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The Controversial Question of Metabolic Syndrome
Managing Benefits for Diabetes: Changing Payer Strategies for Changing Times
Albert Tzeel, MD, MHSA, FACPE
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Teresa L. Pearson, MS, RN, CDE
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Darius N. Lakdawalla, PhD; Michael R. Eber, BSE; Felicia M. Forma, BSc; Jeffrey Sullivan, MS; Pierre-Carl Michaud, PhD; Lily A. Bradley, MBA; and Dana P. Goldman, PhD

The Controversial Question of Metabolic Syndrome

Use of the term metabolic syndrome has been educational for both healthcare professionals and patients.10 It has provided an easily understandable public health message, raised awareness of risk factor clustering as well as the need to identify additional risk factors among healthcare providers, and been an  impetus for healthcare professionals to look beyond only diagnosed diabetes and cardiovascular disease to risk factors that progress to these diseases.11

Finally, additional research should be conducted to fully understand and appreciate the clustering of risk factors identified as metabolic syndrome. Further investigation will be required to better understand if there is underlying  cause, such as a genetic defect. Finding an underlying mechanism would help settle  the controversy as to whether the syndrome is a treatable entity or metabolic syndrome is just a clustering of risk factors. Until that time, educational  endeavors need to continue to identify and reduce the modifiable risk factors for diabetes and CVD. Population-based strategies need to be further  developed and implemented because of the importance of these diseases.

Conclusions

Professional organizations and government agencies are not currently in agreement about whether metabolic syndrome is clinically relevant in predicting the development of diabetes or CVD. Fundamentally, there is disagreement whether metabolic syndrome even fits the criteria of a treatable entity. We do  know that the individual risk factors play an integral role in the development and advancement of these 2 important diseases. Until additional information is  available regarding the potential underlying mechanism of this syndrome, healthcare professionals need to address the rising incidence of obesity and a  sedentary lifestyle that are major contributors to the development of diabetes and heart disease. EBDM

Payer Perspective

Interview With Ross M. Miller, MD, MPH


EBDM: The term “metabolic syndrome” is fairly controversial. What’s your view on whether this classification is practical as a disease or entity?

Dr Miller: I believe it’s a legitimate entity. The guidelines issued jointly from the American Heart Association (AHA) and the National Heart, Lung, and Blood  Institute (NHLBI) in 20051 were a scientific, evidence-based approach to this multiple risk factor complex. It arises from a combination of insulin resistance,  abdominal obesity (abnormal fat disposition), dyslipidemia (high triglycerides and low high-density lipoprotein cholesterol levels), and high blood pressure. The science definitely supports the connection of metabolic disease to coronary heart disease and type 2 diabetes mellitus. According to these guidelines, if  you have at least 3 of the 5 risk factors, you’re at greater risk for these clinical consequences,1 and I totally buy into that.

I know it’s controversial, but where  there is some predictive value behind it, in terms of diabetes and cardiovascular events, I agree with it.

EBDM: Would a highly publicized scoring system of risk factors, similar to the risk score profiles produced by the Framingham Heart Study for heart disease,2 help bolster the case for recognizing and promoting metabolic syndrome within the healthcare community?

Dr Miller: I would love that. It would be similar to the “know your number concept” we have for diabetes and cholesterol. If we could quantify a number based  on the 5 risk factors, with some type of weighting of not only the risk factors themselves but within the 5 factors (ie, how far from the cut points one might be), where it can be calculated as a certain percentage risk over time, such as Framingham, or a certain numerical value that has been modeled with   real-world data, this would be the Holy Grail. Then, all patients need to know is their number and they can work collaboratively with their provider to address their risks through stratified interventions.

EBDM: Are disease management programs well equipped to address patients with metabolic syndrome?

Dr Miller: Yes. Previously, if we had a patient with hypertension, they were enrolled in a hypertension disease management program. If they had dyslipidemia, they were enrolled in a dyslipidemia disease management program, and so on. If they had more than 1 condition—and so many of them do  overlap—they should be in an integrated, coordinated multiple-condition management program. We have this capability today, mostly through use of   interoperable technology. In metabolic syndrome, where multiple conditions overlap, a singular program is more appropriate in order to provide better care coordination, continuity of care, and management in an integrated model.

EBDM: What is your perception of the proportion of patients already in diabetes disease management programs who would actually benefit from metabolic  disease management programs?

Dr Miller: I believe that most of the folks with metabolic syndrome are probably prediabetic anyway. However, patients with diagnosed diabetes may also meet some of the other 5 risk factors. Through diet and exercise, patients with type 2 diabetes can actually improve their glycemic levels and reduce the need for diabetes medications.3

EBDM: Do you think a metabolic disease management program could be effective at preventing full-blown diabetes in those patients with insulin resistance?

Dr Miller: A study by the Centers for Disease Control and Prevention found that approximately 34% of adult Americans may have metabolic syndrome.4 It  has somewhat paralleled the rise of the obesity epidemic in this country. The prevalence of metabolic syndrome is about double the rate for diabetes, so the  idea is to prevent or reverse impaired glucose tolerance in these individuals by employing weight loss through diet and exercise.5

EBDM: You probably remember, in the middle part of the past decade, when sanofi-aventis was trying to bring rimonabant to market with a metabolic syndrome indication. It was primarily a weight-loss agent. The US Food and Drug Administration (FDA) has still not approved any medication with a metabolic syndrome indication. Why do you think that is the case, based on the size of the potential market?

Dr Miller: That’s a difficult and complicated question. I believe that to obtain FDA approval, the manufacturer might have to show improvements to several of the outcome measures across the syndrome (eg, lower blood sugar levels, weight loss, lower blood pressure, improved lipid profiles). This would be  extremely difficult to do in the context of a single, large clinical study. Today, pharmacologic management is related to treating the individual components  of metabolic syndrome, such as statins for dyslipidemia or metformin for elevated blood glucose levels. Most interventions targeting the entire syndrome are   focused on lifestyle modifications—changes in diet and exercise, for instance. Many experts believe that if you focus on weight loss (through diet and  exercise), everything else follows—waist circumference goes down, impaired glucose tolerance improves, hypertension resolves.

I don’t know if the 2 recently approved weight loss products are undergoing clinical studies (or subpopulation analyses) for their effects on these other components of the metabolic  syndrome.

(Editor’s Note: A review of the www.clinicaltrials.gov website revealed a total of 597 interventional clinical trials [phase II or III] for metabolic syndrome,  testing everything from bloodletting and the use of walnuts to rosiglitazone and chloroquine, but not the new weight loss products lorcaserin or the  phentermine/topiramate combination.)

EBDM: Even if the use of the term metabolic syndrome has not been fully accepted, do you believe more physicians today are aware of the inter-relationships among the various risk factors and their management?

Dr Miller: Absolutely. I’m not sure whether it’s because of the coverage of obesity and diabetes epidemics in the lay press or because of the release of the  AHA/NHLBI guidelines, but I definitely think there’s increased awareness. I actually don’t remember even hearing the term metabolic syndrome 15 or 20 years ago in primary care.

EBD: From the standpoint of the Medicaid program in California, what types of public health education are emphasized with regard to the insulin  resistance–cardiovascular–obesity axis of symptoms? Is Medi-Cal formally packaging thisinformation?

Dr Miller: Not that I am aware of as metabolic syndrome per se. A good deal of information has been disseminated on the individual components—there is tons of public education on obesity, including website information, posters geared to consumers, and fax blasts to providers. Some websites, such as WebMD  and Mayo Clinic, which are frequently accessed by the public, provide educational materials on metabolic syndrome and its criteria, but I have not been   involved in packaging it as such for Medicaid recipients and providers. Medicaid has patient messaging that says that if you are overweight and/or have other  risk issues you may have a higher likelihood of developing diabetes. That is “packaging” the message to some respect, but maybe only “soft”   packaging. Employer-sponsored wellness programs are also addressing this condition indirectly because health risk appraisals and biometric lab screenings  commonly identify the components of metabolic syndrome.

Dr Miller is a medical director consultant and physician executive at Cerner Corporation in Los Angeles, CA.

References

1. Grundy SM, Cleeman JI, Daniels SR, et al. AHA/NHLBI scientific statement: diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement. Circulation. 2005;112:2735-2752.

2. Framingham Study Risk Score Profiles. Framingham Heart Study. www.framinghamheartstudy.org/risk/index.html. Accessed December 5, 2012.

3. Kumar AA, Palamaner Subash Shantha G, Kahan S, et al. Intentional weight loss and dose reductions of anti-diabetic medications—a retrospective cohort study. PLoS One. 2012;7(2):e32395.

4. Ervin RB. Prevalence of metabolic syndrome among adults 20 years of age and over, by sex, age, race and ethnicity, and body mass index: United States, 2003–2006. National Health Statistics Reports; no 13. Hyattsville, MD: National Center for Health Statistics, 2009.

5. Diabetes Prevention Program Research Group, Knowler WC, Fowler SE, Hamman RF, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study.Lancet. 2009;374:1677-1686.

Funding Source: None.

Author Disclosures: Mr Mehr reports receiving payment for involvement in the preparation of this article. Ms Zimmerman reports no relationship or financial   interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (SRM); acquisition of data (MPZ, SRM); analysis and interpretation of data (MPZ, SRM); drafting of the manuscript  (MPZ, SRM); critical revision of the manuscript or important intellectual content (MPZ, SRM); and supervision (SRM).
References

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3. Reaven GM. Role of insulin resistance in human disease. Diabetes. 1988;37:1595-1607.


4. Alberti KGMM, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes FederationTask Force on Epidemiology and Prevention; National Heart Lung, and Blood Institute, American Heart Association; World Heart Federation; Interrenational
Atherosclerosis Society; and International Association for the Study of Obesity. Circulation.2009;120:1640-1645.


5. Syndrome. Merriam-Webster Online. www.merriam-webster.com/medical/syndrome. Accessed December 7. 2012.


6. Kahn R, Buse J, Ferrannini E, et al. The metabolic syndrome: time for a critical appraisal. Diabetes Care. 2005;28:2289-2304.


7. Park YW, Zhu S, Palaniappan L, et al. The metabolic syndrome: prevalence and associated risk factor findings in the US population from the Third National Health and Nutrition Examination Survey, 1988-1994. Arch Intern Med. 2003;163:427-436.


8. Grundy SM. Metabolic syndrome pandemic. Arterioscler Thromb Vasc Biol. 2008;28:629-636.


9. Ford ES, Giles WH, Mokdad AH. Increasing prevalence of the metabolic syndrome among U.S. adults. Diabetes Care. 2004;27:2444-2449.


10. Ford ES, Li C, Zhao G. Prevalence and correlates of metabolic syndrome based on a harmonious definition among adults in the US. J Diabetes. 2010;2:180-193.


11. Simmons RK, Alberti KBMM, Gale EAM, et al.The metabolic syndrome: useful concept or clinical tool? report of a WHO expert consultation. Diabetologia. 2010;53:600-605.


12. Boudreau DM, Malone DC, Raebel MA, et al. Health care utilization and costs by metabolic syndrome risk factors. Metab Syndr Relat Disord. 2009; 7:305-314.


13. Long KH, Janssen XZ, Alesci NL. Direct costs associated with overweight, obesity, and metabolic syndrome among health plan members. Presented at the Third Biennial Conference of the American Society of Health Economists. Ithaca, NY; June 2010.


14. Nichols GA, Moler EJ. Metabolic syndrome components are associated with future medical costs independent of cardiovascular hospitalization and  incident diabetes. Metab Syndr Relat Disord. 2011;9:127-133.


15. Norman P. Will metabolic syndrome emerge as a commercial market? Decision Resources. http://decisionresources/com/products-and-services/report?r=spech206607. Accessed December 3, 2012.
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