
The biggest benefit comes from exercise, which will help with diabetes, hypertension, and cholesterol. As Nike says Just Do It.
The Opportunity We Lost
Healthy People 2010 was launched in 2000. The aim of this project was to reduce the number of cardiovascular deaths by 20%. This is certainly a worthy project. The results were published in the Bulletin of the World Health Organization in February.
I’m sure you can guess but we didn’t make it. 400,000 deaths in the U.S. from cardiovascular disease are projected to occur this year. I want to put this into perspective. 416,000 servicemen and women died during World War II. Each year, we lose that many people to heart disease. You would think there would be uproar. The only sound I hear is snacking.
What exactly seems to be the problem? We have had a reduction in improved total cholesterol and in lower blood pressure in men. We have also increased physical activity and decreased smoking. However, this is almost totally offset by an increase in obesity and diabetes.
We must rethink the balance of government and personal responsibility. The government does not make us eat more or make us fat. The government can limit the salt in food and demand that soft drinks be removed from schools. We can develop all sorts of medications, but it seems to come down to what will you do for yourself and most of it seems to revolve around how much you eat. Most diabetes is related to simply being overweight. This is a personal responsibly and until we grasp this future progress may not be made.
The most recent National Health and Nutrition Examination Survey found that most Americans are overweight and one-third are obese. Obesity has overtaken smoking as a major health burden in the United States. This is very apparent if you travel anywhere outside the United States and compare average body size. Don’t go to Disney World, it is truly disheartening.
Let’s all pledge to lose 10 or 15 pounds. We went to the moon. We can understand this problem and solve it. It won’t be solved by drugs, it must be solved by education and the simple understanding that we eat too much. Put down the remote and do something.
Our Radiation Problem…
In the past thirty years, the amount of radiation we are exposed to in the United States has doubled. As reported in the NEJM 362; 10:943-945. What has changed is the amount of radiation that we receive from medical imaging. At the present time, the amount is close to 50%. 30% of that dose comes from cardiac imaging.
If you have chest pain or there is some other abnormality that occurs that leads you to see a cardiologist frequently, the first test you will receive is a nuclear stress test. This test was performed over 9 million times last year and represents one of the largest man made contributors to radiation exposure. It also represents a huge cost to health care and this January Medicare reduced reimbursement on the test by 40%. If the patient’s nuclear stress test is positive, then the next step is often cardiac catheterization.
One would think that this sequence of tests would then often show important disease. One would then be surprised. As reported in the same issue of the NEJM and widely in the lay press this is not the case.
Using the American College of Cardiology National Cardiovascular Data Registry, which we at Holy Cross Hospital participate in, 398,978 patients who had no documented coronary artery disease was abstracted from the registry from January 2004 to April 2008. The data was then collected as to their nuclear stress tests and risk factors.
The disturbing results were that a small minority 37.6% had significant disease as defined by left main stenosis of >50% or >70% stenosis of a major epicardial coronary artery. The strongest risk factors were age, male sex, use of tobacco and the presence of diabetes, dyslipidemia or hypertension. Further, those with the highest Framingham risk scores received more noninvasive testing than those who our guidelines suggest would be benefited.
30% of the patients subjected to cardiac catheterization had no angina. As I have repeatedly blogged about the only reason for invasive tests are to treat angina that is resistant to medical management.
When the data from the whole registry was analyzed the rate of coronary artery disease went up to 60%. Still that means a full 40% of the patients being subjected to cath do not need it in the sense that nothing is found. I can tell you from experience that cath is sometimes done to “finalize” an issue and to move patients to other concerns but this does not account for 40%.
We, as physicians, need to do better to limit not just this radiation exposure but the cost of these tests. Unfortunately, this is just one of the many areas that need addressing in our health care crisis. We are at least identifying these areas and I look to the future to some of the solutions. I will keep you informed as we move forward.
Good is Not Better Than Excellent
The ACCORD trial started in September of 1999. One of the reasons that medical progress is so slow is that it takes so long to do the trials. Mice are easier but they don’t have the illnesses that we do and humans are not as easy to control. 10,000 patients were enrolled in the National Institutes of Health study. This might be a good time to explain this point.
Drug companies are responsible for much of the research that goes on in medicine, but they are generally not the sponsor of trials to determine the “best practices” to take care of chronic illnesses. This is simply because there is no money in it. Therefore, much of the work is done by the government in the form of grants to the National Institutes of Health and often money, drugs, equipment or support is given by drug companies to help the work get done. Sometimes this is voluntary and sometimes it is mandated by the FDA. The work we are doing on the DAPT (Dual Antiplatelet Therapy) Study is an example. It is being run by Harvard with money from various sources heavily supported by Industry because the FDA demanded it. Sometimes this support is very large but not as large as the hundreds of millions of dollars that it takes to approve a new drug.
The ACCORD trial had three parts as described in my last blog. Perhaps the most important part was the first, which asked a simple question. If you normalize a patient Hemoglobin A1C, does that benefit the patient? Diabetes is usually described in many ways but one is a hemoglobin A1C of >6.0%. Hemoglobin A1C is a measure of glucose control over the preceding two to three months. In non-diabetic patients, it is less than 6.0%.
Honestly if you asked any doctor, we would have said of course that is a benefit. Well it’s not the case. In fact it is harmful. Of the 5,123 participants in the standard arm, one half had reached the goal of Hemoglobin A1C of less than 7.5%. Of the 5,128 participants in the intensive arm, half reached the goal of less than 6.0%. This part of the study was to last five years but was stopped after 3.5 years because there was an excess of 54 deaths in the intensive arm. That’s a 22% increased death rate in the intensive group.
The causes of death were similar in both groups and the mechanism for the increased rate of death has not been determined in spite of extensive analysis. The recommendation of the American Diabetes Association clinical guidelines is that Hemoglobin A1C less than 7.0% be maintained.
So much for glucose control, what about blood pressure?
Why We Need to be in ACCORD
My favorite reason for doing research is that I have been fascinated in the past twenty years by what we as doctors think is the correct way to treat patients only to find that when we study the condition, we just have it all wrong. I know that that doesn’t fit with the perception that we “know it all” and can always make “the right call,” but it keeps us real. We can only use the data that is driven by the studies in our attempt to treat patients to the best of our ability. We want the best outcomes for patients.
Diabetes is a terrible chronic illness and it goes hand-in-hand with atherosclerotic disease in all of its forms, stroke, myocardial infarctions, and amputations. It is a terrible scourge, and I deal with it on a daily basis.
In an attempt to determine optimal diabetic treatment, a study was devised and named ACCORD or Action to Control Cardiovascular Risk in Diabetes. This study used the same group of patients to answer three questions that seemed simple at the time.
1. Is intensive gylcemic (sugar) control better?
2. Is lower blood pressure better?
3. Is better lipid control better?
To answer the first question patients were divided into two groups and one was treated in the standard way and one was forced to lower hemoglobin A1C levels than previously recommended. Hemoglobin A1C is a long-term measure of gylcemic control.
To answer the second question, the groups were targeted to a systolic blood pressure of 140 or forced to a systolic of 120. This was unblinded i.e. the investigators knew what they were supposed to do.
To answer the third question the groups received either a statin or a statin and a fenofibrate.
See if you can guess the results. The answer next time…
And Now The Bad…
Over the past several blogs, I wrote about how more and more patients should take statins. Now we have the news that taking statins may increase your risk of diabetes. Published online on February 17th in the journal Lancet was a Meta analysis that was performed on multiple trials of statin use, which included 91,140 patients. As I have mentioned before, statins are the most studied drug known to medical science.
The findings were surprising and widely discussed in the lay press. The authors found that one patient in 255 treated for 4 years will develop diabetes. An individual has a 9% chance of developing diabetes but is given a benefit of the reduction of 5.4 deaths or MI’s per 255 patients. There was no correlation with body mass or with the level of reduction of LDL. Further it doesn’t appear to be related to type of statin or dose.
In individual trials, this risk was greater. In the PROSPER trial with pravastatin, the risk was 32% of developing diabetes and in two trials with rosuvastatin the risk was 18%. Niacin therapy has also been associated with this effect.
It is not clear why this is so. It is confusing because the use of statins in patients with diabetes reduces their risk of death and MI. It would seem prudent to be on the watch for the development of this problem with further testing of glucose levels during treatment. A study is soon to start to determine whether high dose or low dose statins put individuals at more risk.
Although this risk seems clear the benefit here far outweighs the risk. It is important to exercise and to eat as healthy as possible. It is important to be as lean as possible. The cholesterol in your body is 90% manufactured and that is from your particular genetic inheritance. Some thin patients get heart disease, some overweight patients don’t. As I have said before we don’t have a very good understanding of much of this because we lack a basic model to study. No animal gets coronary disease except humans and we don’t study easily. If you are at risk for cardiovascular events, do your heart and brain a favor and take your statins.
Will Cardiac Diagnostics Work?
We, as physicians, are used to measuring things. We measure temperature, blood pressure, height and weight. We measure your blood counts and the level of cholesterol in your blood. We are used to measuring things and part of this derives from the science of medicine.
In general, we believe that it you can measure something you will understand something better and possibly begin to change it. With the development of blood glucose monitors, we are able to be more precise in our control of diabetes. Those of you who are old enough will remember when glucose control was measured by urine test strips. Glucose monitors are now an essential part of diabetic care and are approved by Medicare and Insurance companies. There is some debate as to whether this glucose control does any real good but it is accepted by both physicians and the public.
How do you measure a hearts function. It is not blood pressure because a normal heart can have a blood pressure of 90/60; a failing heart can have a blood pressure of 200/110. The physical signs are rapid weight gain and special sounds we hear in the lungs called rales, which is derived from the French word rattle. A Frenchman Rene Laennec in 1816 developed the first stethoscope, again to measure something.
We measure heart function by measuring the pressure in the heart and lungs. I do this daily at cardiac cath and we have exquisite knowledge about these dynamics. We can also measure the pressures non-invasively by echocardiogram.
In the late 1960’s, two physicians at Cedars-Sinai in Los Angeles developed a catheter that could be placed in a vein and threaded into the heart to measure the pressures in the lungs. Initially known as a Swan-Ganz catheter after its inventors, Jeremy Swan and William Ganz, it eventually became known as a Swan. (Don’t ever be the second name on an invention.) These catheters saved millions of lives and led to an era of improved intensive care. The seminal article was published in the New England Journal of Medicine in August 1970.
We now have two ways that I know of to measure the status of the heart on a day to day basis. The science of these measurements is well understood. FDA before approval of the devices and the measurements demanded proof that the obtaining of the measurements led to good clinical outcomes such as staying out of the hospital with heart failure. We at the Jim Moran Heart and Vascular Institute participated in one of the device approval trials.
Next…the devices and why they may help us better care for patients.
The Effects of Bariatric Surgery on Fatal and Non-Fatal Myocardial Infarction
If weight loss prevented myocardial infarctions, then the ultimate weight loss should be very successful in halting the progress of the disease and in preventing this outcome.
Bariatric surgery is a catch phrase for several operations that can induce and sustain a patient’s weight loss. Patients will often lose 50-75% of their pre-op weight. The procedures vary from the original gastric bypass to laparoscopic gastric banding. All will induce a drastic and prolonged weight loss if patients follow the post-op advice properly.
In several studies, this surgery has been found successful in reversing the diabetic state of patients, and in fact, it is approved for this reason by many insurance companies.
This past October, the Swedish Obese Subjects study (SOS) was presented. This study started in 1987 involved 4047 patients and was prospective and matched. In 2007 it presented the primary endpoint that of mortality. It was published in the N Engl J Med 2007: 357:741-752 and showed a 29% reduction in total mortality when compared to conventional treatment. The treatment group lost an average of 30kg compared to 1 kg in the control arm.
This presentation was regarding a secondary endpoint that of the effect of bariatric surgery on fatal and non fatal myocardial infarction. After follow up of 12.9 years there was no difference. There were 104 myocardial infarctions in the surgery group and 113 events in the control group. Say it aint so!! What? Oh Oh. Well back to the drawing board.
There have been some studies that do show a benefit but they are not as rigorous as this one and they are smaller. We are left with the strong suspicion that maybe it’s true. That we should not smoke, we should strive to weigh as close to the mark as possible, we should control our hypertension and we should take statins if we are at risk. Then we should enjoy our lives because there is just so much one can do.
This surgery is lifesaving and I attempt to get it approved for my patient’s who qualify. We are blessed with a superb center here at Holy Cross and a superb surgical team led by Dr. Michael Perez. It will do many things but it will not prevent myocardial infarctions.
Enjoy life. Our frailties are often genetically endowed and future generations will benefit from the work we do today.
The Truth about Diet and Heart Disease
When I talk with families after an angioplasty, the most common comment is “will you tell him (it’s usually him) to eat better.” Unfortunately people have long memories when it comes to some things, and we as physicians failed in our early attempts to inform patients about how to avoid heart disease. Diet was held out as a way to avoid the illness and alternatively, if you eat terribly, you would get it. Neither is true. Frankly, if diet really caused heart disease, then we would all be dead. Those “billions and billions” served have to count for something. Diet makes you fat and being fat leads to diabetes. The Diabetes Life Style study showed that strict diet and exercise can lead to a halting of the diabetic process and allows patients to stop medications. It unfortunately has little or nothing to do with heart disease.
Genetics is the root cause of this illness and unquestionably cigarette smoking accelerates the process. If your father or mother had coronary disease in their 30’s or 40’s then watch out. If they lived to be 90, then the high likelihood is you will not be afflicted with it. This is not exact but in general it fits. Much of this is related to cholesterol and its metabolism. 90% of your cholesterol level is created by you on a daily basis to serve as the building blocks of cells and proteins. 10% is consumed. In general you cannot lower your cholesterol by diet because of a “feedback loop” in the liver, which senses the amount of cholesterol and then increases the production of it to make up for the loss. This is where statins come in as they terminate the feedback loop.
We are now in the middle of the holidays and it is a time where we often gain weight and then on New Year’s Day resolve to lose it. The day after New Year’s the gym is full and it usually remains that way for two or three days. Then we are just heavier.
Please do not take this as a pass. People should attempt to do what’s right. People should weigh as close to their ideal weight as possible, and study after study has shown that if you weigh less you live longer. The seminal studies on mice show that if you feed them 30% less than “required” the study mice live significantly longer than control mice. This is difficult to do with humans but provocative none the less. You will be much less likely to develop diabetes and have hypertension that is difficult to control. This is where exercise comes in since it “burns” some of those excess calories.
We now have perhaps the ultimate example of fat doesn’t equal heart disease and that will be the subject of my next blog.
Losing Weight to win at Life
In my last blog I wrote about the Metabolic Syndrome. This syndrome figures very prominently in the day to day practice of medicine. The syndrome increases the risk of death and can be treated. However, the treatment is very difficult. Guess what the best treatment is…losing some weight. Although I am not kidding we all know just how difficult that can be.Therapeutic lifestyle modification which includes reducing weight, the total intake of fat and saturated fat, increasing the intake of fiber and increasing physical activity can make a major difference.
In one study of 522 patients 172 men and 350 women who were followed for 3.2 years the risk of diabetes was reduced by 58%. In another study the average weight loss in the treatment group was 9lbs and in the control group was 1.75 lbs.
After therapeutic lifestyle modification, medicine helps to control many of the factors. Stopping smoking is of course a major concern and in another blog I will write about the issues with the various methods.
The drugs are the standard ones we use to treat the specific issues. For high blood pressure, ACE (angiotensin converting enzyme) inhibitors are very helpful. They also are useful in the protection of kidney function in those patients who have diabetes. If you are allergic to ACE inhibitors than ARB’s (angiotensin receptor blockers) are useful but more expensive as they are not yet generically produced.
The treatment of high triglycerides and low HDL is difficult as this is often genetically based. Exercise will help raise HDL’s by 10% and weight lose will often be enough to bring the triglycerides into range. The use of statins will help some, and they are often used because the entire lipid profile is off. Fibrates and niacin are also helpful, but as mentioned in other blogs (July 30, June 19) we are now working on a drug to use instead of niacin because of its poor tolerability.
Diabetes is treated in the usual manner by diet and at times medication, metformin is very useful in this syndrome. Exercise also helps.
Often patients are sick through no fault of their own. This is one area that hard work and lifestyle can make you better. If you think you have this the next step is simple, see your doctor and get to work. The life you save is your own.
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