Treatment of Hyperlipidemia in Primary Practise in Germany: Sub-group Analyses from the 4E-registry with Particular Emphasis on Men and Women with Diabetes Mellitus

Abstract

Aims: To investigate the achievement of treatment goals for low density lipoprotein (LDL) cholesterol in men and women with diabetes mellitus receiving statins in a primary-care setting in Germany.

Methods: 6,827 men and 5,989 women with diabetes mellitus were recruited from among the 28,200 men and 24,200 women participating in the 4E registry of patients being treated with statins for primary hypercholesterolemia unresponsive to diet and lifestyle. Participants were assessed after 6 weeks and 9 months of statin therapy. Attainment of treatment targets was assessed (i) using individual LDL goals based on each participant's individual level of risk and (ii) based on the 2.6 mmol/L target recommended by current European and U.S. guidelines for persons with diabetes.

Results: At baseline, patients with and without diabetes mellitus had similar LDL cholesterol levels patients (men: 4.5±1 vs. 4.7±1 mmol/L, women: 4.7±1 vs. 4.9±1 mmol/L respectively). The mean drop in LDL cholesterol on statin therapy was similar in men and women with and without diabetes, ranging from 26-27 percent all subgroups. After 9 months of statins, individual LDL goals were achieved by 25% of men and 24% of women with diabetes, while only 16% of diabetic men and 12% of diabetic women achieved the 2.6 mmol/L LDL target. These success rates were similar to those of non-diabetics, including those at high risk, in 4E.

Conclusions: Patients with diabetes mellitus in 4E responded just as well to statins as patients without diabetes. However, achievement of treatment goals in patients with diabetes was just as poor as in other high-risk groups in the 4E cohort.

Key words

cardiovascular incidences - cardiovascular risk management - coronary artery disease

References

• 1 Adult Treatment Panel III . Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report.  Circulation. 2002;  106 3143-3421
• 2 Assman G, Benecke H, Neiss A, Cullen P, Schulte H, Bestehorn K. Gap between guidelines and practice: attainment of treatment targets in patients with primary hypercholesterolemia starting statin therapy. Results of the 4E-registry (Efficacy Calculation and Measurements of Cardiovascular and Cerebrovascular Events including Physician's Experience and Evaluation.  European Journal of Cardiovascular Risk and Rehabilitation. 2006;  , (in press)
• 3 Assmann G, Buyken A, Cullen P, Schulte H, von Eckardstein A, Wahrburg U. Pocket guide to prevention of coronary heart disease. 2003 Börm Bruckmeier Verlag, Grünwald, Germany
• 4 Assmann G, Carmena R, Cullen P. et al . Coronary heart disease: reducing the risk. The scientific background for the primary and secondary prevention of coronary heart disease. A worldwide view.  Nutrition Metabolism And Cardiovascular Disease. 1998;  8 205-271
• 5 Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Munster (PROCAM) study.  Circulation. 2002;  105 310-315
• 6 Baigent C, Keech A, Kearney PM. et al . Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins.  Lancet. 2005;  366 1267-1278
• 7 Barrett-Connor EL, Cohn BA, Wingard DL, Edelstein SL. Why is diabetes mellitus a stronger risk factor for fatal ischemic heart disease in women than in men? The Rancho Bernardo Study.  JAMA. 1991;  265 627-631
• 8 Becker A, Bos G, de Vegt F. et al . Cardiovascular events in type 2 diabetes: comparison with nondiabetic individuals without and with prior cardiovascular disease. 10-year follow-up of the Hoorn Study.  Eur Heart J. 2003;  24 1406-1413
• 9 Cho E, Rimm EB, Stampfer MJ, Willett WC, Hu FB. The impact of diabetes mellitus and prior myocardial infarction on mortality from all causes and from coronary heart disease in men.  J Am Coll Cardiol. 2002;  40 954-960
• 10 Colhoun HM, Betteridge DJ, Durrington PN. et al . Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial.  Lancet. 2004;  364 685-696
• 11 Collins R, Armitage J, Parish S, Sleigh P, Peto R. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial.  Lancet. 2003;  361 2005-2016
• 12 De Backer G, Ambrosioni E, Borch-Johnsen K. et al . European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of eight societies and by invited experts).  Atherosclerosis. 2004;  173 381-391
• 13 De Backer G, Ambrosioni E, Borch-Johnsen K. et al . European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice.  Eur Heart J. 2003;  24 1601-1610
• 14 Eberly LE, Cohen JD, Prineas R, Yang L. Impact of incident diabetes and incident nonfatal cardiovascular disease on 18-year mortality: the multiple risk factor intervention trial experience.  Diabetes Care. 2003;  26 848-854
• 15 Euroaspire Group . Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events.  Lancet. 2001a;  357 995-1001
• 16 Euroaspire Group . Lifestyle and risk factor management and use of drug therapies in coronary patients from 15 countries; principal results from EUROASPIRE II Euro Heart Survey Programme.  Eur Heart J. 2001b;  22 554-572
• 17 Evans JM, Wang J, Morris AD. Comparison of cardiovascular risk between patients with type 2 diabetes and those who had had a myocardial infarction: cross sectional and cohort studies.  BMJ. 2002;  324 939-942
• 18 Fornengo P, Bruno G, De Salvia A, Arcari R, Pisu E, Pagano G. Low adherence of General Practitioners to National Cholesterol Education Program guidelines for the management of hyperlipidaemia.  Diabetes Nutr Metab. 2000;  13 263-268
• 19 Haffner SM, Lehto S, Ronnemaa T, Pyörälä K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction.  New Engl J Med. 1998;  339 229-234
• 20 Howard BV, Best LG, Galloway JM. et al . Coronary heart disease risk equivalence in diabetes depends on concomitant risk factors.  Diabetes Care. 2006;  29 391-397
• 21 Hu FB, Stampfer MJ, Solomon CG. et al . The impact of diabetes mellitus on mortality from all causes and coronary heart disease in women: 20 years of follow-up.  Arch Intern Med. 2001;  161 1717-1723
• 22 Huxley R, Barzi F, Woodward M. Excess risk of fatal coronary heart disease associated with diabetes in men and women: meta-analysis of 37 prospective cohort studies.  BMJ. 2006;  332 73-78
• 23 Lee CD, Folsom AR, Pankow JS, Brancati FL. Cardiovascular events in diabetic and nondiabetic adults with or without history of myocardial infarction.  Circulation. 2004;  109 855-860
• 24 Lotufo PA, Gaziano JM, Chae CU. et al . Diabetes and all-cause and coronary heart disease mortality among US male physicians.  Arch Intern Med. 2001;  161 242-247
• 25 Malmberg K, Yusuf S, Gerstein HC. et al . Impact of diabetes on long-term prognosis in patients with unstable angina and non-Q-wave myocardial infarction: results of the OASIS (Organization to Assess Strategies for Ischemic Syndromes) Registry.  Circulation. 2000;  102 1014-1019
• 26 Pajunen P, Koukkunen H, Ketonen M. et al . Myocardial infarction in diabetic and non-diabetic persons with and without prior myocardial infarction: the FINAMI Study.  Diabetologia. 2005;  48 2519-2524
• 27 Simons LA, Simons J. Diabetes and coronary heart disease.  N Engl J Med. 1998;  339 1714-1715
• 28 Straka RJ, Taheri R, Cooper SL, Tan AW, Smith AC. Assessment of hypercholesterolemia control in a managed care organization.  Pharmacotherapy. 2001;  21 818-827
• 29 Turnbull F. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials.  Lancet. 2003;  362 1527-1535
• 30 Whiteley L, Padmanabhan S, Hole D, Isles C. Should diabetes be considered a coronary heart disease risk equivalent?: results from 25 years of follow-up in the Renfrew and Paisley survey.  Diabetes Care. 2005;  28 1588-1593

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