Prevention of macrovascular complications

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1 European Heart Journal Supplements (2003) 5 (Supplement B), B21 B26 Prevention of macrovascular complications Glasgow Royal Infirmary, Glasgow, Scotland The cardiovascular burden of diabetes is well established. Reduction in this burden requires a multifactorial approach, encompassing control of glycaemia, reduction in traditional cardiovascular risk factors (hypertension, hyperlipidaemia), use of antiplatelet agents and angiotensin-converting enzyme inhibitors, and aggressive treatment of coexisting cardiovascular disease. Metformin is the drug of first choice for blood glucose control in most patients, and the newer thiazolidinediones have some additional effects on other aspects of the metabolic syndrome that could provide extended cardiovascular benefit. Several different groups of drugs are of proven benefit in reducing blood pressure, and multiple agents may be required. Statins are of proven benefit for both primary and secondary prevention, but there is less hard evidence available on the use of fibrates in people with diabetes. Use of these multiple potential therapies is included in several guidelines for reducing cardiovascular risk in people with diabetes, but compliance and adherence is a problem. (Eur Heart J Supplements 2003; 5 (Suppl B): B21 B26) 2003 The European Society of Cardiology Key Words: Blood glucose control, cardiovascular risk, diabetes mellitus, hyperlipidaemia, hypertension. Introduction The devastation caused by macrovascular disease in people with diabetes is well established. Epidemiological evidence from Framingham [1] and many other areas demonstrates an increase in coronary heart disease, stroke, peripheral vascular disease, congestive cardiac failure and cardiovascular death in people with diabetes as compared with non-diabetic people. A recent report from a defined geographical area in the U.K. reiterated this excessive cardiovascular burden in a modern setting [2]. Nearly 5000 people with diabetes were followed for 6 years, and at the end of the follow-up period one-quarter of those with diabetes had died. Compared with mortality rates in nondiabetic people in the same geographical area over the same period, the risk for dying was increased in both sexes and at all ages. In the years age group, the relative risk for dying from all causes was increased threefold for men and women, and the risk for dying from cardiovascular disease was increased sixfold for men and women [2]. Because of this premature cardiovascular demise, I previously suggested that diabetes should be defined as a state of premature cardiovascular death which is associated with chronic hyperglycaemia, and may also be associated with blindness and renal failure [3]. There is now extensive evidence that the development and progression of vascular disease can be reduced in people Correspondence: Dr Miles Fisher, Consultant Physician, Glasgow Royal Infirmary, Castle Street, Glasgow G4 0SF, Scotland X/03/0B $35.00/0 with diabetes (Table 1). People with diabetes have been included in many of the large, multicentre studies to reduce cardiovascular risk, and separate analyses of diabetic subgroups were provided in many of these. Fewer cardiovascular studies contained only diabetic people (e.g. the Hypertension in Diabetes Study (HDS) on the treatment of hypertension [4,5], and the Diabetes Atherosclerosis Intervention Study (DAIS) on the treatment of dyslipidaemia with fenofibrate [6] ). There is also evidence that improved control of blood glucose using oral hypoglycaemic agents can be of benefit in reducing cardiovascular events in people with diabetes [7,8] and preliminary evidence suggests that some agents may also be of cardiovascular benefit in people with lesser degrees of glucose intolerance. The present review describes evidence for reduction in cardiovascular risk in diabetes, with mention of some important studies that are currently in progress. Treatment of hyperglycaemia The most important study on control of blood glucose in people with diabetes is the United Kingdom Prospective Diabetes Study (UKPDS) [7,8]. Conceived in the 1970s, that multicentre study was conducted to test the hypothesis that tight control of blood glucose would reduce the development, or progression, of the microvascular complications of diabetes in newly diagnosed patients. A secondary consideration was whether tight control based on therapy either with sulphonylureas or with insulin is 2003 The European Society of Cardiology

2 B22 associated with an increase in cardiovascular events, as was suggested in the University Group Diabetes Program (UGDP) [9]. Tight control of blood glucose was associated with significant reductions in diabetes related and microvascular end-points, and in particular the need for retinal photocoagulation, and there was no difference whether intensive therapy was based on treatment with chlorpropamide, glibenclamide or insulin [7]. When macrovascular outcomes were examined, there was a statistically insignificant reduction in myocardial infarctions. In the control group 16% of participants had a myocardial infarction, and in the intensive treatment group 14% had an infarct (P = 0.052). No statistically significant benefit was seen in any of the other macrovascular outcomes. A subsequent post-hoc epidemiological analysis of the UKPDS data demonstrated a straight-line correlation between the mean HbA1c concentration and the development of microvascular and macrovascular complications [10]. The higher the mean HbA1c in the study, the greater the development of complications. The slope of the line for myocardial infarction was less than that for microvascular disease, and on epidemiological analysis a reduction in mean HbA1c of 1% was associated with a 14% reduction in myocardial infarctions. The UKPDS investigators indicated that the insignificant reduction in myocardial infarctions that was observed in the interventional study was fully compatible with the differences in HbA1c between the two groups, implying that a greater separation would have caused a statistically significant reduction in myocardial infarctions in the intensive treatment group. For overweight patients, a further randomized treatment option in UKPDS was treatment with metformin. Somewhat to the surprise of the investigators, this was the most successful form of therapy [8]. People who were treated with metformin had statistically significant reductions in the development of microvascular and macrovascular complications. Myocardial infarction occurred in 18% of the obese persons in the control group, 15% of overweight persons treated with intensive insulin or sulphonylureas, and 11% of persons treated with metformin. There was also a significant reduction in all-cause mortality in overweight patients treated with metformin. This benefit from metformin could not easily be explained on the basis of metformin s known mode of action, and reductions in HbA1c as an assessment of blood glucose control were similar in the various intervention groups. This suggested an extended benefit beyond blood glucose reduction. Metformin predominantly affects insulin resistance and glucose production at the hepatic level, with minor effects on peripheral insulin resistance. Peripheral insulin resistance predates the development of type 2 diabetes, and insulin resistance is a strong predictor for subsequent development of type 2 diabetes, and for cardiovascular events. A recent addition to the treatment options for diabetes is the thiazolidinediones, which act as peripheral insulin sensitizers. In the short to medium terms they are Table 1 Reduction in cardiovascular risk in people with diabetes Intervention Hypoglycaemic therapy Conventional risk factor reduction Antiplatelet therapy ACE inhibition Lifestyle? Agent/target Metformin (UKPDS) Sulphonylureas/insulin (UKPDS) Acarbose? Thiazolidinediones? Hypertension (HDS, HOT, SHEP Syst-Eur, LIFE) Hyperlipidaemia (4S, CARE, LIPID, HPS) Aspirin Clopidogrel Ramipril (HOPE) Weight loss and/or exercise? See text for definitions of study acronyms. ACE=angiotensinconverting enzyme. useful hypolgycaemic agents, and there is some evidence that their hypoglycaemic effects persist for several years, whereas the effects of sulphonylureas tend to diminish with time. Some preliminary studies have shown that these drugs may have beneficial effects on several components of the metabolic syndrome, and may also improve novel cardiovascular risk factors and markers of atherosclerosis [11]. In a recent report, Haffner et al. [12] demonstrated that the use of rosiglitazone was associated with a significant reduction in C-reactive protein. It is hypothesized that this extended benefit could translate into added cardiovascular benefit, and this is being tested in several randomized, prospective trials with cardiovascular outcomes using rosiglitazone and pioglitazone. Acarbose is another oral hypoglycaemic agent, and a possible late randomization to acarbose or placebo was included in the UKPDS [13]. Acarbose improved blood glucose control, but was not included for long enough to examine microvascular or macrovascular outcomes separately. Acarbose has also been used to treat patients with impaired glucose tolerance, and its use was associated with a significant reduction in the development of diabetes in the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) [14]. A preliminary analysis of cardiovascular outcomes was presented at the meeting of the European Society of Cardiology in Berlin, which indicated a significant reduction in myocardial infarctions in the group treated with acarbose as compared with the control group [15]. If confirmed, this important finding may reawaken interest in acarbose as a treatment for diabetes. Treatment of hypertension in people with diabetes People with diabetes were not included in significant numbers in most of the early, large, multicentre studies on the treatment of hypertension. During recruitment for the UKPDS it was noted that a significant proportion of these newly diagnosed diabetic patients either had a raised blood

3 Prevention of macrovascular complications B23 pressure or were already receiving treatment for hypertension. The Hypertension in Diabetes Study (HDS) was therefore nested as a substudy within the main UKPDS. It included one-quarter of the patients included the whole UKPDS study, and patients were allocated to either tight control of blood pressure or less tight control. Patients in the tight control group were further randomly assigned to treatment based on captopril or atenolol, and the study was terminated when the principle UKPDS blood glucose study finished. The mean blood pressure during the study in the tight control group was 142/82 mmhg, as compared with 154/87 mmhg in the less tight control group. A significant reduction in microvascular end-points was observed in the tight control group. In addition, there were significant reductions in strokes and deaths related to diabetes, but not in all-cause mortality. No difference in benefit was observed on comparing the captopril and atenolol groups, but the study probably did not have sufficient statistical power to detect a difference. Epidemiological analysis of the blood pressure data from HDS showed that for each 10 mmhg reduction in mean systolic blood pressure there was a 13% reduction in microvascular end-points, a 11% reduction in myocardial infarctions and a 15% reduction in deaths related to diabetes [16]. The Hypertension Optimal Treatment (HOT) trial was reported shortly before the HDS [17]. That large study included nearly 19,000 participants, 8% of whom were diabetic. Patients were allocated to three target blood pressures. In the study as a whole, there was benefit in reducing blood pressure to 140 mmhg systolic and 85 mmhg diastolic, but efforts to lower blood pressure lower appeared to yield little further benefit. By contrast, a subgroup analysis of patients with diabetes demonstrated additional benefit in reducing blood pressure to the lowest target. Attained blood pressures were not reported for the diabetic subgroup, but for the study as a whole the mean blood pressure in the tightest control group was 140/81 mmhg. Based on the blood pressures obtained in diabetic patients in HDS and HOT, some guidelines have set a target for blood pressure reduction of less than 140/80 mmhg [18,19]. Other guidelines, based on extrapolation from epidemiological data [16], have set even lower targets [20]. Several other studies have provided useful information on treating hypertension in people with diabetes and on the agents that may be of particular benefit (Table 2). There were significant numbers of patients with diabetes in the Systolic Hypertension in the Elderly Program (SHEP) and in the Systolic Hypertension in Europe (Syst-Eur) trial, and separate diabetic subgroup analyses were reported for both [21,22]. Those studies confirmed the benefit of treating systolic hypertension in people with diabetes, using a treatment regimen based on low-dose chlorthalidone with stepwise addition of atenolol or reserpine in SHEP, and nitrendipine, with the possible addition or substitution of enalapril or hydrochlorothiazide, in Syst-Eur. The Appropriate Blood Pressure Control in Diabetes (ABCD) trial [23] examined a small number of patients with Table 2 Drugs for the treatment of hypertension in people with diabetes Benefit Proven Uncertain Agent Angiotensin-II receptor antagonists (LIFE) ACE inhibitors (HDS, Syst-Eur, HOPE) Beta-blockers (HDS, SHEP) Diuretics (SHEP, Syst-Eur) Calcium channel blockers (HOT, Syst-Eur) Amlodipine (FACET) Doxazozin (ALLHAT) Nisoldipine (ABCD) See text for definitions of study acronyms. ACE=angiotensinconverting enzyme. hypertension and type 2 diabetes, and compared the effects of enalapril and nisoldipine. That study was designed to test the primary hypothesis that intensive blood pressure control would prevent nephropathy, neuropathy, retinopathy and cardiovascular events as compared with moderate control, with the secondary hypothesis that nisoldipine and enalapril would have equal effects. The safety monitoring committee halted the study prematurely because of a greater incidence of fatal and non-fatal myocardial infarction with nisoldipine than with enalapril. The number of myocardial infarctions was small, and it is possible that this was simply a chance finding. The Fosinopril Amlodipine Cardiovascular Events Trial (FACET) [24] also examined a small number of patients with hypertension and diabetes. That study was designed to compare the effects of the agents on serum lipids and diabetes control, and cardiovascular events were assessed as secondary outcomes. Patients received open-label fosinopril or amlodipine, and one-third of the patients crossed over from one group to the other. A 51% reduction in the relative risk for pre-defined cardiovascular events (fatal/non-fatal myocardial infarction, fatal/non-fatal stroke, hospitalized angina) was seen with fosinopril. Again, the number of events was small and this might have been a chance finding. The usefulness of amlodipine in the treatment of hypertension in diabetes should be clarified by the publication of the results from Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) [25]. The recently reported Losartan Intervention For Endpoint Reduction in Hypertension (LIFE) [26] compared losartan and atenolol based therapy in 9193 patients with hypertension and left ventricular hypertrophy. The primary composite end-point was cardiovascular death, myocardial infarction and stroke. Losartan reduced the primary endpoint significantly, with significant reductions in stroke but not myocardial infarction or cardiovascular death. A total of 1195 patients with pre-existing diabetes were included in the study, and the results were reported separately [27]. In participants with diabetes, losartan caused significant reductions in the composite end-point, and in cardiovascular and total mortality, but the reduction in strokes and myocardial infarction was not significant.

4 B24 Treatment of hyperlipidaemia Evidence for the efficacy of cholesterol lowering with statins in diabetic patients with myocardial infarction comes from post-hoc subgroup analysis of the Scandinavian Simvastatin Survival Study (4S) [28], the the Cholesterol and Recurrent Events (CARE) trial [29], and the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) [30]. 4S included patients with previous myocardial or angina pectoris who had a serum cholesterol of mmol. l 1. Within the study there were 202 patients with diabetes, and subgroup analysis showed that the absolute clinical benefit in diabetic patients was, if anything, greater than that in non-diabetic patients, with a 55% reduction in any coronary heart disease event including myocardial infarction [28]. Similar findings were found in the CARE trial [29] and the LIPID study [30]. The CARE trial studied patients with a previous myocardial infarction and total cholesterol concentrations below 6 2 mmol. l 1. Within CARE there were 586 diabetic patients, and the reduction in absolute risk for coronary events for the diabetic group was slightly greater than that in the nondiabetic patients. The LIPID study followed a similar protocol in patients with previous myocardial infarction or unstable angina and a cholesterol of mmol. l 1, and the authors reported no significant heterogeneity in treatment effect in any pre-defined subgroup, including those with diabetes [30]. The Heart Protection Study (HPS) [31] extended the findings of these studies to patients with lower cholesterol concentrations and other forms of vascular disease. Inclusion criteria for HPS were coronary heart disease, cerebrovascular or peripheral vascular disease, diabetes or treated hypertension. Patients were excluded on run-in if their general practitioner considered there to be a clear indication for statin therapy (e.g. they fulfilled criteria for treatment based on the results of previous studies). Patients with prior myocardial infarction or coronary heart disease and diabetes had the greatest event rate in the study, with a rate of 38% over 5 years in the placebo group, which was reduced to 33% with simvastatin. For patients with diabetes and no prior coronary heart disease, an event rate of 19% was reduced to 16% with simvastatin. The diabetic patients included a significant proportion who also had cerebrovascular or peripheral vascular disease, and information on the number of diabetic patients without any prior vascular disease (i.e. true primary prevention) was not provided in the principle publication. Lipid levels before and after simvastatin treatment were not separately provided for patients with diabetes. Without this information, it is difficult to place the HPS in its full context for people with diabetes. Further information on the primary prevention of cardiovascular disease with statins in people with diabetes will be obtained when the Collaborative AtoRvastatin Diabetes Study (CARDS) is completed [32], because that study will exclusively examine diabetic patients with no prior vascular disease. Compared with treatment with statins, there is relatively little clinical evidence for cardiovascular benefit with fibrates in people with diabetes. The Veterans Affairs High- Density Lipoprotein Cholesterol Intervention Trial (VA-HIT) [33] showed that treatment with gemfibrazol is of benefit in reducing hard cardiovascular outcomes in patients who have relatively normal cholesterol concentrations but low high-density lipoprotein cholesterol levels following myocardial infarction. The Diabetes Atherosclerosis Intervention Study (DAIS) used fenofibrate in patients with diabetes and angiographical abnormalities [6]. The use of fenofibrate was associated with reduced progression of coronary artery disease on angiography. There was no statistically significant difference in clinical end-points, and further studies on fibrates, using hard clinical end-points, are underway. Antiplatelet therapy The large meta-analysis performed by the Antiplatelet Trialists Collaboration included 29 trails in high-risk patients, with separate information on diabetes status [34]. The rate of cardiovascular events, including myocardial infarction, was reduced from 22% to 18% in people with diabetes, and from 16% to 13% in non-diabetic patients. Recent further analysis has confirmed a significant, if slight, benefit in people with diabetes [35]. In the Hypertension Optimal Treatment (HOT) study [17], patients were also treated with 75 mg aspirin or placebo in addition to their hypotensive therapy. Patients who received aspirin had a significant reduction in cardiovascular events, and it was reported that the relative benefit was about the same in patients with diabetes, although the specific data for diabetes patients was not provided. Similarly, 20% of the patients included in the Clopidogrel vs Aspirin in Patients at Risk of Ischaemic Events (CAPRIE) study [36] of clopidogrel had prior diabetes, and the benefit was if anything greater in subjects with diabetes. Heart Outcomes Prevention Evaluation (HOPE) study/ramipril The HOPE study [37] was a large, randomized trial with wide entry criteria that examined the hypothesis that angiotensinconverting enzyme (ACE) inhibition using ramipril would reduce cardiovascular events in patients at high risk who would not previously be treated with ACE inhibitors. Diabetes was a pre-defined subgroup, and over 3000 patients with diabetes were recruited who had evidence of vascular disease, or had diabetes and one other cardiovascular risk factor (cholesterol >5 2 mmol. l 1, hypertension, microalbuminuria, smoking) [37]. That study was discontinued prematurely because of a significant reduction in the composite primary end-point of myocardial infarction, stroke and death from cardiovascular disease. In the diabetic patients the primary event rate of the combination of myocardial infarction, stroke and cardiovascular death was reduced by one-quarter in patients on ramipril, and this reduction was seen both in patients

5 Prevention of macrovascular complications B25 with and in those without previous cardiovascular disease [38]. The benefit was greater than could be accounted for by the minor decrease in blood pressure, suggesting wider effects on the cardiovascular system, although this remains controversial. Conclusion There are now a large number of pharmacological interventions based on clinical evidence that can be used to reduce cardiovascular risk in people with diabetes. There are several guidelines that are based on this evidence, and implementation is the challenge that faces health care professionals, whether they see the patient in a primary care setting [39], in a diabetic clinic or in a cardiology clinic. Compliance and adherence to therapy is a major problem, and this will require input from primary care doctors and nurses [39]. Targets based solely on the results of research studies may be impractical and unachievable, and individually tailored targets are needed [40]. References [1] Garcia MJ, McNamara PM, Gordon T, Kannel WB. Morbidity and mortality in diabetics in the Framingham population. Sixteen year follow-up study. Diabetes 1974; 23: [2] Roper NA, Bilous RW, Kelly WF, Unwin NC, Connolly VM. Cause-specific mortality in a population with diabetes. South Tees Diabetes Mortality Study. Diabetes Care 2002; 25: [3] Fisher M, Shaw K. Diabetes: a state of premature cardiovascular death. Practical Diabetes Int 2001; 18: [4] UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: [5] UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ 1998; 317: [6] Diabetes Atherosclerosis Intervention Study Investigators. Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the Diabetes Athersclerosis Intervention Study, a randomised study. Lancet 2001; 357: [7] UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: [8] UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: [9] University Group Diabetes Program. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes mellitus II. Mortality results. Diabetes 1970; 19(suppl 2): [10] Stratton IM, Adler AI, Neil HAW, et al., on behalf of the UK Prospective Diabetes Study Group. Association of glycaemia with macrovascular and microvascular complications on type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: [11] Koshiyama H, Shimono D, Kuwamura N, Minamikawa J, Nakamura Y. Inhibitory effect of pioglitazone on carotid arterial wall thickness in type 2 diabetes. J Clin Endocrinol Metab 2001; 86: [12] Haffner SM, Greenberg AS, Weston WM, Chen H, Freed MI. Effect of rosiglitazone treatment on non-traditional markers of cardiovascular disease in patients with type 2 diabete mellitus. Circulation 2002; 106: [13] Holman RR, Cull CA, Turner RC, on behalf of the UKPDS Study Group. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycaemic control over 3 years (UK Prospective Diabetes Study 44). Diabetes Care 1999; 22: [14] Chiasson J-L, Josse RG, Gomis R, et al., for the STOP-NIDDM Trial Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359: [15] Hanefeld M, Temelkova-Kurktschiev T, on behalf of the STOP- NIDDM Trial Research Group. Acarbose reduces incidence of type 2 diabetes and of myocardial infarction in subjects with impaired glucose tolerance: the STOP-NIDDM trial. Eur Heart J 2002; 4(suppl): 609. [16] Adler AI, Stratton IM, Neil AHW, et al., on behalf of the UK Prospective Diabetes Study Group. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36); prospective observational study. BMJ 2000; 321: [17] Hansson L, Zanchetti A, Carruthers SG, et al., for the HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet 1998; 351: [18] Ramsay LE, Williams B, Johnston GD, et al. British Hypertension Society guidelines for hypertension management 1999: summary. BMJ 1999; 319: [19] Ramsay LE, Williams B, Johnston GD, et al. Guidelines for management of hypertension: report of the third working party of the British Hypertension Society. J Hum Hypertens 1999; 13: [20] Wood D, Durrington P, Poulter N, McInnes G, Rees A, Wray R, on behalf of the Societies. Joint British recommendations on prevention of coronary heart disease in clinical practice. Heart 1998; 20(suppl 2): S1 29. [21] Curb JD, Pressel SL, Cutler JA, et al., for the Systolic Hypertension in the Elderly Program Cooperative Research Group. Effect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. JAMA 1996; 276: [22] Tuomilehto J, Rastenyte D, Birkenhager WH, et al., for the Systolic Hypertension in Europe Trail Investigators. Effects of calcium-channel blockade in older patients with diabetes and systolic hypertension. N Engl J Med 1999; 340: [23] Estacio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Schrier RW. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med 1998; 338: [24] Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril versus Amlodipine Cardiovascular Events randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care 1998; 21: [25] Barzilay JI, Jones CL, Davis BR, for the ALLHAT Collaborative Research Group. Baeline characteristics of the diabetic participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Diabetes Care 2001; 24: [26] Dahlof B, Devereux RB, Kjeldsen S, et al., for the LIFE study group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: [27] Lindholm LH, Ibsen H, Dahlof B, et al., for the LIFE study group. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: [28] Pyorala K, Pedersen TR, Kjekshus J, Faergeman O, Olsson AG, Thorgeirsson G, The Scandinavian Simvastatin Survival Study (4S) Group. Cholesterol lowering with simvastatin improves

6 B26 prognosis of diabetic patients with coronary heart disease. A subgroup analysis of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 1997; 20: [29] Goldberg RB, Mellies MJ, Sacks FM, et al. for the CARE Investigators. Cardiovascular events and their reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction survivors with average cholesterol levels. Subgroup analyses in the Cholesterol And Recurrent Events (CARE) Trial. Circulation 1998; 98: [30] The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998; 339: [31] Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: [32] Colhoun HM, Thomson MJ, Mackness MI, for the CARDS Investigators. Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with type 2 diabetes. Diabetes Med 2002; 19: [33] Rubins HB, Robins SJ, Collins D, et al., for the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. N Engl J Med 1999; 341: [34] Antiplatelet Trialists Collaboration. Collaborative overview of randomised trials of antiplatelet therapy-i: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ 1994; 398: [35] Antithrombotic Trialists Collaboration. Collaborative metaanalysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324: [36] Bhatt DL, Marso SP, Hirsch AT, Ringleb PA, Hacke W, Topol EJ. Amplified benefit of clopidogrel versus aspirin in patients with diabetes mellitus. Am J Cardiol 2002; 90: [37] Gerstein HC, Bosch J, Pogue J, Wayne Taylor D, Zinman B, Yusuf S, the HOPE Study Investigators. Rationale and design of a large study to evaluate the renal and cardiovascular effects of an ACE inhibitor and vitamin E in high-risk patients with diabetes. The MICRO-HOPE Study. Diabetes Care 1996; 19: [38] Heart Outcomes Prevention Evaluation (HOPE) Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet 200; 355: [39] Kenny C. Primary care prevention of cardiovascular disease in diabetes. Practical Diabetes Int 2001; 18: [40] Winocour PH. Effective diabetes care: a need for realistic targets. BMJ 2002; 324:

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