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Should We Be More Aggressive in the Therapy Against Cardiovascular SECTION II Should We Be More Aggressive in the Therapy Against Cardiovascular Risk Factors? Should we prescribe statin and aspirin for every diabetic patient, or is it time for a polypill? ALIN O. STIRBAN, MD effects of treatment with aspirin in people DIETHELM TSCHOEPE, MD with diabetes (9). This evidence has emerged into the recommendations of the American Diabetes Association for treat- The reality of primary and secondary prevention of cardiovascular complications in people with ment with aspirin in any diabetes patient diabetes is alarming, even in developed countries with a well-structured medical system. Even over 30 years (10). Still, the aspirin treat- though therapeutic targets have been more clearly defined during the last decades, their imple- ment in these patients is under-optimal as mentation is still suboptimal. Financial and structural reasons, insufficient information of phy- highlighted above (4,11). Regular treat- sicians and patients, along with a low compliance of the latter are only a few reasons that have ment was documented at the lowest rate been incriminated. To eliminate some of these inconveniences, attempts to standardize and in 13% of people with diabetes free of simplify therapies have been made. Treatment with aspirin and statin for every patient with cardiovascular disease (4). diabetes has been postulated. Some went even further, developing the concept of a “polypill,” an integrated pharmacological agent with up to six different compounds meant to prevent cardio- Dyslipidemia in diabetes is character- vascular disease in the broad population. Likewise, the idea of a “polymeal” tries to implement ized by high LDL cholesterol and triglyc- healthy nutrients into the populations’ lifestyle in a standardized fashion. Our article highlights erides and low HDL cholesterol. Statins some of the advantages and pitfalls of these concepts and reflects our point of view with regard proved risk reduction for major coronary to some treatment aspects in people with diabetes. As part of a pro and contra discussion, our events in the primary and secondary pre- article is arguing against the use of statins in all patients with diabetes and especially against the vention in people with diabetes (12). The indiscriminate use of a polypill. latter group had a higher therapeutic ben- efit than nondiabetic subjects. But statins Diabetes Care 31 (Suppl. 2):S226–S228, 2008 mainly reduce LDL cholesterol (Ϫ18 to Ϫ55%) and exert a modest effect on HDL here is no longer doubt that people The Steno-2 study convincingly cholesterol (ϩ5toϩ15%) and triglycer- with diabetes constitute a popula- showed that beyond guideline-oriented ides (Ϫ7toϪ30%) (13). Still, low HDL T tion at high risk (1,2) and require treatment, continuous lifestyle education cholesterol is a major risk factor for car- special intervention. Guidelines for treat- and motivation, together with a goal- diovascular disease (14,15), and the re- ment of this patient group are available oriented pharmacological treatment, fur- duced effect of statins on HDL could (3), but the reality of guideline implemen- ther confers a cardiovascular risk explain why statins prevent only about tation is disappointing. Only 13–37% of reduction of ϳ50% (8). So, on one hand, one-third of cardiovascular complica- people with diabetes are treated with as- guideline-based treatment does not pro- tions. Increasing HDL cholesterol (e.g., pirin in the U.S. (4), and only around vide the maximum benefit; on the other with niacin [16]) and decreasing triglyc- 27% of dyslipidemic individuals receive hand, in reality, not even guideline goals erides (e.g., with fibrates [17]) might fur- lipid-lowering treatment (5). LDL choles- are achieved in a satisfactory amount of ther mitigate cardiovascular risk. terol of Ͻ100 mg/dl is achieved in 6.2– patients. This leads to the conclusion that Guidelines for the treatment with statins 8.0% of patients for primary prevention a more aggressive treatment is required. have been published (13) underlining and 17.3–21.3% for secondary preven- Beyond blood glucose optimization, also the importance of lifestyle changes. tion after 9 months of therapy (6). Vice antiplatelet and cholesterol-lowering While the need for treating high-risk pa- versa, overtreatment in low-risk patients therapies are two of the most powerful tients was emphasized, no specific phar- often occurs (6). Moreover, an A1C below tools of diabetologists when aiming at re- maceutical recommendations have been 7% is found only in 35.8% of people with ducing diabetes complications. made in lower-risk categories. diabetes (7). Several studies have proven beneficial We therefore do not consider that sta- ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● tin treatment should be initiated in every diabetic patient and advocate the careful From the Heart and Diabetes Center NRW, Ruhr University Bochum, Bad Oeynhausen, Germany. assessment of the lipid profile in each in- Address correspondence and reprint requests to Prof. Dr. Diethelm Tschoepe, Heart and Diabetes Center NRW, Georgstrasse 11, 32545 Bad Oeynhausen, Germany. E-mail: [email protected]. dividual patient before starting dyslipide- The authors of this article have no relevant duality of interest to declare. mia treatment. This article is based on a presentation at the 1st World Congress of Controversies in Diabetes, Obesity and In a controversial article released in Hypertension (CODHy). The Congress and the publication of this article were made possible by unrestricted 2003, Wald and Law (18) introduced the educational grants from MSD, Roche, sanofi-aventis, Novo Nordisk, Medtronic, LifeScan, World Wide, Eli Lilly, Keryx, Abbott, Novartis, Pfizer, Generx Biotechnology, Schering, and Johnson & Johnson. term “polypill” (containing a statin; three DOI: 10.2337/dc08-s254 blood pressure–lowering drugs, e.g., thi- © 2008 by the American Diabetes Association. azide, ␤-blocker, and ACE inhibitor, each S226 DIABETES CARE, VOLUME 31, SUPPLEMENT 2, FEBRUARY 2008 Stirban and Tschoepe at half dose; folic acid, 0.8 mg; and aspi- blood test, suggesting even an over-the- Health and Nutrition Examination Sur- rin, 75 mg). The polypill was suggested to counter availability. In our opinion, this vey. Diabetes Care 24:197–201, 2001 reduce ischemic heart disease by 88% and would open the door to uncontrolled side 5. Bohler S, Scharnagl H, Freisinger F, Sto- stroke by 80% if taken by everyone over effects. jakovic T, Glaesmer H, Klotsche J, Pieper 55 years of age. One of the main argu- The “polypill” chapter is certainly still L, Pittrow D, Kirch W, Schneider H, Stalla GK, Lehnert H, Zeiher AM, Silber S, Koch ments was that adherence to therapy de- open. This concept could prove effective U, Ruf G, Marz W, Wittchen HU: Unmet creases with the increase in number of in carefully selected populations with needs in the diagnosis and treatment of medications (19). Advantages and pitfalls poor compliance or at high risk or in old dyslipidemia in the primary care setting in of the polypill were reviewed in detail and/or plurimorbid patients taking nu- Germany. Atherosclerosis 190:397–407, elsewhere (18,20,21), and we will resume merous medications. A large indiscrimi- 2007 presenting our point of view. native population-based therapy is in our 6. Assmann G, Benecke H, Neiss A, Cullen Our patients present with a puzzle of opinion not suitable. P, Schulte H, Bestehorn K: Gap between clinical features (e.g., dyslipidemia, hy- Lifestyle interventions seem to be the guidelines and practice: attainment of percoagulability, hypertension, insulin most meaningful approach to the reduc- treatment targets in patients with primary resistance, and/or glucose dysmetabo- tion of cardiovascular complications, hypercholesterolemia starting statin ther- apy: results of the 4E-Registry (Efficacy lism), but only few of these conditions are with an impressive power of reducing Calculation and Measurement of Cardio- leading causes for the development and events. Therefore, the concept of “poly- vascular and Cerebrovascular Events progression of complications. To address meal” containing wine, fish, dark choco- including Physicians’ Experience and the main disturbances, variable doses of late, fruits, vegetables, garlic, and Evaluation). Eur J Cardiovasc Prev Rehabil the specific medication is required. The almonds was proposed as a more natural, 13:776–783, 2006 polypill provides fix combination of sub- safer, and probably tastier alternative to 7. McFarlane SI, Castro J, Kaur J, Shin JJ, stances, possibly resulting in undertreat- the polypill. The polymeal was suggested Kelling D Jr, Farag A, Simon N, El-Atat F, ment of the main condition(s) and to reduce cardiovascular disease by over Sacerdote A, Basta E, Flack J, Bakris G, overtreatment of secondary conditions. 75% in people Ն50 years of age (25). The Sowers JR: Control of blood pressure and The polypill also neglects differences in polymeal will certainly not be available in other cardiovascular risk factors at differ- metabolism between younger and older a package at the pharmacy around the ent practice settings: outcomes of care provided to diabetic women compared to people and racial and sex differences. corner, but it constitutes a concept that men. J Clin Hypertens (Greenwich) 7:73– The cost-effectiveness of the polypill might help us change our way of thinking. 80, 2005 was highlighted in several articles Instead of taking a “wonder pill” that 8. Gaede P, Vedel P, Larsen N, Jensen GV, (18,22), but questioned by others (21). A cures almost everyone, we should real- Parving HH, Pedersen O: Multifactorial broad therapy with the polypill has to ize that our unhealthy lifestyle mainly intervention and cardiovascular disease in prove first its efficacy in terms of reducing contributes to the development of com- patients with type 2 diabetes. N Engl J Med end points and costs and increasing com- plications and that this is the place 348:383–393, 2003 pliance. This can be ensured only by where we should start from when mak- 9. Colwell JA: Antiplatelet agents for the pre- large-scale, financial consuming studies, ing a change.
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