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CME/CE

Achieving Guideline Goals in the Patient With Diabetes: Novel Insights Into CV Risk Reduction

  • Authors: Faculty: George L. Bakris, MD, FACP; David S.H. Bell, MB, FACE, FACP; Brent M. Egan, MD; Ronald G. Victor, MD
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Target Audience and Goal Statement

Cardiologists, internists, and other healthcare professionals who manage patients with diabetes and hypertension.

Upon completion of this activity, participants will be able to:

  1. Describe the prevalence of CVD and identify the key CV risk factors in patients with type 2 diabetes
  2. Discuss the importance of using agents that block the sympathetic nervous system in patients with type 2 diabetes to lower CV risk and improve clinical outcomes
  3. Apply treatment guidelines and recent trial data to devise optimal long-term, target-driven strategies for reducing CV risk in patients with type 2 diabetes, with an emphasis on lowering blood pressure
  4. Recognize the clinical features of prediabetes and the metabolic syndrome and adopt management approaches to prevent disease progression


Disclosures

It is the policy of Pragmaton Office of Medical Education (POME) that faculty members of CME/CE-accredited programs must disclose any significant financial interest, arrangement, or affiliation with a corporate organization that may have an impact on the faculty member's presentation, such as grants, research support, honoraria, member of speakers' bureau, consultant, major stockholder, etc.


Author(s)

  • George L. Bakris, MD

    Professor of Preventive Medicine; Vice-Chairman, Department of Preventive Medicine, Rush Medical College, Chicago, Illinois

    Disclosures

    Disclosure: Advisor: Abbott Laboratories, Alteon Inc., AstraZeneca Pharmaceuticals LP, AusAm Biotechnologies, Inc., Biovail Corporation, BMS-Sanofi, Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Company, Forest Laboratories, GlaxoSmithKline, Merck & Company, Inc., Novartis Pharmaceuticals, Inc., Takeda Pharmaceuticals North America, Inc., Wyeth Pharmaceuticals; Research Support: Abbott Laboratories, Alteon Inc., AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Company, Forest Laboratories, GlaxoSmithKline, Merck & Company, Inc., Novartis Pharmaceuticals, Inc.; Speakers' Bureau: Abbott Laboratories, Alteon Inc., AstraZeneca Pharmaceuticals LP, AusAm Biotechnologies, Inc., Biovail Corporation, BMS-Sanofi, Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Company, Forest Laboratories, GlaxoSmithKline, Merck & Company, Inc., Novartis Pharmaceuticals, Inc., Takeda Pharmaceuticals North America, Inc., and Wyeth Pharmaceuticals

  • Ronald G. Victor, MD

    Professor of Medicine, Chief, Section of Endocrinology, Louisiana State University Health Sciences Center, New Orleans, Louisiana

    Disclosures

    Disclosure: Advisor: Biovail Corporation, CVRx, Inc., Novartis Pharmaceuticals, Inc., Pfizer Inc.; Research Support: Pfizer Inc.; Speakers' Bureau: Merck & Company, Inc., Pfizer Inc.; Stockholder: Merck & Company, Inc.

  • Brent M. Egan, MD

    Assistant Professor of Clinical Medicine, Division of General Internal Medicine Duke University Medical Center, Durham, North Carolina

    Disclosures

    Disclosure: Advisor: AstraZeneca Pharmaceuticals LP, Kalypsys, Novartis Pharmaceuticals, Inc., Pfizer Inc.; Research Support: AstraZeneca Pharmaceuticals LP, CV Therapeutics, Novartis Pharmaceuticals, Inc., Pfizer Inc., Sanofi; Speaker: AstraZeneca Pharmaceuticals LP, Merck & Company, Inc., Pfizer Inc.

  • David S. H. Bell, MB

    Professor of Medicine, University of Alabama School of Medicine, Birmingham

    Disclosures

    Disclosure: Advisor: GlaxoSmithKline; Grants or Research Support: GlaxoSmithKline; Speakers' Bureau: GlaxoSmithKline.


Accreditation Statements

    For Physicians

  • This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME). Cerebrio is accredited by the ACCME to provide continuing medical education for physicians.

    POME designates this educational activity for a maximum of 2.0 Category 1 credits toward the AMA Physician's Recognition Award. Each physician should claim only those credits that he/she actually spent in the educational activity.

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    For Pharmacists

  • The Pragmaton Office of Medical Education is accredited by the American Council on Pharmaceutical Education (ACPE) as a provider of continuing pharmaceutical education. This activity will provide a total of 2.0 contact hours (0.2 CEUs) of continuing education credit in states that recognize ACPE-approved providers. Universal Program Number: 084-999-04-001-H01

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


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CME/CE

Achieving Guideline Goals in the Patient With Diabetes: Novel Insights Into CV Risk Reduction

Authors: Faculty: George L. Bakris, MD, FACP; David S.H. Bell, MB, FACE, FACP; Brent M. Egan, MD; Ronald G. Victor, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

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Optimizing Approaches to Reducing Cardiovascular Risk in the Patient With Diabetes, Presented by George L. Bakris, MD, FAHA, FASN

Risk Factors for Cardiovascular Disease

  •  
  • Slide

    Slide 1.

    Optimizing Approaches to Reducing Cardiovascular Risk in the Patient With Diabetes

    (Enlarge Slide)
  • Let's start off with something that you already know. This is from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7). It's important to understand that there are many risk factors for cardiovascular disease (CVD) and 2 notable additions to the list are here. The first is the metabolic syndrome. The other is presence of kidney disease, specifically microalbumineria, which is probably similar to C-reactive protein (CRP) in terms of giving you a signal of inflammatory markers of the vasculature and glomerular filtration rate (GFR) of less than 60.

  • Slide

    Slide 2.

    CVD Risk Factors

    (Enlarge Slide)
  • This is the patient who has a problem and doesn't know it. He is so averse to exercise, but he loves his dog so he buys a treadmill for his dog, because he doesn't want to walk the dog! He's sitting in a chair 6 feet from the television, drinking his regular Coke. Heaven forbid that he lean over and change the channel. He's got the remote control on the armchair. This is what we have to deal with and it's a real problem.

  • Slide

    Slide 3.

    The Problem

    (Enlarge Slide)

Lower Blood Pressure Is Better

  • Now this is a classic paper. It's quoted in the JNC 7 and, in addition, it's something that you need to know. Blood pressure is a continuum. If you go from 140 mm Hg to 139 mm Hg, your risk does not go away all of a sudden. I think that's an obvious but important point that you need to know.

    I want you to focus on the left side of the slide for systolic blood pressure. You'll notice that at ages 40 to 49, going all the way up to ages 80 or 89, the risk goes down to 115 mm Hg. So there is increased risk if you go above a systolic blood pressure of 115 mm Hg. In fact, with a 20-millimeter increase, you double cardiovascular risk within any of those age ranges. So just keep that in mind. I think that's an important point and it really brings home the message that you need to get to blood pressure goal.

  • Slide

    Slide 4.

    IHD Rates by SBP, DBP, and Age: Lower Blood Pressure Is Better

    (Enlarge Slide)
  • Now, there are clinical trials that support the concept that a little goes a long way. I've summarized them for you here. Five- to 10-millimeter differences do make a difference in cardiovascular risk, and for that matter, in kidney outcomes.

  • Slide

    Slide 5.

    Does a 5 to 10 mm Hg Reduction in SBP Make a Difference in CV or Renal Outcomes?

    (Enlarge Slide)
  • In the United Kingdom Prospective Diabetes Study (UKPDS), a 10 mm Hg difference did make a difference in terms of cardiovascular events. In the captopril trial in type 1 diabetes, there was not a huge difference in blood pressure but enough to make a statistically significant difference. In the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) trial, the angiotensin-converting enzyme (ACE) inhibitor group had the highest blood pressure, but there was no difference from the other groups in primary outcome. But when you look at secondary outcomes, there clearly were differences. The Heart Outcomes Prevention Evaluation (HOPE) trial, an important trial epidemiologically, clearly showed in a subgroup of very sick people, a blood pressure difference of 17/10 mm Hg clearly made a difference.

    In fact, here are the data from the UKPDS, showing you very nicely that for blood pressure control, over on the right side of the screen, you have tremendous risk reductions just by lowering blood pressure. Notice, it's not even less than 140 mm Hg, but it's certainly less than 154 mm Hg, and clearly, there is risk benefit across the board for any diabetes endpoint, diabetes-related death, stroke, or microvascular end points -- all are reduced by anywhere from 30% to 40%.

  • Slide

    Slide 6.

    United Kingdom Prospective Diabetes Study (UKPDS): Results

    (Enlarge Slide)
  • These are data from the Reduction of Endpoints in NIDDM With the Angiotensin II Antagonist Losartan (RENAAL) trial in individuals with type 2 diabetes and advanced nephropathy. Here you can see that if you lower the blood pressure to less than 140 mm Hg, you have tremendous benefits in terms of the relationship for the primary composite end point, which was time to dialysis, doubling of creatinine, or death. So again, there is a clear benefit in terms of lowering to the blood pressure goal, approaching the blood pressure goal, and risk benefit.

  • Slide

    Slide 7.

    Event Rate for the Primary Composite End Point and ESRD Alone by SBP Level

    (Enlarge Slide)

Reaching Blood Pressure Goals

  • This is a summary of the world guidelines. It's a busy slide, but you can see that people are trying to focus on differences amongst guidelines. The differences are really subtle and I think they're different just because people like writing guidelines and they want to say there's something different about it! The reality is that, at least in the northern hemisphere, everybody is agreeing that if you have diabetes or hypertension with kidney disease, then less than 130/80 mm Hg is your goal blood pressure, and you should be starting with an ACE inhibitor or an angiotensin receptor blocker (ARB). The asterisk stands for the need for additional therapy in most cases. In fact, diuretics are reasonable additional drugs to achieve blood pressure goals.

  • Slide

    Slide 8.

    What Is the Goal BP and Initial Therapy in Kidney Disease or Diabetes to Reduce CV Risk?

    (Enlarge Slide)
  • In the ALLHAT trial, if you don't look at it carefully, the implication is that this is a monotherapy trial. I'm sure you're all aware that it's not a monotherapy trial. In fact, there was an average of 2 drugs given to each patient and many of the patients got more than 2 drugs. The primary end point is here -- absolutely no difference.

  • Slide

    Slide 9.

    Cumulative Event Rates for the Primary Outcome (Fatal CHD or Nonfatal MI) by ALLHAT Treatment Group

    (Enlarge Slide)
  • Now, is there really a clear superiority of one blood pressure drug class over another? The answer is no. The definitive data are right here. If you look at comparisons and cardiovascular outcomes for various treatments based on differences in blood pressure the reality is that, in general, there are no differences.

  • Slide

    Slide 10.

    BP-Lowering Treatment Trialists: Comparisons of Different Active Treatments

    (Enlarge Slide)
  • The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial is important because the hypothesis was there would be a difference in the outcome favoring the ARB if blood pressure control was the same. You'll notice the primary end point of this trial was not different.

  • Slide

    Slide 11.

    VALUE: Primary Composite Cardiac End Point

    (Enlarge Slide)
  • Now of course people walked away saying: well, there's no difference. Well, just a minute -- the hypothesis was that blood pressures were the same. I want you to look at the bottom panel. The bottom panel shows that within the first 3 to 4 months of the trial, there were huge differences in blood pressure between the groups, favoring amlodipine. It took a while to catch up because this was a trial starting with monotherapy (the old-fashioned way) and then other drugs were slowly added. Now we're in the 21st century and hopefully we're more advanced than that. But 30% of the events in this trial occurred during this period when blood pressures were totally unequal. So it's a very important point to keep in mind when you're looking not only at evaluation of trials, but also when you're taking care of patients. You do not have the luxury of waiting 9 months or a year to get to the blood pressure goal. You need to get there quickly, especially in older people because they are susceptible, especially to stroke.

  • Slide

    Slide 12.

    VALUE: Systolic Blood Pressure in Study

    (Enlarge Slide)
  • In clinical trials we do an excellent job of getting to goal blood pressure. Here are the data from clinical trials achieving goal blood pressure. It's about double what we do based on the National Health and Nutrition Examination Survey (NHANES) data. In clinical trials, they do pill counts on the patients, and if it's off you've lost patients. It's worse than bill collectors if you're in the clinical trial! You need to follow the rules; it's very simple.

    That's not happening in clinical practice. There needs to be time in the office where the physician can communicate with the patient; the patient gets educated, gets involved, understands what's expected of him, and then everybody's on the same page. That's not happening, and that's a real missing link in terms of achieving goal blood pressures.

  • Slide

    Slide 13.

    Systolic Blood Pressure Control in CV Outcome Trials

    (Enlarge Slide)
  • This is a summary of clinical trials looking at how many drugs you need to reach blood pressure goal. You can see that the old number used to be 3.2 and it's now about 2.9 -- it hasn't changed much. This is an important point.

  • Slide

    Slide 14.

    Average Number of Antihypertensive Agents Needed per Patient to Achieve Target BP Goals

    (Enlarge Slide)

Additional Risk Factors for Cardiovascular Disease

  • There's a linear relationship, not only with blood pressure and cardiovascular events, but also with cholesterol and cardiovascular events. This is taken from the updated Adult Treatment Panel (ATP) III guidelines that were published in Circulation very recently.

  • Slide

    Slide 15.

    Log-Linear Relationship Between LDL-C Levels and Relative Risk for CHD

    (Enlarge Slide)
  • With glucose, it's the same benefit: as hemoglobin A1c goes down, you get fewer cardiovascular events. Again, this is a very important point to keep in mind with regard to hemoglobin A1c. This is not just true for blood pressure. It's true for all cardiovascular risk factors that are known to have a major impact in renal functioning.

  • Slide

    Slide 16.

    Incidence of MI and Microvascular Complications by Hemoglobin A1c for White Men Aged 50 to 54 Years at Diagnosis With Mean Duration of Diabetes of 10 Years

    (Enlarge Slide)

Controlling Cardiovascular Disease in Diabetics

  • The Action to Control Cardiovascular Disease in Diabetes (ACCORD) trial is funded by the National Institutes of Health. It's looking at 10,000 diabetics and it's asking, what is the level of blood pressure we should be achieving? They're randomizing to 2 levels of systolic blood pressure, less than 120 mm Hg and less than 140 mm Hg, and hemoglobin A1c less than 6% and less than 7.5%. This trial is fully recruited and the results will be known in early 2009. I'm happy to tell you that they are in fact getting to blood pressure goals of less than 120 mm Hg. It is requiring 3 to 4 drugs and maximal doses of those drugs, and it is requiring major patient participation, but they are doing it. So again, there is evidence that they can do it in a trial. There's no reason that you can't do it in your office with appropriate time and resources.

  • Slide

    Slide 17.

    Action to Control Cardiovascular Disease in Diabetes (ACCORD)

    (Enlarge Slide)
  • Now here's our report card. These are the data from NHANES 1999-2000 in yellow compared with NHANES III. It looks at patients with diabetes and how good a job we're doing. If you look at hemoglobin A1c of less than 7%, you can see that if anything, we're getting worse, not better, in terms of the people achieving goal. If you look at blood pressure, we got a little better, but we're still well below 50%. If you look at cholesterol, even that's below 50%. In fact, if you go over to the far right and look at the yellow bar, we have a number of people with all 3 factors controlled to goal -- 7.3%. Now that's failure in anybody's book. One hundred percent is not what we're looking for here, but at least 50% or 60% is going to be a huge benefit in terms of cardiovascular risk reduction at a societal level.

  • Slide

    Slide 18.

    Percentage of Adults With Diabetes Who Achieved Recommended Levels of Vascular Risk Factors in NHANES

    (Enlarge Slide)
  • There's a big problem. There's a failure to titrate or use combination medications despite knowing the patient is not at goal. This is important and it represents clinical inertia that must be overcome. That was put in the JNC 7 and basically what it says is there are recalcitrant physicians out there who don't want to give more drugs. They don't want to increase the dose. They're either afraid of more phone calls, side effects, or all of the above. So physicians are part of the problem. Lack of time to educate the patient is also a major problem because the patient doesn't know any better, so they're not pushing anything. It's a multifactorial problem.

  • Slide

    Slide 19.

    JNC 7

    (Enlarge Slide)
  • This last slide says it all. These are data published in The New England Journal of Medicine from the Steno Diabetes Clinic in Copenhagen. They have their standard treatment, which isn't bad. And then they decided to get very aggressive and they had an intensive treatment group. This was a group in which hemoglobin A1c counts were lowered to close to 6.5%, the systolic blood pressure was less than 130 mm Hg, the low density lipoprotein (LDL) cholesterol was below 100, everybody got an aspirin, and they were on lifestyle modification. Yes, people did participate and they did get lowered values, very close to all of those values -- and they got a 20% absolute risk reduction. That means they reduced the risk of a cardiovascular event in that group with intensive treatment 20% below the conventional treatment group. The conventional treatment group, by the way, is doing a lot better than the NHANES data that I showed you. So we have a long way to go in terms ofgetting where we need to be in terms of achieving goals.

  • Slide

    Slide 20.

    Intensive Multiple Risk Factor Management

    (Enlarge Slide)