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Cardiovascular Disease Risk Management in Diabetes – The Implications of the REALITY Asia Study
prevention after myocardial infarction: the IDEAL study, a management of hypercholesterolemia in Korea: Return on Med, 2008;358(14):1431–43.
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Associated Articles
Simvastatin with or without Ezetimibe in Lipid-modifying Therapy and Attainment of
Familial Hypercholesterolemia Cholesterol Goals in Europe: the Return on
Kastelein JJ, et al. Expenditure Achieved for Lipid Therapy
N Engl J Med, 2008;358(14):1431–43. (REALITY) Study
Van Ganse E, et al.
Ezetimibe, a cholesterol-absorption inhibitor, reduces levels of Curr Med Res Opin, 2005;21(9):1389–99.
low-density lipoprotein (LDL) cholesterol when added to statin
treatment. However, the effect of ezetimibe on the progression The study’s objective was to determine lipid-modifying therapy
of atherosclerosis remains unknown. The authors conducted practices and their effects on low-density lipoprotein cholesterol
a double-blind, randomised 24-month trial comparing the (LDL-C) and/or total cholesterol (TC) goal attainment in Europeans
effects of daily therapy with 80mg simvastatin either with based on prevailing guidelines at the time of therapy in each country.
placebo or with 10mg ezetimibe in 720 patients with familial The study applied retrospective cohort analysis involving 58,223
hypercholesterolaemia. patients initiated on lipid-modifying therapies in 10 European
countries, with a median patient follow-up on lipid-modifying
Patients underwent B-mode ultrasonography to assess the therapy of 15.3 months. Data on prescriptions of lipid-modifying
intima-media thickness of the walls of the carotid and femoral therapies, laboratory data including LDL-C and TC, achievement of
arteries. The primary outcome measure was the change in the cholesterol goals for LDL-C and/or TC and hospitalisations were
mean carotid-artery intima-media thickness, which was defined obtained from healthcare administrative databases and/or patient
as the average of the means of the far-wall intima-media chart reviews. Results showed that across Europe, statin
thickness of the right and left common carotid arteries, carotid monotherapy was the initial lipid-modifying treatment in 51,786 of
bulbs and internal carotid arteries. The primary outcome, the 58,009 patients (89.3%) with available data. In addition, 38,853 of
mean (±SE) change in the carotid-artery intima-media thickness, 43,410 patients (89.5%) with available follow-up statin potency data
was 0.0058±0.0037mm in the simvastatin-only group and were initiated on statin regimens of medium or lower equipotency.
0.0111±0.0038mm in the simvastatin-plus-ezetimibe (combined- Low-equipotency regimens include atorvastatin 5mg, simvastatin10
therapy) group (p=0.29). Secondary outcomes (consisting of mg and pravastatin 20mg, whereas medium-equipotency regimens
other variables regarding the intima-media thickness of the include atorvastatin 10mg, simvastatin 20mg and pravastatin 40mg.
carotid and femoral arteries) did not differ significantly between Regimens were adjusted to higher equipotency via either up-titration
the two groups. or switches to combination regimens in 16.2% of patients. On
average, 40.5% of patients across Europe who were not initially at
At the end of the study, the mean (±SD) LDL cholesterol level guideline recommended cholesterol goals (either LDL-C or TC) and
was 192.7±60.3mg/dl (4.98±1.56mmol/l) in the simvastatin had follow-up data attained recommended cholesterol levels,
group and 141.3±52.6mg/dl (3.65±1.36mmol/l) in the including <30% of patients in Spain, Italy and Hungary. In many
combined-therapy group (a between-group difference of countries, the likelihood of goal attainment was inversely associated
16.5%; p<0.01). The differences between the two groups in with baseline cardiovascular risk and/or LDL-C levels. The study
reductions in levels of triglycerides and C-reactive protein were concluded that lipid management strategies in Europe during the
6.6 and 25.7%, respectively, with greater reductions in the study period were dominated by statin monotherapy. Even after
combined-therapy group (p<0.01 for both comparisons). Side- prolonged follow-up on lipid-modifying therapy, approximately 60%
effect and safety profiles were similar in the two groups. In of Europeans studied did not achieve guideline-recommended
patients with familial hypercholesterolaemia, combined therapy cholesterol goals. Future emphasis must be placed on subsequent
with ezetimibe and simvastatin did not result in a significant lipid panel monitoring, as well as the use of more efficacious, well-
difference in changes in intima-media thickness compared with tolerated lipid-modifying therapies such as dual cholesterol inhibitors,
simvastatin alone, despite decreases in levels of LDL cholesterol to enable more European patients to attain their recommended
and C-reactive protein. ■ cholesterol goals. ■
ASIA-PACIFIC CARDIOLOGY 15
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