Reconciling Current Diabetes Guidelines

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1 Reconciling Current Diabetes Guidelines Jaime A. Davidson, MD, FACP. FACE Part 1. Diagnosis Welcome. I am Dr. Jaime Davidson, a clinical professor of medicine in the Department of Internal Medicine, Division of Endocrinology at University of Texas Southwestern Medical Center in Dallas. I d like to welcome you to this podcast to discuss the current guidelines as they relate to the diagnosis and treatment of type 2 diabetes mellitus. This podcast is a course in the type 2 diabetes curriculum program. As far as diagnosis is concerned, there are many, many organizations that have different criteria. And the latest from the American Diabetes Association, which appears not to be a real official statement, is that we could diagnose diabetes with an A1C equal to greater than 6.5%. But actually, if we look at NHANES data and we look at the correlation of an A1C of 6.5[%] and the number of patients in percentage that have postprandial greater than 200 [mg/dl], maybe we lose a lot of time diagnosing diabetes with an A1C. And the first and most reliable abnormality that we can use to diagnose diabetes is a postprandial [glucose]. If the patient comes with symptoms of diabetes and the casual glucose is 200 or more, for sure that patient has diabetes. If we want to be absolutely sure, we can repeat that test, and that test for glucose is reliable and very inexpensive. On the other hand if we re trying to actually look for very, very early diabetes, then for sure an A1C is not the choice because it takes many years. For example, if you want to diagnose diabetes early, the fasting glucose is not the best test either. Why? Because the postprandial glucose, in the majority of patients, is higher about five to seven years before the fasting glucose gets to be 126. Then ADA, 6.5% A1C or higher is diabetes. And we agree with that but we meet many patients where the A1C may be 5.9 or 6.0 or 6.1 and they already have diabetes. And that s not an exclusion for diabetes. But if you are a 6.5, for sure you have diabetes. A fasting glucose of 126 or more is diabetes. And the most early test is a postprandial glucose, two hours, 200 or more in an oral GTT oral glucose tolerance test is diabetes. And again I want to finish by saying a random glucose greater than 200, or 200 in a patient with classic symptoms, is type 2 diabetes. How about the American College of Endocrinology and the American Association of Clinical Endocrinologists? There is no mention of A1C as a diagnostic criterion. And the Page 1 of 5

2 reasons I mentioned were the ones that were used by AACE, not to use an A1C for diagnosing criteria. But there will be a letter from AACE saying that they agree that if it s 6.5, the patient has diabetes. Then, as far as AACE is concerned, a 200 postprandial glucose or greater, a fasting glucose 126 or greater, and in a glucose tolerance test or post challenge with 75 grams oral glucose, if at two hours the glucose is 200 or higher, the patient has diabetes. Then let s go and look at who should be screened. Well there are differences between the American Diabetes Association guidelines and the American Association of Clinical Endocrinologists and the American College of Endocrinology. But actually, there are not too many. First, ADA recommends that individuals 45 or older should be screened on an annual basis. AACE recommends that that screening should start at age 30, and the reason why AACE recommends screening after the age of 30 is because in NHANES in the late 1990s, it shows that the largest percentage increase of new cases of type 2 diabetes were in patients ages 30 to 39. In addition to that: somebody that is physically inactive; people that have a first degree relative with diabetes; ethnicity at high risk for diabetes like Latinos, Hispanics, African-Americans, Asians, and Native Americans; females that had a history of gestational diabetes, or gave birth to a baby that was nine pounds or heavier; hypertension many patients develop hypertension before they develop diabetes and we know that that s a risk factor for diabetes (actually some of the treatments that we use may actually increase the rate of conversion to type 2 diabetes); a low HDL or high triglycerides what else could be a cause of low HDL and high triglycerides other than either pre-diabetes or diabetes; a female with a history of polycystic ovary diseases; and A1C in the past of 5.7 or higher; a history of impaired glucose tolerance; a history of impaired fasting glucose; clinical conditions associated with insulin resistance; a history of cardiovascular disease either a stroke or a heart attack, somebody had to have a stent. And the other difference between AACE and ADA is that AACE recommends to add psychiatric illness, not only because there s a very good correlation between especially depression and type 2 diabetes, but many of the antipsychotic agents used today are diabetogenic and we don t want to miss the opportunity to either change the therapy or treat these patients on a timely basis. And therefore, that is the difference. Page 2 of 5

3 If the patient is 45 and normal and none of those risk factors, we don t need to repeat the screening every year but maybe every two to three years. And those are the differences between ADA and AACE. Part 2. Goals of Therapy Once we have a patient diagnosed with type 2 diabetes, the criteria for goals are different between the American Diabetes Association and the American Association of Clinical Endocrinologists and the American College for Endocrinology. ADA has a goal of A1C below seven, a pre-prandial glucose between 70 and 130 and a peak postprandial glucose less than 180. But this peak postprandial glucose in real practice is not so practical because, depending on the carbohydrate load the quantity this peak may vary from patient to patient. Most of the time, it may be at one hour. But at one hour, 180 actually reflects very closely what it will be at two hours. And that should be 140. Then the American Association of Clinical Endocrinologists has for postprandial glucose normal and goals for therapy to 140. And the reason is that in many clinical trials when they actually measure postprandial glucose, below 140 is an achievable goal. If you look at the A1C goal by the American Association of Clinical Endocrinologists, it s below 6.5%. And the reason is the same. The reason is that, in recent clinical trials, we have been able to achieve less than 6.5% in more than 50% of the patients. AACE also has a fasting glucose goal below 110 instead of having a fasting between 70 and 130. And the fasting or pre-prandial goal of 110, again, the reason to have it is because in many trials using a basal insulin in the evenings or combination oral agent very, very few patients were able to reach a target below 100. But more than 50% were able to reach a target of below 110. There s some controversies regarding cardiovascular events and the lowering of A1C. And that may be because we actually treat patients too late. Then if you look at the UKPDS, and this is routine type 1 patients or sometimes also in type 2, if we diagnose diabetes early, we actually prevent complications. If we start treating patients very aggressively when they already have a stroke or an MI or open heart surgery for revascularization, maybe the target should be different. But I believe that the target should be individualized. And if you look at both at ADA and AACE, that s what it says: individualize targets. When you have somebody that is 85 and has a terminal illness or has Alzheimer s, well getting them to A1C of 6.5 or 6 is not fair. But it s also not fair to leave them at 8.5 with nocturia, polyuria, because their care will be more difficult. Then we need to have a balance. Page 3 of 5

4 Patients should be asymptomatic if at all possible without hypoglycemia, without nocturia, polyuria. And in those cases, somebody that is 80 that has Alzheimer s or terminal cancer, they need to live a comfortable life and make life easier for the family. Then in AACE, one of the statements is persistently monitor and titrate pharmacological therapy until all glycemic goals are achieved. And that s Grade A [recommendation]. And the reason for achieving an A1C of 6.5% as a primary goal is because we can achieve it, because we have shown that it prevents complications, microvascular for sure and to some degree macrovascular. But we also recommend in these guidelines to consider other factors other than the ones I told you before. For example, if you have somebody with a history of severe hypoglycemia; hypoglycemia unawareness; patients that have not been educated; that are not motivated; that have shown poor adherence and we haven t been able to teach them--maybe those patients we should actually individualize the A1C goals to 7.0%or 7.5%. Then, customization of the goals of therapy are very important. Part 3. Treatment How about the treatments for type 2 diabetes? There are both ADA and AACE recommendations. ADA has changed, as we know, from allowing us to educate a patient, look and see how they do with diet and exercise, wait three months and then add the first agent. The new guidelines are very specific: once you see somebody with diabetes, from day 1 if the diagnosis is made, in addition to educating the patient, which is extremely essential for the future of that patient, educate them regarding good eating habits, exercise therapy, continuing medications on a regular basis, they recommend to start metformin. And every every single recommendation from all over the world, the first choice of therapy is metformin unless there is some contraindication. And the difference between AACE and ADA is very simple. Not every patient that we get to see in our practices enters with an A1C of 6.5% or 7.0% or 7.5%. If they enter with between 6.5% and 7.5% or 6% and 7.5%, if we want to start therapy, metformin is the drug of choice. But if somebody comes with an A1C of 8.2%, very rarely any monotherapy will get us to goal. And the difference is that by AACE, the A1C between 7.6 and 9%, the recommendation is to start dual therapy. And the dual therapy that is recommended is metformin plus a GLP-1 [agonist], a DPP-4 [inhibitor] or a TZD. And the reasons are very simple: these combinations do not cause hypoglycemia. Also the combination between metformin and a GLP-1 is the one that actually causes the most weight loss. And the combination between metformin and a DPP-4 [inhibitor] is one single pill. And it doesn t cause weight gain. And it doesn t cause hypoglycemia. If there are some contraindications then if you look at the road map, it will tell you we may add Page 4 of 5

5 an SU a sulfonylurea. And the reason is they re very inexpensive. But when we do, we need to start with the lowest possible dose to prevent weight gain and to prevent hypoglycemia. The road map from the American Diabetes Association tells you that after metformin, you have three options. First option is sulfonylureas because they are the cheapest. But if you start an SU with an A1C of 7, chances are that you are going to cause hypoglycemia. And then the patient may not take the medication in the future. If you do [use them] because of cost, then use the lowest possible dose. If you look at ADA, the second choice is a basal insulin. You will never add a basal insulin at an A1C of 7, especially if you give it at bedtime. Because most of these patients have near normal glucoses during the night and you are going to actually increase the risk of nocturnal hypoglycemia. And the third choice is a TZD. And as you know from the FDA, the one of choice is pioglitazone. And it has many advantages. It s one of the drugs that actually, if you look at the AACE road map, is recommended when we have a fatty liver. And pioglitazone doesn t cause hypoglycemia but it may cause a little weight gain, and is contraindicated in patients with congestive heart failure New York [NYHA] Class II and higher. And finally they recommend that, as in the second tier, to use a GLP-1. AACE believes that there is a lot of data with GLP-1s and there s a lot of data with TZDs. And therefore, we feel that many patients will benefit if we choose the right drug for that patient. Then the rationale is to actually achieve the goals of glycemia--a1c, fasting glucose and postprandial glucose--in a recently diagnosed patient, in the shortest period of time without hypoglycemia because of the metabolic memory. Remember we have two studies, the UKPDS--they call it legacy--and we have the DCCT-- and we call it metabolic memory. At the end of the day, you know controlling diabetes early on to target is beneficial to all of our patients with type 1 and type 2 diabetes. Page 5 of 5

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