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Studie IMPROVE- IT u pacientů s diabetes mellitus
Title in English | IMPROVE- IT studies in patients with diabetes mellitus |
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Authors | |
Year of publication | 2015 |
Type | Article in Periodical |
Magazine / Source | Kardiologická revue - Interní medicína |
MU Faculty or unit | |
Citation | |
Field | Cardiovascular diseases incl. cardiosurgery |
Keywords | acute coronary syndrome; LDL cholesterol; combination therapy; ezetimibe; diabetes mellitus |
Description | The IMProved Reduction of Outcomes: Vytorin Effi cacy International Trial (IMPROVE- IT) is evaluating the potential benefi t for reduction of major cardiovascular events from the addition of ezetimibe vs. placebo to 40 mg/ d of simvastatin therapy in patients who present with acute coronary syndromes and have low- density lipoprotein cholesterol. 18,144 patients were enrolled with either ST-segment elevation MI (STEMI, n = 5,192) or UA/ non-ST-segment elevation MI (UA/ NSTEMI, n = 12,952). Primary endpoint occurred in 2,742 patients (34.7%) treated with simvastatin in monotherapy and in 2,572 patients (32.7%) (p = 0.016) treated with combination. Compared to patients with coronary heart disease given the drug simvastatin plus a placebo, those given both simvastatin and the non-statin drug, ezetimibe, had a 6.4 percent lower combined risk of subsequent heart attack, stroke, cardiovascular death, rehospitalisation for unstable angina and procedures to restore blood fl ow to the heart. Heart attacks alone were reduced by 13%, and non-fatal stroke by 20%. Deaths from cardiovascular disease were statistically the same in both groups. Approximately two patients out of every 100 patients treated for seven years avoided a heart attack or stroke. (Number Needed to Treat (NNT) = 50/ 7 years). The results of sub analysis of the IMPROVE IT study with diabetics n = 4.933 (27%) were presented on European Cardiology Congress in London 2015 Diabetics were older, more frequently female and less frequently smoker. The baseline lipid values and the changes did not diff er. The most important fi nding was the eff ect on myocardial infarction and on ischemic stroke (values in %/ 7years). Myocardial infarction appeared in nodiabetics in 12.7 (S) vs. 12.0 (S/ E) and in u diabetics 20.8 (S) vs. 16.4 (/ E), p = 0.002 and for ischemic stroke nondiabetics 3.4 (S) vs. 3.2 (S/ E) and diabetics 6.5 (S) vs. 3.8 (S/ E) p = 0.031. Conclusion: Patients with diabetes mellitus have a higher profi t from adding ezetimibe to statin and this eff ect is not explainable by lipid changes. |